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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 78575

68 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 21, 2017
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Medline Industries Inc

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

68 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 68

Aplicare Povidone-Iodine Prep Pad, Antiseptic, Sterile Solution, Active Ingredient: Povidone-iodine USP 10%. Aplicare, INC., Meriden, CT 06450 USA. NDC: 52380-0111-1

D-0252-2018
Recall number
D-0252-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
11,750 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Part # P-1001; Lots: 58471; 59003; 59723; 60373; 60807; 61187; 61523; 61998; 63974; 64701; 65864 Part # P-1001-8S Lots: 58368; 58371; 58472; 58499; 58686; 58687; 58688; 58816; 58817; 58818; 59002; 59004; 59333; 59334; 59335; 59574; 59724; 59725; 60157; 60237; 60374; 60375; 60507; 60586; 61101; 61368; 61427; 61618; 61750; 61751; 61999; 62067; 62224; 62226; 62557; 62558; 62954; 62955; 63441; 63442; 63443; 63507; 63508; 64002; 64129; 64243; 64245; 64592; 64840; 65081; 65327; 65583; 65681; 65882; 66026; 66040; 66110; 66193; Part # P-1011 Lots: 66549; 66916 Part # P-1011-8S Lots: 66404; 66580; 66622; 66709; 66856

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 2 of 68

Medline CC Drawer 4 IV Circulation Pack, Contains Rx, Single Use Only, contains 2 Prep Pad PVPs. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093

D-0253-2018
Recall number
D-0253-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
51 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: ACC010254A; Lots: 17HD4376; 17HD1709; 17HD1709

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 3 of 68

Medline Vaginal Delivery CDS Pack, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093

D-0254-2018
Recall number
D-0254-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
2 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: CDS830006I; Lots: 17IB3974

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 4 of 68

Medline Vitrectomy CDS Pack, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093

D-0255-2018
Recall number
D-0255-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
5 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: CDS984258F; Lots: 177B1083

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 5 of 68

Medline RAD NECK ENT TRAY Pack, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093

D-0256-2018
Recall number
D-0256-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
4 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYKA1220; Lots: 17FA1301

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 6 of 68

Medline Newborn Kit. Packaged for Medline Industries, Inc., Northfield, IL 60093

D-0257-2018
Recall number
D-0257-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
288 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYKL1133; Lots: 17IA0348; 17GA0975; 17IA0348

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 7 of 68

Medline Concordia Trunk Kit. Packaged for Medline Industries, Inc., Northfield, IL 60093

D-0258-2018
Recall number
D-0258-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
21 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYKM1403; Lots: 17BA1782

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 8 of 68

Medline Concordia Nurse Bag Kit. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093

D-0259-2018
Recall number
D-0259-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
51 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYKM1425; Lots: 17BA1030

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 9 of 68

Medline Pediatric IV Kit. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093

D-0260-2018
Recall number
D-0260-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
50 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYKP1000A; Lots: 17AA2252

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 10 of 68

Medline CNTRL Line Removal Kit Scripps. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093

D-0261-2018
Recall number
D-0261-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
375 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYKSCRIPPSCL1; Lots: 17HA1756

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 11 of 68

Medline Trunk Kit, Non-sterile. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060

D-0262-2018
Recall number
D-0262-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
231 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYKTRUNK1; Lots: 17FA0227; 17FA0470; 17FA1431; 17HA0258; 17HA0259

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 12 of 68

Medline TRAY, CATHETER CARE, LIDDED. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093

D-0263-2018
Recall number
D-0263-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
1,000 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYND12110; Lots: 16KA2117; 16LA1083; 15GA1298; 16KA0905; 16KA2117; 16BA0141

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 13 of 68

Medline Suture Removal Tray. Sterile. Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060

D-0264-2018
Recall number
D-0264-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
65,563 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYND70900; Lots: 17GB6098; 16KB8714; 17GB5103; 17EB4268; 17BB3409; 17SB1821; 17OB8226; 16QB7895; 17EB7214; 16LB5336; 17QB4767; 17MB3722; 17PB7167; 17EB0363; 17DB2103; 17FB2572 Pack Number: DYND70900H; Lots: 16KB8714; 16KB8714; 17EB4268; 17OB8226; 17OB8226; 17EB0363; 17EB0363; 17EB4268; 17EB4268; 16WB5947; 17GB6098; 17GB6098; 17QB4767; 17QB4767; 17MB3722; 17MB3722; 16SB7791; 16TB0404; 17GB6098; 17EB7214; 17EB0363; 17BB3409; 17PB7167; 17PB7167; 17EB7214; 17GB6098; 17PB7167; 17PB7167; 17EB4268; 17EB0363; 17PB7167; 17QB4767; 17QB4767; 17QB4767; 17EB7214; 17EB7214; 17OB8226; 17QB4767; 17BB3409; 17EB7214; 17QB4767; 17QB4767; 17QB4767; 17GB6098; 17GB6098; 17PB7167; 16TB0404; 17PB7167; 17QB4767; 17QB4767; 16WB5947; 17BB3409

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 14 of 68

Medline IV Start Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060

D-0265-2018
Recall number
D-0265-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
10,375 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYND74077; Lots: 16GB2754; 17GB3103; 16IB7722; 17EB6063 Pack Number: DYND74077H; Lots: 17EB6063; 17GB3103

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 15 of 68

Medline Central Line Dressing Change Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060

D-0266-2018
Recall number
D-0266-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
14,675 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYND74661; Lots: 177B1602; 17RB9139; 16WB5199; 17CB7720; 17CB5841; 167B0074; 16GB8853; 16JB0621; 17EB4904; 16TB9798; 165B0465 Pack Number: DYND74661H; Lots: 17EB4904; 17CB5841; 17CB1032; 165B0465; 16WB5199; 17RB9139; 17CB7720; 16JB0621; 16TB9798; 177B1602;

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 16 of 68

Medline Incision and Drainage Tray Kit, Sterile, Single use only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060

D-0267-2018
Recall number
D-0267-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
11 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYNDA1046H; Lots: 16LA0907

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 17 of 68

Medline I&D Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060

D-0268-2018
Recall number
D-0268-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
40 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYNDA1109; Lots: 178B0923

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 18 of 68

Medline Sheath Removal Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60063

D-0269-2018
Recall number
D-0269-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
40 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYNDA1356; Lots: 17DB2820

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 19 of 68

Medline Wound Closure Tray, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093

D-0270-2018
Recall number
D-0270-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
80 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYNDA1465; Lots: 17HB4903; 17CB8548

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 20 of 68

Medline General Purpose Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093

D-0271-2018
Recall number
D-0271-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
700 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYNDA1591; Lots: 17GB5136; 17PB2138

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 21 of 68

Medline DC Line Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060

D-0272-2018
Recall number
D-0272-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
363 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYNDC1971; Lots: 175B1999; Pack Number: DYNDC1971H; Lots: 17OB8570; 175B1999

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 22 of 68

Medline Dressing Change Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060

D-0273-2018
Recall number
D-0273-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
280 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYNDC2282; Lots: 16CB5897; 16PB9981

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 23 of 68

Medline INCISION AND DRAINAGE TRAY Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060

D-0274-2018
Recall number
D-0274-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
60 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYNDD1039; Lots: 17GB4725; 17HB4905

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 24 of 68

Medline Circumcision Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093

D-0275-2018
Recall number
D-0275-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
80 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYNDF1012E; Lots: 17SB5574

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 25 of 68

Medline Catheter Insertion Kit, Sterile. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060

D-0276-2018
Recall number
D-0276-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
4,100 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYNDINSERTKIT; Lots: 17SB3347; 175B1052; 16JB3251; 16IB2940; 17CB4925

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 26 of 68

Medline All Purpose Instrument Tray, Sterile. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060

D-0277-2018
Recall number
D-0277-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
250 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYNDL1488; Lots: 177B0657; 17QB3332

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 27 of 68

Medline General Purpose Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060

D-0278-2018
Recall number
D-0278-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
56 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYNDL1648; Lots: 17FA0144

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 28 of 68

Medline Laceration Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093

D-0279-2018
Recall number
D-0279-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
600 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYNDL1688; Lots: 17HB3112

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 29 of 68

Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060

D-0280-2018
Recall number
D-0280-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
700 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYNDR1018A; Lots: 17RB8658; 17HB1913

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 30 of 68

Medline GHS Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060

D-0281-2018
Recall number
D-0281-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
1100 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYNDR1056; Lots: 17RB9450

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 31 of 68

Medline Staple Remover Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60060

D-0282-2018
Recall number
D-0282-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
248 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYNDR1067; Lots: 17PB4605 Pack Number: DYNDR1067H; Lots: 17PB4605

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 32 of 68

Medline General Purpose Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060

D-0283-2018
Recall number
D-0283-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
80 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYNDR1071; Lots: 17FA1640

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 33 of 68

Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060

D-0284-2018
Recall number
D-0284-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
1,133 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYNDR1109; Lots: 17NB0789; 17EB4269 Pack Number: DYNDR1109H; Lots 17EB4269

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 34 of 68

Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060

D-0285-2018
Recall number
D-0285-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
3800 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYNDR1111; Lots: 17FB1191; 17HB1905 Pack Number: DYNDR1112A; Lots 177B0660; 175B2485

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 35 of 68

Medline Staple Remover Kit, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060

D-0286-2018
Recall number
D-0286-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
600 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYNDR1118; Lots: 17SB4219; 175B2486

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 36 of 68

Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060

D-0287-2018
Recall number
D-0287-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
3,089 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYNDR1157; Lots: 177B0661 Pack Number: DYNDR1157H; Lots: 177B0661; 17QB1693

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 37 of 68

Medline NICC Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060

D-0288-2018
Recall number
D-0288-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
346 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYNDR1161; Lots: 17RB9449 Pack Number: DYNDR1161H; Lots: 17RB9449

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 38 of 68

Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060

D-0289-2018
Recall number
D-0289-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
700 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number:DYNDR1165; Lots: 15HB6327; 15HB4355

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 39 of 68

Medline Skin Staple Remover Kit, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060

D-0290-2018
Recall number
D-0290-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
550 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYNDR1184; Lots: 175B2484; 17HB1903

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 40 of 68

Medline Straight Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060

D-0291-2018
Recall number
D-0291-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
10,298 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYNDR1186; Lots: 17EB0360; 177B1719 Pack Number: DYNDR1186H; Lots: 16PB7974; 17EB0360

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 41 of 68

Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060

D-0292-2018
Recall number
D-0292-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
100 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYNDR1195; Lots: 17AB1899

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 42 of 68

Medline Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093

D-0293-2018
Recall number
D-0293-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
100 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYNDR1199; Lots 16XB4041; 175B2487; 17PB8309

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 43 of 68

Medline Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060

D-0294-2018
Recall number
D-0294-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
1,250 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYNDS1010; Lots 15EB9408

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 44 of 68

Medline General Purpose Instrument Set, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060

D-0295-2018
Recall number
D-0295-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
3,300 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYNDS1014; Lots 17GB3416; 176B2045

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 45 of 68

Liberator Medical Supply Catheter Insertion Tray, Sterile, Single Use Only. Distributed by: Liberator Medical Supply, INC. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060

D-0296-2018
Recall number
D-0296-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
20,430 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYNDT1022E; Lots 17QB4402; 17TB1979

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 46 of 68

Medline Irrigation W/Piston SYR Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093

D-0297-2018
Recall number
D-0297-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
2,336 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYNDT1094 and DYNDT1094H

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 47 of 68

Medline IV Start Kit, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093

D-0298-2018
Recall number
D-0298-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
350 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYNDV1609; Lots 17GB1216

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 48 of 68

Medical Equipment Affiliates IV Start Kit, Sterile, Single Use Only. Packaged in Mexico for Medical Equipment Affiliates., Tahlequah, OK 74464

D-0299-2018
Recall number
D-0299-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
5,400 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYNDV39010; Lots 17QB8612

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 49 of 68

Medline Debridement Tray, Sterile, Single Use Only. Assembled in USA by Medline Industries, Inc., Mundelein, IL 6060

D-0300-2018
Recall number
D-0300-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
90 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYNDW1032

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 50 of 68

Medline Skin Biopsy Pack-LF, Sterile, Single Use Only. Packaged in USA by Medline Industries, Inc., Northfield, IL 60093

D-0301-2018
Recall number
D-0301-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
120 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYNJ0394028; Lots 17HK3191

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 51 of 68

Medline Incision and Drainage Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060

D-0302-2018
Recall number
D-0302-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
2,369 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYNJ07147; Lots 1160B1635; 17RB8957; 16WB2198; 16GB6023; 16KB1547; 17DB1855 Pack Number: DYNJ07147H; Lots 17DB1855; 16WB2198; 17RB8957

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 52 of 68

Medline Pacemaker Implant Pack, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060

D-0303-2018
Recall number
D-0303-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
66 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYNJ32856C; Lots 17SB6210; 17FB5359; 17SB6208

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 53 of 68

Medline Hip Replacement, Kit, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Northfield, IL 60093

D-0304-2018
Recall number
D-0304-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
88 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYNJ48244B; Lots 17FB2504; 17HB2544

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 54 of 68

Medline Incision Drainage Kit, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060

D-0305-2018
Recall number
D-0305-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
149 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: P888943; Lots 17RB8662 Pack Number: P888943H; Lots 17RB8662

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 55 of 68

Medline Anesthesia Kit, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Northfield, IL 60093

D-0306-2018
Recall number
D-0306-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
60 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: DYNJAA6606; Lots 178B1823; 17HB2055

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 56 of 68

Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060

D-0307-2018
Recall number
D-0307-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
49,587 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: MDS701550; Lots 16GB7687; 17HB5153; 16IB0427; 17GB3906; 17AB1937; 17CB7737; 16JB1136; 16JB1137 Pack Number: MDS701550H; Lots 16QB4583; 16IB0427; 17CB7737; 16MB6165; 17GB3906; 17AB1937; 16GB7687; 16JB1137; 17HB5153

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 57 of 68

Medline Incision and Drainage Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060

D-0308-2018
Recall number
D-0308-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
808 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: MDS70815; Lots 16LB2959; 173B1289; 17HB4108; 17FB6679; 16JB8627 Pack Number: MDS70815H; Lots 17FB6679

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 58 of 68

Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060

D-0309-2018
Recall number
D-0309-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
98,901 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: MDS708550; Lots 17GB4997; 17TB7125; 17RB7896; 17HB3784; 17HB4133; 17RB7895; 17FB1724; 17FB2572; Pack Number: MDS708550H; Lots 17GB4997; 17RB7896; 17PB5544; 17FB1724; 16JB1135; 17TB7125; 16SB9345; 17FB2572; 17FB2571; 17RB7895; 17HB3784; 16NB7654; 17FB1721; 16LB8439; 17HB4133; 16WB1269; 16NB8410; 15VB7079

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 59 of 68

Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060

D-0310-2018
Recall number
D-0310-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
195,448 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: MDS708555; Lots 17SB5603; 17PB8319; 177B2065; 17DB2104; 17RB9448; 17RB9451; 17PB8314; 17HB5104; 16XB1090; 17QB0860; 16OB0307; 17DB2777; 16UB2803; Pack Number: MDS708555H; Lots 17PB8319; 173B2496; 16UB2803; 16XB1090; 16SB4453; 16RB1126; 17DB2777; 17QB0860; 16TB8928; 17PB8314; 16IB3745; 17RB9451; 17DB2104; 164B2214; 16KB5659

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 60 of 68

Professional Hospital Supply Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Professional Hospital Supply, Inc., 41980 Winchester Rd., Temecula, CA 92590

D-0311-2018
Recall number
D-0311-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
450 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: P524151; Lots 17HB5103; 17RB8741

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 61 of 68

Medline Suture Removal Pack Latex Safe, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093

D-0312-2018
Recall number
D-0312-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
663 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: P734457; Lots 17GB5158; 17RB8681; 17FB0926

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 62 of 68

Professional Hospital Supply Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Professional Hospital Supply, Inc., 41980 Winchester Rd., Temecula, CA 92590

D-0313-2018
Recall number
D-0313-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
779 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: P888899; Lots 17RB8659; 17GB5162 Pack Number: P888899H; Lots 17RB8659

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 63 of 68

Medline Skin Stapler RMVR, Tray Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060

D-0314-2018
Recall number
D-0314-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
592 ases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: P888937; Lots 177B0658; 17QB8268 Pack Number: P888937H; Lots 17QB8268

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 64 of 68

Medline Incision Drainage Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060

D-0315-2018
Recall number
D-0315-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
Unavailable

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: P888943; Lots 17RB8662 Pack Number: P888937H; Lots 17QB8268

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 65 of 68

Medline Abdominal Surgery II Pack-LF, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093

D-0316-2018
Recall number
D-0316-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
144 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: PHS541637005

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 66 of 68

Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060

D-0317-2018
Recall number
D-0317-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
9,000 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: SD-1010; Lots 17CB8694; 17MB4778; 16KB5621

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 67 of 68

Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060

D-0318-2018
Recall number
D-0318-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
34,495 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Number: Z302-R; Lots 177B2075; 17RB9452; 17QB2640; 17CB4220 Pack Number: Z302-RH; Lots 177B2075; 17QB2640; 17RB9452; 17CB4220; 17NB1933; 17MB0084; 16LB3367

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

drug · product 68 of 68

Medline Incision & Drainage Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093

D-0319-2018
Recall number
D-0319-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
73 cases

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Code information

Pack Numbers: DYNDA1076, DYNDA1076H

Distribution pattern

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

Field note

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