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Recall Observatory FDA recall evidence

Core noun

Device recall evidence

Joined enrichment rows that support device recall linkage and root-cause wording.

Indexed record set

39,516 evidence rows

Page 58 of 1581

Evidence Product Join Root cause
device-recall:cfres:180021 REF: Z2850, 112" (284 cm) 10 Drop Primary set w/2 Clave, Remv 3 Gang 1o2 Manifold w/3 Clave, Baseplate, Rotating Luer w/Filter Cap, 1 Ext, Sterile R, UDI: (01)00887709028241 Official recall number · Z-1918-2020 Mixed-up of materials/components
device-recall:cfres:180793 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175824P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. Official recall number · Z-1870-2020 Process design
device-recall:cfres:180193 Temporary Abutment Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36664 - - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function. Official recall number · Z-1853-2020 Process control
device-recall:cfres:175597 Alinity c Lithium Reagent Kit- intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 08P5320 Official recall number · Z-2552-2019 Under Investigation by firm
device-recall:cfres:175596 MULTIGENT Lithium-intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 8L25-30 Official recall number · Z-2551-2019 Under Investigation by firm
device-recall:cfres:175767 Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore, PAV, 123 Inch. 1 unit per pouch; 50 pouches per case Official recall number · Z-0134-2020 Under Investigation by firm
device-recall:cfres:175771 Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 15 Micron Filter in Sight Chamber, CLAVE Secondary Port, 0.2 Micron Filter, CLAVE Y-Site, Polyethylene Lined Light Resistant Tubing, Distal Microbore Tubing, Secure Lock 272 cm / 15 mL. 1 unit per pouch; 50 pouches per case. Not distributed in the U.S. Official recall number · Z-0137-2020 Under Investigation by firm
device-recall:cfres:176147 Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthopedic implant - Product Usage: The Sidus Stem-Free Shoulder is designed for long-term implantation into the human shoulder joint as a total shoulder arthroplasty in combination with Zimmer or Biomet s glenoid components, or as a hemi shoulder arthroplasty. Official recall number · Z-2762-2019 Labeling mix-ups
device-recall:cfres:173239 B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Number 363032 Official recall number · Z-2489-2019 Other
device-recall:cfres:176324 Centurion CIRCLAMP W/1.3 CM BELL-single-use, disposable instrument used to compress the foreskin of the penis during circumcision of a male infant. ReOrder: 330CR Official recall number · Z-0121-2020 Process control
device-recall:cfres:176287 CENTRAL LINE BUNDLE ECVC6375 Official recall number · Z-0097-2020 Under Investigation by firm
device-recall:cfres:176316 YUKON Polyaxial Screws (3.5 X 12 mm, Owning Site: Leesburg USA 3.5 X 14 mm, 3.5 X 32 mm, 3.5 X 34 mm, 3.5 X 38 mm, 3.5 X 40 mm, 4.0 X 16 mm, 4.0 X 18 mm, 4.0 X 20 mm, 4.0 X 22 mm, 4.0 X 24 mm, 4.0 X 26 mm, 4.0 X 28 mm, 4.0 X 30 mm, 5.0 X 22 mm, 5.0 X 28 mm, 5.0 X 30 mm) Catalog Numbers 7601-03512, 7601-03514, 7601-03532, 7601-03534, 7601-03538L, 7601-03540L, 7601-04016L, 7601-04018L, 7601-04020L, 7601-04022L, 7601-04024L, 7601-04026L, 7601-04028L, 7601-04030, 7601-05022, 7601-05028, 7601-05030 Official recall number · Z-0110-2020 Process control
device-recall:cfres:176290 OR VANTEX 7FR 3L 16CM CVC ECVC6665 Official recall number · Z-0100-2020 Under Investigation by firm
device-recall:cfres:176222 TRIPLE LUMEN BUNDLE KIT ECVC1540 Official recall number · Z-0088-2020 Under Investigation by firm
device-recall:cfres:176216 Neonatal Cap Change Kit DT20315 Official recall number · Z-0082-2020 Under Investigation by firm
device-recall:cfres:176291 VANTEX 7FR, 16CM, 3L CVC BUNDLE ECVC6670 Official recall number · Z-0101-2020 Under Investigation by firm
device-recall:cfres:176223 CENTRAL VENOUS ACCESS DEVICE BUNDLE ECVC2840 Official recall number · Z-0089-2020 Under Investigation by firm
device-recall:cfres:176295 INVASIVE PROCEDURE TRAY MNS9510 Official recall number · Z-0105-2020 Under Investigation by firm
device-recall:cfres:176213 CVC BUNDLE WITHOUT CATH CVI4600 Official recall number · Z-0079-2020 Under Investigation by firm
device-recall:cfres:176315 OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm- intended as an orthopedic implant system (bolt is used to attach the targeting arm to the intramedullary fixation rod) Part number: 01-1503-0032 Official recall number · Z-0125-2020 Device Design
device-recall:cfres:176819 Hemo-Drop Blood Dispenser, Part Number BMP-HEMODROP, used for preparing blood samples. Official recall number · Z-0286-2020 Component change control
device-recall:cfres:176827 Prox Lat Tib Lock Plate and Dist Med Tib Lock Plate Item Nos. 47235700306 47235700308 47235700310 47235700312 47235700314 47235700408 47235700410 47235700412 47235700414 47235700416 47235700504 47235700506 47235700508 47235700510 47235700512 47235700514 47235700518 47235700604 47235700606 47235700608 47235700610 47235700612 47235700614 47235700618 47235700706 47235700708 47235700710 47235700714 47235700808 47235700810 47235700814 47235700906 47235700908 47235700914 47235700918 47235701006 47235701008 47235701010 Official recall number · Z-0309-2020 Packaging change control
device-recall:cfres:176828 DIST LAT FEM LCK PLATE STERILE, Item Nos. 47235710106 47235710110 47235710114 47235710118 47235710122 47235710210 47235710214 47235710218 47235710222 Official recall number · Z-0310-2020 Packaging change control
device-recall:cfres:175976 (1) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Male Luer Lock, REF 041210002A, 25/box, Sterile, Rx; (2) Argon Medical Devices Stopcocks, 1-Way w/Male Luer Lock, REF 041216000A, 25/box, Sterile, Rx; (3) Argon Medical Devices Stopcocks, Double 4-Way Stopcock w/Male Luer Lock, REF 041220001A, 25/box, Sterile, Rx; (4) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Rotating Male Luer Lock, REF 041240002A, Sterile, Rx; (5) Argon Medical Devices Stopcocks, North Carolina Baptist Hospital, Winston-Salem, NC, REF 042597300A, 25/box, Sterile, Rx; and (6) Argon Medical Devices 3 Way Stopcock w/Rotating Adapter (1050psi), REF 196590, 25/box, Sterile, Rx. The firm name on the labels is Argon Medical Devices, Inc., Athens, TX. Official recall number · Z-0290-2020 Equipment maintenance
device-recall:cfres:176787 A&E Medical Thorecon Plating System Kits Model No. 94-1400-04. For fracture fixation or reconstruction of the sternum. Official recall number · Z-0244-2020 Process control

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