Exact FDA event identifier

Event 96401

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

Event summary

Timeline bucket: February 13, 2025
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: MEDLINE INDUSTRIES, LP - Northfield

Dossier provenance

Source snapshots represented here

openFDA Device 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.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

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

8 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.

device · product 1 of 8

Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW; SHEET, DRAPE, SPLIT, ST,10/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS; DRAPE,ABDOMINAL,MAJOR,ST,8/CS; DRAPE,ABDOMINAL,MAJOR,ST,8/CS; DRAPE,SPLIT,CVMAX,6/CS; DRAPE,ORTHOMAX ,BAR,6/CS; DRAPE,FEMORAL,RADIAL,5/CS; DRAPE,C-SECTION,FEN,CLR SCREEN,WIRE,7/CS; DRAPE,HAND,ULTRAGARD,18/CS; DRAPE,HAND,ULTRAGARD,18/CS; DRAPE,U,ORTHOMAX,6/CS; DRAPE,SPLIT,77X120",10/CS; DRAPE,ROBOTIC,W/LEGGING,W/POUCH,5/CS; DRAPE,ROBOTIC,W/LEGGING,W/POUCH,5/CS. Sterile surgical drape.

Z-1363-2025

Recall number: Z-1363-2025
Initiated: February 13, 2025
Classification: Class II
Status: Ongoing
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Quantity: 1,482 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

loss of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential breach in pouch packaging which could lead to loss of sterility.

Code information

Item No. DYNJCDCSEC01, DYNJP2498, DYNJP3102A, DYNJP3103, DYNJP4014, DYNJP4015, DYNJP4124, DYNJP6108, DYNJP8005UG, DYNJP8303, DYNJP8304A, DYNJP9108; UDI (case): 40888277367679, 40080196739494, 40080196778363, 40080196744221, 40080196287308, 40080196770039, 40080196164944, 20888277668840, 40080196574125, 40080196771111, 40080196292432, 40080196152576; UDI (each): 10888277367678, 10080196739493, 10080196778362, 10080196744220, 10080196287307, 10080196770038, 10080196164943, 10888277668843, 10080196574124, 10080196771110, 10080196292431, 10080196152575; Lot No. 45024100168, 31124100039F, 31124090065F, 31124090066F, 31124090067F, 31124090068F, 45024090164, 31124090085F, 31124100084F, 45024100180, 72524050027, 72524060073, 31124090004H, 31124090045F, 45024100184, 45024100185.

Distribution pattern

US Nationwide distribution.

device · product 2 of 8

Proxima Drape labeled as PACK,BASIC,SIRUS,V,5/CS; PACK,BASIC IV,SIRUS,5/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,UNIVERSAL II,SIRUS,7/CS; PACK,LAPAROTOMY,NO GOWN,10/CS; PACK,CYSTOSCOPY,PK VI,14/CS; PACK,CYSTOSCOPY,PK VI,14/CS; PACK,OB III,GRADUATED UNDERBUTTOCK,6/CS; PACK,LAVH,AURORA,4/CS. Sterile surgical drape.

Z-1364-2025

Recall number: Z-1364-2025
Initiated: February 13, 2025
Classification: Class II
Status: Ongoing
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Quantity: 1,490 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

loss of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential breach in pouch packaging which could lead to loss of sterility.

Code information

Item No. DYNJP1020S, DYNJP1025S, DYNJP1040, DYNJP1055S, DYNJP3000, DYNJP5050, DYNJP6060S, DYNJP9120A; UDI (case): 40080196308126, 40080196308133, 40080196722892, 40080196308195, 40080196722946, 40080196753391, 40884389110295, 40080196915416; UDI (each): 10080196308125, 10080196308132, 10080196722891, 10080196308194, 10080196722945, 10080196753390, 10884389110294, 10080196915415; Lot No. 31124090044H, 31124090028F, 31124080024F, 31124080061F, 31124090029F, 31124090089F, 31124100077F, 31124090030H, 31124090054F, 31124070070F, 31124080063F, 45024090166, 31124100007F.

Distribution pattern

US Nationwide distribution.

device · product 3 of 8

Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape.

Z-1365-2025

Recall number: Z-1365-2025
Initiated: February 13, 2025
Classification: Class II
Status: Ongoing
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Quantity: 114 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

loss of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential breach in pouch packaging which could lead to loss of sterility.

Code information

Item No. DYNJ84258A & DYNJ84258B; UDI (case): 40195327650743 & 40198459117986; UDI (each): 10195327650742 & 10198459117985; Lot No. (Shelf Life) 24HBK264 (12/31/26) & 24IBD271 (7/31/26). .

Distribution pattern

US Nationwide distribution.

device · product 4 of 8

Proxima Drape labeled as MINOR PACK and LAPAROSCOPY. Sterile surgical drape.

Z-1366-2025

Recall number: Z-1366-2025
Initiated: February 13, 2025
Classification: Class II
Status: Ongoing
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Quantity: 506 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

loss of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential breach in pouch packaging which could lead to loss of sterility.

Code information

Item No. DYNJ34603F & DYNJ903916I; UDI (case): 40198459143596 & 40195327580118; UDI (each): 10198459143595 & 10195327580117; Lot No. (Shelf Life) 25AMD464(11/30/2029), 24JMC011(04/30/2029), 25ABA362(09/30/2025), 24KBT718(02/28/2026), 24JBE997(09/30/2025), 24IBM203(02/28/2026).

Distribution pattern

US Nationwide distribution.

device · product 5 of 8

Proxima Drape labeled as FACE LIFT. Sterile surgical drape.

Z-1367-2025

Recall number: Z-1367-2025
Initiated: February 13, 2025
Classification: Class II
Status: Ongoing
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Quantity: 16 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

loss of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential breach in pouch packaging which could lead to loss of sterility.

Code information

Item No.DYNJ910462; UDI (case): 40195327695638; UDI (each): 10195327695637; Lot No. (Shelf Life) 24JMD608 (06/30/2026).

Distribution pattern

US Nationwide distribution.

device · product 6 of 8

Proxima Drape labeled as HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY PACK-LF, TOTAL HIP PACK-LF, SHOULDER W/POUCH-LF, VEIN PACK. Sterile surgical drape.

Z-1368-2025

Recall number: Z-1368-2025
Initiated: February 13, 2025
Classification: Class II
Status: Ongoing
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Quantity: 2,422 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

loss of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential breach in pouch packaging which could lead to loss of sterility.

Code information

Item No. DYNJ35520B, DYNJ38529F, DYNJ43406F, DYNJ43421D, DYNJ69185A, DYNJ69340B, DYNJ88923; UDI (case): 40198459106904, 40195327693870, 40198459074005, 40198459074784, 40195327582839, 40198459026127, 40198459216856; UDI (each): 10198459106903, 10195327693879, 10198459074004, 10198459074783, 10195327582838, 10198459026126, 10198459216855; Lot No. (Shelf Life) 24KMB843(05/31/2027), 24IMD400(01/31/2027), 24IMB784(01/31/2027), 24LBK460(02/28/2027), 24JBY288(12/31/2026), 24LBJ155(01/31/2027), 24JBU154(12/31/2026), 24HBP361(11/30/2026), 24HBA919(10/31/2026), 24JBX700(06/30/2026), 24JBC370(04/30/2026), 24IBI711(04/30/2026), 24HBO453(04/30/2026), 24HBA954(01/31/2026), 24JBK365(04/30/2026), 24HBR810(04/30/2026), 24GBX503(03/31/2026), 24LBO297(06/30/2026), 24JBV432(06/30/2026), 24IBU974(05/31/2026), 24HBR072(04/30/2026), 25ABB569(02/10/2026).

Distribution pattern

US Nationwide distribution.

device · product 7 of 8

Proxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. Sterile surgical drape.

Z-1369-2025

Recall number: Z-1369-2025
Initiated: February 13, 2025
Classification: Class II
Status: Ongoing
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Quantity: 220 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

loss of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential breach in pouch packaging which could lead to loss of sterility.

Code information

Item No. DYNJ53968P; UDI (case): 40195327532759; UDI (each): 10195327532758; Lot No. (Shelf Life) 24KMC372 (3/31/2026), 24IMJ082 (4/30/2026), 24HMK377 (4/30/2026). .

Distribution pattern

US Nationwide distribution.

device · product 8 of 8

Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL HIP, TOTAL KNEE, SPINE. Sterile surgical drape.

Z-1370-2025

Recall number: Z-1370-2025
Initiated: February 13, 2025
Classification: Class II
Status: Ongoing
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Quantity: 1,118 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

loss of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential breach in pouch packaging which could lead to loss of sterility.

Code information

Item No. CDS985210G, CDS985210G, CDS985210G, DYNJ65826A, DYNJ65826A, DYNJ65826A, DYNJ65826A, DYNJ87398, DYNJ87398, DYNJ908743C, DYNJ908743C, DYNJ908743C, DYNJ908743C, DYNJ908744C, DYNJ908744C, DYNJ908744C, DYNJ910326B; UDI (case): 40195327553310, 40195327516193, 40198459034405, 40195327636297, 40195327636280, 40198459075002; UDI (each): 10195327553319, 10195327516192, 10198459034404, 10195327636296, 10195327636289, 10198459075001; Lot No. (Shelf Life) 24LBK011(04/30/2026), 24JBR548(02/28/2026), 24IBN166(02/28/2026), 24KMF425(06/30/2026), 24JMI243(06/30/2026), 24IMI316(05/31/2026), 24HMH127(04/30/2026), 24JBW476(02/28/2026), 24HBK163(02/28/2026), 24KBA490(02/28/2026), 24JBM980(02/28/2026), 24JBB973(02/28/2026), 24IBQ750(03/31/2026), 24JBM981(02/28/2026), 24JBH713(02/28/2026), 24HBJ792(02/28/2026), 24KBQ357(12/31/2025).

Distribution pattern

US Nationwide distribution.