FDA (Devices) recall action 96401

MEDLINE INDUSTRIES, LP - Northfield recalled 8 products on 2025-03-26

The FDA (Devices) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.

Products: 8
Announced: 2025-03-26
Critical: 0
Units: 7,368

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–8 of 8

HighFDA (Devices)··2025-03-26
Surgical Drape Packs Recalled for Potential Sterility Breach in Packaging
Medline Industries is recalling Proxima Sterile Surgical Drape packs due to a potential breach in the pouch packaging that could lead to loss of sterility. The recall affects 1,490 units distributed nationwide.
Product
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; PAC
Category
Distribution
0 states
HighFDA (Devices)··2025-03-26
Medline Proxima sterile surgical drapes recalled due to potential packaging breach
Medline is recalling 1,482 units of Proxima sterile surgical drapes due to potential breaches in pouch packaging that could compromise sterility. No illnesses have been reported.
Product
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; DRA
Category
Distribution
0 states
HighFDA (Devices)··2025-03-26
Proxima Drape sterile drapes recalled for potential packaging breach risk
Medline Industries is recalling Proxima Drape sterile surgical drapes due to potential breaches in pouch packaging that could compromise sterility. The recall affects 2,422 units distributed nationwide.
Product
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.
Category
Distribution
0 states
HighFDA (Devices)··2025-03-26
Surgical drapes recalled due to potential sterility breach in packaging
Medline Industries is recalling Proxima Drape surgical drapes nationwide due to a potential breach in pouch packaging that could lead to loss of sterility. The recall affects 1,118 units distributed in the US.
Product
Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL HIP, TOTAL KNEE, SPINE. Sterile surgical drape.
Category
Distribution
0 states
HighFDA (Devices)··2025-03-26
Sterile surgical drapes recalled due to potential packaging breach
Medline Industries is recalling 220 Proxima Drape sterile surgical drapes nationwide due to a potential breach in pouch packaging that could compromise sterility.
Product
Proxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. Sterile surgical drape.
Category
Distribution
0 states
HighFDA (Devices)··2025-03-26
Medline Proxima Sterile Surgical Drapes Recalled for Packaging Breach Risk
Medline Industries is recalling Proxima Drape sterile surgical drapes due to potential packaging breach that could compromise sterility. The recall affects 16 units distributed nationwide.
Product
Proxima Drape labeled as FACE LIFT. Sterile surgical drape.
Category
Distribution
0 states
HighFDA (Devices)··2025-03-26
Proxima Drape surgical drapes recalled due to potential sterility loss
Medline Industries recalls 506 units of Proxima Drape surgical drapes nationwide due to potential packaging breaches that could compromise sterility. Affected drapes were labeled as MINOR PACK or LAPAROSCOPY variants.
Product
Proxima Drape labeled as MINOR PACK and LAPAROSCOPY. Sterile surgical drape.
Category
Distribution
0 states
HighFDA (Devices)··2025-03-26
Sterile Surgical Drape Recalled Due to Potential Packaging Breach
Medline Industries is recalling 114 units of Proxima Drape surgical drapes due to a potential breach in pouch packaging that could compromise sterility. Affected units were distributed nationwide.
Product
Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape.
Category
Distribution
0 states