Food, drugs, devices › MEDLINE INDUSTRIES, LP - Northfield
Device recall: Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW; SHEET, DRAPE, SPLIT, ST,10/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/
FDA enforcement event 96401 is a device recall by MEDLINE INDUSTRIES, LP - Northfield of Northfield, IL, initiated 13 Feb 2025 and classified Class II, with 8 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 85% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. MEDLINE INDUSTRIES, LP - Northfield has 120 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL.
Reason for recall
"Potential breach in pouch packaging which could lead to loss of sterility."
Distribution
"US Nationwide distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1363-2025 | 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;… | 1,482 units | Class II | Ongoing | 26 Mar 2025 |
| Z-1364-2025 | 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;… | 1,490 units | Class II | Ongoing | 26 Mar 2025 |
| Z-1365-2025 | Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape. | 114 units | Class II | Ongoing | 26 Mar 2025 |
| Z-1366-2025 | Proxima Drape labeled as MINOR PACK and LAPAROSCOPY. Sterile surgical drape. | 506 units | Class II | Ongoing | 26 Mar 2025 |
| Z-1367-2025 | Proxima Drape labeled as FACE LIFT. Sterile surgical drape. | 16 units | Class II | Ongoing | 26 Mar 2025 |
| Z-1368-2025 | 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. | 2,422 units | Class II | Ongoing | 26 Mar 2025 |
| Z-1369-2025 | Proxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. Sterile surgical drape. | 220 units | Class II | Ongoing | 26 Mar 2025 |
| Z-1370-2025 | Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL HIP, TOTAL KNEE, SPINE. Sterile surgical drape. | 1,118 units | Class II | Ongoing | 26 Mar 2025 |
Context
Other enforcement events for MEDLINE INDUSTRIES, LP - Northfield
All 120 events for MEDLINE INDUSTRIES, LP - Northfield
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Potential breach in pouch packaging which could lead to loss of sterility."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.