Recall archive / FDA device enforcement
Centurion manual surgical kits labeled as: a) ST. VIRTUS SPLINTER FORCEP 6" (SF8246), Product Code 66580; b) DEBRIDEM... — FDA record Z-1442-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 23, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Centurion manual surgical kits labeled as: a) ST. VIRTUS SPLINTER FORCEP 6" (SF8246), Product Code 66580; b) DEBRIDEMENT TRAY, Product Code I86630; c) BIOPSY INSTRUMENT PACK, Product Code I86690; d) DEBRIDEMENT TRAY, Product Code I86815; e) IR ADSON FORCEP & NEEDLE HOLDER, Product Code MNS12675; f) TOENAIL REMOVAL KIT, Product Code SUT20350 MEDLINE GENERAL PURPOSE INST. TRAY, Product Code DYNDA2346A
- Reason
- Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- Classification
- Class II
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 7950 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1442-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | a) 66580, UDI/DI 10653160028963 (case) 00653160028966 (each), Lot Numbers: 2023041090; b) I86630, UDI/DI 00653160286540 (case) 10653160286547 (each), Lot Numbers: 2023101190; c) I86690, UDI/DI 00653160290752 (case) 10653160290759 (each), Lot Numbers: 2023103190; d) I86815, UDI/DI 00653160342291 (case) 10653160342298 (each), Lot Numbers: 2023112190; e) MNS12675, UDI/DI 00653160337341 (case) 10653160337348 (each), Lot Numbers: 2023070390; f) SUT20350, UDI/DI 00653160306552 (case) 10653160306559 (each), Lot Numbers: 2023022290, 2023041190, 2023042490, 2023052390, 2023101890 MEDLINE: UDI/DI 20193489191582 (case) 10193489191585 (each), Lot Numbers: 2023062290, 2023081490 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide and the countries of Panama, Canada.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Apr 10, 2024
- Recall initiation date
- Feb 23, 2024
- Center classification date
- Mar 29, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.