High FDA (Devices)·Z-1442-2024·Announced 2024-04-10

Centurion Manual Surgical Kits Recalled Due to Weak Seal

Medline Industries is recalling Centurion manual surgical kits due to weak seals that may compromise sterility. Approximately 7,950 units were distributed nationwide and internationally.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This Class II recall involves no reported illnesses or injuries, but addresses a risk-of-harm scenario: compromised sterility of surgical instruments could lead to patient infection or adverse outcomes. Sterility is the essential safety attribute of surgical instruments. The defect—weak seals—directly undermines this critical function, meeting the criterion for high-severity risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medline Industries, LP is recalling Centurion manual surgical kits, including multiple product variants: ST. VIRTUS SPLINTER FORCEP, debridement trays, biopsy instrument packs, IR ADSON FORCEP & NEEDLE HOLDER, toenail removal kits, and general purpose instrument trays. Approximately 7,950 units are affected.

The kits may have weak seals that could result in a breach of sterility if the seal fails. The manufacturer notes that the weak seal may not be detectable by users before use.

Affected products were distributed nationwide in the United States as well as to Panama and Canada. No illnesses or injuries have been reported. Healthcare facilities and individuals who possess these kits should discontinue use and contact Medline Industries or their medical supplier for replacement or instruction on proper handling.

The recalled product

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 HOLD
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Category: Medical Device — Surgical Instruments
Hazard: seal-failure
sterility-breach
Affected units: 7,950

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 29 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 29 products in this recall →

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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Same hazard · seal failure