CLASS II ONGOING Device recall · Reported 10 Apr 2024 · FDA Enforcement Report
Centurion manual surgical kits labeled as recalled
Medline Industries LP - Northfield is recalling Centurion manual surgical kits labeled as: a) ST. Virtus Splinter Forcep 6" (SF8246), distributed nationwide in the US. The recall was initiated on 23 Feb 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1442-2024
- FDA event ID
- 94136
- Recalling firm
- Medline Industries LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Feb 2024
- FDA classified
- 29 Mar 2024
- Reported
- 10 Apr 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 23 Feb 2024 | Recall initiated by company | |
| 29 Mar 2024 | Classified by FDA | +35 days |
| 10 Apr 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Panama, Canada.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Panama, Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
28 other products · FDA event 94136This product is part of a recall event; the main page for the event is Centurion manual surgical kits labeled as recalled.
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|---|---|---|---|---|---|
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| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Other | Nationwide |