Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
Centurion manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code TRI55405; b) SUTURE REMOVAL SET, Product Code 60265 MEDLINE manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code 60280; b) SUTURE REMOVAL TRAY, Product Code 86125; c) SUTURE REMOVAL KIT, Product Code SR60555; d) SKIN STAPLE REMOVER, Product Code TRI44105
Why it was 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.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
a) TRI55405, UDI/DI 20193489112709 (case) 10193489112702 (each), Lot Numbers: 2023022390 b) 60265, UDI/DI 50653160090982 (case) 00653160090987 (each), Lot Numbers: 2023041190 MEDLINE: a) 60280, UDI/DI 20193489111948 I(case) 10193489111941 (each), Lot Numbers: 2023031790, 2023070590, 2023112790; b) 86125, UDI/DI 20193489111832 (case) 10193489111835 (each), Lot Numbers: 2023032090, 2023120490; c) SR60555, UDI/DI 20193489111955 (case) 10193489111958 (each), Lot Numbers: 2023111590; d) TRI44105, UDI/DI 20193489112730 (case) 10193489112733 (each), Lot Numbers: 2023072490
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Panama, Canada.
Recall record
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product type
- Devices
- Recall number
- Z-1445-2024
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Origin
- Northfield, IL
- Recall initiated
- 2024-02-23
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-1445-2024 · Source: openFDA enforcement.