STERILE STRT KELLY HEMOSTAT (SK8039S), Medline Item No.… recallZ-0754-2025 · MEDLINE INDUSTRIES, LP - Northfield · initiated Nov 12, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
FDA root cause category: Process control
What the company is doing
On November 25, 2024, the firm notified customers via letters titled IMMEDIATE ACTION REQUIRED. Customers were informed that specific items and lots of Pure Pouch Single-Sterile and Sterile Kits are being recalled due to weak seals. Affected product must be destroyed. The letter included instructions on actions to take to be issued a credit. Customers should immediately check their stock for affected product and quarantine all units. Affected lots should be destroyed. When the recalling firm has received your completed destruction form, your account will be issued a credit, if applicable. If you have any questions, please contact 866-359-1704.
Recall details
- Recall number
- Z-0754-2025
- Status
- Open, Classified
- Initiated by the company
- Nov 12, 2024
- Posted by the FDA
- Dec 23, 2024
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 21,440 total
- Product code
- HRQ
- Distribution
- US Nationwide distribution.
Product description
STERILE STRT KELLY HEMOSTAT (SK8039S), Medline Item No. 66695
Code information (models, lots, serial numbers)
UDI: 00653160024869 (ea) 60653160024861 (case); Lot 2023011990
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Centurion 66695Centurion Medical Products Corporation · HEMOSTAT2 recalls0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 95843).
- Z-0755-2025 · Open, ClassifiedO.R. SCISSORS, S/B, 5.5 STERILE, Medline Item No. DYND04000
- Z-0756-2025 · Open, ClassifiedST OR MAYO HEGAR NEEDLEHOLDER 6"(OR2500), Medline Item No. 67870
- Z-0757-2025 · Open, ClassifiedSTERILE MAGILL FORCEP (MAGF9), Medline Item No. 66790
- Z-0758-2025 · Open, ClassifiedST REPROCESSED BRUNS CURETTE #00 (BC00), Medline Item No. 67600K
- Z-0759-2025 · Open, ClassifiedST IUD REMOVAL HOOK 10" (504090), Medline Item No. I68785
- Z-0760-2025 · Open, ClassifiedRUMMELL, Medline Item No. ST006ST
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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