Centurion Hemostat Kits Recalled Due to Weak Seal Sterility Breach Risk
Medline Industries is recalling Centurion Hemostat kits because weak seals may allow sterile contents to become contaminated. The weak seal may not be apparent to users before the instrument is used.
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 is an FDA Class II recall of surgical instruments due to a functional defect (weak seals) that compromises sterility. While no illnesses or injuries have been reported, the potential for surgical site infection makes this a risk-of-harm product, meeting the criteria for High severity.
Plain-English summary
Medline Industries, LP is recalling multiple lots of Centurion Hemostat kits distributed for use in surgical procedures. The hemostats are being recalled because they may have weak seals that could compromise sterility if the seal fails. The weak seal may not be readily detectable by users.
If a seal fails, the sterile contents of the kit may be exposed to contamination. This could result in the use of non-sterile instruments during surgical procedures, posing an infection risk to patients undergoing surgery.
The recalled products include multiple hemostat variants across different product codes. Approximately 80,903 units were distributed nationwide in the United States as well as to Panama and Canada. The recall impacts units manufactured in 2023.
Healthcare facilities and individual users should check their inventory against the provided lot numbers and product codes. Contact your supplier or Medline Industries for information on replacements or returns of affected inventory.
The recalled product
- Product
- Centurion Hemostat kits labeled as: a) STERILE CURV KELLY HEMOSTAT, Product Code 65340; b) STERILE CURV MOSQUITO HEMOSTAT (MHS103), Product Code 66145; c) STERILE STRT KELLY HEMOSTAT (SK8039), Product Code 66170; d) STERILE CURV KELLY HEMOSTAT (CK8040), Product Code 66175
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- sterility-breach
- infection-risk
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) 65340
- UDI/DI 10653160038023 (case) 00653160038026 (each)
- Lot Numbers: 2023041090
- 2023061290
- 2023091190
- b) 66145
- UDI/DI 70653160008783 (case) 00653160008784 (each)
- Lot Numbers: 2023042690
- 2023042790
- 2023072790
- c) 66170
- UDI/DI 70653160024035 (case) 00653160024036 (each)
- Lot Numbers: 2023031090
- 2023041790
- d) 66175
- UDI/DI 60653160039575 (case) 00653160039573 (each)
- Lot Numbers: 2023031390
- 2023050990
- 2023082490
- 2023103090
Distribution
Distributed nationwide across the United States.
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