Medline Recalls Centurion CirClamp Sterile Surgical Devices for Packaging Defects
Medline Industries is recalling 498,354 units of Centurion CirClamp sterile surgical clamps due to holes in the packaging that may compromise sterility assurance. No illnesses or injuries have been reported.
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 device is recalled for packaging holes that compromise sterility assurance of surgical clamps. Although no illnesses or injuries have been reported, the defect creates a risk-of-harm to patients from potential infection, meeting the rubric criterion for Score 3 (High severity).
Plain-English summary
Medline Industries, LP is recalling 498,354 units of Centurion CirClamp sterile surgical clamps across multiple product variants. The recall affects devices distributed worldwide, including the United States, India, and Panama.
The affected devices have been identified as having holes in their packaging. Because these devices are marked as sterile, packaging integrity is essential for maintaining sterility assurance. Holes in the packaging could allow contamination that compromises the sterile status of the devices.
Affected customers and healthcare facilities should immediately stop using the recalled devices. Consult the lot number list provided by the FDA to verify if products in your inventory are affected. Contact Medline Industries for instructions on return or replacement of recalled devices.
The recalled product
- Product
- (1) Centurion Sterile CirClamp, Reorder #200CR; (2) Centurion CirClamp with 1.1cm Bell and Insert, Reorder #210CR, Sterile; (3) Centurion CirClamp with 1.13cm Bell and Insert, Reorder #230CR, Sterile; (4) Centurion CirClamp with 1.45cm Bell and Insert, Reorder #245CR, Sterile;
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- packaging-defect
- sterility-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)
- (1) Reorder #200CR - lot numbers 2021100190
- 2021121390
- 2022012090
- and 2023071801
- UDI-DI each - 10653160278139
- UDI-DI case - 10653160278139
- (2)Reorder #210CR - lot numbers 2022081901
- 2023071901
- 2023091101
- 2023110801
- and 2024012901
- UDI-DI each - 00653160197440
- UDI-DI case - 10653160197447
- (3) Reorder #230CR - lot numbers 2021100190
- 2021121690
- 2023071801
- 2023090501
- 2023103001
- 2023111301
- 2023112101
Distribution
Distributed nationwide across the United States.
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