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.
(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; (5) Centurion CirClamp with 1.1cm Bell, Reorder #310CR, Sterile; (6) Centurion CirClamp with 1.1cm Bell Reprocessed, Reorder #310CRK, Sterile; (7) Centurion CirClamp with 1.3cm Bell, Reorder #330CR, Sterile; (8) Centurion CirClamp with 1.3cm Bell Reprocessed, Reorder #330CRK, Sterile; (9) Centurion CirClamp with 1.6cm Bell, Reorder #345CR, Sterile; (10) Centurion CirClamp with 1.45cm Bell, Reorder #3145CR, Sterile; (11) Centurion CirClamp with 1.1cm Bell & Insert Reprocessed, Reorder #CR210K, Sterile; (12) Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Sterile; (13) Centurion CirClamp with 1.145cm Bell & Insert Reprocessed, Reorder #CR245K, Sterile; (14) Centurion CirClamp with 1.6cm Bell Reprocessed, Reorder #CR345K, Sterile; and (15) Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder #CR3145K.
Why it was recalled
Product has been identified as having holes in the packaging.
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
(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, 2024010301, 2024012401, and 2024020190; UDI-DI each - 00653160197457; UDI-DI case - 10653160197454; (4) Reorder #245CR - lot numbers 2021102590, 2023071901, 2023083001, 2023100401, 2023101201, 2023103001, 2023111001, 2023112101, 2024011701, 2024030501, and 2024041801; UDI-DI each - 00653160197464; UDI-DI case - 10653160197461; (5) Reorder #310CR - lot numbers 2021100590, 2021101190, 2022050401, 2022050601, 2022081201, 2022112801, 2022120101, 2023012401, 2023031501, 2023032101, 2023040601, 2023040701, 2023041201, 2023041401, 2023041701, 2023042101, 2023042401, 2023042501, 2023042701, 2023042801, 2023050401, 2023050501, 2023050901, 2023051801, 2023112001, 2023121101, 2023121901, 2023122901, 2024010801, 2024011001, 2024012590, 2024021201, 2024022001, 2024022701, 2024030401, 2024030601, 2024031101, 2024031501, 2024031801, 2024032101, 2024032601, 2024040301, 2024041001, 2024041201, and 2024042201; UDI-DI each - 00653160197471; UDI-DI case - 10653160197478; (6) Reorder #310CRK - lot numbers 2021092490, 2021092990, 2021101190, 2021102890, 2021110590, 2021120690, 2021120990, 2021122090, 2021122790, 2022010590, 2022011090, 2022020390, 2022022201, 2022030290, 2022030101, 2022030401, 2022031601, 2022032301, 2022032501, 2022032901, 2022040101, 2022040501, 2022041201, 2022042001, 2022042201, 2022052701, 2022062201, 2022062901, 2022080201, 2022081601, 2022090201, 2022090801, 2022092701, 2022101001, 2022111401, 2022111801, 2022120601, 2023010301, 2023010901, 2023020201, 2023021001, 2023021501, 2023022001, 2023022101, 2023022701, 2023031401, 2023031601, 2023032001, 2023032301, 2023032801, 2023033001, 2023040401, 2023051801, 2023052301, 2023052501, 2023053001, 2023053101, 2023081501, 2023101801, 2023111001, 2023120701, 2023121801, 2024010401, 2024011801, 2024022701, 2024032801, and 2024041601; UDI-DI each - 10653160309895; UDI-DI case - 00653160309898; (7) Reorder #330CR - lot numbers 2021102590, 2022120701, 2022120901, 2023012701, 2023013001, 2023052201, 2023072701, 2023081501, 2023111401, 2024010301, 2024030701, 2024031301, 2024031901, 2024032801, 2024032901, and 2024041001; UDI-DI each - 00653160197495; UDI-DI case - 10653160197492; (8) Reorder #330CRK - lot numbers 2021092490, 2021092990, 2021101190, 2021102690, 2021110890, 2021112990, 2021120690, 2021121590, 2021122090, 2022010590, 2022011090, 2022012090, 2022020390, 2022021890, 2022022101, 2022022801, 2022030290, 2022030301, 2022030701, 2022031701, 2022032301, 2022041801, 2022042101, 2022042501, 2022062701, 2022070101, 2022091201, 2022092101, 2022101301, 2022101701, 2022102801, 2022110901, 2022121401, 2022121901, 2023010901, 2023011101, 2023011701, 2023012001, 2023020601, 2023021701, 2023022401, 2023030601, 2023030901, 2023031001, 2023032101, 2023032301, 2023033001, 2023040301, 2023041301, 2023041801, 2023041901, 2023050201, 2023051501, 2023053101, 2023060701, 2023061201, 2023061401, 2023061601, 2023062001, 2023062301, 2023062701, 2023062901, 2023071001, 2023082201, 2023082501, 2023090701, 2023091901, 2023092501, 2023101601, 2024011501, 2024011801, 2024012401, 2024012690, 2024020201, 2024020890, 2024020601, 2024020801, 2024022890, 2024031201, 2024031801, and 2024041801; UDI-DI each - 10653160309901; UDI-DI case - 00653160309904; (9) Reorder #345CR - lot numbers 2023083001 and 2023122001; UDI-DI each - 00653160197501; UDI-DI case - 10653160197508; (10) Reorder #3145CR - lot numbers 2021102590, 2022092701, 2022111701, 2022112901, 2023061401, 2023062101, 2023083101, 2024013101, 2024022890, 2024030101, and 2024042201; UDI-DI each - 00653160197488; UDI-DI case - 10653160197485; (11) Reorder #210K - lot numbers 2021102590, 2021111890, 2022012490, 2022101901, 2022110801, 2022122101, 2023052301, 2023071201, 2023081001, 2023083001, 2023111301, 2024010801, and 2024012690; UDI-DI each 10653160312932; UDI-DI case - 00653160312935; (12) Reorder #230K - lot numbers 2022070590, 2022081590, 2022090990, 2022110401, 2022110890; UDI-DI each - 10653160312895; UDI-DI case - 00653160312898; (13) Reorder #245K - lot numbers 2021102590, 2022022490, 2022031490, 2022033001, 2022080501, 2022082201, 2022100501, 2022102801, and 2022110401; UDI-DI each - 10653160312901; UDI-DI case - 00653160312904; (14) Reorder #345K - lot numbers 2022012090, 2022072190, 2022082290, 2022090690, 2022110301, 2022122201, and 2023030201;, UDI-DI each 10653160312949; UDI-DI case - 00653160312942; and (15) Reorder #3145K - lot numbers 2021122090, 2021122190, 2022022190, 2022030790, 2022031701, 2022032501, 2022033101, 2022041201, 2022051001, 2022052401, 2022052701, 2022080501, 2022081801, 2022100401, 2022102601, 2022112901, 2023011101, 2023062101, 2023081501, and 2024012901; UDI-DI each - 10653160312956; UDI-DI case - 00653160312959.
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
Worldwide distribution - US Nationwide and the countries of India and Panama.
Recall record
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product type
- Devices
- Recall number
- Z-0133-2025
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Northfield, IL
- Recall initiated
- 2024-09-03
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-0133-2025 · Source: openFDA enforcement.