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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

MEDLINE INDUSTRIES, LP - Northfield: Centurion Sterile CirClamps Recalled for Packaging Holes and Sterility Loss

Agency Publication Date: October 18, 2024
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Summary

Medline Industries, LP is recalling 498,354 units of Centurion CirClamp sterile kits because holes were found in the product packaging. These sterile kits, which include various bell sizes and inserts for medical procedures, were distributed worldwide, including throughout the United States. Because the packaging is damaged, the devices inside can no longer be guaranteed as sterile, and using a contaminated device could lead to serious patient infections.

Risk

Holes in the medical packaging allow environmental contaminants and pathogens to enter the sterile field, potentially causing healthcare-associated infections in patients during surgical or medical procedures. While no specific injuries were mentioned in the notice, the use of non-sterile equipment in a sterile environment poses a significant health risk.

What You Should Do

  1. Immediately locate and identify any affected Centurion CirClamp products by checking the Reorder and Lot numbers on the packaging. Affected Reorder numbers include #200CR, #210CR, #230CR, #245CR, #310CR, #310CRK, #330CR, #330CRK, #345CR, #3145CR, #CR210K, #CR230K, #CR245K, #CR345K, and #CR3145K.
  2. Check your specific lot numbers against the extensive list provided, which includes codes such as 2023071801, 2024012901, 2024042201, and many others manufactured between 2021 and 2024.
  3. Stop using any products identified as part of this recall immediately and quarantine them to prevent accidental use in medical procedures.
  4. Contact Medline Industries, LP directly to receive instructions on how to return the affected sterile kits or to learn about available replacement options.
  5. Healthcare providers should contact their patients if they suspect a non-sterile device was used in a recent procedure and monitor for signs of infection.
  6. For further questions regarding this recall, contact Medline Industries or the FDA's medical device line at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Quarantine and return product

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Centurion Sterile CirClamp
Model / REF:
200CR
UPC Codes:
10653160278139
Lot Numbers:
2021100190
2021121390
2022012090
2023071801
Product: Centurion CirClamp with 1.1cm Bell and Insert
Model / REF:
210CR
UPC Codes:
00653160197440
10653160197447
Lot Numbers:
2022081901
2023071901
2023091101
2023110801
2024012901
Product: Centurion CirClamp with 1.13cm Bell and Insert
Model / REF:
230CR
UPC Codes:
00653160197457
10653160197454
Lot Numbers:
2021100190
2021121690
2023071801
2023090501
2023103001
2023111301
2023112101
2024010301
2024012401
2024020190
Product: Centurion CirClamp with 1.45cm Bell and Insert
Model / REF:
245CR
UPC Codes:
00653160197464
10653160197461
Lot Numbers:
2021102590
2023071901
2023083001
2023100401
2023101201
2023103001
2023111001
2023112101
2024011701
2024030501
2024041801
Product: Centurion CirClamp with 1.1cm Bell
Model / REF:
310CR
UPC Codes:
00653160197471
10653160197478
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
2024042201
Product: Centurion CirClamp with 1.1cm Bell Reprocessed
Model / REF:
310CRK
UPC Codes:
10653160309895
00653160309898
Lot Numbers (67):
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
Product: Centurion CirClamp with 1.3cm Bell
Model / REF:
330CR
UPC Codes:
00653160197495
10653160197492
Lot Numbers:
2021102590
2022120701
2022120901
2023012701
2023013001
2023052201
2023072701
2023081501
2023111401
2024010301
2024030701
2024031301
2024031901
2024032801
2024032901
2024041001
Product: Centurion CirClamp with 1.3cm Bell Repprocessed
Model / REF:
330CRK
UPC Codes:
10653160309901
00653160309904
Lot Numbers (81):
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
Product: Centurion CirClamp with 1.6cm Bell
Model / REF:
345CR
UPC Codes:
00653160197501
10653160197508
Lot Numbers:
2023083001
2023122001
Product: Centurion CirClamp with 1.45cm Bell
Model / REF:
3145CR
UPC Codes:
00653160197488
10653160197485
Lot Numbers:
2021102590
2022092701
2022111701
2022112901
2023061401
2023062101
2023083101
2024013101
2024022890
2024030101
2024042201
Product: Centurion CirClamp with 1.1cm Bell & Insert Reprocessed
Model / REF:
CR210K
UPC Codes:
10653160312932
00653160312935
Lot Numbers:
2021102590
2021111890
2022012490
2022101901
2022110801
2022122101
2023052301
2023071201
2023081001
2023083001
2023111301
2024010801
2024012690
Product: Centurion CirClamp with 1.3cm Bell & Insert Reprocessed
Model / REF:
CR230K
UPC Codes:
10653160312895
00653160312898
Lot Numbers:
2022070590
2022081590
2022090990
2022110401
2022110890
Product: Centurion CirClamp with 1.145cm Bell & Insert Reprocessed
Model / REF:
CR245K
UPC Codes:
10653160312901
00653160312904
Lot Numbers:
2021102590
2022022490
2022031490
2022033001
2022080501
2022082201
2022100501
2022102801
2022110401
Product: Centurion CirClamp with 1.6cm Bell Reprocessed
Model / REF:
CR345K
UPC Codes:
10653160312949
00653160312942
Lot Numbers:
2022012090
2022072190
2022082290
2022090690
2022110301
2022122201
2023030201
Product: Centurion Sterile CirClamp with 1.45cm Bell Reprocessed
Model / REF:
CR3145K
UPC Codes:
10653160312956
00653160312959
Lot Numbers:
2021122090
2021122190
2022022190
2022030790
2022031701
2022032501
2022033101
2022041201
2022051001
2022052401
2022052701
2022080501
2022081801
2022100401
2022102601
2022112901
2023011101
2023062101
2023081501
2024012901

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95337
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: Authorized medical distributors; Hospitals; Clinics
Manufactured In: United States
Units Affected: 498,354 kits
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.