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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: Various Medical Kits Recalled for Breach of Sterility Risk

Agency Publication Date: March 29, 2024
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Summary

Medline Industries is recalling over 1.1 million Centurion and Medline brand surgical and medical kits because the packaging may have a weak seal. This defect could allow the contents to become contaminated or lose their sterility, which may not be visible to the medical professional or user. These kits, including suture removal trays, dental kits, and various surgical instruments, were distributed worldwide between February 2023 and early 2024. Consumers and healthcare providers should contact the manufacturer or their healthcare professional for further instructions.

Risk

If the sterile seal on these medical instruments is compromised, patients are at a higher risk of developing infections during or after medical procedures. While no injuries have been reported specifically in this data, the weak seal might not be detectable by all users, leading to the use of non-sterile tools in sterile environments.

What You Should Do

  1. Immediately check your inventory for Centurion or Medline kits, including Trach Brushes, Dental Instrument Kits (DH760), Suture Removal Trays, and Forcep Kits.
  2. Verify the Lot Numbers and UDI codes against the affected products list; common lot numbers begin with '2023' (such as 2023021090, 2023042690, and 2023111090).
  3. Look for UDI/DI identifiers on the case or individual packaging, such as 50653160004750 (case) or 00653160004755 (each).
  4. Stop using any affected products immediately and quarantine them to prevent further use in clinical settings.
  5. Contact Medline Industries, LP at 1-800-MEDLINE or visit their website for instructions on returning the product and obtaining a refund or replacement.
  6. If you are a patient and believe one of these products was used during your care, contact your healthcare provider to discuss any potential risks or concerns.
  7. For further questions regarding this recall, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Quarantine and Contact Manufacturer

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

Affected Products

Product: Centurion STERILE TRACH BRUSH
Model / REF:
6225ST
UPC Codes:
50653160004750
00653160004755
Lot Numbers:
2023021090
Product: Centurion FCP MAGILL CATH 7.5 IN PED
Model / REF:
67575
UPC Codes:
00653160352054
10653160352051
Lot Numbers:
2023071390
Product: Centurion STERILE COTTON DENTAL ROLLS 6/PK
Model / REF:
9125ST6
UPC Codes:
10653160129257
00653160129250
Lot Numbers:
2023022290
2023042490
2023060790
Product: Centurion STERILE BLOOD COLLECTION TUBE, 10ML
Model / REF:
6430ST
UPC Codes:
20653160172663
00653160172669
Lot Numbers:
2023042690
2023103090
Product: Centurion DENTAL INSTRUMENT KIT
Model / REF:
DH760
UPC Codes:
20653160237713
00653160237719
Lot Numbers:
2023042790
2023110990
Product: Centurion SUTURE REMOVAL TRAY / SET
Model / REF:
TRI55405
60265
60280
86125
SR60555
TRI44105
UPC Codes:
20193489112709
10193489112702
50653160090982
20193489111948
20193489111832
20193489111955
20193489112730
Lot Numbers:
2023022390
2023041190
2023031790
2023070590
2023112790
2023032090
2023120490
2023111590
2023072490
Product: Medline O.R. SCISSORS, S/B, 5.5 STERILE
Model / REF:
DYND04000
UPC Codes:
20193489191346
10193489191349
Lot Numbers:
2023021490
2023050390
2023051090
2023050490
2023101690
2023112290

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94136
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: Authorized Medical Distributors; Medline Industries; Direct Hospital Sales
Manufactured In: United States
Units Affected: 29 products (1700; 480 units; 100 units; 1350 units; 2310 units; 100 units; 440 units; 760 units; 1520 units; 3860 units; 274410 units; 80903 units; 20614 units; 12980 units; 60075 units; 7950 units; 1335 units; 568,849 units; 23,290 units; 150 units; 300 units; 1700 units; 84224 units; 270 units; 1350 units; 4200 units; 2458 units; 800 units; 0)
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.