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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

MEDLINE INDUSTRIES, LP - Northfield: Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.

Agency Publication Date: January 27, 2023
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Affected Products

Product: Non-sterile procedural trays labeled as CRANI, 2 per case

Item Number: DYNJ900413P, UDI/GTIN Case: 40195327031665, UDI/GTIN Each: 40195327031665, Lot Number: 22JDB689

Lot Numbers:
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Product: Non-sterile procedural trays labeled as LAPAROSCOPIC, 2 per case

Item Number: DYNJ900415L, UDI/GTIN Case: 40195327029426, UDI/GTIN Each: 10195327029425, Lot Numbers: 22HBO658, 22JBV699

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Numbers
Product: Non-sterile procedural trays labeled as LAPAROTOMY CDS, 2 per case

Item Number: CDS980894A, UDI/GTIN Case: 40889942401292, UDI/GTIN Each: 10889942401291, Lot Numbers: 22HMD613, 22JMB665

Lot Numbers:
Numbers
Product: Non-sterile procedural trays labeled as MAJOR/MINOR, 3 per case

Item Number: DYNJ900416M, UDI/GTIN Case: 40195327031672, UDI/GTIN Each: 10195327031671, Lot Number: 22IBQ980

Lot Numbers:
Number
Product: Non-sterile procedural trays labeled as ORTHO TRAUMA, 1 per case

Item Number: DYNJ908295, UDI/GTIN Case: 40195327029570, UDI/GTIN Each: 10195327029579, Lot Numbers: 22IBN449, 22JBQ931

Lot Numbers:
Numbers
Product: Non-sterile procedural trays labeled as THEDA CLARK TOTAL KNEE CDS, 1 per case

Item Number: CDSOPP508AG, UDI/GTIN Case: 40195327145140, UDI/GTIN Each: 10195327145149, Lot Number: 22HBO323

Lot Numbers:
Number
Product: Non-sterile procedural trays labeled as TOTAL KNEE KIT, 1 per case

Item Number: DYNJ904310F, UDI/GTIN Case: 40195327116188, UDI/GTIN Each: 10195327116187, Lot Number: 22IBD724;

Lot Numbers:
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Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91387
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Manufactured In: United States
Units Affected: 7 products (12 cases (24 units); 260 cases (520 units); 57 cases (114 units); 160 cases (480 units); 216 units; 45 units; 16 units)

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.

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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 · 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.