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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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Critical RiskFDA Device

Medline Industries, Inc.: Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc.

Agency Publication Date: February 21, 2014
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Affected Products

Product: ANGIOGRAPHY PACK; REF: DYNJ26855D; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.

Pack Number: DYNJ26855D; Lots: 13EB2046, 13EB8965

Product: ANGIO PACK #2; REF: DYNJ39185; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.

Pack Number: DYNJ39185; Lots: 13EB2046, 13FB1553, 13GB2605

Product: HEART CATH CUSTOM PACK; REF: DYNJ39747A; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.

Pack Number: DYNJ39747A; Lots: 13EB2095, 13EB3153, 13FB4157, 13RB0832, 13GB2692

Product: CATH LAB CUSTOM PACK; REF: DYNJ40926; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.

Pack Number: DYNJ40926; Lot: 13FB4759

Lot Numbers:
13FB4759
Product: CATH TRAY; REF: DYNJ41101; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.

Pack Number: DYNJ41101; Lot: 13FB5744

Lot Numbers:
13FB5744
Product: CATH PACK; REF: DYNJ41103; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.

Pack Number: DYNJ41103; Lots: 13GB5484, 13GB9975

Product: STERILE SAMPLE BUILD; REF: SAMP0144; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures..

Pack Number: SAMP0144; Lots: 13CD2145, 13CD2146

Product: STERILE SAMPLE CATH LAB PACK; REF: SAMP0213; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures.

Pack Number: SAMP0213; Lot: 13CD1774

Lot Numbers:
13CD1774
Product: STERILE SAMPLE BUILD; REF: SAMP0147; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures.

Pack Number: SAMP0147; Lot: 13CD2146

Lot Numbers:
13CD2146
Product: CATH ANGIOGRAPHY DRAPE PACK; REF: DYNJ40851; Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures.

Pack Number: DYNJ40851; Lot: 13FB8753

Lot Numbers:
13FB8753
Product: CATH PACK; REF: DYNJ40904; Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures.

Pack Number: DYNJ40904; Lot: 13GB9975

Lot Numbers:
13GB9975

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 66080
Status: Resolved
Manufacturer: Medline Industries, Inc.
Manufactured In: United States
Units Affected: 11 products (1,194 units; 768 units; 160 units; 120 units; 304 units; 120 units; 10 units; 10 units; 5 units; 50 units; 112 units)

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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.