Class IIOngoingZ-2517-2026
Merit Medical Systems, Inc. recalls Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645 0…
Due to unsealed portions of pouches.
Merit Medical Systems,…UTJun 24, 2026
Wire, Guide, Catheter recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–7 of 7 recalls
Class IOngoingZ-2397-2026
ARROW INTERNATIONAL, LLC recalls Description/REF: RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-1A
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if ster…
ARROW INTERNATIONAL, L…NCJun 24, 2026
Class IIOngoingZ-1829-2026
Medline Industries, LP recalls Medline Namic Guidewires: 1) GUIDEWIRE 3MMJ 0.035X260CM LT
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Medline Industries, LPILApr 29, 2026
Class IIOngoingZ-1777-2026
Cook Incorporated recalls COOK MEDICAL Approach CTO-18 Micro Wire Guide
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Cook IncorporatedINApr 15, 2026
Class IIOngoingZ-1776-2026
Cook Incorporated recalls COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Cook IncorporatedINApr 15, 2026
Class IIOngoingZ-1775-2026
Cook Incorporated recalls COOK MEDICAL Approach CTO-6 Micro Wire Guide
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Cook IncorporatedINApr 15, 2026
Class IIOngoingZ-1734-2025
Galt Medical Corporation recalls GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous proce…
Due to a potential open seal in the sterile barrier packaging.
Galt Medical Corporati…TXMay 14, 2025