All Medical Device Recalls

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-1774-2026

Molded Products Inc recalls See Luer Cap Set

Molded Products, Inc. is voluntarily conducting a medical device recall of the MPC-130 See Luer Cap Set based on a confirmed complaint of the threaded sleeve not being engaged and becoming un-attached.

Molded Products IncIAApr 15, 2026

Class IIOngoingZ-1773-2026

XTANT Medical Holdings, Inc recalls XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm

Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.

XTANT Medical Holdings…MTApr 15, 2026

Class IIOngoingZ-1772-2026

Beckman Coulter, Inc. recalls MicroScan Neg MIC 3J REF C54814

Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics

Beckman Coulter, Inc.CAApr 15, 2026

Class IIOngoingZ-1769-2026

Tornier, Inc recalls Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat

Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with the Tornier HRS Max system.

Tornier, IncMNApr 15, 2026

Class IOngoingZ-1730-2026