Class IIOngoingZ-1778-2026
Cook Incorporated recalls COOK MEDICAL Arterial Pressure Monitoring Tray
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Cook IncorporatedINApr 15, 2026
Recalls in Indiana
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 25–36 of 71 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-1476-2026
Roche Diagnostics Operations, Inc. recalls cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample s…
Software defect, which allows the system to accept erroneous, non-monotonous calibrations for Spline-type assays. Cobas pro integrated solutions is an automated analyzer, intended for running qualitative, semi-quantitati…
Roche Diagnostics Oper…INMar 11, 2026
Class IIOngoingZ-1009-2026
Roche Diagnostics Operations, Inc. recalls The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptav…
Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to delayed or incorrect diagnosis, as well as delay of treatment or incorrect treatment.
Roche Diagnostics Oper…INJan 14, 2026
Class IIOngoingZ-0995-2026
Cook Incorporated recalls R¿sch-Uchida Transjugular Liver Access Sets
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification.…
Cook IncorporatedINDec 31, 2025
Class IIOngoingZ-0994-2026
Cook Incorporated recalls Ring Transjugular Intrahepatic Access Sets
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification.…
Cook IncorporatedINDec 31, 2025
Class IIOngoingZ-0993-2026
Cook Incorporated recalls Flexor Check-Flo Introducers and Sets
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification.…
Cook IncorporatedINDec 31, 2025
Class IIOngoingZ-0983-2026
Zimmer, Inc. recalls Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Fe…
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture.…
Zimmer, Inc.INDec 31, 2025
Class IIOngoingZ-0982-2026
Zimmer, Inc. recalls Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Fe…
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture.…
Zimmer, Inc.INDec 31, 2025
Class IIOngoingZ-0981-2026
Zimmer, Inc. recalls Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Fe…
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture.…
Zimmer, Inc.INDec 31, 2025