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Browse Device Recalls

437 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 437 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 437 FDA device recalls.

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DateProductReasonClassFirm
Sep 14, 2012 Trilogy F/M Acetabular Shell without holes SOLID HA. Several ODs: 38MM, 40MM,... Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the po... Class II Zimmer, Inc.
Sep 14, 2012 Trilogy F/M Acetabular Shell without holes. Several ODs: 40MM, 42MM, 44MM, 46... Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the po... Class II Zimmer, Inc.
Sep 14, 2012 Trilogy Acetabular Shell Spiked. The Trilogy Acetabular System is indicate... Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the po... Class II Zimmer, Inc.
Sep 14, 2012 Trilogy Acetabular AB Shells with Cluster Holes. The Trilogy Acetabular Sy... Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the po... Class II Zimmer, Inc.
Sep 14, 2012 Trilogy Acetabular Shells with Holes. The Trilogy Acetabular System is ind... Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the po... Class II Zimmer, Inc.
Sep 14, 2012 Trilogy F/M Acetabular Shell with Uni-Hole. The Trilogy Acetabular System ... Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the po... Class II Zimmer, Inc.
Sep 14, 2012 Trilogy Acetabular AB Shells with Holes. The Trilogy Acetabular System is ... Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the po... Class II Zimmer, Inc.
Sep 13, 2012 CPT Hip System Femoral Stem Petite, Item No. 00-8011-000-05. CPT stems are... Zimmer Inc. is initiating a removal of the CPT Modular Stem (item 00-8011-001-00), CPT Stem Petit... Class II Zimmer, Inc.
Sep 13, 2012 CPT Modular Stem, Item No. 00-8011-001-00; Lot 61947708. CPT stems are pri... Zimmer Inc. is initiating a removal of the CPT Modular Stem (item 00-8011-001-00), CPT Stem Petit... Class II Zimmer, Inc.
Sep 13, 2012 CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-8114-001-10. CP... Zimmer Inc. is initiating a removal of the CPT Modular Stem (item 00-8011-001-00), CPT Stem Petit... Class II Zimmer, Inc.
Sep 7, 2012 Cemented Tibial Drill Product Usage: The cemented tibial drill is used to... Zimmer is initiating a recall of the Cemented Tibial Drill for the Zimmer Persona Personalized Kn... Class II Zimmer, Inc.
Sep 5, 2012 ATS 3000 Automatic Tourniquet System w/HOSES AND LOP SENSOR Intended to... Zimmer is conducting a voluntary removal of some Zimmer A.T.S. 3000 tourniquets after receiving c... Class II Zimmer, Inc.
Sep 4, 2012 Anatomical Shoulder" Ball taper for humeral stem Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Zimmer Inverse/Reverse Screw system, Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 MS-30 Shaft, Sterile, Rx Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Anatomical Shoulder" Revision Humeral stem,7,9,12,14 and Anatomical Shoulder... Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Biolox¿ delta Ceramic Femoral Head Rx only, sterile Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Metasul¿ LDH¿ Head Rx Sterile Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Anatomical Shoulder" Fracture Humeral Head Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 MS-30¿ Proximal positioner Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 CoCr Head, sterile, Rx Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Wagner cone Prosthesis, uncemented, sterile, Rx Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Wagner SL Revision Stem, uncemented Sterile Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Alloclassic¿ SL-Offset Stem sterile, Rx Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Sirus¿ intramedullary nail for tibia, cannulated ¿ Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Dynesys¿ L.I.S. Stabilizing cord Rx, Sterile Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 NCB¿-PT lateral proximal 3 hole tibial plate Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Dynesys¿ Universal spacer 6-45 Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Dynesys¿ Set screw M6 Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Metasul¿ Durom¿ Femoral component Sterile, Rx Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 NCB¿-PH Plate Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Dynesys¿ HA Pedicle + set screw Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Fitmore" Hip Stem Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Kopf Adapter S Sterile, Rx Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 NCB¿ cancellous screw Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Anatomical Shoulder" Humeral Head Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Original M.E. Mueller" Low Profile Cup Sterile, Rx Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 CLS Stem Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 MS-30¿ Distal centralizer, cemented, sterile, Rx Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Anatomical Shoulder" Humeral stem Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 MS-30¿ Stem Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Dynesys¿ Revision + set screw Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Anatomical Shoulder" Inverse/Reverse Glenoid Sterile, Rx Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Anatomical Shoulder" Inverse Humeral Cup Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 zimmer Anatomical Shoulder Glenoid S, cemented, sterile; REF 01.04214.340 P... Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Biolox¿ Option Ceramic Femoral Head System Rx, sterile Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Anatomical Shoulder" Inverse/Reverse Humeral PE-Insert Sterile, Rx Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Alloclassic SL Shaft Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Anatomical Shoulder" Fracture Humeral stem Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 DTO" Implant Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.