Browse Device Recalls

2,549 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,549 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 2,549 FDA device recalls in IN.

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DateProductReasonClassFirm
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.
Sep 4, 2012 NCB¿ screw ¿ 4.0 self-tapping Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Dynesys¿ Top-Loading System Cannulated Pedicle + Set Screw Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Aug 31, 2012 Multipolar¿ Bipolar Cup Liner 22 mm LD.; Item 00-5001-040-22 Product Usa... Zimmer Inc. is initiating a removal of the Multipolar¿ Bipolar Cup Liner 22 mm J.D. (item 00-5001... Class II Zimmer, Inc.
Aug 27, 2012 Trilogy II Constrained Liner The Trilogy Longevity Constrained Liner ser... Trilogy Longevity Constrained Liner devices were packaged in incorrect cartons. The product is p... Class II Zimmer, Inc.
Aug 23, 2012 Universal Flex2 Breathing Circuit Class I 510(k) Exempt An anesthesia b... King Systems received a customer complaint indicating that the customer had ordered a breathing c... Class I King Systems Corp.
Aug 23, 2012 Optilock T15 AO Driver (3.5mm). Intended Use: The OptiLock Upper Extremity... Field complaints indicate that recent shipments of the 14-400795 and 36505 drivers do not properl... Class II Biomet, Inc.
Aug 23, 2012 Optilock 2.7 mm Screw Inserter. Intended Use: The OptiLock Upper Extremity... Field complaints indicate that recent shipments of the 14-400795 and 36505 drivers do not properl... Class II Biomet, Inc.
Aug 22, 2012 S-Rom¿ Total Hip System Poly Liner Packaging: The insert is placed into ... Orthopaedics, Inc. (DePuy) is issuing a voluntary recall of four lots of the S-ROM" liner becaus... Class II DePuy Orthopaedics, Inc.
Aug 14, 2012 JUGGERKNOT IN¿GUIDE PUNCH, 2.9MM. The JuggerKnot 2.9mm In-Guide Punch is i... Investigation found that the current design of the product allows the press-fit of the knob/shaft... Class II Biomet, Inc.
Jul 31, 2012 DePuy Custom Implant Devices Packaging: Packaging was not standardized o... In connection with a Warning Letter received from the U.S. Food & Drug Administration on December... Class II DePuy Orthopaedics, Inc.
Jul 24, 2012 Altrx" Altralinked" Polyethylene liners Description: An acetabular liner i... In the recalled lot, the products were not machined according to the production router, a size 52... Class II DePuy Orthopaedics, Inc.
Jul 18, 2012 00-4309-028-01 - Trabecular Metal Reverse Shoulder Liner 40mm 65¿ Neck Angle ... Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to re... Class II Zimmer, Inc.
Jul 18, 2012 00-4309-029-00- Trabecular Metal Reverse Shoulder Liner 36mm, Nonsterile Per... Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to re... Class II Zimmer, Inc.
Jul 18, 2012 Trabecular Metal Reverse Shoulder Liner 40mm, part 00-4309-028-00 - Per s... Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to re... Class II Zimmer, Inc.
Jul 18, 2012 00-4309-029-01 - Trabecular Metal Reverse Shoulder Liner 36 mm 65¿¿ Neck Angl... Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to re... Class II Zimmer, Inc.
Jul 17, 2012 13.5 mm x 50 mm BrainPath Sheath The NICO BrainPath is a family of product... BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeled as 60mm. The length c... Class II Nico Corp.
Jul 17, 2012 13.5 mm x 60 mm BrainPath Sheath The NICO BrainPath is a family of product... BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeled as 60mm. The length c... Class II Nico Corp.
Jul 13, 2012 The NCB Polyaxial Locking Plate System NCB screws 26mm: 02.03155.026, non-ste... Zimmer investigation following a complaint found one lot of NCB Polyaxial Locking Plate System NC... Class II Zimmer, Inc.
Jun 18, 2012 Advanta 2 Bed. The Advanta 2 Bed is intended for low to moderate acuity pa... During an evaluation of Advanta 2 siderail samples returned from the field it was found that the ... Class II Hill-Rom, Inc.
Jun 14, 2012 OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compressi... The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device. Class II OrthoPediatrics Corp
Jun 5, 2012 PathFinder NXT Pivoting Percutaneous Rod Holder This device is an instrume... Complaints have been reported where, during surgery, the surgeon was unable to loosen or remove ... Class II Zimmer, Inc.
Jun 5, 2012 Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-1 (angle hand... Zimmer is recalling Pathfinder NXT Fixed Percutaneous Rod Holder, because complaints have been ... Class II Zimmer, Inc.
Jun 5, 2012 Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-2 (straight h... Zimmer is recalling Pathfinder NXT Fixed Percutaneous Rod Holder, because complaints have been ... Class II Zimmer, Inc.
May 16, 2012 LUSTER HIP SZ 2 Packaging: The product was packaged within inner and outer... DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... Class II DePuy Orthopaedics, Inc.
May 16, 2012 ULTIMA*LX STM,POL 10/12TAP/3M Packaging: The product was packaged within i... DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... Class II DePuy Orthopaedics, Inc.
May 16, 2012 LUSTER HIP SZ 8 Packaging: The product was packaged within inner and outer... DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... Class II DePuy Orthopaedics, 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.