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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.