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 |
|---|---|---|---|---|
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail 125¿ 11 mm x 180 mm, Item Number: 814311180 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 180 mm, Item Number: 814313180 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 420 mm, Item Number: 814413420 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 460 mm, Item Number: 814611460 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 260 mm, Item Number: 814413260 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 360 mm, Item Number: 814409360 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail 125¿ 9 mm x 180 mm, Item Number: 814309180 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Right 130¿ 15 mm x 360 mm, Item Number: 814515360 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 280 mm, Item Number: 814613280 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 380 mm, Item Number: 814509380 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 300 mm, Item Number: 814409300 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 360 mm, Item Number: 814509360 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 400 mm, Item Number: 814611400 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Right 130¿ 15 mm x 400 mm, Item Number: 814515400 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 360 mm, Item Number: 814611360 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 280 mm, Item Number: 814511280 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 360 mm, Item Number: 814411360 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 460 mm, Item Number: 814513460 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 460 mm, Item Number: 814309460 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 440 mm, Item Number: 814309440 | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Jul 16, 2018 | Roche cobas p 612 pre-analytical system (63x) Model: 07563116001 The cob... | Sample material may potentially come in contact with the pipetting nozzle during operation of cob... | Class II | Roche Diagnostics Corporation |
| Jul 12, 2018 | Peg Fully Threaded, Locking, 2.5mm x 10mm, Item Number 131212610 Orthopedic d... | A size 22mm threaded peg was found in the package of a 10mm unit. | Class II | Zimmer Biomet, Inc. |
| Jun 22, 2018 | Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-00... | The PPK System Spacer Block Alignment Tower mating feature that mates with the spacer block was u... | Class II | Zimmer Biomet, Inc. |
| Jun 21, 2018 | CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511 | Two lots of femoral stems were labeled as Size 11. However, they are actually Size 12. Potential ... | Class II | DePuy Orthopaedics, Inc. |
| Jun 19, 2018 | NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath ... | Mislabeled hook pouch included a transport/storage label rather than the product label containin... | Class II | Nico Corp. |
| Jun 18, 2018 | Connecting Bolt, Model 14-442093 | Product was manufactured from the incorrect material, which shows a potential decrease in the fat... | Class II | Zimmer Biomet, Inc. |
| Jun 8, 2018 | ECHO Bi-Metric Hip System, Reduced Proximal Profile, Standard 135o neck, item... | Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingl... | Class II | Zimmer Biomet, Inc. |
| Jun 8, 2018 | ARCOS Modular Revision Hip System, item number 11-300814 orthopedic hip pros... | Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingl... | Class II | Zimmer Biomet, Inc. |
| May 31, 2018 | VentriClear Ventricular Drainage Catheter Set, Cat. No. N-VVDC-01-ABRM Pro... | This lot of VentriClear failed endotoxin testing. Potential adverse events include immune respon... | Class II | Cook Inc. |
| May 30, 2018 | Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size ... | Class II | Zimmer Biomet, Inc. | |
| May 30, 2018 | Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size ... | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... | Class II | Zimmer Biomet, Inc. |
| May 30, 2018 | Zimmer M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Extended Offset, 00-77... | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... | Class II | Zimmer Biomet, Inc. |
| May 30, 2018 | Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size ... | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... | Class II | Zimmer Biomet, Inc. |
| May 30, 2018 | Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size ... | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... | Class II | Zimmer Biomet, Inc. |
| May 30, 2018 | Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size ... | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... | Class II | Zimmer Biomet, Inc. |
| May 30, 2018 | Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size ... | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... | Class II | Zimmer Biomet, Inc. |
| May 30, 2018 | Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size ... | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... | Class II | Zimmer Biomet, Inc. |
| May 30, 2018 | Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size ... | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... | Class II | Zimmer Biomet, Inc. |
| May 30, 2018 | Zimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ Technology Cementless, Size 5... | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... | Class II | Zimmer Biomet, Inc. |
| May 30, 2018 | Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size ... | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... | Class II | Zimmer Biomet, Inc. |
| May 30, 2018 | Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size ... | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... | Class II | Zimmer Biomet, Inc. |
| May 30, 2018 | Zimmer¿ M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Standard Offset; 00-7... | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... | Class II | Zimmer Biomet, Inc. |
| May 30, 2018 | Zimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ Technology Cementless, Size 6... | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... | Class II | Zimmer Biomet, Inc. |
| May 30, 2018 | Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size ... | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... | Class II | Zimmer Biomet, Inc. |
| May 24, 2018 | Vanguard Complete Knee System; E1 Vanguard PS Tibial Bearing; Model Numbers E... | Two lots of tibial bearings were commingled. There is a possibility that a 14mm tibial bearing is... | Class II | Zimmer Biomet, Inc. |
| May 18, 2018 | Biomet Modular Primary Tibial Tray Implants; Modular Interlok Primary Tray (s... | One lot of 75mm tibial tray is potentially etched and labeled as a 79 mm tibial tray. This may le... | Class II | Zimmer Biomet, Inc. |
| May 16, 2018 | G-PIN 2.8BL 3.2PL 60CM 2PK; 467265 Intended to be used as a guide pin for... | The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... | Class II | Zimmer Biomet, Inc. |
| May 16, 2018 | 3.2MM X 510MM COCR THD TIP; 14-443053 Intended to be used as a guide pin ... | The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... | Class II | Zimmer Biomet, Inc. |
| May 16, 2018 | BALL TIP GUIDE WIRE 2.0MMX60CM; 469020 Intended to be used as a guide pin... | The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... | Class II | Zimmer Biomet, Inc. |
| May 16, 2018 | BALL TIP GUIDE WIRE 3.2MMX98CM; 469060 Intended to be used as a guide pin... | The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... | Class II | Zimmer Biomet, 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.