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 |
|---|---|---|---|---|
| Nov 9, 2012 | EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The Biomet Rail S... | It was reported that the number scale/graduation markings were missing on 14 pieces of the swivel... | Class II | Biomet, Inc. |
| Nov 6, 2012 | Echo Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless Porous ... | It was reported that the surgeon noticed that the Echo 11mm hip stem had an etching indicating it... | Class II | Biomet, Inc. |
| Nov 2, 2012 | KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices... | The firm received two complaints from a user facility in New Jersey regarding color-coded EtO ste... | Class II | King Systems Corp. |
| Nov 2, 2012 | KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Si... | The firm received two complaints from a user facility in New Jersey regarding color-coded EtO ste... | Class II | King Systems Corp. |
| Nov 2, 2012 | KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 20 device... | The firm received two complaints from a user facility in New Jersey regarding color-coded EtO ste... | Class II | King Systems Corp. |
| Nov 2, 2012 | KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Si... | The firm received two complaints from a user facility in New Jersey regarding color-coded EtO ste... | Class II | King Systems Corp. |
| Nov 2, 2012 | KING LAD SILI CONE SINGLE USE, King Systems devices/case, ETO Sterile. Size... | The firm received two complaints from a user facility in New Jersey regarding color-coded EtO ste... | Class II | King Systems Corp. |
| Nov 2, 2012 | KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie10 devices/c... | The firm received two complaints from a user facility in New Jersey regarding color-coded EtO ste... | Class II | King Systems Corp. |
| Nov 2, 2012 | KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices... | The firm received two complaints from a user facility in New Jersey regarding color-coded EtO ste... | Class II | King Systems Corp. |
| Nov 2, 2012 | KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Si... | The firm received two complaints from a user facility in New Jersey regarding color-coded EtO ste... | Class II | King Systems Corp. |
| Nov 2, 2012 | KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices... | The firm received two complaints from a user facility in New Jersey regarding color-coded EtO ste... | Class II | King Systems Corp. |
| Nov 2, 2012 | KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices... | The firm received two complaints from a user facility in New Jersey regarding color-coded EtO ste... | Class II | King Systems Corp. |
| Nov 1, 2012 | OSS Reamer Sleeve REF132-472661 KNEE REAMER SLEEVE 8.0 THRU 12.5 STAINLESS ST... | Biomet has initiated this action following an investigation which identified that the thin shaft ... | Class II | Biomet, Inc. |
| Nov 1, 2012 | Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. T... | On cobas c 701 and cobas c 702 modules of the Cobas 8000 series analyzer, a mismatch between the ... | Class II | Roche Diagnostics Operations, Inc. |
| Nov 1, 2012 | OSS Reamer Sleeve REF132-472662 KNEE REAMER SLEEVE 13.0 thru 20.0 STAINLES... | Biomet has initiated this action following an investigation which identified that the thin shaft ... | Class II | Biomet, Inc. |
| Nov 1, 2012 | Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Impla... | The items in this lot are missing the ion implantation feature. The surface of the head may be so... | Class II | Biomet, Inc. |
| Oct 31, 2012 | Liko Overhead Rail System, Ceiling Mounted Rail Systems for all Liko Stationa... | Liko/Hill-Rom to date has received two reports from facilities alleging that the overhead rail sy... | Class II | Hill-Rom, Inc. |
| Oct 18, 2012 | 4.5mm PLEO Osteotomy Guide. OrthoPediatrics Corp. markets a pediatric, ext... | Complaint received from sales representative that the drill guide tubes would not screw into repl... | Class II | OrthoPediatrics Corp |
| Oct 4, 2012 | Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a met... | The color code on label conflicts with the liner size (liner size 24 should be green, not yellow) | Class II | Biomet, Inc. |
| Sep 21, 2012 | NexGen CompleteKnee Solution Stemmed Nonaugmentable Tibial component The N... | Zimmer is initiating a lot specific recall of the NexGen¿ Stemmed Nonaugmentable Tibial Component... | Class II | Zimmer, Inc. |
| Sep 20, 2012 | The TM Ardis Interbody System Inserter Stainless Steel, Rubber, Silicone Non ... | Zimmer Spine is has received complaints of difficulty in turning the implant release knob of the... | Class II | Zimmer, Inc. |
| Sep 20, 2012 | The Trilogy Acetabular System Shell with Cluster Holes Porous 56 mm O.D. S... | Zimmer Trilogy¿ Acetabular System Shell with Cluster Holes, Porous,56 MM O.D., sterile; is missin... | Class II | Zimmer, Inc. |
| Sep 14, 2012 | Trilogy Acetabular Shell with Cluster Holes. 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 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 | Trochar Scalpel Instrument (Surgical Punch) OrthoPediatrics intramedullary... | A complaint received from sales representative that a replenishment instrument was too short. Upo... | Class II | OrthoPediatrics Corp |
| 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. |
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.