Browse Device Recalls
3,264 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,264 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 3,264 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 7, 2016 | Medacta International SA, M.U.S.T. Rod, REF 03.50.433, Size 5.5mm, Length 480... | Damaged packaging, lack of sterility assurance | Class II | Medacta Usa Inc |
| Dec 7, 2016 | Femoral Integral Shaft & Stem 15x27 HA Coated; Femoral Integral Shaft & Ste... | The recalling firm has received 5 customer inquiries reporting that at least one pouch of the dou... | Class II | Stanmore Implants Worldwide Ltd. |
| Dec 7, 2016 | Tibial Component Fixed Hinge Small Long; Tibial Component Fixed Hinge Small S... | The recalling firm has received 5 customer inquiries reporting that at least one pouch of the dou... | Class II | Stanmore Implants Worldwide Ltd. |
| Dec 6, 2016 | Reprocessed Electrophysiology Catheter Cables Catalog Number: CB3434CT, D134... | A breach in the sterile packaging may have occurred resulting in potentially non-sterile product. | Class II | Stryker Sustainability Solutions |
| Dec 6, 2016 | Reprocessed Ablation Catheter Cable Catalog Number: CR3425CT, CR3434CT Ab... | A breach in the sterile packaging may have occurred resulting in potentially non-sterile product. | Class II | Stryker Sustainability Solutions |
| Nov 29, 2016 | Atrium Medical Oasis Blood Recovery Drains as follows: 3650-100 Oasis Blood ... | Outer Packaging is not sterile | Class II | Atrium Medical Corporation |
| Nov 29, 2016 | Atrium Medical 3620-100: Oasis dual chamber drain with in-line connectors (2 ... | Outer Packaging is not sterile | Class II | Atrium Medical Corporation |
| Nov 29, 2016 | Atrium Medical 16400 Express Mini 500 dry seal drain Product Usage: To evac... | Outer Packaging is not sterile | Class II | Atrium Medical Corporation |
| Nov 29, 2016 | Atrium Medical Ocean Blood Recovery Drains as follows: 2050-000 Ocean Blood... | Outer Packaging is not sterile | Class II | Atrium Medical Corporation |
| Nov 29, 2016 | Atrium Medical Ocean Drains as follows: 2002-000 Ocean single drain, with i... | Outer Packaging is not sterile | Class II | Atrium Medical Corporation |
| Nov 29, 2016 | Atrium Medical Pediatric Chamber Ocean Drains as follows: 2012-320 Ocean In... | Outer Packaging is not sterile | Class II | Atrium Medical Corporation |
| Nov 29, 2016 | Atrium Medical Oasis Single Drain as follows: 3600-100 Oasis single drain w... | Outer Packaging is not sterile | Class II | Atrium Medical Corporation |
| Nov 29, 2016 | Atrium Medical Oasis Pediatric Drain as follows: 3612-100 Oasis Infant/Pedi... | Outer Packaging is not sterile | Class II | Atrium Medical Corporation |
| Nov 29, 2016 | Atrium Medical Dual Chamber Ocean Drains as follows: 2020-000 Ocean dual ch... | Outer Packaging is not sterile | Class II | Atrium Medical Corporation |
| Nov 29, 2016 | Atrium Medical 400 Series Express Drains as follows: 4000-100N Express sing... | Outer Packaging is not sterile | Class II | Atrium Medical Corporation |
| Nov 11, 2016 | Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endosco... | An increase in reports indicating that the reprocessed H12LP Trocar adjustable plug may break in ... | Class II | Stryker Sustainability Solutions |
| Nov 9, 2016 | GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stry... | A review of packaging revealed the seal integrity of the pouch may be compromised. More specifica... | Class II | Stryker Howmedica Osteonics Corp. |
| Nov 9, 2016 | Elana Surgical KitHUD The Elana Surgical KitHUD, when connected to the Spect... | Elana has issued this Field Action to voluntarily remove specific serial numbers of our Elana Sur... | Class II | Elana, Inc. |
| Oct 31, 2016 | ELCA Coronary Atherectomy Catheter. Models: 110-001, 110-002, 110-004, 114-00... | Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Cath... | Class II | Spectranetics Corporation |
| Oct 31, 2016 | Turbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159,... | Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Cath... | Class II | Spectranetics Corporation |
| Oct 31, 2016 | Bridge Occlusion Balloon. Model: 590-001 Temporary vessel occlusion of the s... | Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Cath... | Class II | Spectranetics Corporation |
| Oct 20, 2016 | Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number S... | The sterile packaging may contain small channels in the seal of the pouch, If the channels are p... | Class II | Micromedics, Inc. |
| Oct 14, 2016 | Covidien Precision Specimen Container- 4 oz (118 mL), Plastic Screw Top Cap, ... | Sterility of the outer surface of the container compromised due to packaging defect. | Class II | Covidien LLC |
| Oct 12, 2016 | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCR... | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | Class II | DePuy Spine, Inc. |
| Oct 12, 2016 | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE OVERSIZED SCREW ... | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | Class II | DePuy Spine, Inc. |
| Oct 12, 2016 | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED OVERSIZED SCRE... | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | Class II | DePuy Spine, Inc. |
| Oct 12, 2016 | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SC... | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | Class II | DePuy Spine, Inc. |
| Oct 12, 2016 | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCRE... | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | Class II | DePuy Spine, Inc. |
| Oct 12, 2016 | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-TAPPING ... | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | Class II | DePuy Spine, Inc. |
| Oct 12, 2016 | Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic ... | According to firm ( Bausch & Lomb, Inc. ) on June 17, 2016 a packaging operator notified his sup... | Class II | Bausch & Lomb, Inc. |
| Oct 12, 2016 | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCR... | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | Class II | DePuy Spine, Inc. |
| Sep 29, 2016 | FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is inten... | A complaint was received on September 27th, 2016 at a medical center in Germany for delamination ... | Class I | SentreHeart Inc |
| Sep 29, 2016 | Professional Hospital Supply, Inc Custom Packaging containing the Devon Light... | Added Instructions for Use: After application, inspect the Light Glove for barrier integrity | Class II | Covidien LLC |
| Sep 14, 2016 | BIOMET 3i LOW PROFILE ABUTMENT QUICKBRIDGE An endosseous dental implant abut... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED TEMPORARY CYLINDER An endosseous ... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 3MM(H) An endosseous dental im... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 3.4MM(D) X 2MM(H) An endosseous denta... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 4.1MM(D) X 3MM(H) An endosseous d... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) TRANSFER IMPRESSION COPING An e... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 4MM(H) An endosseous d... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 1MM(H) An endoss... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i LOW PROFILE ABUTMENT HEXED TEMPORARY CYLINDER An endosseous dent... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i LOW PROFILE ABUTMENT HEALING CAP An endosseous dental implant abut... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 5MM(H) An endosseous dental im... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 4MM(H) An endoss... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i LOW PROFILE ABUTMENT (HEXED) PICK-UP IMPRESSION COPING An endosseo... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 4.1MM(D) X 5MM(H) An endosseous d... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 3.4MM(D) X 4MM(H) An endosseous d... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H) An endosseous den... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 3.4MM(D) X 2MM(H) An endosseous d... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
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.