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 |
|---|---|---|---|---|
| Sep 14, 2016 | BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED PREFORMANCE TEMPORARY CYLINDER An... | 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 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 CERTAIN LOW PROFILE 30¿ ABUTMENT 3.4MM(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 LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(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 LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 1MM(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 ABUTMENT 4.1MM(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 ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(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 (NON-HEXED) PICK-UP IMPRESSION COPING An en... | 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 17¿ ABUTMENT 4.1MM(D) X 2MM(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 2MM(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 30¿ ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental i... | 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 4.1MM(D) X 1MM(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 ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(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 TITANIUM RETAINING SCREW An endosseous dental... | 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 4.1MM(D) X 1MM(H) An endosseous dental implan... | 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 4.1MM(D) X 3MM(H) An endosseous dental implan... | 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 2MM(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 3MM(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 LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental im... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Aug 23, 2016 | Integra Lumbar Drainage Set, REF 910120A, Sterile EO, Rx only, primary packag... | During final sampling inspection, one of the lots was discovered with a total incomplete packagin... | Class II | Integra LifeSciences Corp. |
| Aug 23, 2016 | CUSA Dissectron Fingertip Laparoscopic Cannula, REF F75221, Sterile EO, Rx on... | During final sampling inspection, one of the lots was discovered with a total incomplete packagin... | Class II | Integra LifeSciences Corp. |
| Aug 23, 2016 | Integra Straight Ventricular Catheter F8, 25 cm, Sterile EO, Rx only, package... | During final sampling inspection, one of the lots was discovered with a total incomplete packagin... | Class II | Integra LifeSciences Corp. |
| Aug 23, 2016 | Integra Drainage Accessory Kits, REF 910122, Sterile EO, Rx only, packaged in... | During final sampling inspection, one of the lots was discovered with a total incomplete packagin... | Class II | Integra LifeSciences Corp. |
| Aug 23, 2016 | Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, ... | During final sampling inspection, one of the lots was discovered with a total incomplete packagin... | Class II | Integra LifeSciences Corp. |
| Aug 23, 2016 | Integral Lumbar Drainage Set, REF 910420, Sterile EO, Rx only, primary packag... | During final sampling inspection, one of the lots was discovered with a total incomplete packagin... | Class II | Integra LifeSciences Corp. |
| Aug 17, 2016 | Sagittal Blade 18.0X0.97X90MM, Model Number: 6118-097-090 Product Usage: ... | Stryker Instruments is voluntarily recalling the Sagittal Blade 18.0X.97X90MM due to the potentia... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Aug 5, 2016 | Polypropylene Surgical Sutures, brand Webglo, for vet use. Product is sterile... | Polypropylene Surgical Sutures are recalled because the seals may become open during distribution... | Class II | Riverpoint Medical, LLC |
| Aug 5, 2016 | Nylon Surgical Suture for human use and vet use, sold under brand name Riverl... | Nylon Surgical Sutures are recalled because the seals may become open during distribution or subs... | Class II | Riverpoint Medical, LLC |
| Aug 2, 2016 | Acecide-C High Level Disinfectant & Sterilant 875 mL. Packaging is 6 inner ca... | Certain lots of the acid solution in Acecide-C are degrading faster than normal. | Class II | Best Sanitizers Inc |
| Jul 26, 2016 | Cobalt HV Bone Cement Product Usage: Cobalt HV Bone Cement provides two s... | The outer packaging was mislabeled on the box indicating "Cobalt HV with Gentamicin". The bone c... | Class II | Encore Medical, Lp |
| Jul 19, 2016 | Smith & Nephew Whipknot Soft Tissue Cinch (USP#5) suture. PN: 7211015 Used ... | Sterility compromised due to breach in sterile packaging | Class II | Smith & Nephew, Inc. |
| Jul 15, 2016 | Affinity Four Birthing Bed Model P3700 The primary packaging is pictured... | Class II | Hill-Rom, Inc. | |
| Jul 14, 2016 | Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Mi... | Ecolab is recalling 2 models of Angiography Drapes with Radiation Shields because the sterile pac... | Class II | Ecolab Inc |
| Jul 13, 2016 | 6F/7F MynxGrip Vascular Closure Device; Product Model MX6721, Product Usa... | A total of 70 6F/7F Mynx Grip devices were shipped from a distributor using improper transport/pa... | Class II | AccessClosure, Inc., A Cardinal Health Company |
| Jul 5, 2016 | AmediCheck Instant Test Cup, Part No. C-C0501A-3A Product Usage: The Amed... | Branan Medical is recalling the AmediCheck Instant Test Cup, a 5 panel drug cup, because it may e... | Class III | Branan Medical Corporation |
| Jun 30, 2016 | Avenir M¿ller Stem 4 Standard Avenir M¿ller Stem 6 Lateral Hip joint meta... | Product mix-up. The Avenir M¿ller Stem 6 lateral uncemented might be placed in the packaging o... | Class II | Zimmer Gmbh |
| Jun 27, 2016 | CORE¿ Trumpet Handpiece with 5mm x 32cm Length Probe , Catalog Number CD8400 ... | The packaging seal may contain a crease. The crease may result in an open channel. These channel... | Class II | ConMed Corporation |
| Jun 27, 2016 | CORE¿ Suction Irrigation Handpiece Y-Tubing set, with 5mm x 32cm Length Probe... | The packaging seal may contain a crease. The crease may result in an open channel. These channel... | Class II | ConMed Corporation |
| Jun 27, 2016 | CORE¿ Suction Irrigation Handpiece without Probe for Single Solution or Dual ... | The packaging seal may contain a crease. The crease may result in an open channel. These channel... | Class II | ConMed Corporation |
| Jun 27, 2016 | CORE¿ Trumpet Handpiece only, Catalog Number CD8450 The CORE Trumpet (CD81XX... | The packaging seal may contain a crease. The crease may result in an open channel. These channel... | Class II | ConMed Corporation |
| Jun 27, 2016 | CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single So... | The packaging seal may contain a crease. The crease may result in an open channel. These channel... | Class II | ConMed Corporation |
| Jun 27, 2016 | CORE¿ Suction Irrigation Handpiece without Probe for Single Solution Bags, Ca... | The packaging seal may contain a crease. The crease may result in an open channel. These channel... | Class II | ConMed Corporation |
| Jun 27, 2016 | CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single So... | The packaging seal may contain a crease. The crease may result in an open channel. These channel... | Class II | ConMed Corporation |
| Jun 22, 2016 | Clearview MONO (Whole Blood, Serum, Plasma), Catalog No. 92401 a simple tes... | The Positive Control information referencing human plasma as the antibody material described in t... | Class III | Alere San Diego, Inc. |
| Jun 22, 2016 | Stanbio Rely Mono Rapid Test, Catalog No. 6200-010L and 6200-020L a simple ... | The Positive Control information referencing human plasma as the antibody material described in t... | Class III | Alere San Diego, Inc. |
| Jun 22, 2016 | Proadvantage Mono Rapid Test Cassette, Catalog No. P080016 a simple test th... | The Positive Control information referencing human plasma as the antibody material described in t... | Class III | Alere San Diego, Inc. |
| Jun 22, 2016 | Signify Mono (Whole Blood, Serum, Plasma), Catalog No. 01P52-25 a simple te... | The Positive Control information referencing human plasma as the antibody material described in t... | Class III | Alere San Diego, Inc. |
| Jun 22, 2016 | Cardinal Health Mono Rapid Test, Catalog No. B1077-28, a simple test that u... | The Positive Control information referencing human plasma as the antibody material described in t... | Class III | Alere San Diego, Inc. |
| Jun 22, 2016 | Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 a simple ... | The Positive Control information referencing human plasma as the antibody material described in t... | Class III | Alere San Diego, Inc. |
| Jun 22, 2016 | Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92... | The Positive Control information referencing human plasma as the antibody material described in t... | Class III | Alere San Diego, 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.