Browse Device Recalls

3,191 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,191 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 3,191 FDA device recalls.

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DateProductReasonClassFirm
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
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.

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.