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Browse Device Recalls

1,503 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,503 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 1,503 FDA device recalls in FL.

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DateProductReasonClassFirm
Oct 6, 2016 14cm QD Angle Attachment Product Usage: Product attachment Supplied Directions for Use (DFU) did not contain a recommended service interval. Class II The Anspach Effort, Inc.
Oct 6, 2016 IMRI AIR CONTROL Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class II The Anspach Effort, Inc.
Oct 6, 2016 SMALL ATTACHMENT, J-LATCH Supplied Directions for Use (DFU) did not contain a recommended service interval. Class II The Anspach Effort, Inc.
Oct 6, 2016 6.8cm Controlled Depth Attachment Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class II The Anspach Effort, Inc.
Oct 6, 2016 Electric Handpiece EM Hand Control Product Usage: Electric system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class II The Anspach Effort, Inc.
Oct 6, 2016 14cm QD Angle Attachment Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class II The Anspach Effort, Inc.
Oct 6, 2016 Keyless Driver Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class II The Anspach Effort, Inc.
Oct 6, 2016 SCC Soft Computer Softbank II software Product Usage: Supports single and... Software error. Potential for incorrect results Class II Soft Computer Consultants, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 8F C70¿ S79CM D84CM Catalog # AB081045 Is designed... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 8F C120¿ S61CM D66CM Catalog # AB081043 Is design... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 8F C90¿ S79CM D84CM Catalog # AB081046 Is designed ... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB10218 Is des... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 8F C120¿ S79CM D84CM Catalog # AB081047 Is design... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 8F C70¿ S61CM D66CM Catalog # AB081041 Is designed... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 10F C120¿ S79CM D84CM Catalog # AB101078 Is desig... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 10F C120¿ S61CM D66CM Catalog # AB101075 Is desig... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 10F C55¿ S61CM D66CM Catalog # AB101072 Is designe... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Cata... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR BREEZEWAY 10F S60.8CM D65.6CM FIRM TIP Catalog # AB1061FT Is designed ... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S79CM D84CM GLOBAL Cat... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBAL Cata... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 10F C70¿ S79CM D84CM Catalog # AB101077 Is design... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 8F C55¿ S79CM D84CM Catalog # AB081044 Is designed... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB101218 Is de... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C120¿ S61CM D66CM GLOBAL Cat... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 8F STRAIGHT S61CM D66CM Catalog # AB081210 Is des... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 8F C55¿ S61CM D66CM Catalog # AB081040 Is designed... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 8F C90¿ S61CM D66CM Catalog # AB081042 Is designed... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBALCatal... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S79CM D84CM GLOBAL Cat... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 10F C70¿ S61CM D66CM Catalog # AB101073 Is design... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 10F C55¿ S79CM D84CM Catalog # AB101076 Is design... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZWAY 8F STRAIGHT S79CM D84CM Catalog # AB081211 Is desi... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S61CM D66CM GLOBAL Ca... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 10F C90¿ S79CM D84CM Catalog # AB101078 Is designe... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Cata... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S79CM D84CM GLOBAL Cat... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZWAY 10F STRAIGHT S79CM D84CM Catalog # AB101219 Is des... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Sep 29, 2016 Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only Product Usage: ... Failure of the Offset Cup Reamer Handle not engaging its mating components. Class II Mako Surgical Corporation
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

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.