Browse Device Recalls
222 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 222 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 222 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 31, 2020 | CERTAIN BELLATEK TIN ABUTMENT 5.0MM Reference Number: IEDAN5 | Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing... | Class II | Biomet 3i, LLC |
| Aug 31, 2020 | CERTAIN BELLATEK TITANIUM ABUTMENT 6.0MM Reference Number: IEDAT6 | Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing... | Class II | Biomet 3i, LLC |
| Aug 31, 2020 | BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Reference Numbe... | Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing... | Class II | Biomet 3i, LLC |
| Aug 31, 2020 | CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: IEDAT4 | Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing... | Class II | Biomet 3i, LLC |
| Aug 31, 2020 | CERTAIN BELLATEK TIN ABUTMENT 4.1MM Reference Number: IEDAN4 | Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing... | Class II | Biomet 3i, LLC |
| Aug 31, 2020 | CERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM Reference Number: IEDAT5 | Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing... | Class II | Biomet 3i, LLC |
| Aug 31, 2020 | BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: EDAT4 | Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing... | Class II | Biomet 3i, LLC |
| Jan 10, 2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 6MM(H) Refe... | Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... | Class II | Biomet 3i, LLC |
| Jan 10, 2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 3MM(H) Refere... | Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... | Class II | Biomet 3i, LLC |
| Jan 10, 2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 4MM(H) Refere... | Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... | Class II | Biomet 3i, LLC |
| Jan 10, 2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) ... | Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... | Class II | Biomet 3i, LLC |
| Jan 10, 2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 7.5MM(P) X 4MM(H) Reference... | Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... | Class II | Biomet 3i, LLC |
| Jan 10, 2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 3MM(H) Referen... | Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... | Class II | Biomet 3i, LLC |
| Jan 10, 2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 4MM(H) Referen... | Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... | Class II | Biomet 3i, LLC |
| Jan 10, 2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 7.5MM(P) X 4MM(H) Refer... | Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... | Class II | Biomet 3i, LLC |
| Jan 10, 2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 6MM(H) Referen... | Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... | Class II | Biomet 3i, LLC |
| Jan 10, 2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 4MM(H) Referen... | Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... | Class II | Biomet 3i, LLC |
| Jan 10, 2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 3MM(H) Refe... | Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... | Class II | Biomet 3i, LLC |
| Jan 10, 2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 3MM(H) Referen... | Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... | Class II | Biomet 3i, LLC |
| Jan 10, 2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 6MM(H) Refere... | Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... | Class II | Biomet 3i, LLC |
| Jan 10, 2020 | CERTAIN¿ BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 4MM(H) Ref... | Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... | Class II | Biomet 3i, LLC |
| Jan 10, 2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 3MM(H) Referenc... | Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... | Class II | Biomet 3i, LLC |
| Jan 10, 2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) ... | Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... | Class II | Biomet 3i, LLC |
| Jan 10, 2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 6MM(H) Refere... | Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... | Class II | Biomet 3i, LLC |
| Jan 10, 2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H) Refer... | Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... | Class II | Biomet 3i, LLC |
| Jan 10, 2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 3MM(H) Refere... | Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... | Class II | Biomet 3i, LLC |
| Jan 10, 2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 6MM(H) Referen... | Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... | Class II | Biomet 3i, LLC |
| Jan 10, 2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 4MM(H) Refe... | Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... | Class II | Biomet 3i, LLC |
| Jan 10, 2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 6MM(H) Referen... | Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... | Class II | Biomet 3i, LLC |
| Jan 10, 2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 3MM(H) Referenc... | Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... | Class II | Biomet 3i, LLC |
| Feb 26, 2019 | CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number ILDAT3 - Product ... | During manufacturing, the screw stop ledge was not made to specification and location within the ... | Class II | Biomet 3i, LLC |
| Feb 26, 2019 | CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number IEDAN3 - Product Usage... | During manufacturing, the screw stop ledge was not made to specification and location within the ... | Class II | Biomet 3i, LLC |
| Feb 26, 2019 | CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IEDAT3 - Product ... | During manufacturing, the screw stop ledge was not made to specification and location within the ... | Class II | Biomet 3i, LLC |
| Feb 26, 2019 | CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IIAT3 - Product ... | During manufacturing, the screw stop ledge was not made to specification and location within the ... | Class II | Biomet 3i, LLC |
| Feb 26, 2019 | CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number ILDAN3 - Product Usage... | During manufacturing, the screw stop ledge was not made to specification and location within the ... | Class II | Biomet 3i, LLC |
| Mar 8, 2017 | BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within ... | A single lot of product that potentially has a single part within the lot that does not match the... | Class II | Biomet 3i, 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 |
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.