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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 14, 2020 | A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 90M... | Distributed to the field without having completed design history files or design transfer activities | Class II | Biomet |
| May 14, 2020 | A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM LOCKING PEG 60MM , Item Numbe... | Distributed to the field without having completed design history files or design transfer activities | Class II | Biomet |
| May 14, 2020 | A.L.P.S. T15 Multi-Directional Locking Screw 3.5mm x 60mm, Item Number: 11001... | Distributed to the field without having completed design history files or design transfer activities | Class II | Biomet |
| May 14, 2020 | A.L.P.S PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 3.2MM, Item... | Distributed to the field without having completed design history files or design transfer activities | Class II | Biomet |
| May 14, 2020 | DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left) -... | The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled. | Class II | Neocis Inc. |
| May 1, 2020 | Biomet Outer Sheath 4.5/5.0,6.5- Orthopedic Manual Surgical Instrument Produ... | Device and tray that houses the device did not pass steam sterilization process validation testing | Class II | Biomet |
| May 1, 2020 | Biomet Screw Instrument Tray 6.5/80MM- Surgical Tray Product Code: 246111003 | Device and tray that houses the device did not pass steam sterilization process validation testing | Class II | Biomet |
| Apr 20, 2020 | Renuvion/ J-Plasma Precise Handpiece. Catalog numbers BVX-150B, BVX-270B, B... | Unexpected stress fractures on the shaft of the hand piece may result in fragmentation during cli... | Class II | Bovie Medical Corporation |
| Apr 20, 2020 | Renuvion/ J-Plasma Precise Open Handpiece. Catalog numbers BVX-044-BPS, BVX-... | Unexpected stress fractures on the shaft of the hand piece may result in fragmentation during cli... | Class II | Bovie Medical Corporation |
| Apr 20, 2020 | TRUE METRIX SELF MONITORING BLOOD GLUCOSE SYSTEM - Product Usage: is intended... | One (1) TRUE METRIX AIR blood glucose meter distributed in the United States was packaged into a ... | Class II | Trividia Health, Inc. |
| Apr 3, 2020 | Heartware HVAD Pump Implant accessories, Product (REF) Number 1153 | The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-im... | Class I | Heartware, Inc. |
| Apr 3, 2020 | Heartware HVAD Pump Implant Kit, Product (REF) Number 1104JP | The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-im... | Class I | Heartware, Inc. |
| Apr 3, 2020 | Heartware HVAD Pump Implant Kit, Product (REF) Number 1104 | The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-im... | Class I | Heartware, Inc. |
| Apr 3, 2020 | Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125 | The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-im... | Class I | Heartware, Inc. |
| Apr 3, 2020 | Heartware HVAD Pump Implant Kit, Product (REF) Number 1103 | The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-im... | Class I | Heartware, Inc. |
| Mar 2, 2020 | Merits E604 Pilot Navigator Stairlift - Product Usage: To transport patients ... | Pinion gear may disengage from track allowing lift to slip or jolt. | Class II | Merits Holdings Co. dba Merits Health Products,... |
| Feb 17, 2020 | iChemVELOCITY Strips, Catalog 800-7212 | The Leukocyte and Compensation pads were switched on some vials of lot number 7212269M of the iCh... | Class II | Beckman Coulter, Inc. |
| Feb 6, 2020 | Monitor for the Functional Imaging System for Magnetic Resonance Imaging System | Insufficient shielding of Philips SensaVue DVI Adapter for computer monitor. | Class II | Invivo Corporation |
| Jan 27, 2020 | Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices ar... | These Truliant Splined Stem Extension, 18mm x 120mm were found to have a labeling error. The uppe... | Class II | Exactech, Inc. |
| Jan 27, 2020 | fridababy SmileFrida the TOOTHHUGGER 18+ months Triple Angle Brush Cleans A... | FridaBaby has been made aware through customer reports that the product is being used outside of ... | Class II | Fridababy LLC |
| Jan 23, 2020 | HeartWare HVAD System Battery Charger The HeartWare HVAD System is indica... | Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVA... | Class I | Heartware, Inc. |
| Jan 23, 2020 | HeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD System... | Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVA... | Class I | Heartware, Inc. |
| 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 |
| Jan 8, 2020 | Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S | Cordis is recalling one (1) lot of POWERFLEX P3 PTA Dilatation Catheter due to the potential for ... | Class II | Cordis Corporation |
| Jan 2, 2020 | Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; ... | A mix-up of autosampler tube positions with a possibility of misidentification of sample results ... | Class II | Clinical Diagnostic Solutions, Inc. |
| Dec 23, 2019 | MVAP MEDICAL SUPPLIES INC, Mavidon CardioPrep Single, 24 use cups, Re order #... | Samples of 114gm tubes of Lemon Prep, collected during a Food and Drug Administration inspection ... | Class II | Carroll-Baccari, Inc. |
| Dec 23, 2019 | PediaPrep Tubes (MD0033-T) and Single use cups (MD0033-SUP) | Samples of 114gm tubes of Lemon Prep, collected during a Food and Drug Administration inspection ... | Class II | Carroll-Baccari, Inc. |
| Dec 23, 2019 | Wave Prep Tubes (1710-03) and single use cups (17--00-24) | Samples of 114gm tubes of Lemon Prep, collected during a Food and Drug Administration inspection ... | Class II | Carroll-Baccari, 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.