Browse Device Recalls
1,516 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,516 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 1,516 FDA device recalls in FL.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 10, 2018 | ProSun Onyx 32 Sli Intensive (12 minutes) tanning bed, Model 32/1. Labeled a... | ProSun International LLC discovered discrepancies in their Quality Control Checklist documentatio... | Class II | ProSun International, LLC |
| Dec 5, 2018 | Equinoxe Preserve Humeral Stem, 8mm Product Usage: The Equinoxe Preserve ... | Possibility that the Equinoxe Preserve Humeral Stem, 8mm, was inadvertently packaged with an Opt... | Class II | Exactech, Inc. |
| Nov 19, 2018 | Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on... | Potentially lead to anchor breakage during insertion, | Class II | Arthrex, Inc. |
| Nov 19, 2018 | Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600... | HVAD Battery Charger units manufactured with wrong inductors. | Class II | Heartware, Inc. |
| Nov 5, 2018 | enVista One Piece Hydrophobic Acrylic Intraocular lens - Is indicated for... | Cosmetic imperfections on the surface of some lenses. | Class II | Bausch & Lomb Surgical, Inc. |
| Nov 2, 2018 | RadPRO(R) Mobile 40kW Digital X-Ray System - Model: SM-40HF-B-D-C Produ... | There is a potential for the RadPRO Mobile 40kW Digital X-Ray System Model SM-40HF-B-D-C to separ... | Class II | Virtual Imaging, Inc. |
| Nov 2, 2018 | Ascom Telligence Nurse Call System | There is an issue that could cause the Telligence System Gateway II, NGGTWY2 H, to stop communica... | Class II | Ascom (US) Inc. |
| Oct 16, 2018 | Family Wellness First Aid Sterile Gauze Pad 3 in x 3 in, 10 CT. White, ble... | Potential that gauze pads may not be fully sterilized | Class II | ASO, LLC |
| Sep 26, 2018 | TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straig... | During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connecto... | Class I | Oscor, Inc. |
| Sep 24, 2018 | Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388 | The Invasive Blood Pressure (IBP) numeric values will freeze on the display when any of the follo... | Class II | Invivo Corporation |
| Sep 13, 2018 | 3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibul... | There is potential to break during use. | Class II | Arthrex, Inc. |
| Sep 5, 2018 | Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to ... | Product may not meet the internal manufacturing shaft subassembly burst strength specification (F... | Class II | Cordis Corporation |
| Aug 28, 2018 | Heart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers: 14... | Certain HVAD System Controller units may not meet the labeled standard for protection against wat... | Class II | Heartware, Inc. |
| Aug 27, 2018 | Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System Product Usage... | The Li-ion Battery Housing for the AR-400 DrillSaw Sports 400 System may not provide a complete s... | Class II | Arthrex, Inc. |
| Aug 21, 2018 | Genicon GENILook Model 200-005-251, 5mm diameter, 150mm length (one cannula, ... | There is potential for the plastic optical tip to become detached from the metal shaft. | Class II | Genicon, Inc. |
| Aug 21, 2018 | Genicon Natura Model 210-005-052, 5mm diameter, 70mm length (two cannula, thr... | There is potential for the plastic optical tip to become detached from the metal shaft. | Class II | Genicon, Inc. |
| Aug 21, 2018 | Genicon GENILook Model 200-105-152, 5mm diameter, 100mm length (2 cannula) - ... | There is potential for the plastic optical tip to become detached from the metal shaft. | Class II | Genicon, Inc. |
| Aug 21, 2018 | Genicon GENILook Model 200-105-251, 5mm diameter, 150mm length (1 cannula) - ... | There is potential for the plastic optical tip to become detached from the metal shaft. | Class II | Genicon, Inc. |
| Aug 21, 2018 | Genicon GENILook Model 200-105-252, 5mm diameter, 150mm length (2 cannula) - ... | There is potential for the plastic optical tip to become detached from the metal shaft. | Class II | Genicon, Inc. |
| Aug 21, 2018 | Genicon Natura Model 210-005-151; 5mm diameter, 100mm length (one cannula, th... | There is potential for the plastic optical tip to become detached from the metal shaft. | Class II | Genicon, Inc. |
| Aug 21, 2018 | Genicon Natura Model 210-005-251, 5mm diameter, 150mm length (one cannula, th... | There is potential for the plastic optical tip to become detached from the metal shaft. | Class II | Genicon, Inc. |
| Aug 21, 2018 | Genicon Natura Model 210-005-051; 5mm diameter, 70mm length (one cannula, thr... | There is potential for the plastic optical tip to become detached from the metal shaft. | Class II | Genicon, Inc. |
| Aug 21, 2018 | Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: S... | The Equinoxe Reverse Drill Bit Kits may contain two 2mm diameter drill bits instead of one 2mm di... | Class II | Exactech, Inc. |
| Aug 21, 2018 | Genicon GENILook Model 200-005-153; 5mm diameter, 100mm length (three cannula... | There is potential for the plastic optical tip to become detached from the metal shaft. | Class II | Genicon, Inc. |
| Aug 21, 2018 | Genicon Natura Model 210-105-251, 5mm diameter, 150mm length (1 cannula) - Pr... | There is potential for the plastic optical tip to become detached from the metal shaft. | Class II | Genicon, Inc. |
| Aug 21, 2018 | Genicon GENILook Model 200-005-151, 5mm diameter, 100mm length (one cannula, ... | There is potential for the plastic optical tip to become detached from the metal shaft. | Class II | Genicon, Inc. |
| Aug 21, 2018 | Genicon GENILook Model 200-105-151, 5mm diameter, 100mm length (one cannula) ... | There is potential for the plastic optical tip to become detached from the metal shaft. | Class II | Genicon, Inc. |
| Aug 21, 2018 | Genicon Natura Model 210-005-152, 5mm diameter, 100mm length (two cannula, th... | There is potential for the plastic optical tip to become detached from the metal shaft. | Class II | Genicon, Inc. |
| Aug 21, 2018 | Genicon GENILook Model 200-005-152, 5mm diameter, 100mm legnth (2 cannula, th... | There is potential for the plastic optical tip to become detached from the metal shaft. | Class II | Genicon, Inc. |
| Aug 3, 2018 | Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Versio... | Released with an incorrect, older firmware version installed. May result in intermittent loss of... | Class II | Invivo Corporation |
| Aug 1, 2018 | Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, ... | Potentially counterfeit products in/and counterfeit packaging were imported to the U.S. | Class II | Allied Vision Group Inc |
| Jul 24, 2018 | Stryker Mako Vizadisc Hip Procedure Tracking Kit | Specific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Procedure Tracking Kit... | Class II | Mako Surgical Corporation |
| Jul 24, 2018 | Stryker Mako Vizadisc Knee Procedure Tracking Kit | Specific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Procedure Tracking Kit... | Class II | Mako Surgical Corporation |
| Jul 23, 2018 | Johnson and Johnson Vision Care 1-Day ACUVUE MOIST Daily Wear, 8.5 Base Curve... | Johnson and Johnson Vision Care received a number of reports of a partially formed contact lens, ... | Class II | Johnson & Johnson Vision Care, Inc. |
| Jul 13, 2018 | Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components f... | Exactech is recalling the Tibial Alignment Guide because the Global Trade Item Number (GTIN) on t... | Class II | Exactech, Inc. |
| Jul 12, 2018 | OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left, REF ZBH-PSN... | Some sensors were reported to have fluid inside the posterior lateral corner post-surgery. | Class II | Orthosensor, Inc. |
| Jul 12, 2018 | OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, REF ZBH-PSNC... | Some sensors were reported to have fluid inside the posterior lateral corner post-surgery. | Class II | Orthosensor, Inc. |
| Jul 12, 2018 | OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, REF ZBH-PSN... | Some sensors were reported to have fluid inside the posterior lateral corner post-surgery. | Class II | Orthosensor, Inc. |
| Jul 12, 2018 | OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, REF ZBH-PS... | Some sensors were reported to have fluid inside the posterior lateral corner post-surgery. | Class II | Orthosensor, Inc. |
| Jul 12, 2018 | OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Right, REF ZBH-PS... | Some sensors were reported to have fluid inside the posterior lateral corner post-surgery. | Class II | Orthosensor, Inc. |
| Jul 12, 2018 | OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, REF ZBH-PSN... | Some sensors were reported to have fluid inside the posterior lateral corner post-surgery. | Class II | Orthosensor, Inc. |
| Jun 29, 2018 | Baby Quasar Plus, Light Therapy System, packaging, box, sleeve and user manua... | Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the p... | Class II | Quasar Bio-Tech, Inc. |
| Jun 29, 2018 | Quasar MD Plus, Light Therapy System, packaging, box, sleeve and user manual.... | Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the p... | Class II | Quasar Bio-Tech, Inc. |
| Jun 29, 2018 | Pure Rayz, Light Therapy System, packaging, box, sleeve and user manual. Hand... | Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the p... | Class II | Quasar Bio-Tech, Inc. |
| Jun 27, 2018 | Genicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device i... | Genicon is providing updated IFU labeling to users to provide clarity on how to use the device fo... | Class II | Genicon, Inc. |
| Jun 22, 2018 | Clarity Urocheck 10SG Urinalysis Strips, Model # DTG-10SG Product Usage: ... | Clarity Diagnostics LLC discovered specific lots of Clarity 10SG Strips are not compatible for u... | Class III | Clarity Diagnostics Llc |
| Jun 18, 2018 | J-Plasma Precise 360, single use, disposable. The Bovie J-Plasma Precise ... | There is a potential risk associated with the PEEK tip of the J-Plasma Precise 360 Handpiece sepa... | Class II | Bovie Medical Corporation |
| May 15, 2018 | CAREstream ProNox Nitrous Oxide Delivery System labeled as the following: ... | Two analgesic gas delivery system oxygen/nitrous oxide mixers were reported to have delivered hig... | Class II | CAREstream Medical LLC |
| May 10, 2018 | Rio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS... | Out of tolerance. | Class II | Mako Surgical Corporation |
| May 8, 2018 | Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total... | Potentially have non-conforming internal threads. | Class II | Exactech, 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.