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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.

Clear
DateProductReasonClassFirm
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.
May 2, 2018 Heartware Medtronic HVAD System for cardiac use. Including the following pa... Possible transient electrical connection interruption between an HVAD System power source (Batter... Class I Heartware
Apr 12, 2018 VitalGo Total Lift Bed VG-TLB425T-TQR, Version 71064V0-27003 Potential for unintentional movement of the support surface of the bed from tilted position to ho... Class II Vitalgo Inc.
Apr 9, 2018 VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit IFU contained an automated cleaning process for the VerteLP Instrument Tray that was not validated Class II VGI Medical, LLC
Mar 14, 2018 PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 45356424190... The real-time numeric value for ventricular end-diastolic pressure (EDP) displayed on the Live Di... Class II Invivo Corporation
Feb 27, 2018 FlareHawk Interbody Fusion System (previously XCage Interbody Fusion System) ... Recently Integrity Implants uncovered a discrepancy in the cleaning parameters in several of thei... Class II Integrity Implants Inc.
Feb 8, 2018 J-Plasma Precise(R) OPEN, Catalog Numbers: BVX-044-BPP, BVX-044-BPS, BVX-150-... Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiec... Class II Bovie Medical Corporation
Feb 8, 2018 J-Plasma(R) Handpiece, Catalog Numbers: GS-018C, GS-270C, BVX-270B Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiec... Class II Bovie Medical Corporation
Feb 8, 2018 J-Plasma Precise(R) FLEX, Catalog Number: BVX-500BF Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiec... Class II Bovie Medical Corporation
Feb 8, 2018 J-Plasma Precise(R), Catalog Numbers: BVX-150B, BVX-150N, BVX-330B, BVX- 330... Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiec... Class II Bovie Medical Corporation
Feb 8, 2018 J-Plasma Precise 360(R), Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BV... Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiec... Class II Bovie Medical Corporation
Jan 24, 2018 DynaCad software consist of an MR Analysis Server software and the viewer wor... Following update from 3.3 to 3.5 of the DynaCAD software it was noted that the Ktrans map was not... Class II Invivo Corporation
Jan 19, 2018 Restoris MCK Onlay Insert Extractor. Possible hinge pin disassociation from the Mako Onlay Insert Extractor. Class II Mako Surgical Corporation
Jan 5, 2018 Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic ... Contains a gel-like contaminant that may affect product performance. Class III Diamedix Corporation

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.