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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 1, 2021 SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is ind... There is a potential for distal tip dislodgement or separation. Class II Cordis Corporation
Aug 31, 2021 Medtronic sterile single-use blades that are components of the StraightShot M... There was an increase in complaints related to tip breaks and wobble/vibration. Class II Medtronic Xomed, Inc.
Aug 31, 2021 Medtronic sterile single-use blades that are components of the StraightShot M... There was an increase in complaints related to tip breaks and wobble/vibration. Class II Medtronic Xomed, Inc.
Aug 31, 2021 Medtronic Sterile single-use blades that are components of the StraightShot M... There was an increase in complaints related to tip breaks and wobble/vibration. Class II Medtronic Xomed, Inc.
Aug 30, 2021 OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Com... Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. Class II Exactech, Inc.
Aug 30, 2021 OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Ti... Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. Class II Exactech, Inc.
Aug 30, 2021 OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK ... Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. Class II Exactech, Inc.
Aug 30, 2021 TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the f... Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. Class II Exactech, Inc.
Aug 30, 2021 OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Component... Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. Class II Exactech, Inc.
Aug 30, 2021 OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a.... Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. Class II Exactech, Inc.
Aug 30, 2021 OPTETRAK Comprehensive Knee System custom devices labeled as the following: ... Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. Class II Exactech, Inc.
Aug 30, 2021 Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylen... Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. Class II Exactech, Inc.
Aug 30, 2021 ARTHROFOCUS Polyethylene Tibial Inserts (Product Line: 256-12-XX, 256-13-XX).... Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. Class II Exactech, Inc.
Aug 12, 2021 EcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue), EcoGel 200 MultiP... Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... Class I AMTEC SALES Inc
Aug 6, 2021 Medtronic HVAD Pump Implant Kits There is more force required to slide the driveline cover (boot cover) away from the connector af... Class II Heartware, Inc.
Jul 27, 2021 CareStart COVID-19 Antigen Rapid Diagnostic Test for the detection of SARS-Co... Products may have been distributed to customers other than laboratories certified under the Clini... Class II Versea Diagnostics LLC
Jul 27, 2021 Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Qual... Products may have been distributed to customers other than laboratories certified under the Clini... Class II Versea Diagnostics LLC
Jul 27, 2021 Status COVID-19/Flu Rapid Immunoassay for Direct Detection and Differential D... Products may have been distributed to customers other than laboratories certified under the Clini... Class II Versea Diagnostics LLC
Jul 27, 2021 FaStep COVID-19 IgG/IgM Rapid Test Device Qualitative detection and differen... Products may have been distributed to customers other than laboratories certified under the Clini... Class II Versea Diagnostics LLC
Jul 21, 2021 Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598A Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are bein... Class I Cordis Corporation
Jul 21, 2021 Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MB Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are bein... Class I Cordis Corporation
Jul 21, 2021 Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598B Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are bein... Class I Cordis Corporation
Jul 21, 2021 Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are bein... Class I Cordis Corporation
Jul 21, 2021 Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter,... Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are bein... Class I Cordis Corporation
Jul 19, 2021 Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X The balloon protective sheath may potentially be contaminated with a foreign material left over f... Class II Cordis Corporation
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis ... Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was mar... Class II Exactech, Inc.
Jun 29, 2021 Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip pro... Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was mar... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 23, 2021 Kaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 and 1.1.2 Kits: C10... Software anomalies that may lead to the generation of erroneous results. Class II Beckman Coulter, 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.