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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
Jun 13, 2016 Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure o... Potential sterility deficiency. Class II Biomet Microfixation, LLC
Jun 8, 2016 HeartWare Ventricular Assist System Controller Product Usage: For use as... Loose connector ports in controller body. Class I Heartware, Inc.
May 26, 2016 Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femor... Labeled with the incorrect Global Trade Item Number (GTIN). The GTIN on the label identifies the... Class II Exactech, Inc.
May 26, 2016 Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femor... Labeled with the incorrect Global Trade Item Number (GTIN). The GTIN on the label identifies the... Class II Exactech, Inc.
May 20, 2016 Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz. Product did not meet specifications for Zinc Acetate (OOS). Class II Amerx Health Care Corp.
May 6, 2016 Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Chan... A diode was inadvertently not assembled into the system, which may result in coil overheating Class II Invivo Corporation
May 4, 2016 Cordis PRECISE (R) PRO RX Nitinol Stent System (Carotid) Inability to deploy the stent or partial stent deployment. Class II Cordis Corporation
May 4, 2016 Cordis PRECISE (R) RX Nitinol Stent System (Biliary) Inability to deploy the stent or partial stent deployment. Class II Cordis Corporation
Apr 22, 2016 BioSync Anatomic Cotton Wedge, 20 x 6.5 mm.; Used for internal bone fixation ... Potential for polystyrene particulate presence. Class II Arthrex, Inc.
Apr 22, 2016 BioSync Anatomic Cotton Wedge, 20 x 4.5 mm.; Used for internal bone fixation ... Potential for polystyrene particulate presence. Class II Arthrex, Inc.
Apr 22, 2016 BioSync Anatomic Cotton Wedge, 20 x 5.5 mm.; Used for internal bone fixation ... Potential for polystyrene particulate presence. Class II Arthrex, Inc.
Apr 22, 2016 BioSync Anatomic Cotton Wedge, 16 x 4.5 mm.; Used for internal bone fixation ... Potential for polystyrene particulate presence. Class II Arthrex, Inc.
Apr 22, 2016 BioSync Anatomic Cotton Wedge, 16 x 5.5 mm.; Used for internal bone fixation ... Potential for polystyrene particulate presence. Class II Arthrex, Inc.
Apr 22, 2016 BioSync Anatomic Cotton Wedge, 16 x 6.5 mm.; Used for internal bone fixation ... Potential for polystyrene particulate presence. Class II Arthrex, Inc.
Apr 21, 2016 The Red Head 2 Reusable Fat Harvesting Canister, Product # RH-2, Non-Sterile.... During an FDA inspection it was found that the products are marketed without a cleared 510k, nor ... Class II Miami Fat Supply, Inc
Apr 20, 2016 Acorn 130 Stairlift, Brooks 130 Stairlift, Acorn 180 Stairlift, and Acorn Out... The design of the seats did not consistently have the adequate strength required to support the c... Class II Acorn Stairlifts, Inc
Apr 15, 2016 Volt Resistance Heated Lower Back Garment Deep penetrating heat garment and ... During an FDA inspection it was found that the firm claims unapproved therapy and medical claims ... Class II 2k Innovations Inc.
Apr 15, 2016 Volt Resistance Heated Therapy Foot Wrap Deep penetrating heat garment and w... During an FDA inspection it was found that the firm claims unapproved therapy and medical claims ... Class II 2k Innovations Inc.
Apr 15, 2016 Ziehm Solo, Mobile C-arm for Mobile Fluoroscopic Imaging Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute time... Class II Ziehm Imaging Inc
Apr 15, 2016 Volt Resistance Heated Neck Garment Deep penetrating heat garment and wraps During an FDA inspection it was found that the firm claims unapproved therapy and medical claims ... Class II 2k Innovations Inc.
Apr 15, 2016 Ziehm Vision2, Mobile C-arm for Mobile Fluoroscopic Imaging Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute time... Class II Ziehm Imaging Inc
Apr 15, 2016 Volt Resistance Unisex Rechargeable Heated Slipper (All sizes) Deep penetra... During an FDA inspection it was found that the firm claims unapproved therapy and medical claims ... Class II 2k Innovations Inc.
Apr 15, 2016 Volt Resistance Heated Elbow Garment Deep penetrating heat garment and wraps During an FDA inspection it was found that the firm claims unapproved therapy and medical claims ... Class II 2k Innovations Inc.
Apr 15, 2016 Ziehm Vision RFD, Mobile C-arm for Mobile Fluoroscopic Imaging Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute time... Class II Ziehm Imaging Inc
Apr 15, 2016 Volt Resistance Heated Therapy Shoulder Wrap Deep penetrating heat garment a... During an FDA inspection it was found that the firm claims unapproved therapy and medical claims ... Class II 2k Innovations Inc.
Apr 15, 2016 Volt Resistance Heated Socks (All sizes) Deep penetrating heat garment and w... During an FDA inspection it was found that the firm claims unapproved therapy and medical claims ... Class II 2k Innovations Inc.
Apr 15, 2016 Volt Resistance Heated Slipper Black (All sizes) Deep penetrating heat garme... During an FDA inspection it was found that the firm claims unapproved therapy and medical claims ... Class II 2k Innovations Inc.
Apr 15, 2016 Volt Resistance Heated Slipper (All sizes) Deep penetrating heat garment an... During an FDA inspection it was found that the firm claims unapproved therapy and medical claims ... Class II 2k Innovations Inc.
Apr 15, 2016 Ziehm Vision RFD Mot, Mobile C-arm for Mobile Fluoroscopic Imaging Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute time... Class II Ziehm Imaging Inc
Apr 15, 2016 Volt Resistance Heated Slipper Gray (All sizes) Deep penetrating heat garmen... During an FDA inspection it was found that the firm claims unapproved therapy and medical claims ... Class II 2k Innovations Inc.
Apr 15, 2016 Volt Resistance Frostie Heated Gloves (All sizes) Deep penetrating heat garm... During an FDA inspection it was found that the firm claims unapproved therapy and medical claims ... Class II 2k Innovations Inc.
Apr 15, 2016 Ziehm Vision RFD 3D Mobile C-arm for Mobile Fluoroscopic Imaging Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute time... Class II Ziehm Imaging Inc
Apr 15, 2016 Volt Resistance Heated Therapy Knee Wrap Deep penetrating heat garment and w... During an FDA inspection it was found that the firm claims unapproved therapy and medical claims ... Class II 2k Innovations Inc.
Apr 15, 2016 Ziehm Vision R, Mobile C-arm for Mobile Fluoroscopic Imaging Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute time... Class II Ziehm Imaging Inc
Apr 12, 2016 Novation Press-Fit Splined, Standard Offset, HA Coated, 12/14 Taper, Size 11,... Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supp... Class II Exactech, Inc.
Apr 12, 2016 Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 54mm, O.D. (Acetabula... Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supp... Class II Exactech, Inc.
Apr 12, 2016 Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 13, Femoral St... Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supp... Class II Exactech, Inc.
Apr 12, 2016 Novation Press-Fit Tapered, Standard Offset, HA Coated, 12/14 Taper, Femoral... Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supp... Class II Exactech, Inc.
Apr 12, 2016 Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 56mm, O.D. (Acetabula... Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supp... Class II Exactech, Inc.
Apr 12, 2016 Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 14, Femoral St... Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supp... Class II Exactech, Inc.
Mar 28, 2016 ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 1.5 MM, Par... Certain lots of the Otologic Curved Micro (OCM) Diamond Ball Burrs may be missing the diamond coa... Class II The Anspach Effort, Inc.
Mar 28, 2016 ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 2.0 MM, Par... Certain lots of the Otologic Curved Micro (OCM) Diamond Ball Burrs may be missing the diamond coa... Class II The Anspach Effort, Inc.
Mar 22, 2016 AllergiEnd ST-9 Multiple Skin Test Applicator (Item 1000) and AllergiEnd ST-9... During an FDA inspection it was found that the products are marketed without a cleared 510k. Class II Medscience Inc
Mar 10, 2016 Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reage... The reagent pack may result in elevated platelet background during Drew3 Hematology Analyzer rout... Class II Jas Diagnostics/Drew Scientific
Feb 29, 2016 Medica ISE Module Calibrant A; 500 mL - 140 mmol/L Na+, 125 mmol/L Cl-, buffe... Lot was not functioning properly and not exhibiting the correct physical properties. Class III AMS Diagnostics, LLC
Feb 23, 2016 RESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons spec... Potential disassociation of the orientation pin. Class II Mako Surgical Corporation
Feb 17, 2016 Acorn 180 Curved Stairlift Aluminum rivets holding the base squab to the framer under prolonged customer use were seen to el... Class II Acorn Stairlifts Inc
Jan 29, 2016 Trinity Acetabular Shell Product Usage: Total Hip Replacement. Potential for abrasion of the sterile barrier pouches of the new packaging system. Class II Corin USA Limited
Jan 29, 2016 Trinity Acetabular Shell Product Usage Total Hip Replacement. Potential for abrasion of the sterile barrier pouches of the new packaging system. Class II Corin USA Limited
Jan 29, 2016 Trinity Acetabular System Product Usage - Total Hip Replacement. Potential for abrasion of the sterile barrier pouches of the new packaging system. Class II Corin USA Limited

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.