Browse Device Recalls

1,506 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,506 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 1,506 FDA device recalls in FL.

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DateProductReasonClassFirm
Nov 28, 2012 ANSPACH***Arthroscopic Knotless Suture Anchor***Rx Only*** This device is ... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF 98-0020***Modified Arthroscopic Knotless Suture Anchor Deployme... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF SP-4605-00***Arthroscopic Suture Anchor assembly with Suture Th... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF SP-4601-00***1mm Coarse Diamond Ball for Adjustable 25cm Mia At... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF 98-0035***Custom eMax 2 Plus Motor with microMax Disconnect Sle... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF SP-5000-00***Threaders, Arthroscopic Suture Anchor***Rx Only***... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF 98-0042***XMax Motor with Custom Hose***Rx Only*** This devi... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF 98-0022***8 mm Coarse Headless Screw with Driver***Rx Only*** ... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF SP-3012-00***13 mm Drill with Depth Stop for Short Heavy Duty A... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF SP-4604-00***3mm Fluted Ball for Adjustable 25cm Mia Attachment... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***Modified QD11 Attachment with Soft Tissue Protector***Rx Only*** ... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF 98-0023***Custom 5 cm Extension Bearing Sleeve***Rx Only*** ... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***Custom QD11 Attachment with thinner nose tube***Rx Only*** This ... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF 98-0016***eMax 2 Modified Hand Control***Rx Only*** This dev... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***MA Attachment, Straight version Custom***Rx Only*** This device ... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF 98-0033***Custom Autolube Food Guard***Rx Only*** This devic... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 15, 2012 ConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm Orthope... ConMed Linvatech recalled one lot of their PopLok bone Punch 3.5mm because the metal shaft diamet... Class II Linvatec Corp. dba ConMed Linvatec
Nov 5, 2012 Exactech NOVATION CROWN CUP +5mm LATERALIZED LINER, Use with Crown Cup Only, ... Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation C... Class II Exactech, Inc.
Nov 5, 2012 Exactech NOVATION CROWN CUP, NEUTRAL LINER, Use with Crown Cup Only, GXL UHMW... Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation C... Class II Exactech, Inc.
Oct 29, 2012 Cordis, a Johnson and Johnson Company, ExoSeal(TM) 6F Vascular Closure Devi... Affected lots of Cordis ExoSeal (TM) VCD have been sterilized using a process that did not achiev... Class II Cordis Corporation
Oct 26, 2012 Multiples Anspach Micro Curved Attachments (MCA) and Curved Burr Support S le... During a recent review of documentation Anspach determined that the current directions for use fo... Class II The Anspach Effort, Inc.
Oct 25, 2012 Quasar MD is an infrared LED lamp that is labeled in part: "***QUASAR MD***Br... Quasar Bio-Tech is recalling their Baby Quasar, Baby Quasar Pink, Quasar Power Pack, and Quasar M... Class II Quasar Bio-Tech, Inc. dba Silver Bay LLC
Oct 25, 2012 Baby Quasar (LAB-001-D, BQ101) and Baby Quasar Pink (LAB-046-A BQ101-P) are... Quasar Bio-Tech is recalling their Baby Quasar, Baby Quasar Pink, Quasar Power Pack, and Quasar M... Class II Quasar Bio-Tech, Inc. dba Silver Bay LLC
Oct 25, 2012 Quasar Power Pack contains a Baby Quasar and a Baby Blue. The Baby Quasar is ... Quasar Bio-Tech is recalling their Baby Quasar, Baby Quasar Pink, Quasar Power Pack, and Quasar M... Class II Quasar Bio-Tech, Inc. dba Silver Bay LLC
Oct 15, 2012 Invivo Corporation Expression MRI Patient Monitoring System. The Expressio... Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling the Expressi... Class II Invivo Corporation
Sep 28, 2012 Product is Full OSSEOTITE 2 Tapered Certain Implant, Model Number XIFNT413, a... Biomet 3i recalled Full OSSEOTITE 2 Tapered Certain Implant and Full OSSEOTITE Parallel Walled Ce... Class II Biomet 3i, LLC
Sep 28, 2012 Product is Full OSSEOTITE Parallel Walled Certain Implant, Model Number IFOA4... Biomet 3i recalled Full OSSEOTITE 2 Tapered Certain Implant and Full OSSEOTITE Parallel Walled Ce... Class II Biomet 3i, LLC
Sep 24, 2012 PREMIER LIFECARE RECLINER 5400 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 20... The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 1... Class II Winco Mfg., LLC
Sep 24, 2012 Designer Care Cliner 6700/6704/6710 WITH CAL TB 133 UPGRADE PURCHASED JAN ... The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 1... Class II Winco Mfg., LLC
Sep 24, 2012 Cozy Comfort Premier Recliner 5580 WITH CAL TB 133 UPGRADE PURCHASED JAN 01,... The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 1... Class II Winco Mfg., LLC
Sep 24, 2012 PREMIER CARE RECLINER 5570/5574 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2... The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 1... Class II Winco Mfg., LLC
Sep 20, 2012 CapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system. ... Captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device premature... Class II Captiva Spine, Inc
Sep 12, 2012 The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000). The RIO is inten... MAKO Surgical Group recalled their RIO System software, version 2.4 and is implementing software ... Class II Mako Surgical Corporation
Sep 5, 2012 Anspach Effort, Inc., 98-0061 MA-15C Bearing Sleeve with Removable Bur Guar... Contact between the bur and bur guard could generate metal fragments that may or may not be visi... Class II The Anspach Effort, Inc.
Aug 24, 2012 The brand name is MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Exten... Iradimed Corporation is recalling MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension... Class II Iradimed Corporation
Aug 21, 2012 Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE*... Vycor Medical recalled their VBAS (Vycor Viewsite Brain Access System) because an unidentified bl... Class I Vycor Medical, Inc.
Aug 6, 2012 The Is-anti-Sm test kits****Catalog No: 720-240*** Product Usage: The Diame... Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering hi... Class II Diamedix Corporation
Aug 3, 2012 Osseotite Tapered Certain Implant 5 X 10mm Model INT510 Biomet 3i Dental I... Biomet 3i recalled their Osseotite Tapered Certain Implant, Model # INT510 due to a small percen... Class II Biomet 3i, LLC
Jul 27, 2012 AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Regular. AquaLin... Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the w... Class II Nipro Medical Corporation
Jul 27, 2012 AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Regular. AquaLiner ... Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the w... Class II Nipro Medical Corporation
Jul 27, 2012 AquaLiner Hydrophilic Guidewire 0.035" X 180cm, Angle / Regular. AquaLiner... Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the w... Class II Nipro Medical Corporation
Jul 27, 2012 AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Stiff. AquaLiner Hy... Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the w... Class II Nipro Medical Corporation
Jul 27, 2012 AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Stiff. AquaLiner... Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the w... Class II Nipro Medical Corporation
Jul 25, 2012 Myocardial Heart Wires Intended for temporary atrial and ventricular pacin... Oscor, Inc. in Palm Harbor, FL is recalling myocardial heart wires, models TME60S, TME64S, TME64C... Class II Oscor, Inc.
Jul 10, 2012 Caremor Cliner is labeled in part: "***Manufactured By Winco***Ocala, FL 344... Winco Mfg., LLC in Ocala, FL is recalling the Caremor Cliner model numbers 5351 and 5361. The rec... Class II Winco Mfg., LLC
Jul 10, 2012 Caremor Cliner"***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***... Winco Mfg., LLC in Ocala, FL is recalling the Caremor Cliner model numbers 5351 and 5361. The rec... Class II Winco Mfg., LLC
Jul 9, 2012 Plasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators and p... On 07/09/2012, Apheresis Technologies, Inc. initiated a recall on the Plasma Pump Model PP-04a du... Class II Apheresis Technologies, Inc.
Jul 6, 2012 PopLok Punch labeled in part: "PKL-35M***3.5mm***QTY 1***PopLok Punch***ConM... ConMed Linvatec recalled one lot of their PopLok bone Punch 3.5MM because the metal shaft diamete... Class II Linvatec Corp. dba ConMed Linvatec
Jun 26, 2012 "***PressFT***2.6 w/ One #2 (5 metric) Hi-Fi***Suture***NP261***2009-02***CON... Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items N... Class II Linvatec Corp. dba ConMed Linvatec
Jun 26, 2012 "***PressFT***2.1 w/ Two #0 (3.5 metric) Hi-Fi***Sutures***NP212***2009-02***... Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items N... Class II Linvatec Corp. dba ConMed Linvatec

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.