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
Mar 18, 2013 Ref: VP1600 HD Still Capture System ConMed Linvatec . Captures, stores a... The VP1600 HD Still Capture Image System is recalled due to an anomaly between the software code ... Class II Linvatec Corp. dba ConMed Linvatec
Mar 18, 2013 ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument f... Due to lack of sterilization. Class II Clorox Healthcare Holdings, LLC (dba HealthLink)
Mar 18, 2013 HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy. Due to lack of sterilization. Class II Clorox Healthcare Holdings, LLC (dba HealthLink)
Mar 18, 2013 PSS Select medical products***Biopsy Punches*** Disposable manual instrume... Due to lack of sterilization. Class II Clorox Healthcare Holdings, LLC (dba HealthLink)
Mar 15, 2013 Insight Instruments MIS ( Multi-Port Illumination System) Illuminated pi... Insight Instruments, Inc., Stuart, FL is recalling M.I.S. (Multi-Port Illumination System), Ophth... Class II Insight Instruments, Inc.
Mar 13, 2013 SLIDERPREP PLUS SLIDE PREPARATION CENTRIFUGE. Produce a monolayer of cells... Separation Technology, Inc. recalled SlidePrep Plus Cytology Centrifuges manufactured prior to Ja... Class II Separation Technology, Inc.
Mar 6, 2013 GENESYS Cross FT Suture Anchor with Two #2 (5 metric) Hi-FI Registered Trade ... Incorrect blue/white suture was used. Class II Linvatec Corp. dba ConMed Linvatec
Mar 6, 2013 Advanced Orthogonal Percussion Adjusting Instrument Indicated for use by ... Unapproved medical device Class II Advanced Orthogonal Equipment, Incorporated
Mar 4, 2013 REF 8229705 x1 NIM TriVantage EMG Endotracheal Tube 5.0 mm I.D. x 6.5 mm O.D.... In March 2013, Medtronic issued a recall of the NIM TriVantage EMG Endotracheal Tube due to cuff ... Class I Medtronic Xomed, Inc.
Feb 25, 2013 Duane Reade TRUEtrack monitor kit, UPC# 6 39194 01679 7 Part # A4006-81 Th... Meter kit outer boxes containing 10 ct. test strips state incorrect storage temperature range. Class II Nipro Diagnostics, Inc.
Feb 24, 2013 Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control, used fo... Elevated MCV results on the 1311-682, 1311-683, and 1311-684 lots. Class II Clinical Diagnostic Solutions
Feb 15, 2013 PROGRESSIVE MEDICAL Laparoscopic Electrode PTFE Coated L Hook 33cm. Inten... Firm is recalling due to concerns regarding changes that were made to the PTFE coating materials. Class II Unimed Surgical Products, Inc.
Feb 5, 2013 SpineNet Anterior Cervical Cage, Lordotic, Peek (originally submitted as Dayt... The recall decision has been made because because it has recently been determined that the instru... Class II SpineNet
Feb 5, 2013 Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovasc... Dilatation catheters could exhibit radial versus axial tears should they burst during inflation. Class II Cordis Corporation
Feb 4, 2013 SpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow A... SpineNet was marketing this device to be used with SpineNet ACC device without FDA clearance or a... Class II SpineNet
Feb 1, 2013 Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer a... A dimensional mismatch was identified which can potentially allow for interference between devices. Class II Exactech, Inc.
Jan 24, 2013 D3000 Advantage Drive System, 115v Product Usage: The Advantage Drive Sy... The Membrane Switch Panel (referred to as "front panel" of the component part number A34-003-207,... Class III Linvatec Corp. dba ConMed Linvatec
Jan 24, 2013 D3000I Advantage Drive System, 230v, surgical instrument motor. Product Us... The Membrane Switch Panel (referred to as "front panel" of the component part number A34-003-207,... Class III Linvatec Corp. dba ConMed Linvatec
Dec 27, 2012 Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) HeartWare, Inc. of Miami Lakes, FL is recalling their Ventricular Assist System due to the loosen... Class II Heartware Inc
Dec 21, 2012 1-DAY ACUVUE MOIST Brand Contact Lenses, soft disposable contact lenses. T... Limited number of individual contact lens packages may not have been completely sealed. Class II Johnson & Johnson Vision Care, Inc.
Dec 21, 2012 ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR, Soft, disposable contact... Limited number of individual contact lens packages may not have been completely sealed. Class II Johnson & Johnson Vision Care, Inc.
Nov 28, 2012 ANSPACH***Custom XMax Motor, Pneumatic***Rx Only*** This device is intende... 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 98-0043***Custom Device eMax 2 Plus Hand Control that will work... 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-5001-00***20 degree Angle Driver (MA-D20) - Custom***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 98-0025***Custom MDA Tube for use with MA-D20 Attachment***Rx O... 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 98-0008***7cm Medium Attachment Custom***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***REF 98-0021***eMax2 Console with Irrigation***Rx Only*** This de... 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 98-0003***Sagittal microSaw Attachment Custom***Rx Only*** T... 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-98-0062***Custom Device eMax2 Plus Hand Control***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 98-0029***8 mm Coarse Threaded Headless Bone Screw***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***Knotless Suture Anchor Deployment Tool, Custom***Rx Only*** Thi... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the Anspach Custom Devices. The u... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF 98-0044***Custom Device Speed Reducer with Bumper***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***1.85mm x 16 mm Fluted Router for MRI***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 98-0024***Nose Cone Cover***Rx Only*** This device is intend... 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 98-0031***Custom Medium Attachment, with 5 mm Extended Tapered ... 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 98-0012***Shoulder Implant 011mm Rod, 20cm Long, Custom***Rx On... 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-98-0056***Custom Device Autolube III modified with a swivel***R... 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-3100-00***5mm Coarse Diamond Ball, 11.5 OAL***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 98-0001***eMax Hand Control***Rx Only*** This device is inte... 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-4602-00***2mm 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 SP-4603-00***3mm 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 98-0010***2.37mm Spiral Drill, for Short Attachment (Non-Steri... 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 98-0037***Custom Device SC2102 with fast stop firmware***Rx Onl... 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 MCA5-1SD with Extended Exposure***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 SP-3101-00***Adjustable 25 Cm Mia Attachment, Custom***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***eMax2 Lower Profile Foot Pedal***Rx Only*** This device is inten... 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-3014-00***4mm Fluted Ball for MRI***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 98-0034***Custom XMax Motor, Pneumatic with Hand Control and Cu... 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 98-0019***Modified MDA Tube with MA-D20 Attachment***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 98-0048***Custom Circular ePLUS-FP***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.

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.