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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Device Recalls

1,516 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,516 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 1,516 FDA device recalls in FL.

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DateProductReasonClassFirm
Mar 29, 2012 MCA5-1SD - 1MM Diamond Ball, 5.6CM. All lots are included in recall. Inte... The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... Class II The Anspach Effort, Inc.
Mar 29, 2012 MCA7-15SD - 1.5MM Diamond Ball, 7.3CM. All lots are included in recall. I... The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... Class II The Anspach Effort, Inc.
Mar 29, 2012 MCA7-15SB - 1.5MM Fluted Ball, 7.3CM. All lots are included in recall. In... The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... Class II The Anspach Effort, Inc.
Mar 23, 2012 ***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile ... Biomet 3i is recalling their product Full Osseotite Tapered Certain Implant IFNT611. The depth o... Class II Biomet 3i, LLC
Mar 14, 2012 Ultrafill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: Ult... Surgical Tissue Network Inc., DBA TissueNet Inc. recalled their UltraFill DBM Putty-Porcine (1 cc... Class II Surgical Tissue Network, Inc.
Mar 14, 2012 UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: ... Surgical Tissue Network Inc., DBA TissueNet Inc. recalled their UltraFill DBM Putty-Porcine (1 cc... Class II Surgical Tissue Network, Inc.
Mar 14, 2012 UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: U... Surgical Tissue Network Inc., DBA TissueNet Inc. recalled their UltraFill DBM Putty-Porcine (1 cc... Class II Surgical Tissue Network, Inc.
Feb 4, 2012 "****ORTHO SENSOR**12-123-A Knee Trial for Trithion***1560 Saw grass Corpora... Ortho sensor in Sunrise, FL is recalling the Graphics User Interface Software 1.8 (which was upda... Class II Orthosensor
Jan 24, 2012 REF 101-45-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 4.5mm***Use... Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices... Class II Exactech, Inc.
Jan 24, 2012 REF 101-05-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 3.2mm***Use... Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices... Class II Exactech, Inc.
Jan 24, 2012 REF 101-45-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 4.5mm***Use... Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices... Class II Exactech, Inc.
Jan 24, 2012 REF 101-45-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 4.5mm***Use... Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices... Class II Exactech, Inc.
Jan 24, 2012 REF 101-05-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 3.2mm***Use... Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices... Class II Exactech, Inc.
Jan 24, 2012 REF 101-05-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 3.2mm***Use... Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices... Class II Exactech, Inc.
Jan 9, 2012 "***Electric Systems Foot Control with Direction Only***Rx Only***" Produc... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the foot control/foot pedal due t... Class II The Anspach Effort, Inc.
Jan 9, 2012 "***Electric Systems Foot Control with Direction and Irrigation***Rx Only***"... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the foot control/foot pedal due t... Class II The Anspach Effort, Inc.
Jan 9, 2012 "***Electric Systems Foot Control****Rx Only***" Product Usage: Cutting a... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the foot control/foot pedal due t... Class II The Anspach Effort, Inc.
Nov 4, 2011 Implant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection... On November 3, 2011 Biomet 3i, Palm Beach Gardens, FL initiated a recall of their Osseotite Certa... Class II Biomet 3i, LLC
Oct 17, 2011 OPTETRAK LOGIC Proximal Tibial Spacer & Screws (2) 2.5 LT BLUE Size 2.5, 8mm*... Exactech, Inc. of Gainesville, FL recalled their Optetrak Proximal Tibial Spacer after the device... Class II Exactech, Inc.
Oct 17, 2011 SoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51... On 10/17/2011 SCC Soft Computer, Clearwater, FL initiated a correction on SoftLab with SA INST ve... Class II SCC Soft Computer
Sep 23, 2011 Product is labeled in part: "***OPTETRAK***TIBIAL TRAY***TRAPEZOID CEMENTED*... Exactech, Inc. Gainesville, FL is recalling their Optetrak Cemented Trapezoid Tibial Tray, Size 1... Class II Exactech, Inc.
Sep 23, 2011 Product is labeled in part: "***OPTETRAK RBK***TIBIAL TRAY***FINNED, CEMENT... Exactech, Inc. Gainesville, FL is recalling their Optetrak Cemented Trapezoid Tibial Tray, Size 1... Class II Exactech, Inc.
Sep 19, 2011 .***ANSPACH***Sterile. REF SHD-4820DS***QTY: 1, 4.8 mm x 2mm Twist Drill with... Anspach Effort, Inc. Palm Beach Gardens, FL is recalling their Single Use Sterile Bone Cutting B... Class II The Anspach Effort, Inc.
Sep 9, 2011 Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only Recall was initiated due to the observation of separation between clear layers of the pouch durin... Class II The Anspach Effort, Inc.
Aug 19, 2011 OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 ... Exactech, Inc. of Gainesville, FL is recalling their Optetrak Logic Posterior Stabilized Tibial I... Class II Exactech, Inc.
Aug 12, 2011 CrossFT Punch, Product Number PFT-45M. Manufacturer: CONMED LINVATEC. The i... ConMed Linvatec recalled lot number #156920, PFT-45M, CrossFT Punch because there is a possibilit... Class II Linvatec Corp. dba ConMed Linvatec
Jul 1, 2011 Catheter Irrigation Set labeled in part: ***24K Arthroscopy Outflow/Suction T... ConMed Linvatec recalled their 24k Arthroscopy Outflow/Suction Tubing Set (Product Number 24k100)... Class II Linvatec Corp. dba ConMed Linvatec
Jun 24, 2011 ***REF SC2101***eMax 2 Plus Console, Single Port, with Irrigation***SN G17307... The RPM of the Motor Handpiece may be less than 80,000 RPM. Class II The Anspach Effort, Inc.
Jun 24, 2011 ***REF SC2102***eMax 2 Plus Console, Single Port, no Irrigation***SN G1630788... The RPM of the Motor Handpiece may be less than 80,000 RPM. Class II The Anspach Effort, Inc.
Jun 24, 2011 ***REF SC2100***eMax 2 Plus Console***SN G 10307653002*** Product Usage: ... The RPM of the Motor Handpiece may be less than 80,000 RPM. Class II The Anspach Effort, Inc.
May 31, 2011 BioDerm Liberty 3.0 External Male Catheter Specialty Type with integral colle... On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component skin wipes for the BioDerm ... Class II BioDerm, Inc.
May 31, 2011 BioDerm Safe n' Dry 21006 (Component: SKIN-PREP Protective wipes). The rec... On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component (Smith and Nephew skin wipe... Class II BioDerm, Inc.
May 31, 2011 BioDerm Liberty Pouch Clean & Dry External Male Catheter Specialty Type with ... On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component skin wipes for the BioDerm ... Class II BioDerm, Inc.
May 20, 2011 ***REF LS7700***Qty 1*** EC REP*** ConMed Linvatec Xenon Universal Light Source Linvatec Corporation dba ConMed Linvatec, Largo, FL initiated a recall of their products LS7700 X... Class II Linvatec Corp. dba ConMed Linvatec
May 20, 2011 ***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source Linvatec Corporation dba ConMed Linvatec, Largo, FL initiated a recall of their products LS7700 X... Class II Linvatec Corp. dba ConMed Linvatec
May 6, 2011 Pneumatic Systems Operating Manual (part numbers 19-0005) utilized with the P... Anspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling... Class II The Anspach Effort, Inc.
May 6, 2011 Cutting Bur Chart (part number 20-0019) utilized with the Electric and Pneuma... Anspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling... Class II The Anspach Effort, Inc.
May 6, 2011 Product Catalog (part number 20-0020) utilized with the Electric and Pneumati... Anspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling... Class II The Anspach Effort, Inc.
Mar 31, 2011 Anspach REF: TURQ-434-4 Twist Drill for 1.5mm x 4mm screw. Rx only Single... Cutter was longer than was stated on the label Class II The Anspach Effort, Inc.
Mar 31, 2011 AnspacSingle use Sterile bone cutting burs.h REF: S-1504TD Twist Drill for 1.... Cutter was longer than was stated on the label Class II The Anspach Effort, Inc.
Mar 24, 2011 Boule Con-Diff Hematology Control For in vitro diagnostic use as a control... Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (Produc... Class III Clinical Diagnostic Solutions
Mar 24, 2011 Boule Con-Diff Hematology Control For in vitro diagnostic use as a control... Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (Produc... Class III Clinical Diagnostic Solutions
Mar 24, 2011 Boule Con-Diff Hematology Control For in vitro diagnostic use as a control... Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (Produc... Class III Clinical Diagnostic Solutions
Mar 4, 2011 ***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone. Due to three batches of product may have diamond grit size larger than intended applied to the he... Class II The Anspach Effort, Inc.
Jan 31, 2011 Sleek OTW***REF 426-1201X***Inflated Balloon Dia/mm***1.25***Inflated Balloon... On 1/20/2011 Cordis Corporation , Miami Lakes, FL initiated a recall of their Sleek OTW PTA Dilat... Class II Cordis Corporation
Jan 31, 2011 Sleek ***OTW ***Ref ***426-1501X***Inflated Balloon Dia/mm 1.5 Inflated Ballo... On 1//20/2011 Cordis Corporation , Miami Lakes, FL initiated a recall of their Sleek OTW PTA Dila... Class II Cordis Corporation
Sep 27, 2010 Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 ... In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtroni... Class II Medtronic Xomed, Inc.
Sep 27, 2010 Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 ... In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtroni... Class II Medtronic Xomed, Inc.
Sep 27, 2010 Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 ... In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtroni... Class II Medtronic Xomed, Inc.
Aug 4, 2010 Boule Con-Diff Hematology Control 9 vials. For in vitro diagnostic use as ... Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled the Boule Con Diff US Tri Pack (Pr... Class III Clinical Diagnostic Solutions

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.