Browse Device Recalls

1,040 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,040 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 1,040 FDA device recalls, Class III.

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DateProductReasonClassFirm
Nov 15, 2011 Sunquest Laboratory : intended for use by professionals working in a clini... Online calculations may not be performed as expected or may yield results that are different than... Class III Sunquest Information Systems, Inc.
Oct 19, 2011 Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit compris... Linear performance information in product insert does not match that listed in the approved prema... Class III Medtest Holdings, Inc.
Oct 11, 2011 Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for t... A recall was initiated because Beckman Coulter has identified a negative bias in test results whe... Class III Beckman Coulter Inc.
Aug 12, 2011 Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage... In GUI inquiry, searching by ID (CID) may return the wrong patient demographic data if the access... Class III Sunquest Information Systems, Inc.
Apr 28, 2011 Sunquest Laboratory SMART & Sunquest Laboratory SMART Select In Online Entry (OEx) there are two scenarios where a Test result from one container may file to ... Class III Sunquest Information Systems, 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 Mini-Infuser Model 150XL Single Speed Infusion Pump, an Rx battery operated s... Should a battery with the minimum contact diameter (.51 inches) be placed on the battery spring (... Class III Baxter Healthcare Corp.
Mar 4, 2011 Mini-Infuser Model 300XL Multispeed Infusion Pump, an Rx battery operated syr... Should a battery with the minimum contact diameter (.51 inches) be placed on the battery spring (... Class III Baxter Healthcare Corp.
Dec 31, 2010 ULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File. The Ki... The impacted product was not intended for commercial distribution to end users. Class III Kimberly-Clark Corporation
Nov 22, 2010 The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level ... Incorrect control range in product labeling Class III Medtest Holdings, Inc.
Aug 18, 2010 G7 HPLC. Used as an aid in the detection and presumptive identification of... The Beta-thalessemia Mode of the G7 Analyzer-Beta Thalassemia Mode is an automated High Performan... Class III Tosoh Bioscience Inc
Aug 4, 2010 Boule Con Diff US Tri Pack, 6 Vials. For in vitro diagnostic use as a cont... Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled the Boule Con Diff US Tri Pack (Pr... Class III Clinical Diagnostic Solutions
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
Jul 21, 2009 Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(H... Individual vials of calibrator and standard were mislabeled; specifically the units on the vial l... Class III Medtest Holdings, Inc.
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 400mm Straight Rod, Part Number: 60101-400. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 50 MM Lordosed Rod, Part Number: 60100-050. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 80mm Straight Rod, Part Number: 60101-080. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 120mm Lordosed Rod, Part Number: 60100-120. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 90mm Straight Rod, Part Number: 60101-090. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 50mm Straight Rod, Part Number: 60101-050. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 110mm Straight Rod, Part Number: 60101-110. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 40mm Straight Rod, Part Number: 60101-040. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 30mm Straight Rod, Part Number: 60101-030. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 70 MM Lordosed Rod, Part Number: 60100-070. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 70mm Straight Rod, Part Number: 60101-070. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 110mm Lordosed Rod, Part Number: 60100-110. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 80 MM Lordosed Rod, Part Number: 60100-080. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 100mm Straight Rod, Part Number: 60101-100. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 40 MM Lordosed Rod, Part Number: 60100-040.... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 120mm Straight Rod, Part Number: 60101-120. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 90 MM Lordosed Rod, Part Number: 60100-090. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 100mm Lordosed Rod, Part Number: 60100-100. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 60 MM Lordosed Rod, Part Number: 60100-060. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 30 MM Lordosed Rod, Part Number: 60100-030.... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 17, 2009 Mercury Spinal System DIA 5.5 x 60mm Straight Rod, Part Number: 60101-060. ... Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class III Spinal Elements, Inc
Apr 13, 2009 Sunquest Encompass The reporting site is using the Encompass software in a... Sunquest is recalling the Sunquest Encompass versions 2.4 and later because the specimen collect ... Class III Sunquest Information Systems, Inc.
Jun 20, 2008 Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument ZIMMER CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Univers... Class III Orthosoft, Inc. dba Zimmer CAS
Jun 6, 2006 Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The ... The barcode for the ABL77 on the insert incorrectly enters a control range for pH of 7.90-7.95 in... Class III Radiometer America 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.