Browse Device Recalls

49 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 49 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 49 FDA device recalls.

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Date	Product	Reason	Class	Firm
Mar 1, 2024	Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170	There is a potential that the Cholestech LDX battery (an external battery pack available as an op...	Class II	Alere San Diego, Inc.
Jun 24, 2022	The Cholestech LDX¿ System combines enzymatic methodology and solidphase tec...	Cholesterol test cassettes package insert is to be updated with new bilirubin interference inform...	Class II	Alere San Diego, Inc.
Feb 15, 2019	Alere Cholestech LDX Analyzer, model # 14-874 containing power supplies with ...	The polarity of the output of power supply was reversed. Due to polarity of the output of power...	Class II	Alere San Diego, Inc.
Nov 14, 2017	Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591...	The recalled lots have demonstrated unexpected false positive THC results.	Class II	Alere San Diego, Inc.
Oct 12, 2016	Alere Triage Total 5 Control Level 1, Model No. 88753 Description of the p...	Encoded with incorrect ranges that are not consistent with the ranges printed on the Expected Val...	Class II	Alere San Diego, Inc.
Aug 2, 2016	LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassett...	Incorrect expiration date on the magnetic strip that does not match the labeled expiration date.	Class III	Alere San Diego, Inc.
Jul 11, 2016	Alere INRatio PT/INR System Professional Model Numbers: 0100004 Product U...	Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitori...	Class I	Alere San Diego, Inc.
Jul 11, 2016	Alere INRatio2 PT/INR Home Monitoring System Model Number: 0200432, 0200433 ...	Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitori...	Class I	Alere San Diego, Inc.
Jul 11, 2016	INRatio Prothrombin Time (PT) Monitoring System Model Number: 0100007 Pr...	Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitori...	Class I	Alere San Diego, Inc.
Jul 11, 2016	Alere INRatio Replacement Monitor Model Number: 0100137 Usage: The INRa...	Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitori...	Class I	Alere San Diego, Inc.
Jul 11, 2016	Alere INRatio2 PT/INR Professional Testing System Model Number: 0200431 P...	Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitori...	Class I	Alere San Diego, Inc.
Jul 11, 2016	Alere INRatio/ INRatio2 PT/INR Test Strips Model Number: 99007EU, 99007G1, 9...	Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Test Str...	Class I	Alere San Diego, Inc.
Jul 11, 2016	Alere INRatio2 PT/INR Professional Monitoring System Model Number: 55128A ...	Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitori...	Class I	Alere San Diego, Inc.
Jul 11, 2016	Alere INRatio2 Replacement Monitor (Home) Model Number: 0200457 Product U...	Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitori...	Class I	Alere San Diego, Inc.
Jul 11, 2016	Alere INRatio PT/INR Test Strips Model Number: 0100071, 0100139 Product U...	Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitori...	Class I	Alere San Diego, Inc.
Jun 22, 2016	Clearview MONO (Whole Blood, Serum, Plasma), Catalog No. 92401 a simple tes...	The Positive Control information referencing human plasma as the antibody material described in t...	Class III	Alere San Diego, Inc.
Jun 22, 2016	Stanbio Rely Mono Rapid Test, Catalog No. 6200-010L and 6200-020L a simple ...	The Positive Control information referencing human plasma as the antibody material described in t...	Class III	Alere San Diego, Inc.
Jun 22, 2016	Proadvantage Mono Rapid Test Cassette, Catalog No. P080016 a simple test th...	The Positive Control information referencing human plasma as the antibody material described in t...	Class III	Alere San Diego, Inc.
Jun 22, 2016	Signify Mono (Whole Blood, Serum, Plasma), Catalog No. 01P52-25 a simple te...	The Positive Control information referencing human plasma as the antibody material described in t...	Class III	Alere San Diego, Inc.
Jun 22, 2016	Cardinal Health Mono Rapid Test, Catalog No. B1077-28, a simple test that u...	The Positive Control information referencing human plasma as the antibody material described in t...	Class III	Alere San Diego, Inc.
Jun 22, 2016	Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 a simple ...	The Positive Control information referencing human plasma as the antibody material described in t...	Class III	Alere San Diego, Inc.
Jun 22, 2016	Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92...	The Positive Control information referencing human plasma as the antibody material described in t...	Class III	Alere San Diego, Inc.
Aug 27, 2015	Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773. Enables u...	Alere San Diego is recalling the Alere Cholestech LDX Multianalyte Control because the assigned c...	Class III	Alere San Diego, Inc.
Dec 5, 2014	INRatio Monitors - 0100004 Alere INRatio PT/INR System Professional - 01000...	In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantl...	Class I	Alere San Diego, Inc.
Dec 5, 2014	INRatio 2 Monitors - 0200431 Alere INRatio 2 PT/INR Professional Testing Sys...	In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantl...	Class I	Alere San Diego, Inc.
Dec 5, 2014	Alere INRatio PT/INR Test Strips, Alere INRatio PT/INR System Professional ...	In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantl...	Class I	Alere San Diego, Inc.
May 30, 2014	Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoa...	Alere San Diego is recalling Alere Triage BNP Calibrators for the Beckman Coulter Access Family o...	Class III	Alere San Diego, Inc.
May 2, 2014	Alere Triage¿ D-Dimer Test PN 98100, Lot W53884B. The Alere Triage¿ D-Dimer...	Alere initiated this recall because a limited number of Alere Triage¿ D-Dimer devices from PN 981...	Class II	Alere San Diego, Inc.
Apr 16, 2014	Alere INRatio2 PT/INR Professional Test Strips, Model Number: 99008G2. The Al...	Test Strips may report an inaccurately low INR result. Several patients had a therapeutic or nea...	Class I	Alere San Diego, Inc.
Mar 20, 2014	Alere Triage BNP Test for the Beckman Coulter Access Family of Immunoassay Sy...	These lots may not recover within range when tested using certain commercially available controls.	Class II	Alere San Diego, Inc.
Feb 5, 2014	Product Brand Name(s): Alere Triage¿ TOX+MTD Drug Screen, Catalog Number 9440...	Alere San Diego, Inc. is initiating a recall of the Alere Triage¿ TOX Drug Screen, Catalog Number...	Class II	Alere San Diego, Inc.
Oct 23, 2013	Product Brand Name(s): Alere Cholestech LDX¿ Lipid Profile"GLU Test Cassette,...	Alere initiated a recall of Cholestech LDX Lipid Profile-GLU test cassettes, Catalog Number 10-99...	Class III	Alere San Diego, Inc.
Sep 23, 2013	Alere Triage¿ TOX Drug Screen Control 1 Product Generic Name: Quality Cont...	Alere San Diego, Inc. initiated a voluntary recall of Alere Triage TOX Drug Screen Control 1 (PN ...	Class III	Alere San Diego, Inc.
Jun 3, 2013	Product Brand Name(s): Innovacon Oral Fluid Drug Screen Device, OrALert O...	Alere initiated this recall of certain lots of the Oral Fluid Drug Screen Device because the spon...	Class II	Alere San Diego, Inc.
Apr 16, 2013	Alere" hCG Combo Cassette (20/10 mIU/mL) Kit. Product Usage: The AlereT...	The firm initiated recall of Alere" hCG Combo Cassette (20/10 mIU/mL) kit PN 92215, lots hCG11101...	Class II	Alere San Diego, Inc.
Mar 6, 2013	The Alere Cholestech LDX¿ high sensitivity C-Reactive Protein (hsCRP) Test Ca...	The Alere Cholestech LDX¿ hsCRP cassette (PN 12-807) may have increased imprecision relative to ...	Class II	Alere San Diego, Inc.
Mar 6, 2013	Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitr...	The recall was initiated because Alere San Diego has an update for the Alere Cholestech LDX ALT A...	Class II	Alere San Diego, Inc.
Feb 26, 2013	IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog ...	Alere San Diego is recalling the Clearview Mononucleosis Cassette because the positive control in...	Class III	Alere San Diego, Inc.
Jan 21, 2013	Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 45821...	Alere San Diego Inc. is recalling the Cardinal Health hCG Cassette Rapid Test because some of the...	Class III	Alere San Diego, Inc.
Oct 22, 2012	Alere Cholestech LDX Multianalyte Control, 2 vial set, Catalog Number: 88769 ...	Out of range (increased) HDL Cholesterol results.	Class III	Alere San Diego, Inc.
Oct 22, 2012	Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88...	Out of range (increased) HDL Cholesterol results.	Class III	Alere San Diego, Inc.
Jul 12, 2012	Alere Triage TOX Drug Screen 9 Panel, P/N: 94402. The Alere Triage TOX Dru...	Alere San Diego is recalling Alere Triage TOX Drug Screen because there is a possibility that aft...	Class II	Alere San Diego, Inc.
May 22, 2012	Alere Triage BNP PN 98000XR Intended to be used as an aid in the diagnosis...	Certain lots of the affected products may have significantly decreased precision relative to the ...	Class I	Alere San Diego, Inc.
May 22, 2012	Alere Triage Cardiac Panel PN 97000HS Used for the quantitative determinat...	Certain lots of the affected products may have significantly decreased precision relative to the ...	Class I	Alere San Diego, Inc.
May 22, 2012	Triage D-dimer PN 98100 Used as an aid in the assessment and evaluation of...	Certain lots of the affected products may have significantly decreased precision relative to the ...	Class I	Alere San Diego, Inc.
May 22, 2012	Alere Triage Profiler SOB Panel PN 97300 Used for the determination of cre...	Certain lots of the affected products may have significantly decreased precision relative to the ...	Class I	Alere San Diego, Inc.
May 22, 2012	Alere Triage CardioProfiler Panel PN 97100CP Used for the quantitative det...	Certain lots of the affected products may have significantly decreased precision relative to the ...	Class I	Alere San Diego, Inc.
May 14, 2012	Alere Triage Tox+MTD Drug Screen, PN 94400 Product Usage: The Alere Triag...	A recall was initiated because Alere San Diego has confirmed that the Triage TOX Drug Screen may ...	Class II	Alere San Diego, Inc.
May 28, 2009	Triage TOX Drug Screen Panel, Model# 94400. Product Usage: The Triage T...	Biosite is recalling the Triage TOX Drug Screen kits where the box containing test devices becaus...	Class II	Alere San Diego, 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.