Browse Device Recalls

2,907 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,907 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 2,907 FDA device recalls in 2015.

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Date	Product	Reason	Class	Firm
Nov 16, 2015	ProScProScreen 10 Panel Cup with Adulterants, Item No. PSCupA-10AM	Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t...	Class III	Ameditech Inc
Nov 16, 2015	DrugSmart Dip (MET/OPI2)+AMP+BZO+COC+THC, Item No. 30600D	Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t...	Class III	Ameditech Inc
Nov 16, 2015	ProScreen 9 Panel Cup w/Adulterants, Item No. PSCUPA-9BO300	Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t...	Class III	Ameditech Inc
Nov 16, 2015	Immutest 5 Pnl Drug Cup w/ Adult -waived, Item No. IMCA-5AB-W	Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t...	Class III	Ameditech Inc
Nov 16, 2015	ProScreen 12 Drug Cup w/Adulteration, Item No. PSCupA-12TBU	Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t...	Class III	Ameditech Inc
Nov 16, 2015	iCup DX 12 Panel w/ Adulterant, Item No. I-DXA-1127-023	Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t...	Class III	Ameditech Inc
Nov 16, 2015	Radiographic Transparency for Certain and External Connection Tapered Implant...	Images contained within radiographic transparency ART 1036 are undersized.	Class II	Biomet 3i, LLC
Nov 16, 2015	DrugSmart 11 Test Cup, Item No. 61127D	Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t...	Class III	Ameditech Inc
Nov 16, 2015	ProScreen 10 Drug Panel Cassette Test, Item No. PSP-10PPX	Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t...	Class III	Ameditech Inc
Nov 16, 2015	1 Step 12 Panel Cup, Item No. NBCA-12M-W	Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of ...	Class III	Ameditech Inc
Nov 16, 2015	BZO Strip Dip Card (300ng/ml)*, Item No. 100170	Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t...	Class III	Ameditech Inc
Nov 16, 2015	iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013	Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t...	Class III	Ameditech Inc
Nov 16, 2015	10-Panel Pipette Drug Screen, Item No. PSP-10M	Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t...	Class III	Ameditech Inc
Nov 16, 2015	ProScreen Cup CLIA with 6 Panel Drug, Item No. PSCup-6MB-W	Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t...	Class III	Ameditech Inc
Nov 16, 2015	Immutest 10 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-10M5	Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t...	Class III	Ameditech Inc
Nov 16, 2015	Immutest 12 Panel Cup w/Adulteration, Item No. IMCA-11OP	Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t...	Class III	Ameditech Inc
Nov 16, 2015	ProScreen CLIA Waived Cup with 6 Drugs, Item No. PSCup-6BO-W	Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t...	Class III	Ameditech Inc
Nov 16, 2015	ImmuTest Cup 7-panel w/ Adulteration, Item No. IMCA-7P	Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t...	Class III	Ameditech Inc
Nov 16, 2015	11 Panel Card (OPI 300) w/Adult, Item No. 71125AA	Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t...	Class III	Ameditech Inc
Nov 16, 2015	DrugSmart Cup 10, Item No. 61093D-3C, 61085D, 61015D	Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t...	Class III	Ameditech Inc
Nov 13, 2015	Maquet HCU 30 Coolant Type R134A Filling weight 250 g 120 V 50-60 Hz 1920 W ...	Failure of the HEATER-COOLER UNIT (HCU 30) Type 2 power supply board. A drop of more than 10% vol...	Class II	Maquet Cardiovascular Us Sales, Llc
Nov 13, 2015	GE Healthcare Optima CL323i Product Usage: The angiographic X-ray system...	GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable ...	Class II	GE Medical Systems, LLC
Nov 13, 2015	Intravascular (IV) Administration Sets, Model No. 54IV12, 54IV22, 54IV32, MK2...	Edward Lifesciences is recalling Intravascular (IV) Administration Sets due to the requirement o...	Class II	Edwards Lifesciences, LLC
Nov 13, 2015	GE Healthcare Optima IGS 320. Product Usage: The angiographic X-ray syste...	GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable ...	Class II	GE Medical Systems, LLC
Nov 13, 2015	Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Steril...	Sterilmed, Inc. is voluntarily recalling all unexpired Reprocessed Tourniquet Cuffs. Sterilmed ca...	Class II	STERILMED, INC.
Nov 12, 2015	ORTHO SPEC GRP CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-075 Post-Op...	Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion...	Class II	Corflex
Nov 12, 2015	HAILEY ORTHO CONTENDER POST-OP-KNEE BRACE Model : 75-7500-038 Post-Operativ...	Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion...	Class II	Corflex
Nov 12, 2015	Alaris EtCO2 Module, Model 8300. A capnograph that continuously monitors end...	CareFusion is recalling the Alaris EtCO2 module model 8300 because it may have been tested during...	Class II	CareFusion 303, Inc.
Nov 12, 2015	Perseus A500 Anesthesia Workstation, MK06000. Intended for use in anesthet...	There is a potential problem with the device main power switch of the Perseus A500 Anesthesia Wor...	Class I	Draeger Medical, Inc.
Nov 12, 2015	Digital Temple Thermometer labeled under: Bestmed, Good Neighbor (Amerisource...	An incorrect calibration of the thermometer that causes the device to display inaccurate and freq...	Class II	Bestmed, LLC
Nov 12, 2015	CT ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-011 Post-Opera...	Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion...	Class II	Corflex
Nov 12, 2015	ADV ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-231 Post-Operati...	Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion...	Class II	Corflex
Nov 12, 2015	Corflex Contender Post-Op Knee Brace Lite Model: 75-7500-000 Post-Operative...	Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion...	Class II	Corflex
Nov 12, 2015	BRIELLE ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-087 Post-O...	Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion...	Class II	Corflex
Nov 12, 2015	CONTENDER POST-OP-KNEE BRACE FULL FOAM Model: 75-7550-000 Post-Operative Kn...	Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion...	Class II	Corflex
Nov 11, 2015	Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement...	Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems	Class II	Siemens Healthcare Diagnostics Inc
Nov 11, 2015	Siemens Acute Care BHCG TestPak-an in vitro diagnostic product intended to be...	Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems	Class II	Siemens Healthcare Diagnostics Inc
Nov 11, 2015	Siemens Acute Care BHCG CalPak-in vitro diagnostic product intended to be use...	Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems	Class II	Siemens Healthcare Diagnostics Inc
Nov 11, 2015	Siemens Acute Care CKMB TestPak- in vitro diagnostic test for the measuremen...	Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems	Class II	Siemens Healthcare Diagnostics Inc
Nov 11, 2015	Siemens Acute Care CCRP CalPak-in vitro diagnostic product intended to be use...	Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems	Class II	Siemens Healthcare Diagnostics Inc
Nov 11, 2015	Siemens Acute Care pBNP TestPak- in vitro diagnostic test for the quantitativ...	Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems	Class II	Siemens Healthcare Diagnostics Inc
Nov 11, 2015	Siemens Acute Care" MYO TestPak-in vitro diagnostic test for the quantitative...	Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems	Class II	Siemens Healthcare Diagnostics Inc
Nov 11, 2015	Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926....	During an internal testing, Natus Medical Incorporated, identified that in Neuro Works 8.1 with Q...	Class II	Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Nov 11, 2015	Siemens Acute Care MYO DilPak Catalog Number: CMYO-D SMN:10445081 in vitro...	Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems	Class II	Siemens Healthcare Diagnostics Inc
Nov 11, 2015	Siemens Acute Care DDMR TestPak Catalog Number: CDDMRE SMN: 10701511 in ...	Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems	Class II	Siemens Healthcare Diagnostics Inc
Nov 11, 2015	Siemens Acute Care CKMB DilPak- an in vitro diagnostic product intended to be...	Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems	Class II	Siemens Healthcare Diagnostics Inc
Nov 11, 2015	Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended...	The Nebulizer mask malfunctions in that there is reduced or no aerosol output. The malfunction o...	Class II	ConvaTec, Inc
Nov 11, 2015	Siemens Acute Care" CCRP TestPak-in vitro diagnostic product intended to be u...	Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems	Class II	Siemens Healthcare Diagnostics Inc
Nov 10, 2015	Reagent Management System (RMS) Dimension RxL Max w/o HM Product Usage: T...	Siemens has identified RMS refrigeration compressors that are missing the safety cover on the el...	Class II	Siemens Healthcare Diagnostics Inc.
Nov 10, 2015	Reagent Management System (RMS) Dimension EXL with LM Product Usage: Th...	Siemens has identified RMS refrigeration compressors that are missing the safety cover on the el...	Class II	Siemens Healthcare Diagnostics 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.