Browse Device Recalls

395 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 395 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 395 FDA device recalls.

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Date	Product	Reason	Class	Firm
Apr 9, 2019	ALINITY i Anti-TPO Calibrators - Product Usage: The Alinity i Anti-TPO Calibr...	Devices were delivered without the required dry ice.	Class III	Abbott Laboratories
Apr 9, 2019	ARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage: The AR...	Devices were delivered without the required dry ice.	Class III	Abbott Laboratories
Apr 9, 2019	ARCHITECT Intact PTH Calibrators - Product Usage: The ARCHITECT Intact PTH Ca...	Devices were delivered without the required dry ice.	Class III	Abbott Laboratories
Apr 5, 2019	TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 P...	In reported cases, the device log on the TactiSys Quartz Equipment operating on Software Version ...	Class II	Abbott Laboratories Inc. (St Jude Medical)
Apr 5, 2019	Alinity i Processing Module, 03R65 01, with the below components. a. TED (...	Potential loose cable connections on the reagent cooler, which could result in temperature errors...	Class II	Abbott Gmbh & Co. KG
Mar 7, 2019	Abbott Alinity ci-series System Control Module software version 2.5.1; LN 3R7...	Potential performance issues in the Alinity-ci software version 2.5.1	Class II	Abbott Gmbh & Co. KG
Feb 26, 2019	Abbott Alinity i Processing Module LN 03R65-01 - Product Usage: The Alinity i...	The safety interlock covering the septum piercing probes within the bulk solution bottle holder m...	Class II	Abbott Gmbh & Co. KG
Feb 26, 2019	Abbott Alinity c Processing Module LN 03R67-01 - Product Usage: The Alinity c...	The safety interlock covering the septum piercing probes within the bulk solution bottle holder m...	Class II	Abbott Gmbh & Co. KG
Feb 20, 2019	CELL-DYN Emerald analyzer, REF 09H39-01. The CELL-DYN Emerald is an autom...	There is a potential for the device to generate Quality Control (QC) low or out-of-range low for ...	Class II	Abbott Laboratories
Feb 5, 2019	Abbott Alinity i Estradiol Reagent Kit - Product Usage: Alinity i Estradiol a...	Patient results may be falsely elevated. This patient impact only applies to patients currently ...	Class II	Abbott Ireland Diagnostics Division
Feb 5, 2019	Abbott ARCHITECT Estradiol Reagent Kit - Product Usage: The ARCHITECT Estradi...	Patient results may be falsely elevated. This patient impact only applies to patients currently ...	Class II	Abbott Ireland Diagnostics Division
Jan 2, 2019	ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium assay is u...	Abbott internal testing has identified that the Magnesium urine application demonstrates depresse...	Class II	Abbott Laboratories, Inc
Dec 20, 2018	Alinity i Processing Module, (a) Part Number 03R65-01 (b) Part Number A-30...	Abbott has identified an issue with the Alinity i Gear Pump Assembly (part number A 30108552 01) ...	Class II	Abbott Gmbh & Co. KG
Nov 21, 2018	Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferriti...	Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in so...	Class II	Abbott Ireland Diagnostics Division
Nov 21, 2018	Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532	Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in so...	Class II	Abbott Ireland Diagnostics Division
Nov 21, 2018	Alinity i TSH Reagent Kit, List Number 07P4830	Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in so...	Class II	Abbott Ireland Diagnostics Division
Nov 21, 2018	Alinity i Free T4 Reagent Kit, List Number 07P7030	Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in so...	Class II	Abbott Ireland Diagnostics Division
Nov 21, 2018	Alinity i Estradiol Reagent Kit, List Number 07P5020	Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in so...	Class II	Abbott Ireland Diagnostics Division
Nov 21, 2018	Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121	Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in so...	Class II	Abbott Ireland Diagnostics Division
Nov 21, 2018	Alinity i Progesterone Reagent Kit, List Number 08P3620	Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in so...	Class II	Abbott Ireland Diagnostics Division
Nov 19, 2018	St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. ...	The device is unable to pair with the mobile app due to the device incorrectly determining the ce...	Class II	Abbott
Oct 12, 2018	ARCHITECT Total T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR pla...	Samples tested using ARCHITECT Free T3 or ARCHITECT Total T3 assays may show depressed results du...	Class II	Abbott Ireland Diagnostics Division
Oct 12, 2018	ARCHITECT Free T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR plat...	Samples tested using ARCHITECT Free T3 or ARCHITECT Total T3 assays may show depressed results du...	Class II	Abbott Ireland Diagnostics Division
Sep 24, 2018	Disposable 25GA Vitrectomy Cutter, REF NGP0025, RX Only, Abbott Medical Optic...	Packaging error, 20GA Vitrectomy Cutter may be found in a 25GA package. Use of a Vitrectomy cutt...	Class II	Johnson & Johnson Surgical Vision Inc
Sep 13, 2018	Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification...	Inaccurate potassium results may be generated. When testing with control fluid and/or patient sam...	Class II	Abbott Point Of Care Inc.
Sep 7, 2018	APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Clas...	The firm identified customer sites where modules which the safety pacemaker label is missing. Inf...	Class II	Abbott Laboratories, Inc
Aug 29, 2018	IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software p...	Quality control results are not processed for Abbott Diagnostics Alinity ci series (abdicqii) ins...	Class II	Data Innovations, LLC
Aug 28, 2018	Abbott ARCHITECT cSystems ICT Module, REF 09D28-03. Product Usage: The AR...	There is a potential to generate falsely elevated serum or plasma chloride results when using the...	Class II	Abbott Laboratories, Inc
Jul 18, 2018	Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21.	The product has a stability issue which may lead to an error code indicating "Unable to calculate...	Class II	Abbott Laboratories, Inc
Jul 18, 2018	Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341.	The product has a stability issue which may lead to an error code indicating "Unable to calculate...	Class II	Abbott Laboratories, Inc
Jul 17, 2018	Abbott ARCHITECT c8000 Processing Module, List No. 01G06 - Product Usage: The...	There is a potential to generate incorrect results on the instrument if particular error codes ar...	Class II	Abbott Laboratories, Inc
Jul 17, 2018	Abbott ARCHITECT c16000 Processing Module, List No. 03L77 - Product Usage: Th...	There is a potential to generate incorrect results on the instrument if particular error codes ar...	Class II	Abbott Laboratories, Inc
Jul 17, 2018	Abbott ARCHITECT c4000 Processing Module, List No. 02P24 - Product Usage: The...	There is a potential to generate incorrect results on the instrument if particular error codes ar...	Class II	Abbott Laboratories, Inc
Jul 3, 2018	PLUS 30 PRIORITY PACK Accessory Kit Product Usage: Is recommended for use...	Incorrect expiration being entered for one lot.	Class II	Abbott Vascular
Jun 21, 2018	Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the TECNIS iTEC Preloaded Del...	Expired intraocular lenses were distributed.	Class II	Johnson & Johnson Surgical Vision Inc
Jun 14, 2018	CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Ele...	Abbott is advising customers that a small number of CardioMEMS(R) Hospital Electronics Systems (M...	Class II	Abbott Laboratories, Inc.
May 16, 2018	The,K -ASSAY HP assay is intended for the quantitative determination of hum...	An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ...	Class II	Abbott Laboratories, Inc
May 16, 2018	C3 is an in vitro diagnostic assay for the quantitative determination of C3 i...	An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ...	Class II	Abbott Laboratories, Inc
May 16, 2018	Transferrin is an in vitro diagnostic assay for the quantitative determinatio...	An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ...	Class II	Abbott Laboratories, Inc
May 16, 2018	Apolipoprotein B is an in vitro diagnostic assay for the quantitative determi...	An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ...	Class II	Abbott Laboratories, Inc
May 16, 2018	Immunoglobulin G is an in vitro diagnostic assay for the quantitative determi...	An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ...	Class II	Abbott Laboratories, Inc
May 16, 2018	Immunoglobulin A is an in vitro diagnostic assay for the quantitative determi...	An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ...	Class II	Abbott Laboratories, Inc
May 16, 2018	Apolipoprotein A1 is an in vitro diagnostic assay for the quantitative determ...	An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ...	Class II	Abbott Laboratories, Inc
May 16, 2018	Immunoglobulin M is an in vitro diagnostic assay for the quantitative determi...	An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ...	Class II	Abbott Laboratories, Inc
May 16, 2018	C4 is an in vitro diagnostic assay for the quantitative determination of C4 i...	An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ...	Class II	Abbott Laboratories, Inc
Apr 5, 2018	Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 1...	Reports of outflow graft twist occlusions. Patients whose devices experience outflow graft occlu...	Class I	Abbott
Dec 14, 2017	ARCHITECT DHEA-S Reagent Product Usage: It is a chemiluminescent micropar...	Falsely elevated results may be obtained when using the ARCHITECT DHEA-S assay with samples from ...	Class II	Abbott Gmbh & Co. KG
Dec 8, 2017	ARCHITECT c16000 Cuvette Segment, Part #09D32-05/ 03L77, a component to the A...	There is a potential to generate falsely depressed patient results in the cuvettes adjacent to th...	Class II	Abbott Laboratories, Inc
Dec 8, 2017	ARCHITECT c4000 Cuvette Segment, Part #02P75-01/02P24, a component to the ARC...	There is a potential to generate falsely depressed patient results in the cuvettes adjacent to th...	Class II	Abbott Laboratories, Inc
Dec 8, 2017	ARCHITECT c8000 Cuvette Segment, Part #01G46-01/01G06, a component to the ARC...	There is a potential to generate falsely depressed patient results in the cuvettes adjacent to th...	Class II	Abbott Laboratories, 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.