Browse Device Recalls

96 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 96 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 96 FDA device recalls.

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Date	Product	Reason	Class	Firm
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)
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
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
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 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
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
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
Sep 29, 2017	Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemis...	The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 has the possibility...	Class II	Abbott Laboratories, Inc
Sep 29, 2017	ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITE...	The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 has the possibility...	Class II	Abbott Laboratories, Inc
Apr 18, 2017	ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent micr...	Firm has identified that ARCHITECT SHBG results generated with the Potassium EDTA specimen tube t...	Class II	Abbott Laboratories
Feb 13, 2017	CELL-DYN Ruby System: List Number: 08H6701; Hematology: The CELL-DYN R...	The Pump Relay Printed Circuit Board Assembly (PCBA) used in the CELL-DYN Ruby instrument may pre...	Class II	Abbott Laboratories
Oct 11, 2016	ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for t...	Abbott has identified negative interference from the drug N-Acetyl Cysteine (NAC) with the ARCHIT...	Class II	Abbott Laboratories
Mar 24, 2016	CELL-DYN Emerald Cleaner, product number 09H46-02. 960mL. IVD; Hematolo...	Three lots of CELL-DYN Emerald Cleaner may have occurrences where the analyzer generates Quality ...	Class II	Abbott Laboratories
Mar 24, 2016	The ARCHITECT Estradiol Kit Intended to measure estradiol, an estrogenic ...	Interaction of Fulvestrant with the ARCHITECT Estradiol assay, leading to falsely elevated estrad...	Class II	Abbott Laboratories
Sep 9, 2015	ARCHITECT i2000SR System The Abbott ARCHITECT System is intended for In Vit...	Incorrect tubing.	Class II	Abbott Laboratories, Inc
Jun 11, 2015	ARCHITECT c8000 System List Number 01G06-98 Product Usage: The Abbott ARC...	The ARCHITECT c8000 instrument contains tubing that does not meet specifications and has the pote...	Class II	Abbott Laboratories
May 11, 2015	Alkaline Wash, List number 9D31-20, a cleaning solution used by the Abbott Ar...	The product is leaking from the cap and crystallization was noted as present around the cap.	Class II	Abbott Laboratories
Jan 15, 2015	ARCHITECT c4000 Cuvette Segment, List number 02P75-01. The firm name on the ...	There is a potential to generate falsely-depressed patient results in the cuvettes adjacent to th...	Class II	Abbott Laboratories, Inc
Jul 22, 2014	ICT Serum Calibrator REF 146-03. For use in the calibration of the serum ...	ICT Serum Calibrator may generate lower than expected Potassium Quality Control (QC) and patient ...	Class II	Abbott Laboratories
Apr 30, 2014	HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c 1 x 1.6 mL a...	HbA1c Calibrators LN 4P52-02, lot 45063UQ12 may contain a value sheet for a different HbA1c calib...	Class II	Abbott Laboratories
Apr 7, 2014	Lipase Reagent, 7D80. Used to measure lipase in human serum on the Archite...	Package inserts have incorrect SmartWash parameters for Triglyceride.	Class II	Abbott Laboratories, Inc
Feb 12, 2014	ARCHITECT Intact PTH Controls consists of 3 x 1 Bottle (8.0 mL each) of PTH (...	Abbott has confirmed that a performance shift in the ARCHITECT Intact PTH assay has the potential...	Class II	Abbott Laboratories
Feb 12, 2014	ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL each). Calibra...	Abbott has confirmed that a performance shift in the ARCHITECT Intact PTH assay has the potential...	Class II	Abbott Laboratories
Aug 12, 2013	Clinical Chemistry Phosphorus Reagent The Phosphorus assay is used for th...	Reagent lots 64736UN12, 03991UN13, 51611UN13, 74805UN12, and 03992UN13 have incorrect expiration ...	Class II	Abbott Laboratories, Inc
Jul 23, 2013	DRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott L...	Surveillance of reagent stability for specific lots of DRI Cocaine Metabolite Reagent show an un...	Class II	Microgenics Corp
Dec 18, 2012	ARCHITECT HBsAg Qualitative Assay, List Number 4P53 and ARCHITECT HBsAg Quali...	Abbott has identified that assay files for the ARCHITECT HBsAg Qualitative and HBsAg Qualitative ...	Class II	Abbott Laboratories, Inc
Dec 12, 2012	Abbott Laboratories, ARCHITECT 25-OH Vitamin D Reagent Kit, 03L52-25 (ROW) an...	The Architect 25-OH Vitamin D assay has the potential to generate falsely elevated or falsely dep...	Class II	Abbott Laboratories
Nov 16, 2012	Clinical Chemistry Phenobarbital, list number 1E08	Abbott Diagnostics is recalling Clinical Chemistry Phenobarbital reagent lots 62299UN12 and 85773...	Class II	Abbott Laboratories, Inc
May 30, 2012	ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (...	The six ARCHITECT CA 19-9XR reagent lots are demonstrating a shift up in patient results. The Ab...	Class II	Abbott Laboratories

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.