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
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
Sep 12, 2017	i-STAT DE handheld data processing module for clinical use, Software Version ...	Issues resulting from upgrade to software version 2.8: (1) Location, operator, stored patient lis...	Class II	Abbott Point Of Care Inc.
Apr 26, 2017	Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia). The Absorb ...	Abbott Vascular is initiating a recall of the Absorb Bioresorbable Vascular Scaffold (BVS) System...	Class I	Abbott Vascular
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
Apr 1, 2017	Healon V, Part No. 10290045	Remote possibility that certain solutions in these lots may contain microscopic glass particles d...	Class II	Abbott Medical Optics Inc. (AMO)
Apr 1, 2017	Healon Duet, Part No. 10290080, 10220010, 10220011 and 10220012	Remote possibility that certain solutions in these lots may contain microscopic glass particles d...	Class II	Abbott Medical Optics Inc. (AMO)
Apr 1, 2017	Healon, Part No. 10290953, 10295210, 10200011, 10200012, 10201012, 10203012, ...	Remote possibility that certain solutions in these lots may contain microscopic glass particles d...	Class II	Abbott Medical Optics Inc. (AMO)
Apr 1, 2017	Healon 5 Pro, Part No. 10270015	Remote possibility that certain solutions in these lots may contain microscopic glass particles d...	Class II	Abbott Medical Optics Inc. (AMO)
Apr 1, 2017	Healon Pro, Part No. 10270012	Remote possibility that certain solutions in these lots may contain microscopic glass particles d...	Class II	Abbott Medical Optics Inc. (AMO)
Apr 1, 2017	Healon GV, Part No. 10294701, 10294801, 10200014, 10201014, 10202014, 10203014	Remote possibility that certain solutions in these lots may contain microscopic glass particles d...	Class II	Abbott Medical Optics Inc. (AMO)
Mar 30, 2017	AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cut...	Packaging error. 20GA Vitrectomy Cutters may be found in a 25GA package and 25GA Vitrectomy Cut...	Class II	Abbott Medical Optics Inc. (AMO)
Mar 22, 2017	NC Tenku RX PTCA Balloon Catheter, Part No. 1012448-08T, 1012448-12T, 101244...	Products from the identified lots may exhibit difficulty in removing the protective balloon sheat...	Class I	Abbott Vascular
Mar 22, 2017	NC Traveler RX Coronary Dilatation Catheter, Part No. 1013152-12, 1013152-15...	Products from the identified lots may exhibit difficulty in removing the protective balloon sheat...	Class I	Abbott Vascular
Mar 22, 2017	NC Trek RX Coronary Dilatation Catheter, Part No. 1012448-06, 1012448-08, 101...	Products from the identified lots may exhibit difficulty in removing the protective balloon sheat...	Class I	Abbott Vascular
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
Feb 10, 2017	StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI...	Abbott Vascular is recalling the StarClose SE Vascular Closure System because it may exhibit diff...	Class II	Abbott Vascular
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
Aug 26, 2016	AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model No. Z9002 Th...	Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked ...	Class II	Abbott Medical Optics Inc. (AMO)
Aug 26, 2016	TECNIS Multifocal 1-Piece Intraocular Lens, Model No. ZKB00, ZLB00; The pro...	Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked ...	Class II	Abbott Medical Optics Inc. (AMO)
Aug 26, 2016	TECNIS 1-Piece IOL, Model No. ZCB00 The product is indicated for implantatio...	Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked ...	Class II	Abbott Medical Optics Inc. (AMO)
Aug 26, 2016	TECNIS OptiBlue 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, ...	Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked ...	Class II	Abbott Medical Optics Inc. (AMO)
Aug 26, 2016	TECNIS Multifocal Foldable Acrylic Intraocular Lens, Model No. ZMA00 The pro...	Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked ...	Class II	Abbott Medical Optics Inc. (AMO)
Aug 26, 2016	SENSAR 1-Piece IOL, Model No. AAB00 The product is indicated for implantatio...	Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked ...	Class II	Abbott Medical Optics Inc. (AMO)
Aug 26, 2016	SENSAR Foldable IOL with OptiEdge Design, Model No. AR40e The product is ind...	Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked ...	Class II	Abbott Medical Optics Inc. (AMO)
Aug 26, 2016	TECNIS Symfony Extended Range of Vision IOL, Model No. ZXR00 The product is ...	Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked ...	Class II	Abbott Medical Optics Inc. (AMO)
Aug 26, 2016	TECNIS 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. ...	Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked ...	Class II	Abbott Medical Optics Inc. (AMO)
Aug 26, 2016	TECNIS OptiBlue 1-Piece Intraocular Lens (IOL), Model No. ZCB00V The product...	Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked ...	Class II	Abbott Medical Optics Inc. (AMO)
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
Feb 4, 2016	MitraClip Clip Delivery System, product number MSK0101. The MitraClip System ...	Abbott Vascular has recently received reports of cases on Clip Delivery System devices that conta...	Class I	Abbott Vascular
Sep 9, 2015	ARCHITECT i2000SR System The Abbott ARCHITECT System is intended for In Vit...	Incorrect tubing.	Class II	Abbott Laboratories, Inc
Aug 12, 2015	FIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size Diameter:...	The expiration date was incorrectly printed on the pouch/box labels of 19 products that were ship...	Class III	Abbott Electrophysiology
Jun 15, 2015	i-Stat PT/INR Cartridges List number 03P89-24 The cartridges are packaged ...	Certain lots of PT/INR cartridges may generate a higher than typical number of PT/INR star outs p...	Class II	Abbott Point Of Care 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
Feb 20, 2015	OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and C...	Device may experience loss of suction during treatment resulting in scoring the cornea during len...	Class II	Abbott Medical Optics, Inc.
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
Nov 6, 2014	Abbott Healon EndoCoat Ophthalmic Viscosurgical Device 3% sodium hyaluronate...	AMO has received complaints where the finger grip dislodged while depressing the syringe plunger....	Class II	Abbott Medical Optics Inc (AMO)
Oct 23, 2014	Abbott m2000sp, an automated system for performing sample preparation for nuc...	Some versions of Application Specifications (App Spec) are incompatible with m2000sp system softw...	Class II	Abbott Molecular
Sep 11, 2014	ARCHITECT Total T3 Reagent Kit (7K64) consists of: - 1 or 4 Bottle(s) (6....	17% of ARCHITECT Total T3 Reagent Kit, LN 7K64-20/-25 reagent lots 38901UI00 and 38901UI01 may ex...	Class II	Abbott Ireland Diagnostics Division
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
Jun 19, 2014	5 mL Reaction Vessels (a consumable of the Abbott m2000sp Automated Fluid Han...	Abbott Molecular identified that some of the 5 ml Reaction Vessels (RVs) contained in lots 569440...	Class II	Abbott Molecular
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 10, 2014	enGen Laboratory Automation Systems (enGen) with TCAutomation -- For in vit...	Software anomaly: potential for delay in the reporting of patient sample test results when using ...	Class II	Ortho-Clinical Diagnostics
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 19, 2014	FreeStyle Flash Blood Glucose Monitors System. Meter made in China; Dis...	Abbott Diabetes Care has identified through internal testing and investigation that all non-appli...	Class I	Abbott Diabetes Care, Inc.
Feb 19, 2014	FreeStyle Blood Glucose Monitors System. For in vitro diagnostic use only. S...	Abbott Diabetes Care has identified through internal testing and investigation that all non-appli...	Class I	Abbott Diabetes Care, 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

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.