Browse Device Recalls

3,029 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,029 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 3,029 FDA device recalls in 2016.

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DateProductReasonClassFirm
Aug 29, 2016 TriMed Semi-Tubular Plate, 10-Hole, Model No. SMTP-10 Contoured plate with... TriMed is recalling the Semi-Tubular Plates with 10 holes (SMTP-10) because a non-locking screw p... Class II Trimed Inc
Aug 29, 2016 BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit - 1) UPN # H... Medline Industries, Inc. supplies Navilyst with sterile package gloves included in the tandem pac... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Aug 29, 2016 ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model... The ROI-A Anterior Delivery Device T-Handle, part number SI-ROIA-0023 has experienced binding of ... Class II LDR Spine USA, Inc.
Aug 29, 2016 TANDEM (TM) INTL COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71324038,... Some Bipolar shells were manufactured with an out of specification retainer groove. Class II Smith & Nephew, Inc.
Aug 29, 2016 TANDEM (TM) COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71322040, 7132... Some Bipolar shells were manufactured with an out of specification retainer groove. Class II Smith & Nephew, Inc.
Aug 29, 2016 BioFlo PICC with ENDEXO and PASV Valve Technology Maximal Barrier Nursing Kit... Medline Industries, Inc. supplies Navilyst with sterile package gloves included in the tandem pac... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
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 HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A The handle can separate from the MRx housing due to breakage of mounts on the rear case. Class II Philips Electronics North America Corporation
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 G1 Dissection Tool - 7mm FBALL L; For cutting and shaping bone including spin... Product Code L- 7B-G1 was inadvertently released off of hold status and the affected products wer... Class II The Anspach Effort, Inc.
Aug 26, 2016 G1 Dissection Tool - 6MM CRS DBALL, 2mm Shaft EXP, M; For cutting and shaping... The firm discovered on March 4, 2016 that several product codes were inadvertently left off of Ho... Class II The Anspach Effort, Inc.
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 Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patie... The connector may disconnect from the tracheostomy tube during use. Class I Teleflex Medical
Aug 26, 2016 G1 Dissection Tool - 3mm FLUTED BALL; For cutting and shaping bone including ... The firm discovered on March 4, 2016 that several product codes were inadvertently left off of Ho... Class II The Anspach Effort, Inc.
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 G1 Dissection Tool - 3mm CRS DBALL, 2mm SHAFT EXP, M; For cutting and shaping... The firm discovered on March 4, 2016 that several product codes were inadvertently left off of Ho... Class II The Anspach Effort, Inc.
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)
Aug 25, 2016 St¿ckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung ... Sorin/LivaNova is initiating a field correction on the S5 Heart-lung machine because of the poten... Class II Sorin Group USA, Inc.
Aug 25, 2016 Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Thawi... Products contain international package insert and not the correct USA package insert Class III CooperSurgical, Inc.
Aug 25, 2016 Spacelabs Healthcare Xhibit Central Station, Model 96102, Version 1.1.2. Xh... The firm received multiple reports of Xhibit Telemetry System going offline or locking up. In add... Class II Spacelabs Healthcare Inc
Aug 25, 2016 United Nuclear Scientific High Power Handheld Lasers. Laser products Failure to comply with the laser class limitation listed in the performance standard for Specific... Class II United Nuclear Scientific Supplies, LLC
Aug 25, 2016 Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freez... Products contain international package insert and not the correct USA package insert Class III CooperSurgical, Inc.
Aug 25, 2016 Dimension IRON Flex reagent cartridges Siemens Healthcare Diagnostics has become aware of deferoxamine interference with Dimension and D... Class III Siemens Healthcare Diagnostics, Inc.
Aug 25, 2016 The Medix NatalCare LX Intensive Care Incubator. Neonatal incubator. Item n... NatalCare LX incubators may have a defective base where the weld holding the wheel bushing to the... Class II Natus Medical Incorporated
Aug 25, 2016 Dimension Vista IRON Flex reagent cartridges Siemens Healthcare Diagnostics has become aware of deferoxamine interference with Dimension and D... Class III Siemens Healthcare Diagnostics, Inc.
Aug 25, 2016 Merit Inflation Syringe Kit. Catalog Number KOS-02857 Merit Medical Systems, Inc. announces a voluntary field action for Merit Inflation Syring Kit due... Class II Merit Medical Systems, Inc.
Aug 25, 2016 Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280. Xhibit Te... The firm received multiple reports of Xhibit Telemetry System going offline or locking up. In add... Class II Spacelabs Healthcare Inc
Aug 24, 2016 Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography... The infant performance test did not meet the test specification for the Infant Head Uniformity te... Class II Philips Medical Systems
Aug 24, 2016 WECK¿ Horizon" Manual-Load Ligating Clip Applier, For Medium-Large Size Horiz... Misbranded: Incorrect etching on the device. Class II Teleflex Medical
Aug 24, 2016 Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X... The infant performance test did not meet the test specification for the Infant Head Uniformity te... Class II Philips Medical Systems
Aug 24, 2016 Fruit Punch Glucose, 100 Gram Concentration, Liquid, 4/Pack of 6 Bottles, 24... Out of Specification Microbiological test results Class II Azer Scientific, Inc.
Aug 24, 2016 Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND Integra LifeSciences has been notified of a medical device recall by Adaptive Surgical, LLC invol... Class II Integra LifeSciences Corp. d.b.a. Integra Pain ...
Aug 24, 2016 SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number ... Siemens received multiple customer complaints indicating an increase in false positive and indete... Class II Siemens Healthcare Diagnostics, Inc.
Aug 24, 2016 Tego Connector, Item No. D1000, NM1000 The Tego¿ Needle Free Access Device... ICU Medical Inc. has identified a potential risk of leaking with certain Tego Connector devices. Class II ICU Medical, Inc.
Aug 24, 2016 0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacter... Baxter Healthcare Corporation is issuing a voluntary product recall for all unexpired lots of the... Class I Baxter Corporation Englewood
Aug 24, 2016 SIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM (RUM), REF/Catalog Number ... Siemens received multiple customer complaints indicating an increase in false positive and indete... Class II Siemens Healthcare Diagnostics, Inc.
Aug 24, 2016 Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray... The infant performance test did not meet the test specification for the Infant Head Uniformity te... Class II Philips Medical Systems
Aug 24, 2016 Glucose Tolerance Beverage- Orange 50 gram Concentration, Liquid 4/Pack of 6 ... Out of Specification Microbiological test results Class II Azer Scientific, Inc.
Aug 24, 2016 R&D Systems, Quantikine¿ IVD¿sTfR Immunoassay Kit, for the quantitative deter... R&D Systems, Inc. received two customer complaints that results of the Controls provided with the... Class II R & D Systems, Inc.
Aug 24, 2016 Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray... The infant performance test did not meet the test specification for the Infant Head Uniformity te... Class II Philips Medical Systems
Aug 24, 2016 PHS Spinal Tray 24G Gertie Marx, Catalogue No. 899379. Intended to provide... Integra LifeSciences has recently identified that one lot of Spinal Tray 24 G Gertie Marx Catalog... Class II Integra LifeSciences Corp. d.b.a. Integra Pain ...
Aug 23, 2016 Integra Lumbar Drainage Set, REF 910120A, Sterile EO, Rx only, primary packag... During final sampling inspection, one of the lots was discovered with a total incomplete packagin... Class II Integra LifeSciences Corp.
Aug 23, 2016 CUSA Dissectron Fingertip Laparoscopic Cannula, REF F75221, Sterile EO, Rx on... During final sampling inspection, one of the lots was discovered with a total incomplete packagin... Class II Integra LifeSciences Corp.
Aug 23, 2016 Integra Straight Ventricular Catheter F8, 25 cm, Sterile EO, Rx only, package... During final sampling inspection, one of the lots was discovered with a total incomplete packagin... Class II Integra LifeSciences Corp.
Aug 23, 2016 Integra Drainage Accessory Kits, REF 910122, Sterile EO, Rx only, packaged in... During final sampling inspection, one of the lots was discovered with a total incomplete packagin... Class II Integra LifeSciences Corp.

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.