Browse Device Recalls

1,023 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,023 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 1,023 FDA device recalls — Class III.

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Date	Product	Reason	Class	Firm
Feb 19, 2019	Micro Knife 5.0mm 30¿, Part Number 0001522 The Beaver¿ Micro Knife 5.0mm...	The product contains a misprinted expiration date on the peel pack. Both were printed as "180615...	Class III	Beaver Visitec
Feb 15, 2019	QuickTox 5 Panel Drug Screen DipCard	Mixed Products containing QuickTox 5 Panel Drugs Screen Dipcard (P/N QT11, LOT #188787) and Alere...	Class III	Ameditech Inc
Feb 7, 2019	Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The gui...	Frayed pieces of the mounting card being inside the primary packaging.	Class III	Cordis Corporation
Feb 7, 2019	Liquid Immunoassay Premium Controls, Model Number LIA3105 Product Usage: ...	The target value for uptake is incorrect on the value sheet for an analyzer. The target value fo...	Class III	Randox Laboratories Ltd.
Feb 7, 2019	Immunoassay Premium Controls, Model Numbers IA2633 and IA2638 Product Usag...	The target value for uptake is incorrect on the value sheet for an analyzer. The target value fo...	Class III	Randox Laboratories Ltd.
Feb 7, 2019	Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 Product...	The target value for uptake is incorrect on the value sheet for an analyzer. The target value fo...	Class III	Randox Laboratories Ltd.
Feb 5, 2019	Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures	Inner blister pack label is incorrect and does not match the correct external box label.	Class III	SPINEART SA
Jan 28, 2019	LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130, 2017-08-15, IPX1, RXOn...	Incorrect labeling; it was identified that some Datapad devices contained incorrect labels. Speci...	Class III	LivaNova USA Inc.
Jan 25, 2019	PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film REF: XJUB8, XJM73, ...	Due to an inhomogeneous coating solution, pinholes can become visible in even dark images. Visibi...	Class III	Agfa N.V.
Jan 25, 2019	INTEGRA, Drill CS 4.5, quick coupling single use, REF 430453	Products were distributed with the incorrect instructions for use.	Class III	AAP Implantate Ag
Jan 25, 2019	INTEGRA, Drill CS 4.0, quick coupling single use, REF 430425	Products were distributed with the incorrect instructions for use.	Class III	AAP Implantate Ag
Jan 16, 2019	CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321	Supplier testing showed that the absorbance rate of the Ethyl Alcohol Assay did not meet internal...	Class III	Carolina Liquid Chemistries
Jan 16, 2019	CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321		Class III	Carolina Liquid Chemistries
Jan 14, 2019	RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device	The device labels are not UDI compliant. The missing UDI compliance information on the labelling ...	Class III	Teleflex Medical
Jan 14, 2019	RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection device	The device labels are not UDI compliant. The missing UDI compliance information on the labelling ...	Class III	Teleflex Medical
Jan 11, 2019	Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (l...	Shelf life of the product may be reduced due to degradation of the assay.	Class III	Lin-Zhi International Inc
Jan 9, 2019	Insufflation tubing to be used with varies insufflator units. REF 031200-10; ...	The sterile single-use tubing may contain higher ethylene oxide (EO) residues than the acceptable...	Class III	Karl Storz Endoscopy
Jan 2, 2019	BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 66...	A customer site was identified to have three FACSLyric IVD systems with FACSuite clinical v1.1.1 ...	Class III	Becton, Dickinson and Company, BD Biosciences
Dec 26, 2018	Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) G...	On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the VERIGENE(R) Amplifica...	Class III	Luminex Corporation
Dec 5, 2018	Breast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100	The sterility may be compromised due to a potential breach in the packaging, even though it may a...	Class III	Medela Inc
Dec 4, 2018	Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6	Gauss Surgical is updating the Instructions for Use (IFU) for our Triton Sponge System in order t...	Class III	Stryker Instruments Div. of Stryker Corporation
Nov 28, 2018	IntellaTip MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irri...	Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These change...	Class III	Boston Scientific Corporation
Nov 28, 2018	Blazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrig...	Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These change...	Class III	Boston Scientific Corporation
Nov 28, 2018	IntellaNav MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irri...	Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These change...	Class III	Boston Scientific Corporation
Nov 16, 2018	Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-...	The product was packaged with the Instructions for Use for a different product (Ascension First C...	Class III	Ascension Orthopedics, Inc
Nov 1, 2018	Quantikine¿ IVD¿ ELISA, Human sTfR Immunoassay kit. Product Usage: The Qu...	The Human sTfR Quantikine IVD ELISA Kit, catalog # DTFR1, lot P180151 was packed with the incorre...	Class III	R & D Systems, Inc.
Oct 30, 2018	Porcine Anorganic Bone Mineral 4.0cc	There is a possibility that the product labeled as 4.0cc volume may only contain 2.0cc volume an...	Class III	Collagen Matrix Inc
Oct 24, 2018	NEOCONNECT, Enteral Extension with ENFit connector, REF EXT-60NC The NeoM...	The sterile pouch label states the expiration date is 2016-11-19, but the correct expiration date...	Class III	Neomed Inc
Oct 9, 2018	Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog ...	Discolored powder has confirmed the presence of a foreign substance	Class III	Fresenius Medical Care Renal Therapies Group, LLC
Oct 9, 2018	Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Num...	Discolored powder has confirmed the presence of a foreign substance	Class III	Fresenius Medical Care Renal Therapies Group, LLC
Oct 9, 2018	Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Catalog Num...	Discolored powder has confirmed the presence of a foreign substance	Class III	Fresenius Medical Care Renal Therapies Group, LLC
Oct 5, 2018	Hemoglobin A1c Control, Part no. 220232 for use as quality control material t...	Tosoh Bioscience has become aware of potential degradation of HbA1c control lot # 7055 before the...	Class III	Tosoh Bioscience Inc
Sep 21, 2018	BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos...	The device may not function at the lower end (<15 deg. C) of the labeled operating temperatures. ...	Class III	Becton Dickinson & Co.
Sep 11, 2018	R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, RE...	The kit was provided without a copy of the lot-specific kit booklet and the Calibrator 0 vial 18D...	Class III	R & D Systems, Inc.
Aug 16, 2018	BioMend Extend, REF# 0142Z, Synthetic bone grafting material.	There is a possibility that the product was packaged in the wrong box. Specifically, the product...	Class III	Collagen Matrix, Inc.
Aug 16, 2018	Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35	Medtronic has determined that the French size indicator on the inner pouch may incorrectly reflec...	Class III	Medtronic Vascular
Aug 10, 2018	Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CA...	Vials of the autoHDL/LDL Calibrator were shipped without a vial label.	Class III	Medtest Holdings, Inc.
Aug 6, 2018	Laparoscopy Instruments Instructions For Use (IFU) for the following: 1)Monop...	The Manual cleaning process and the usability of the reprocessing instruction by the user had not...	Class III	Dannoritzer Medizintechnik GmbH & Co. KG
Aug 2, 2018	Campylobacter Blood Free Selective Medium, PN 7527A Used with cefoperazon...	The product is labeled with an incorrect expiration date.	Class III	Acumedia Manufacturers, Inc.
Aug 2, 2018	Palcam Agar Base, Acumedia, PN 7669, Product Usage - Dehydrated culture media...	Expiration date on the label is incorrect. Correct expiration date was November 30, 2020 and labe...	Class III	Acumedia Manufacturers, Inc.
Jul 13, 2018	Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gase...	The product was mislabeled with the incorrect label.	Class III	Smiths Medical ASD Inc.
Jul 11, 2018	VITROS Chemistry Products Cl- Slides, Product Code 844 5207 Product Usage:...	The slides do not meet the maximum allowable interference (MAI) claims for triglyceride interfere...	Class III	Ortho-Clinical Diagnostics
Jul 11, 2018	VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage ...	The slides do not meet the maximum allowable interference (MAI) claims for triglyceride interfere...	Class III	Ortho-Clinical Diagnostics
Jul 11, 2018	VITROS Chemistry Products CREA Slides, Product Code 680 2584 Product Usag...	The slides did not meet the current claims for Limit of Blank (LoB), Limit of Detection (LoD) and...	Class III	Ortho-Clinical Diagnostics
Jul 11, 2018	VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage:...	The slides failed to meet current claims for Limit of Blank (LoB), Limit of Detection (LoD) and L...	Class III	Ortho-Clinical Diagnostics
Jul 6, 2018	smiths medical portex First Breath Adult Nasal Cannula, REF 001285, Flared Ti...	"Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires befo...	Class III	Smiths Medical ASD Inc.
Jul 6, 2018	smiths medical portex First Breath Nasal Oxygen Cannula, REF 001292, with Gas...	"Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires befo...	Class III	Smiths Medical ASD Inc.
Jul 6, 2018	smiths medical portex First Breath Adult Nasal Cannula, REF 001283, Non-flare...	"Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires befo...	Class III	Smiths Medical ASD Inc.
Jul 6, 2018	smiths medical portex First Breath Adult Nasal Cannula, REF 001289, Curved Fl...	"Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires befo...	Class III	Smiths Medical ASD Inc.
Jul 6, 2018	smiths medical portex First Breath Nasal Oxygen Cannula, REF 001293, with Gas...	"Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires befo...	Class III	Smiths Medical ASD 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.