Browse Device Recalls

2,276 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,276 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 2,276 FDA device recalls in 2022.

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Date	Product	Reason	Class	Firm
Sep 19, 2022	Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro di...	Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. In the wors...	Class II	Siemens Healthcare Diagnostics, Inc.
Sep 19, 2022	Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnost...	Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. In the wors...	Class II	Siemens Healthcare Diagnostics, Inc.
Sep 19, 2022	125 series iGO2 Portable Oxygen Concentrator-indicated for the administratio...	An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patie...	Class II	DeVilbiss Healthcare LLC
Sep 16, 2022	Prep-Fill Guarded Luer Connector (GLC): a. Part Number 57-400, Female Lo...	Blister package had an unsealed edge compromising sterility.	Class II	International Medical Industries, Inc.
Sep 16, 2022	Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical a...	Update to the Instruction for Use (IFU): Olympus is adding a new warning against the use of acces...	Class II	Olympus Corporation of the Americas
Sep 16, 2022	LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004	Retroactively reported correction from 2022: A software defect may cause an incorrect (Fail-Stop)...	Class II	Fresenius Kabi USA, LLC
Sep 15, 2022	Extension Set, EXT SET W/CARESITE, 6IN., Product Code 470169, 50 units per ca...	The extension set has a high probability of failure which could lead to possible leakage or detac...	Class II	B. Braun Medical, Inc.
Sep 15, 2022	BD Vacutainer Tube Sodium Fluoride: 100 mg, Potassium Oxalate: 20 mg, Catalog...	The affected product contains isobutylene which has recently demonstrated potential interference ...	Class II	Becton Dickinson & Company
Sep 15, 2022	ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 uni...	The extension set has a high probability of failure which could lead to possible leakage or deta...	Class II	B. Braun Medical, Inc.
Sep 15, 2022	CARESITE SMALLBORE EXT SET T-PORT 5 IN., Product Code 470114, 100 units per c...	The extension set has a high probability of potential failure which could lead to possible leakag...	Class II	B. Braun Medical, Inc.
Sep 15, 2022	B. Braun CARESITE Port Access Kit w/Tegaderm, REF 375214, Central Venous (car...	The kits were incorrectly labeled with an extended expiration date of 02/21/2024 instead of 02/10...	Class II	Medical Action Industries, Inc. 306
Sep 14, 2022	Prismaflex HF Set: HF1000 (product code 107140), HF1400 (product code 107142...	Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Ex...	Class II	Baxter Healthcare Corporation
Sep 14, 2022	Disc Preparation instruments contained in the following products: CI-11050-0...	Due to manufacturing instruments which included additional features and adequate consideration wa...	Class II	Alphatec Spine, Inc.
Sep 14, 2022	Prismaflex M Set: M150 (product code 109990). For use in providing continuo...	Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Ex...	Class II	Baxter Healthcare Corporation
Sep 14, 2022	Prismaflex M Set: M60 (product code 106696), M100 (product code 106697). Fo...	Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Ex...	Class II	Baxter Healthcare Corporation
Sep 14, 2022	Prismaflex ST Set: ST60 (product code 107643), ST100 (product code 107636), ...	Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Ex...	Class II	Baxter Healthcare Corporation
Sep 14, 2022	ARIES SARS-CoV-2 Assay, REF: 50-10047	A part defect with the wash 1 syringe of an SARS-CoV-2 assay could lead to incomplete extraction ...	Class II	Luminex Corporation
Sep 14, 2022	Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male Lue...	Sterile extension sets were distributed without an expiration date	Class II	Avanos Medical, Inc.
Sep 14, 2022	ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 ...	Mislabeling: the corrugate label, lidstock, banner card, and peel sticker accompanying the affe...	Class II	ARROW INTERNATIONAL Inc.
Sep 14, 2022	Prismaflex HF20 Set (product code 109841). For use in providing continuous f...	Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Ex...	Class II	Baxter Healthcare Corporation
Sep 13, 2022	NovoTHOR Gen 2.5 XL whole body red light therapy bed, model S2184.	Failure of ball stud components causing the gas strut on one side to detach from the canopy, maki...	Class II	Thor Photomedicine Ltd
Sep 13, 2022	G041 POD, THOR NOVO GEN 2.0 XL whole body red light therapy bed, model S1177	Failure of ball stud components causing the gas strut on one side to detach from the canopy, maki...	Class II	Thor Photomedicine Ltd
Sep 13, 2022	NovoTHOR Gen 2.0 whole body red light therapy bed, model S1176	Failure of ball stud components causing the gas strut on one side to detach from the canopy, maki...	Class II	Thor Photomedicine Ltd
Sep 13, 2022	NovoTHOR Gen 2.5 Regular whole body red light therapy bed, model S2183	Failure of ball stud components causing the gas strut on one side to detach from the canopy, maki...	Class II	Thor Photomedicine Ltd
Sep 12, 2022	Orthex Large Bone Shoulder Bolt, model no. AS-17	Bolt breakage on the head or threaded portion, which may cause loss of strut continuity with fram...	Class II	OrthoPediatrics Corp
Sep 9, 2022	MEDLINE 24 BLOOD CLUTURE KIT, Reorder #: DYNDH1632	Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration d...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Sep 9, 2022	MEDLINE BLOOD CLUTURE KIT, Reorder #: DYNDH1592	Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration d...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Sep 9, 2022	MEDLINE PRE-OP CHG BATHING KIT Reorder #: P164756	Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration d...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Sep 9, 2022	MEDLINE PHERIPHERAL BLOOD CULTURE DRAW, Reorder #: DYNDH1561	Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration d...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Sep 9, 2022	MEDLINE ADLT BLOOD CLUTURE COLLECT KIT, Reorder #: DYNDH1245	Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration d...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Sep 8, 2022	Product/Part: MitraClip G4 CDS NT REPAIR-MR Clinical/CDS0704-NT, MitraClip G...	An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked...	Class II	Abbott Vascular
Sep 8, 2022	Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91	The kits are being recalled due to a lack of sterility of a spare needle contained within the kit...	Class II	SunMed Holdings, LLC
Sep 8, 2022	Product/Part: MitraClip NTR Clip Delivery System US/CDS0601-NTR, MitraClip N...	An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked...	Class II	Abbott Vascular
Sep 8, 2022	cobas 5800 instrument, Material No. 08707464001. Used for automated Polymeras...	Reported false positive and invalid results on the affected devices due to anomalous baselines. T...	Class II	Roche Molecular Systems, Inc.
Sep 8, 2022	Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR, MitraClip G...	An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked...	Class II	Abbott Vascular
Sep 8, 2022	Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0	The display screen may become frozen and unresponsive to user input, triggering an alarm that is ...	Class I	Fresenius Kabi USA, LLC
Sep 7, 2022	Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308...	Product pouch label does not match up with carton label	Class II	BALT USA, LLC
Sep 7, 2022	CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545	One lot of chest tube insertion trays, containing a silk suture component that is restricted to 1...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Sep 7, 2022	THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S...	Manufacturing error resulted in potential contamination of Bi-Directional navigation catheter irr...	Class II	Johnson & Johnson Surgical Vision, Inc.
Sep 6, 2022	Philips Respironics DreamWear Full Face Mask	No contraindication/warning regarding magnetic components in CPAP masks for patients with implant...	Class I	Philips Respironics, Inc.
Sep 6, 2022	Therapy Mask 3100 NC/SP	No contraindication/warning regarding magnetic components in CPAP masks for patients with implant...	Class I	Philips Respironics, Inc.
Sep 6, 2022	MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This...	Device may intermittently fail to produce audio. Turning the unit off and on does not resolve the...	Class II	Philips North America Llc
Sep 6, 2022	Philips Respironics Amara View Minimal Contact Full-Face Mask	No contraindication/warning regarding magnetic components in CPAP masks for patients with implant...	Class I	Philips Respironics, Inc.
Sep 6, 2022	DreamWisp Nasal Mask with Over the Nose Cushion	No contraindication/warning regarding magnetic components in CPAP masks for patients with implant...	Class I	Philips Respironics, Inc.
Sep 6, 2022	Wisp and Wisp Youth Nasal Mask	No contraindication/warning regarding magnetic components in CPAP masks for patients with implant...	Class I	Philips Respironics, Inc.
Sep 2, 2022	Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360	The scalpel holder may separate from the handle for certain lots. If the tip falls off during use...	Class II	Steris Corporation
Sep 2, 2022	Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002	COVID test kit shelf life was periodically extended, as real-time stability test timepoints passe...	Class II	LUMINOSTICS, INC dba CLIP HEALTH
Sep 2, 2022	Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code C...	Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barc...	Class III	Baxter Healthcare Corporation
Sep 1, 2022	Recreo Hair Growth Laser Comb	The firm distributed the laser products without affixing the warning, aperture, certification, an...	Class II	OMM Imports, Inc. dba Zero Gravity
Sep 1, 2022	Veritas Advanced Infusion Packs. Used in ophthalmic procedures.	As a result of returned product complaints for Veritas Phaco packs related to broken or cracked i...	Class II	Johnson & Johnson Surgical Vision, 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.