Browse Device Recalls

2,601 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,601 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 2,601 FDA device recalls in 2023.

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Date	Product	Reason	Class	Firm
Oct 27, 2023	PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610	Due to incorrect product labeling	Class II	Limacorporate S.p.A
Oct 27, 2023	vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used wi...	Two patient circuits, 29028-003 and 29028-004, for the 3100 High Frequency Oscillatory ventilator...	Class II	Vyaire Medical
Oct 26, 2023	RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 100 -Intended fo...	RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodi...	Class II	Siemens Healthcare Diagnostics Inc
Oct 26, 2023	RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 750-Intended for ...	RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodi...	Class II	Siemens Healthcare Diagnostics Inc
Oct 26, 2023	RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for ...	RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodi...	Class II	Siemens Healthcare Diagnostics Inc
Oct 26, 2023	RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for ...	RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodi...	Class II	Siemens Healthcare Diagnostics Inc
Oct 25, 2023	INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040	COVID-19 rapid antigen at home tests were released with an incorrect expiration date of 05 April ...	Class II	PHASE SCIENTIFIC INTERNATIONAL LIMITED
Oct 25, 2023	VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only. VITR...	Ortho Clinical Diagnostics (QuidelOrtho) confirmed during routine testing that some lots from Coa...	Class II	Ortho-Clinical Diagnostics, INc.
Oct 25, 2023	ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical C...	Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there i...	Class II	Elekta, Inc.
Oct 25, 2023	ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Partic...	Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there i...	Class II	Elekta, Inc.
Oct 25, 2023	CD11b APC: ASR, REF: 340936, and CE, REF: 333143	In vitro diagnostics product that impacts the quality of cell staining can cause low or dim fluor...	Class II	Becton, Dickinson and Company, BD Biosciences
Oct 25, 2023	ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation T...	Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there i...	Class II	Elekta, Inc.
Oct 25, 2023	Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 ...	Use of a 1.4 drill in hard bone conditions caused increased insertion forces leading to subsequen...	Class II	Riverpoint Medical, LLC
Oct 25, 2023	ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiati...	Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there i...	Class II	Elekta, Inc.
Oct 25, 2023	ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charg...	Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there i...	Class II	Elekta, Inc.
Oct 25, 2023	ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; M...	Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there i...	Class II	Elekta, Inc.
Oct 24, 2023	Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111	Affected Liberty Select cyclers may display an incorrect time stamp on the treatment data report ...	Class III	Fresenius Medical Care Holdings, Inc.
Oct 24, 2023	Injection Needle, REF: 25207	The efficacy of the manual cleaning process cannot be assured for the affected injection needles ...	Class II	Karl Storz Endoscopy
Oct 24, 2023	Injection Needle, LUER-lock,0.8mm, REF: 26175PD	The efficacy of the manual cleaning process cannot be assured for the affected injection needles ...	Class II	Karl Storz Endoscopy
Oct 24, 2023	Injection Needle, single cvd. 70 degrees, REF: 738750; Injection Needle, sing...	The efficacy of the manual cleaning process cannot be assured for the affected injection needles ...	Class II	Karl Storz Endoscopy
Oct 24, 2023	Injection Needle, curved 23 cm, REF: 8598A; Injection Needle, straight, 23 cm...	The efficacy of the manual cleaning process cannot be assured for the affected injection needles ...	Class II	Karl Storz Endoscopy
Oct 24, 2023	CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A	There is the potential that cooler-heater devices may contain bacterial contamination which could...	Class II	CardioQuip, LLC
Oct 24, 2023	Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A	The efficacy of the manual cleaning process cannot be assured for the affected injection needles ...	Class II	Karl Storz Endoscopy
Oct 24, 2023	GRAPHENANO DENTAL G-CAM, Product Codes: a) 95 Multichroma 14LB2, REF GC00089...	Machining error on cams renders the device unusable.	Class II	GRAPHENANO DENTAL SL
Oct 24, 2023	CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A	There is the potential that cooler-heater devices may contain bacterial contamination which could...	Class II	CardioQuip, LLC
Oct 23, 2023	Intera 1.5T	Potential component failure in the Gradient Coil could product smoke and/or fire.	Class II	Philips North America Llc
Oct 23, 2023	Intera 1.5T Power/Pulsar	Potential component failure in the Gradient Coil could product smoke and/or fire.	Class II	Philips North America Llc
Oct 23, 2023	Achieva 1.5T Conversion	Potential component failure in the Gradient Coil could product smoke and/or fire.	Class II	Philips North America Llc
Oct 23, 2023	Achieva 1.5T Initial System	Potential component failure in the Gradient Coil could product smoke and/or fire.	Class II	Philips North America Llc
Oct 23, 2023	Achieva 1.5T	Potential component failure in the Gradient Coil could product smoke and/or fire.	Class II	Philips North America Llc
Oct 23, 2023	Ingenia 1.5T CX	Potential component failure in the Gradient Coil could product smoke and/or fire.	Class II	Philips North America Llc
Oct 23, 2023	SmartPath to dStream for 1.5T	Potential component failure in the Gradient Coil could product smoke and/or fire.	Class II	Philips North America Llc
Oct 23, 2023	stryker Sage PrimaFit External Urine Management System for the Female Anatomy	A small percentage of devices in three lots of product may contain a tape with a natural rubber l...	Class II	Sage Products Inc
Oct 19, 2023	Combo Kit Consists OF 10-110/INS-4500/INS-7040- For access to the subarachnoi...	Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split withou...	Class II	Integra LifeSciences Corp.
Oct 19, 2023	Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimula...	Units distributed in Korea and Turkey that did not have the correct firmware installed to support...	Class II	Medtronic Neuromodulation
Oct 19, 2023	Integra¿ Cranial Access Kit-For access to the subarachnoid space or the later...	Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split withou...	Class II	Integra LifeSciences Corp.
Oct 19, 2023	Para-Pak Clean Vial-For the collection, transportation, preservation, and exa...	Plastic vials contain a manufacturing defect may cause an increased risk of leakage and presents ...	Class II	Meridian Bioscience Inc
Oct 19, 2023	Integra Cranial Access Kit- For access to the subarachnoid space or the later...	Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split withou...	Class II	Integra LifeSciences Corp.
Oct 19, 2023	Integra Cranial Access Kit-For access to the subarachnoid space or the latera...	Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split withou...	Class II	Integra LifeSciences Corp.
Oct 19, 2023	Integra Cranial Access Kit -For access to the subarachnoid space or the later...	Defect in the outer packaging of the Cranial Access Kits can cause the packaging to split without...	Class II	Integra LifeSciences Corp.
Oct 19, 2023	Integra¿ Cranial Access Kit-For access to the subarachnoid space or the later...	Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split withou...	Class II	Integra LifeSciences Corp.
Oct 19, 2023	ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-...	The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containin...	Class II	Abbott Laboratories
Oct 19, 2023	Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DY...	The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containin...	Class II	Abbott Laboratories
Oct 19, 2023	Medline Leg bag, REF DYND12578	Undeclared latex	Class II	MEDLINE INDUSTRIES, LP - Northfield
Oct 19, 2023	Integra Cranial Access Kit-For access to the subarachnoid space or the latera...	Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split withou...	Class II	Integra LifeSciences Corp.
Oct 19, 2023	Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, pres...	Plastic vials contain a manufacturing defect may cause an increased risk of leakage and presents ...	Class II	Meridian Bioscience Inc
Oct 19, 2023	CardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16A	There is a potential for the heating-chamber to malfunction resulting in melting/burning of the h...	Class II	CardioQuip, LLC
Oct 19, 2023	Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module...	The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containin...	Class II	Abbott Laboratories
Oct 19, 2023	Cardinal Health Clean Stool Transportation System-For the collection, transpo...	Due to a manufacturing defect, certain Para-Pak vials may be at risk for leakage.	Class II	Meridian Bioscience Inc
Oct 19, 2023	epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), ...	Siemens Healthcare Diagnostics Inc. has confirmed a potential issue that could occur under certai...	Class II	Siemens Healthcare Diagnostics 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.