Browse Device Recalls

1,062 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,062 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 1,062 FDA device recalls in OH.

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Date	Product	Reason	Class	Firm
Nov 10, 2023	Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682R	There is a manufacturing defect affecting specific rotator lots. Within this population, the inne...	Class II	Smiths Medical Asd Inc
Nov 10, 2023	48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R	There is a manufacturing defect affecting specific rotator lots. Within this population, the inne...	Class II	Smiths Medical Asd Inc
Nov 6, 2023	Curaplex Field Cric Kit with ET Tube, Item Number 36611. The kit provides he...	It was determined that the Endotracheal Tube Holder included in certain kits is not compatible wi...	Class II	Sarnova HC, Llc
Nov 6, 2023	Curaplex Cricothyrotomy Field Kit with Instruments, Kwik Cric MVP, 6.0mm, Ite...	It was determined that the Endotracheal Tube Holder included in certain kits is not compatible wi...	Class II	Sarnova HC, Llc
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	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	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
Sep 5, 2023	Zimmer Dermatome Blades- 10-pack boxes of blades. Intended for use with the d...	Skin grafts thin and non-uniform when using the affected blades. The issue would be identified at...	Class II	Zimmer Surgical Inc
Jun 15, 2023	DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also ser...	Premature failure of the seat during use, the plastic eyelets of the folding mechanism of the dev...	Class II	Invacare Corporation
Jun 15, 2023	MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handsw...	An issue with the Suction Coagulator product family may lead to fluid ingress into the handpiece....	Class II	Megadyne Medical Products, Inc.
Jun 1, 2023	MEGADYNE MEGA SOFT Universal Patient Return Electrode. used during electrosu...	Firm has received reports of patient burns in surgical procedures where device was used.	Class I	Megadyne Medical Products, Inc.
Jun 1, 2023	MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrode. used during elect...	Firm has received reports of patient burns in surgical procedures where device was used.	Class I	Megadyne Medical Products, Inc.
Jun 1, 2023	MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode. used during...	Firm has received reports of patient burns in surgical procedures where device was used.	Class I	Megadyne Medical Products, Inc.
Jun 1, 2023	MEGADYNE MEGA SOFT Reusable Patient Return Electrode. used during electrosur...	Firm has received reports of patient burns in surgical procedures where device was used.	Class I	Megadyne Medical Products, Inc.
Jun 1, 2023	MEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgery	Firm has received reports of patient burns in surgical procedures where device was used.	Class I	Megadyne Medical Products, Inc.
Jun 1, 2023	MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. used during electrosu...	Firm has received reports of patient burns in surgical procedures where device was used.	Class I	Megadyne Medical Products, Inc.
Jun 1, 2023	MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode. used during elec...	Firm has received reports of patient burns in surgical procedures where device was used.	Class I	Megadyne Medical Products, Inc.
Jun 1, 2023	MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during elec...	Firm has received reports of patient burns in surgical procedures where device was used.	Class I	Megadyne Medical Products, Inc.
May 16, 2023	Aeris Balloon Dilation Catheter	Devices were mislabeled.	Class II	Bryan Medical Inc
Apr 10, 2023	Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062	In the remote occurrence in which the electrical contactor component present in the drying chambe...	Class II	Steris Corporation
Mar 17, 2023	Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44 ...	Light handle covers may separate from the light handle (detach and fall off) during use, this cou...	Class II	Steris Corporation
Mar 17, 2023	Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)-...	Light handle covers may separate from the light handle (detach and fall off) during use, this cou...	Class II	Steris Corporation
Mar 7, 2023	REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Inten...	Error in the Introduction section of the user manual that indicates the device may be used for th...	Class II	Compass Health Brands (Corporate Office)
Feb 1, 2023	MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhi...	Kits with affected microtiter plates have the potential to produce low OD values, causing the run...	Class II	Quidel Corporation
Feb 1, 2023	BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein...	New warnings and precautionary statements on product labelling: Reagent 2 (R2) of BIOPHEN Protein...	Class II	Aniara Diagnostica LLC
Jan 20, 2023	SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious...	Screw connection between the turbine head and the push button may loosen and fall off during the ...	Class II	Coltene Whaledent Inc
Jan 3, 2023	Digital VIPR ROC-9839 Roberts Oxygen Ready to Use Digital VIPR (head only)...	Gauge malfunction: Digital gauge displays an incorrect tank pressure - displays pressure higher t...	Class II	Western/Scott Fetzer Company
Dec 15, 2022	Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative d...	Leakage of the original specimen from the plastic microfluidic cartridge (PIE), possibility that ...	Class II	Meridian Bioscience Inc
Dec 12, 2022	VERIFY Dual Species Self-Contained Biological Indicators, 50 per box Item Nu...	Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus s...	Class II	Steris Corporation
Dec 12, 2022	VERIFY Steam Test Pack (20 Tests and 5 controls) Item Number: S3065 Inten...	Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus s...	Class II	Steris Corporation
Dec 12, 2022	VERIFY Dual Species Self-Contained Biological Indicators, 100 per box Item N...	Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus s...	Class II	Steris Corporation
Dec 12, 2022	VERIFY Steam Test Pack (20 Tests and 20 controls) Item Number: S3069 Inte...	Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus s...	Class II	Steris Corporation
Oct 17, 2022	GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to ...	Two electronic diode components (D1 & D4) placed in the reverse orientation on the controller pri...	Class II	Steris Corporation
Oct 7, 2022	FERNO POWER X1 AMBULANCE COT- Item #0015807/UDI-DI 00190790002183 with 36V ...	Batteries could become unstable when not properly maintained and/or subjected to repeated drops, ...	Class II	Ferno-Washington 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
Aug 10, 2022	Verify SixCess Challenge Pack. Used to confirm that critical parameters of s...	Product contains incorrect chemical indicators in packaging.	Class III	Steris Corporation Hopkins Facility
Jul 11, 2022	NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Par...	Due to a defect identified on the EPG controller printed circuit board assembly, device performan...	Class I	Synapse Biomedical Inc
Jun 28, 2022	BIOPHEN UFH Control Plasma	Incorrect product labeling was included in the package.	Class III	Aniara Diagnostica LLC
Jun 22, 2022	Revogene, Catalog no. 610210. IVD test instrument	When a run is aborted, the cooling period protection does not occur and the user is able to open ...	Class II	Meridian Bioscience Inc
Jun 10, 2022	Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Ca...	Between March 2, 2021 and December 31, 2021, the product label used in production did not contain...	Class III	Invacare Corporation
May 31, 2022	NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # ...	Firm has revised labeling to consistently call out storage conditions and revised the instruction...	Class III	Synapse Biomedical Inc
Apr 26, 2022	4 Series CX phototherapy units equipped with Daavlin's ClearLink Control Syst...	Software issue, resuming an interrupted treatment will result in swap of utilized calibration tre...	Class II	Daavlin Distributing Company
Apr 26, 2022	1 Series CX phototherapy units equipped with Daavlin's ClearLink Control Syst...	Software issue, resuming an interrupted treatment will result in swap of utilized calibration tre...	Class II	Daavlin Distributing Company
Apr 22, 2022	Reliance Synergy Washer/Disinfector	The firm identified that when the electrical contactor component in the drying chamber of the Was...	Class II	Steris Corporation
Mar 30, 2022	HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4	Small patient labels do not match the primary device label. The primary device label accurately i...	Class II	Devicor Medical Products Inc
Mar 30, 2022	Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V	The battery wiring harness on affected wheelchairs may become disconnected during shipment from t...	Class II	Invacare Corporation
Mar 22, 2022	Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 2,000 per case 10 sleeves of 2...	Product not approved for release for US distribution	Class II	Steris Corporation
Mar 22, 2022	Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 5,000 per case 25 sleeves of 2...	Product not approved for release for US distribution	Class II	Steris Corporation
Feb 15, 2022	Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in c...	The photomultiplier tube, may have compromised functionality in some instruments. As a result, th...	Class II	Meridian Bioscience Inc
Jan 10, 2022	Voyager Rollator-intended as a mechanical walker Model Number: RLEU10xx (RLE...	Wheel spoke may crack causing the wheel to separate from the axle may result in patient injuries,...	Class II	Compass Health Brands (Corporate Office)

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.