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
Sep 11, 2023	Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.0MM, Catal...	An error was identified on the expiration date of the product label. The shelf life for the produ...	Class II	Stryker Corporation
Sep 11, 2023	Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.0MM TIP, Ca...	An error was identified on the expiration date of the product label. The shelf life for the produ...	Class II	Stryker Corporation
Sep 11, 2023	Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 0.5MM TIP, Ca...	An error was identified on the expiration date of the product label. The shelf life for the produ...	Class II	Stryker Corporation
Sep 11, 2023	Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 1.5MM TIP, Ca...	An error was identified on the expiration date of the product label. The shelf life for the produ...	Class II	Stryker Corporation
Sep 11, 2023	Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.5MM, Catal...	An error was identified on the expiration date of the product label. The shelf life for the produ...	Class II	Stryker Corporation
Sep 11, 2023	Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural...	Infusion Pumps with affected software revision may fail to detect air in line, which may lead to ...	Class I	EITAN MEDICAL LTD
Sep 11, 2023	Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 0.5MM TIP, Ca...	An error was identified on the expiration date of the product label. The shelf life for the produ...	Class II	Stryker Corporation
Sep 11, 2023	Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 1.5MM TIP, Ca...	An error was identified on the expiration date of the product label. The shelf life for the produ...	Class II	Stryker Corporation
Sep 11, 2023	GS0008 2Y - Burn Pack - STL, Item Number 880082025	Medical convenience kit contains Zimmer Dermatome Blades which were recalled by Zimmer due to 38 ...	Class II	ROi CPS LLC
Sep 11, 2023	Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 0.5MM TIP, Ca...	An error was identified on the expiration date of the product label. The shelf life for the produ...	Class II	Stryker Corporation
Sep 11, 2023	Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.5MM TIP, Ca...	An error was identified on the expiration date of the product label. The shelf life for the produ...	Class II	Stryker Corporation
Sep 8, 2023	Centricity Universal Viewer Workflow Manager, Image processing radiological s...	When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a thir...	Class II	GE Healthcare
Sep 8, 2023	Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-...	An actuator separated from the pivot mechanism on a lower monitor boom system column. The lower b...	Class II	Omega Medical Imaging, Inc.
Sep 8, 2023	F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)	There is a potential interruption of data communication between E-modules inserted in the F2-01 F...	Class II	GE Medical Systems China Co., Ltd.
Sep 8, 2023	Universal Viewer Workflow Manager, Image processing radiological system	When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a thir...	Class II	GE Healthcare
Sep 7, 2023	Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARAC...	Custom surgical procedure packs contain latex gloves but are labeled as "latex free".	Class II	Alcon Research, LLC
Sep 7, 2023	Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software ve...	CORI software was missing a planning stage that appears in cases of significant knee deformation ...	Class II	Blue Belt Technologies, Inc
Sep 7, 2023	Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35	Inadvertent release of embolectomy catheters that may experience slower than normal balloon defla...	Class II	Edwards Lifesciences, LLC
Sep 6, 2023	2008T HD SYS. CDX BLUESTAR	Potential PCBA leaching from tubing of hemodialysis machines.	Class I	Fresenius Medical Care Holdings, Inc.
Sep 6, 2023	Meera Mobile Operating Table-to support and position the patient immediately ...	Under certain conditions, an issue might prevent the device from performing as intended. A specif...	Class II	Getinge Usa Sales Inc
Sep 6, 2023	BD Pyxis CII Safe ES, REF: 1116-00; and BD Pyxis : CII Safe ES Desktop PC, Wi...	When global edit is used to update multiple formulary properties simultaneously, the following pr...	Class II	CareFusion 303, Inc.
Sep 6, 2023	RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (1) RX4041, (...	RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not mee...	Class II	Randox Laboratories Ltd.
Sep 6, 2023	AU/DxC AU Chemistry Transferrin REF: OSR6152 Immune complexes formed in solu...	The firm has identified that the Transferrin reagent does not meet the Instructions for Use (IFU)...	Class II	Beckman Coulter Biomedical Division
Sep 6, 2023	2008T Hemodialysis System without CDX	Potential PCBA leaching from tubing of hemodialysis machines.	Class I	Fresenius Medical Care Holdings, Inc.
Sep 6, 2023	2008T HD SYS. CDX W/BIBAG BLUESTAR	Potential PCBA leaching from tubing of hemodialysis machines.	Class I	Fresenius Medical Care Holdings, Inc.
Sep 6, 2023	2008T GEN 2 Bibag without CDX	Potential PCBA leaching from tubing of hemodialysis machines.	Class I	Fresenius Medical Care Holdings, Inc.
Sep 6, 2023	2008T Hemodialysis System w/Bibag	Potential PCBA leaching from tubing of hemodialysis machines.	Class I	Fresenius Medical Care Holdings, Inc.
Sep 6, 2023	RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: R...	RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not mee...	Class II	Randox Laboratories Ltd.
Sep 6, 2023	2008T HD SYS. W/O CDX W/BIBAG BLUESTAR	Potential PCBA leaching from tubing of hemodialysis machines.	Class I	Fresenius Medical Care Holdings, Inc.
Sep 6, 2023	RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (re...	RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not mee...	Class II	Randox Laboratories Ltd.
Sep 6, 2023	Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gase...	The complaint involved the absence of a component called "ASM Filter-Pro ABG SYR CAP" from the pa...	Class II	Smiths Medical ASD Inc.
Sep 6, 2023	RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000	RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not mee...	Class II	Randox Laboratories Ltd.
Sep 6, 2023	2008T Hemodialysis SYS, with CDX	Potential PCBA leaching from tubing of hemodialysis machines.	Class I	Fresenius Medical Care Holdings, Inc.
Sep 6, 2023	2008T HD SYS. W/O CDX BLUESTAR	Potential PCBA leaching from tubing of hemodialysis machines.	Class I	Fresenius Medical Care Holdings, Inc.
Sep 6, 2023	RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000	RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not mee...	Class II	Randox Laboratories Ltd.
Sep 6, 2023	RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical sho...	Coating hex did not engage with the Straight Mod Hexdriver or with the Hex Head Screw Driver	Class II	Encore Medical, LP
Sep 6, 2023	Venue Go Standard Carts Ref: (H45181VC and H45103VCW), used with Venue Go R2,...	Some Venue Go Standard Carts can develop an internal failure of the vertical/horizontal tilt adju...	Class II	GE MEDICAL SYSTEMS, ISRAEL LTD.
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
Sep 5, 2023	Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN...	Product was re-processed and re-sterilized by a third party using packaging configurations and a ...	Class II	Atrium Medical Corporation
Sep 5, 2023	Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN...	Product was re-processed and re-sterilized by a third party using packaging configurations and a ...	Class II	Atrium Medical Corporation
Sep 5, 2023	MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 ...	Software update	Class II	Mazor Robotics Ltd
Sep 1, 2023	Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-0...	Potential for breach of Tyvek seals.	Class II	Onkos Surgical, Inc.
Sep 1, 2023	Male-Female Midsection with the following sizes and model numbers. a. Male...	Potential for breach of Tyvek seals.	Class II	Onkos Surgical, Inc.
Sep 1, 2023	Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, ...	Potential for breach of Tyvek seals.	Class II	Onkos Surgical, Inc.
Sep 1, 2023	General Pack, REF BBGP31C	During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252...	Class II	American Contract Systems, Inc.
Sep 1, 2023	Pediatric Urology Wolson Pack, REF BPPU55A	During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252...	Class II	American Contract Systems, Inc.
Sep 1, 2023	Breast Plastics Pack, REF BBPL20D	During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252...	Class II	American Contract Systems, Inc.
Sep 1, 2023	Sub Q Recorder Pack, REF BPRC87A	During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252...	Class II	American Contract Systems, Inc.
Sep 1, 2023	(1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNE...	In some cases, when lubricating grease is present within the headband of the over-ear headphones...	Class II	Siemens Medical Solutions USA, Inc
Sep 1, 2023	Robotics Pack, REF SSRO22D	During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252...	Class II	American Contract Systems, 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.