Browse Device Recalls

3,013 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,013 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 3,013 FDA device recalls in 2018.

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Date	Product	Reason	Class	Firm
Jul 31, 2018	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03	The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac...	Class II	Oridion Medical 1987 Ltd.
Jul 31, 2018	Capnostream20 (US) M W/PRINTER TO MASIMO, Part Number CS08751	The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac...	Class II	Oridion Medical 1987 Ltd.
Jul 31, 2018	Capnostream20 (INTL) N W/PRINTER REFURBISHED, CS78658	The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac...	Class II	Oridion Medical 1987 Ltd.
Jul 31, 2018	Capnostream20 (INTL) M REFURBISHED, CS78654	The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac...	Class II	Oridion Medical 1987 Ltd.
Jul 31, 2018	Capnostream20 (US) M TO MASIMO, Part Number CS08750	The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac...	Class II	Oridion Medical 1987 Ltd.
Jul 31, 2018	ENDOLOGIX AFX2 Bifurcated Endograft System, Stent Graft System, Rx Only, Ster...	Endologix is notifying physicians of patient tailored surveillance recommendations as well as gen...	Class I	Endologix
Jul 31, 2018	Capnostream20 (US)M REFURBISHED, Part Number CS78653	The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac...	Class II	Oridion Medical 1987 Ltd.
Jul 31, 2018	CAPNOSTREAM 20P (INTL) N, Part Number CS08652-01	The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac...	Class II	Oridion Medical 1987 Ltd.
Jul 31, 2018	Capnostream20 N CYVITAL, CS08799	The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac...	Class II	Oridion Medical 1987 Ltd.
Jul 31, 2018	ENDOLOGIX AFX Endovascular AAA System, Stent Graft System, Rx Only, Sterile E...	Endologix is notifying physicians of patient tailored surveillance recommendations as well as gen...	Class I	Endologix
Jul 31, 2018	Capnostream20 (US) M W/PRINTER REFURBISHED, Part Number CS78659	The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac...	Class II	Oridion Medical 1987 Ltd.
Jul 31, 2018	Capnostream20 (INTL) M W/PRINTER REFURBISHED, CS78660	The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac...	Class II	Oridion Medical 1987 Ltd.
Jul 31, 2018	CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS051COV-03	The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac...	Class II	Oridion Medical 1987 Ltd.
Jul 31, 2018	CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657	The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac...	Class II	Oridion Medical 1987 Ltd.
Jul 31, 2018	Capnostream20 (US) M, Part Number CS08653	The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac...	Class II	Oridion Medical 1987 Ltd.
Jul 31, 2018	CAPNOSTREAM 20P (INTL) N W/PRINTER, Part Number CS08658-01	The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac...	Class II	Oridion Medical 1987 Ltd.
Jul 31, 2018	CAPNOSTREAM 20 (INTL) N, Part Number CS08652	The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac...	Class II	Oridion Medical 1987 Ltd.
Jul 31, 2018	CAPNOSTREAM 20P (INTL) N - ROHS, Part Number CS08652-03	The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac...	Class II	Oridion Medical 1987 Ltd.
Jul 31, 2018	Capnostream20 M NICU (CPM), CS08654RN	The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac...	Class II	Oridion Medical 1987 Ltd.
Jul 31, 2018	Capnostream20 (INTL) N REFURBISHED, CS78652	The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac...	Class II	Oridion Medical 1987 Ltd.
Jul 31, 2018	Capnostream20 (INTL) M, CS08654	The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac...	Class II	Oridion Medical 1987 Ltd.
Jul 31, 2018	CAPNOSTREAM 20 (INTL) N W/PRINTER, Part Number CS08658	The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac...	Class II	Oridion Medical 1987 Ltd.
Jul 31, 2018	ENDOLOGIX AFX/AFX2, Proximal (Aortic) Extension Endograft, Rx Only, Sterile E...	Endologix is notifying physicians of patient tailored surveillance recommendations as well as gen...	Class I	Endologix
Jul 31, 2018	Capnostream20 (US) N W/PRINTER REFURBISHED, Part Number CS78657	The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac...	Class II	Oridion Medical 1987 Ltd.
Jul 31, 2018	CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01	The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac...	Class II	Oridion Medical 1987 Ltd.
Jul 31, 2018	CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS08658-03	The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac...	Class II	Oridion Medical 1987 Ltd.
Jul 31, 2018	Capnostream20 M ADULT ICU (CPM), CS08654RA	The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac...	Class II	Oridion Medical 1987 Ltd.
Jul 30, 2018	Zimmer Natural Nail Tibial Nail - Yellow 8.3mm, Model Number 47249534008 P...	The item is labeled as an 8.3mm, but it is actually a 12 mm.	Class II	Zimmer Biomet, Inc.
Jul 30, 2018	ARROW¿ Bipolar Electrode Catheter with shrouded pins , 6 Fr, 110 cm Product ...	Products are labeled with an incorrect expiration date	Class II	Arrow International Inc
Jul 30, 2018	UniCel DxH 900 Coulter Cellular Analysis System, REF number C11478 Product...	Complaints received of sporadic erroneously elevated platelet results without flags or system mes...	Class I	Beckman Coulter Inc.
Jul 30, 2018	CIVCO Needle Guide, REF 676-144, QTY 24, STERILE EO	The assembly of the needle guides were found to be either missing adhesive or did not have adequa...	Class II	Civco Medical Instruments Co. Inc.
Jul 30, 2018	CIVCO Needle Guide, REF 676-150, QTY 24, STERILE EO	The assembly of the needle guides were found to be either missing adhesive or did not have adequa...	Class II	Civco Medical Instruments Co. Inc.
Jul 30, 2018	Vitality¿ Spinal Fixation System. Spinal Interlaminal, Appliance, Fixation, (...	The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vita...	Class II	Zimmer Biomet Spine Inc.
Jul 30, 2018	Vitality¿ Spinal Fixation System. Thoracolumbosacral pedicle screw system (no...	The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vita...	Class II	Zimmer Biomet Spine Inc.
Jul 30, 2018	Vitality¿ Spinal Fixation System.Spinal Intervertebral Body, Appliance, Fixat...	The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vita...	Class II	Zimmer Biomet Spine Inc.
Jul 30, 2018	UniCel DxH 600 Coulter Cellular Analysis System, REF number B23858. Produc...	Complaints received of sporadic erroneously elevated platelet results without flags or system mes...	Class I	Beckman Coulter Inc.
Jul 30, 2018	UniCel DxH 800 Coulter Cellular Analysis System, REF numbers 629029, B24465, ...	Complaints received of sporadic erroneously elevated platelet results without flags or system mes...	Class I	Beckman Coulter Inc.
Jul 29, 2018	Artis Q Interventional Fluoroscopic X-Ray System, Model Numbers 10848280, 108...	Temperature of the detector may fall out of its designed working range (cool down) due to incorre...	Class II	Siemens Medical Solutions USA, Inc
Jul 29, 2018	ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000	Temperature of the detector may fall out of its designed working range (cool down) due to incorre...	Class II	Siemens Medical Solutions USA, Inc
Jul 27, 2018	ZIMMER Oscillating Saw Blade -Cutting 75mm x 19mm x 1.00/1.27mm.intended for ...	Mislabeled: Actual blade width is 19 mm but the label indicates a width of 25 mm.	Class II	Synvasive Technology Inc
Jul 27, 2018	Sysmex XN-Series Fluorocell PLT, Catalog #CD994563. Distributed in the U.S....	The fluorescent platelet counts (PLT-F) and immature platelet fraction (IPF) values can be falsel...	Class II	Sysmex America, Inc.
Jul 27, 2018	Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers A...	Affected lots of reprocessed arthroscopic shavers may display the incorrect catalog number and sp...	Class II	Stryker Sustainability Solutions
Jul 26, 2018	AMSCO V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Syst...	There is the potential for a scenario where a punctured cup of sterilant expires while the system...	Class II	Steris Corporation
Jul 26, 2018	Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Prod...	Revised replacement instructions for the Li-ion battery packs used in BIS Vista and BIS View Moni...	Class II	Covidien LLC
Jul 26, 2018	Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: H...	When creating a correction plan with the Correct Axial First button selected and the No. of cor...	Class II	Stryker GmbH
Jul 26, 2018	Microdot Xtra blood glucose test strips	The firm reported that a faulty cutting/punching machine did not meet specifications after being ...	Class II	Cambridge Sensors Limited
Jul 25, 2018	Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Pro...	There was a potential that a 25-gauge infusion cannula may be included within the procedure pak i...	Class II	Alcon Research LLC
Jul 25, 2018	Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists...	After running the calibration curve, the recovery of the IgM kit control results decrease demonst...	Class II	The Binding Site Group, Ltd.
Jul 25, 2018	HYTEC Stop Solution (Allergy), 300ml bottle containing 1N sodium hydroxide so...	Some of the Stop Solution bottles, a caustic solution, have been reported to leak.	Class II	Hycor Biomedical LLC
Jul 25, 2018	PR1000 Pivot Rehab Bed AC powered adjustable bed.	Under certain conditions, when pivoting bed to the extreme left there are situations where the wi...	Class II	Med-Mizer, 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.