Browse Device Recalls

5,543 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,543 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 5,543 FDA device recalls.

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DateProductReasonClassFirm
Apr 24, 2020 Medtronic Bone Void Filler, Large - Product Usage: is an injectable, moldab... Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may... Class II Medtronic Sofamor Danek USA Inc
Apr 24, 2020 Extremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, mold... Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may... Class II Medtronic Sofamor Danek USA Inc
Apr 24, 2020 Medtronic Bone Void Filler, Small - Product Usage: is an injectable, moldab... Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may... Class II Medtronic Sofamor Danek USA Inc
Apr 24, 2020 Sterile Disposable Connectors ASY Y CONN 3/8 X 3/8 X 3/8 24 REF/ GTIN for Ins... The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... Class II LivaNova USA Inc.
Apr 24, 2020 Sterile Disposable Connectors ASY S CONN 3/16X1/8 RDR ANLD24 REF/ GTIN for In... The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... Class II LivaNova USA Inc.
Apr 24, 2020 Sterile Disposable Connectors ASY STR CONN 1/4 STRLE 24. REF/ GTIN for Insert... The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... Class II LivaNova USA Inc.
Apr 24, 2020 DeRoyal Sterile Custom Kits packaged as a Piggy Back with the BD PosiFlush SF... DeRoyal manufactured procedure packs using BDPosiFlush syringes which were subsequently recalled... Class II DeRoyal Industries Inc
Apr 24, 2020 Sterile Disposable Connectors ASY RDC Y 1/2X3/8X3/8 STR 24 REF/ GTIN for Inse... The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... Class II LivaNova USA Inc.
Apr 24, 2020 Vein Irrigation Cannula with blunt tip. ASY VIC, STERILE 25/CS REF/ GTIN for ... The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... Class II LivaNova USA Inc.
Apr 24, 2020 Sterile Disposable Connectors ASY 1/2 CONN W/LL STRLE 24 REF/ GTIN for Insert... The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... Class II LivaNova USA Inc.
Apr 13, 2020 Cardiovascular Monitoring Device accessory - Product Usage: The chest pneumog... The labeling of the Philips Chest Pneumograph does not include a statement indicating that the pr... Class II Philips North America, LLC
Apr 13, 2020 Magnetic Resonance Imaging Diagnostic Device accessory - Product Usage: The c... The labeling of the Philips Chest Pneumograph does not include a statement indicating that the pr... Class II Philips North America, LLC
Apr 8, 2020 Arterial Line Kit 20ga X 3", Model 498411B, Rx Only, Sterile EO, UDI: 008863... Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of... Class II Argon Medical Devices, Inc
Apr 8, 2020 Arterial Line Kit 20ga X 3", Model 498106, Rx Only, Sterile EO, UDI: 0088633... Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of... Class II Argon Medical Devices, Inc
Apr 8, 2020 PAC Tray/5 Catheter Introducer Tray 8F, Model 497424, Rx Only, STERILE EO, UD... Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of... Class II Argon Medical Devices, Inc
Apr 7, 2020 Oryx Cervical Screw Caddy, Model Number BTA-172, as part of the Oryx Cervical... Cervical screw caddies have incorrect text markings for the 4.5mm Fixed and Variable rescue screw... Class II Innovasis, Inc
Apr 6, 2020 SKAFFOLD RENU FLOW, 5CC. Product Number: SKMA-FL05, UDI: 813845020849 - Prod... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 EXACTECH OSSILIX FORM (MX), 5CC. Product Number: 660-01-05, UDI: 81384502102... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 EXACTECH OSSILIX FORM (MX), 10CC. Product Number: 660-01-10, UDI: 8138450210... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 OSTEOVATION EX, 3CC, IMPACT FORMULA. Product Number: 390-0203, UDI: 81384502... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 ACUMED IMPACT 5CC. Product Number: 65-0105-S, UDI: 813845020252 - Product Us... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 ACUMED IMPACT 10CC. Product Number: 65-0110-S, UDI: 813845020269 - Callos is... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 OSTEOVATION, 5CC, INJECT FORMULA. Product Number: 390-2005, UDI: 81384502005... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 SK SKAFFOLD IMPRESS 10CC. Product Number: SKAF-IM10, UDI: 813845020795 - Pro... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 SKAFFOLD RENU FLOW, 10CC. Product Number: SKMA-FL10, UDI: 813845020856 - Pro... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 OSTEOVATION, 3CC, IMPACT FORMULA. Product Number: 390-2103, UDI: 81384502007... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 CRANIOSCULPT FLOW, 10CC. Product Number: C-FLOW10CC, UDI: 813845020368 - - P... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 OSTEOVATIONEX, INJECT 3CC. Product Number: 390-0003, UDI: 813845020016 - Pro... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 CRANIOSCULPT, FLOW 5CC. Product Number: C-FLOW5CC, UDI: 813845020337 - Produ... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 CRANIOSCULPT, CMF IMPACT, 5CC, Product Number: C-CMF5CC, UDI: 813845020948 -... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 MEDTRONIC BONE VOID FILLER, SMALL. Product Number: C07A, UDI: 813845020504 -... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 CRANIOSCULPT FLOW, OUS, 5CC Product Number: C-FLOW5CC-OUS, UDI: 813845020351... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 CRANIOSCULPT C, 10CC. Product Number: C-C10CC, UDI: 813845021129 - Product U... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 CRANIOSCULPT C, 3CC. Product Number: C-C3CC, UDI: 813845021105 - Product Usa... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 OSTEOVATIONEX 2CC INJECT FORMULA. Product Number: 390-0002, UDI: 81384502000... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 CRANIOSCULPT C, 5CC. Product Number: C-C5CC, UDI: 813845021112 - - Product U... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 OSTEOVATION, 10CC, INJECT FORMULA. Product Number: 390-2010, UDI: 8138450200... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 SKAFFOLD FLOW, 3CC and SKAFFOLD FLOW (MX) 3CC. Product Number: SKMX-FL03, UD... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 SKAFFOLD CMF IMPRESS (MP), 5CC. Product Number: CMMP-IM05, UDI: 813845020689... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 ACUMED CALLOS INJECT 3CC. Product Number: 65-0003-S, UDI: 813845020221 - Pr... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 ACUMED CALLOS INJECT 10CC. Product Number: 65-0010-S, UDI: 813845020245 - Pr... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 OSTEOVATION RMX 5CC. Product Number: 390-6001, UDI: 813845021082 - Product U... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 OSTEOVATION IMPACT 10CC and OSTEOVATION, 10CC, IMPACT FORMULA, Product Number... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 CRANIOSCULPT FLOW, CAN, 10CC, Product Number: C-FLOW10CC-CAN, UDI: 813845020... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 SKAFFOLD FLOW (MX) 5CC. Product Number: SKMX-FL05, UDI: 813845020894 - Produ... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 CRANIOSCULPT FLOW, 3CC. Product Number: C-FLOW3CC, UDI: 813845020320 - - Pro... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 CRANIOSCULPT, CMF IMPACT, 10CC, Product Number: C-CMF10CC, UDI: 813845020955... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 SKAFFOLD FLOW, 10CC. Product Number: SKMX-FL10, UDI: 813845020900 - Product ... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 CRANIOSCULPT, CMF IMPACT, 3CC Product Number: C-CMF3CC, UDI: 813845020931 - ... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc
Apr 6, 2020 EXACTECH OSSILIX FIL (MX), 5CC. Product Number: 660-02-05, UDI: 813845021006... Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... Class II Skeletal Kinetics, Llc

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.