Browse Device Recalls

2,055 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,055 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 2,055 FDA device recalls in N/A.

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DateProductReasonClassFirm
Jun 21, 2018 Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 1... The catheters are suspected to contain defective sensors; if used, defective catheter will show l... Class II Degania Silicone, Ltd.
Jun 21, 2018 Foley Catheter with temperature sensor 400TM 16FR, Catalogue Number 102201101... The catheters are suspected to contain defective sensors; if used, defective catheter will show l... Class II Degania Silicone, Ltd.
Jun 11, 2018 MyLab Seven, Model 6400 The probe power monitoring settings have been found to be not appropriate under specific operati... Class II ESAOTE S.P.A.
Jun 11, 2018 MyLab Alpha, Model 7400 The probe power monitoring settings have been found to be not appropriate under specific operati... Class II ESAOTE S.P.A.
Jun 11, 2018 MyLab Gamma, Model 7410 The probe power monitoring settings have been found to be not appropriate under specific operati... Class II ESAOTE S.P.A.
Jun 8, 2018 Liquid Cardiac Control - Level 3, cat. no. CQ5053 Product Usage: This pro... The device is not suitable for the control of the Troponin T assay due to unacceptable variation ... Class II Randox Laboratories Ltd.
Jun 6, 2018 RayStation Radiation Therapy Treatment Planning System, Model nos. 2.5, 3.5, ... The firm has learned that some RayStation/RayPlan users have commissioned machines with erroneous... Class II RAYSEARCH LABORATORIES AB
Jun 1, 2018 Micro Surgery Handpiece SGA, Model SGA-E2S Order Code: H265, Manufactured b... Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions... Class II Nakanishi Inc.
Jun 1, 2018 Surgical Handpiece, Model: SGS-E2G Order Code: H185, Nakanishi Inc. The S... Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions... Class II Nakanishi Inc.
Jun 1, 2018 Surgical Handpiece, Model: SGA-E2G Order Code: H184, Nakanishi Inc. The... Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions... Class II Nakanishi Inc.
Jun 1, 2018 Micro Surgery Handpiece SGS, Model: SGS-ES, Order Code: H264, Manufactured by... Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions... Class II Nakanishi Inc.
Jun 1, 2018 Micro Surgery Handpiece SGA, Model SGA-ES, Order Code:H263, Manufactured by:... Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions... Class II Nakanishi Inc.
Jun 1, 2018 Micro Surgery Handpiece SGS, Model: SGS-E2S, Order Code: H266, Manufactured b... Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions... Class II Nakanishi Inc.
Jun 1, 2018 Surgical Handpiece, Model: SGA-E Order Code: H083, Nakanishi Inc. The S... Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions... Class II Nakanishi Inc.
Jun 1, 2018 Surgical Handpiece, Model: SGS-E, Order Code: H084, Nakanishi Inc. The SG... Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions... Class II Nakanishi Inc.
May 31, 2018 N Latex CDT Kit Siemens Healthcare Diagnostics has observed a negative bias for the carbohydrate-deficient transf... Class II CSL Behring GmbH
May 28, 2018 EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use. Underfilled reagent well that could lead to incorrect results Class II QIAGEN
May 18, 2018 Natus Neurology ErgoJust Carts labeled as the following: ICU Cart Export For ... Natus Neuro has discovered a possible manufacturing defect in the ErgoJust mobile cart that may c... Class II Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
May 18, 2018 EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ... There is a potential for a disruption in one or more of the triple layer membranes of the ventric... Class I BERLIN HEART GMBH
May 15, 2018 XLTEK EMU40EX EEG Headbox Possible degradation of an internal electronic component over time which may cause the XLTEK EMU ... Class II Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
May 14, 2018 Aortic Arterial Cannula 24 Fr (O.D.); 23 cm (L); with 3/8-inch connector with... This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could bre... Class II Maquet Cardiopulmonary Ag
May 14, 2018 Minicon Clinical Sample Concentrators for In Vitro Diagnostic Use 9031 (Model... In vitro diagnostic devices, used greater than 6 months after date of manufacture, may have incre... Class II Merck Millipore Ltd.
May 14, 2018 Aortic Arterial Cannula 20 Fr (O.D.); 23 cm (L); with 3/8-inch wide connector... This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could bre... Class II Maquet Cardiopulmonary Ag
May 14, 2018 Aortic Arterial Cannula 22 Fr (O.D.); 23 cm (L); with 3/8-inch connector with... This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could bre... Class II Maquet Cardiopulmonary Ag
May 8, 2018 ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Dev... Replacement of units lacking an updated device approval. Class II MEDTECH SAS
May 7, 2018 AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6... Some left-handed gloves contain powder. Powdered surgical gloves are a banned medical device in t... Class II WRP Asia Pacific Sdn Bhd
May 4, 2018 Farabeuf Clamp for 3.5mm Screws PRO, Catalog # 705463 Laser etching which indicates whether the device is in compression or distraction mode appears ... Class II Stryker GmbH
Apr 19, 2018 VOLISTA StandOP (model 600) surgical lights shipped from October 2012 until J... Potential keypad failure on VOLISTA StandOP Surgical Lights. Class II Maquet SAS
Apr 4, 2018 CARDIOHELP Gas Bottle Holder HKH 8880, Product Code/Part Number 70105.0901 ... There is a possibility for the clamps of the gas bottle holder to crack or break when exposed to ... Class II Maquet Cardiopulmonary Ag
Mar 26, 2018 MultiDim Eleva 708032 As a multifunctional universal imaging application... The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the... Class II Philips Medical Systems Nederlands
Mar 26, 2018 Mutlidiagnost-Eleva with Flat Detector 708034 As a multifunctional univers... The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the... Class II Philips Medical Systems Nederlands
Mar 26, 2018 MultiDiagnostic-Eleva with Flat Detector 708038 As a multifunctional unive... The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the... Class II Philips Medical Systems Nederlands
Mar 26, 2018 MultiDiagnostic-Eleva with Flat Detector 708035 As a multifunctional unive... The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the... Class II Philips Medical Systems Nederlands
Mar 26, 2018 MultiDiagnost Eleva 708036 As a multifunctional universal imaging applicat... The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the... Class II Philips Medical Systems Nederlands
Mar 26, 2018 708033 URODiagnost As a multifunctional universal imaging application syst... The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the... Class II Philips Medical Systems Nederlands
Mar 26, 2018 Mutlidiagnost-Eleva with Flat Detector Eleva with Flat Detector 708037 As... The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the... Class II Philips Medical Systems Nederlands
Mar 23, 2018 Color Gram 2 (COLOR GRAM 2 - F), these stains are used to stain bacterial and... A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable... Class II BioMerieux SA
Mar 23, 2018 The PREVI¿ Color Gram dyes are used with the PREVI¿ Color Gram instrument to ... A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable... Class II BioMerieux SA
Mar 23, 2018 Oxidase Reagent (ref: 55635): This test is used to detect the production of t... A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable... Class II BioMerieux SA
Mar 23, 2018 The VITEK 2 Gram Negative Susceptibility Card is intended for use with the VI... A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable... Class II BioMerieux SA
Mar 23, 2018 The VITEK 2 Neisseria-Haemophilus identification card (NH) is intended for us... A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable... Class II BioMerieux SA
Mar 23, 2018 The VITEK 2 Gram-Positive identification card (GP) is intended for use with t... A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable... Class II BioMerieux SA
Mar 23, 2018 VIDAS TOXO IgG Avidity is an automated qualitative test for use on the VIDAS ... A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable... Class II BioMerieux SA
Mar 23, 2018 The VITEK¿ 2 Anaerobic and Corynebacteria identification card (ANC) is intend... A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable... Class II BioMerieux SA
Mar 23, 2018 The VITEK¿ 2 Gram Positive Susceptibility Card is intended for use with the V... A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable... Class II BioMerieux SA
Mar 19, 2018 Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVI... Teleflex Medical is recalling the affected product because there may be missing or incomplete inf... Class II Teleflex Medical Europe Ltd
Mar 12, 2018 McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological mo... Change Healthcare has identified an issue where, under certain circumstances, the Real Time Monit... Class II McKesson Israel Ltd.
Mar 12, 2018 Hinge Coupling Hoffmann LRF Catalog # 4933-0-800 Intended for fixation of ... The wrong parts were picked for packaging. The connecting Nuts were packed in the packaging labe... Class II Stryker GmbH
Mar 9, 2018 Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD.... The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the... Class II The Binding Site Group, Ltd.
Mar 2, 2018 Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI83... Randox has now released further steps to avoid contamination of the Lipase Assay on Rx instrume... Class II Randox Laboratories Ltd.

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.