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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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DateProductReasonClassFirm
Dec 12, 2018 Dimension Vista 500, Analyzer, chemistry Model no. 10284473 When the Millipore Water Purification Module Progard Pretreatment Packs are used with Dimension V... Class II Siemens Healthcare Diagnostics, Inc.
Dec 12, 2018 Epix Electrosurgical Probes with Smoke Evacuation, Angled L-Hook Tip, 5mm x 4... Unintentional shifting of the tip insulation of the firm's electrosurgical probes. Class II Applied Medical Resources Corp
Dec 12, 2018 GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with... Unintentional shifting of the tip insulation of the firm's electrosurgical probes. Class II Applied Medical Resources Corp
Dec 12, 2018 Dimension Vista 1500, Analyzer, chemistry Model no. 10444801 When the Millipore Water Purification Module Progard Pretreatment Packs are used with Dimension V... Class II Siemens Healthcare Diagnostics, Inc.
Dec 12, 2018 Proteus 235 Product Usage: The Proton Therapy System - Proteus 235 (brand... There is a risk of detachment of the Compact Gantry Rolling Floor. Class II Ion Beam Applications S.A.
Dec 11, 2018 VITROS Chemistry Products VALP Reagent Pack. For in vitro diagnostic use only... Negative bias results when using VITROS VALP Reagent, GEN 25. Class II Ortho-Clinical Diagnostics
Dec 11, 2018 U by Kotex¿ Sleek¿, Regular Tampons, 34 Count Potential for tampon to come apart upon removal. Class II Kimberly-Clark Corporation
Dec 11, 2018 U by Kotex¿ Sleek¿, Regular/Super Tampons, 34 Count Multipack Potential for tampon to come apart upon removal. Class II Kimberly-Clark Corporation
Dec 11, 2018 AMIA Automated Peritoneal Dialysis System Product Usage: It is intended ... Potential for the software on Automated PD System cyclers which can cause shortened dwell times d... Class II Baxter Healthcare Corporation
Dec 11, 2018 Kaguya Automated Peritoneal Dialysis System Product Usage: It is intended... Potential for the software on Automated PD System cyclers which can cause shortened dwell times d... Class II Baxter Healthcare Corporation
Dec 11, 2018 U by Kotex¿ Sleek¿, Regular Tampons, 18 Count Potential for tampon to come apart upon removal. Class II Kimberly-Clark Corporation
Dec 11, 2018 U by Kotex¿ Sleek¿, Regular Tampons, 3 Count Potential for tampon to come apart upon removal. Class II Kimberly-Clark Corporation
Dec 10, 2018 JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 1-2 , REF 74013986 The JOURNE... Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch Class II Smith & Nephew, Inc.
Dec 10, 2018 ProSun V3 42 Xlc(160w)(10 minutes) tanning bed, Model 500. Labeled as the fo... ProSun International LLC discovered discrepancies in their Quality Control Checklist documentatio... Class II ProSun International, LLC
Dec 10, 2018 Genius Knee Cemented CR Femoral Component Product Usage: Knee replacement... Product mix up Class II Signature Orthopedics Pty Limited
Dec 10, 2018 ProSun Onyx 32 Sli Intensive (12 minutes) tanning bed, Model 32/1. Labeled a... ProSun International LLC discovered discrepancies in their Quality Control Checklist documentatio... Class II ProSun International, LLC
Dec 10, 2018 JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 5-6 , REF 74013988 The JOURNE... Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch Class II Smith & Nephew, Inc.
Dec 10, 2018 VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device i... No results/incorrect results due to failure of the hybridization heater. Class II Luminex Corporation
Dec 10, 2018 Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE. The incorrect sensor was used in the assembly of the camera in the scanner instrument which can p... Class II Leica Biosystems Imaging, Inc.
Dec 10, 2018 JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 7-8 , REF 74013988 The JOURNE... Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch Class II Smith & Nephew, Inc.
Dec 10, 2018 JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 3-4 , REF 74013987 The JOURNE... Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch Class II Smith & Nephew, Inc.
Dec 10, 2018 Genius Knee Cemented Tibial Component Product Usage: Knee replacement com... Product mix up Class II Signature Orthopedics Pty Limited
Dec 7, 2018 Siemens ADVIA Centaur aTG (100 test kit) Siemens Material Number (SMN): 1049... Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit lots ending in 316 and lower and Atel... Class II Siemens Healthcare Diagnostics, Inc
Dec 7, 2018 PROXIMATE¿ HCS Hemorrhoidal Circular Stapler Product Code: PPH01 PPH01: ... Hemorrhoidal Circular Stapler may have been assembled without a washer, this may potentially caus... Class II Ethicon Endo-Surgery Inc
Dec 7, 2018 PROXIMATE¿ PPH Hemorrhoidal Circular Stapler Product Code:PPH03 PPH03: Th... Hemorrhoidal Circular Stapler may have been assembled without a washer, this may potentially caus... Class II Ethicon Endo-Surgery Inc
Dec 7, 2018 Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diamet... The incorrect outer carton box was used for the product. Class II Spectranetics Corporation
Dec 7, 2018 Atellica IM aTG (500 test kit) Siemens Material Number (SMN): 10995462 Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit lots ending in 316 and lower and Atel... Class II Siemens Healthcare Diagnostics, Inc
Dec 7, 2018 Siemens Atellica IM aTG (100 test kit) Siemens Material Number (SMN): 10995461 Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit lots ending in 316 and lower and Atel... Class II Siemens Healthcare Diagnostics, Inc
Dec 7, 2018 LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (... The reaming guide and the guide rod can't be screwed into the intended depth. The reason for this... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Dec 7, 2018 SiemensADVIA Centaur aTG (500 test kit) Siemens Material Number (SMN): 10492399 Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit lots ending in 316 and lower and Atel... Class II Siemens Healthcare Diagnostics, Inc
Dec 6, 2018 I-View¿ Contrast Enhanced Digital Mammography, ASY-08109 Calibration issue not possible to visualize contrast uptake in the subtracted mammography images Class II Hologic, Inc.
Dec 6, 2018 BARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature Sensing... Some SureStep" Foley Tray Systems with product catalog number A319418AM and lot number NGCT1929 c... Class II Bard Medical Division
Dec 6, 2018 Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and RE... Under certain circumstances, the percutaneous pin adapter used with the StealthAir Frame Assembly... Class II Medtronic Navigation, Inc.
Dec 6, 2018 Vyon DUALSTOP White Cap used for intravascular lines Product Code: 9888.002-... DualStop Caps defect causing leaks in affected product Class II Vygon U.S.A.
Dec 6, 2018 VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE)... VisuMax devices with software version 2.10.13 and activated SW-Module ReLEx (SMILE) option may ex... Class II Carl Zeiss Meditec, Inc.
Dec 6, 2018 Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - ... DualStop Caps defect causing leaks in affected product Class II Vygon U.S.A.
Dec 5, 2018 The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to ... When racks are front-loaded onto the sample presentation unit while samples from the automation l... Class II Beckman Coulter Inc.
Dec 5, 2018 UniCel DxC 660i, 680i, 860i, and 880i SYNCHRON Access Clinical Systems, that ... When racks are front-loaded onto the sample presentation unit while samples from the automation l... Class II Beckman Coulter Inc.
Dec 5, 2018 Breast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100 The sterility may be compromised due to a potential breach in the packaging, even though it may a... Class III Medela Inc
Dec 5, 2018 Toothete Oral Care Sodium Bicarbonate Mouthpaste, Net Wt. 1/3 oz/ 9g, include... A voluntary recall of a lot (67924) of Independent Care System due to the potential for damaged S... Class II Sage Products Inc
Dec 5, 2018 Equinoxe Preserve Humeral Stem, 8mm Product Usage: The Equinoxe Preserve ... Possibility that the Equinoxe Preserve Humeral Stem, 8mm, was inadvertently packaged with an Opt... Class II Exactech, Inc.
Dec 4, 2018 Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6 Gauss Surgical is updating the Instructions for Use (IFU) for our Triton Sponge System in order t... Class III Stryker Instruments Div. of Stryker Corporation
Dec 4, 2018 Da Vinci Xi/X EndoWrist Monopolar Curved scissors (MCS), model number 470179-... This recall is being initiated because lots of EndoWrist Monopolar Curved Scissor instruments ar... Class II Intuitive Surgical, Inc.
Dec 4, 2018 BiMobile UHMWPE Liner: ID-28mm/OD-50mm, Reference Number 184-260/02 The LI... The internal labeling included with these implants may include incorrect part numbers and could r... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Dec 4, 2018 Randox CALCIUM (Ca) COLORIMETRIC METHOD RX DAYTONA PLUS Cat. No. CA 8309 R1... Update to the carryover avoidance technical bulletin to introduce additional steps for reagent ca... Class II Randox Laboratories Ltd.
Dec 4, 2018 BiMobile UHMWPE Liner: ID-28mm/OD-54mm, Reference Number 184-260/04 The LI... The internal labeling included with these implants may include incorrect part numbers and could r... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Dec 4, 2018 MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology i... If a Setup field (CT, kV, MV or MVCT) is created by COPYING a treatment field or another setup fi... Class II Elekta, Inc.
Dec 4, 2018 DX-D 600 DIRECT RADIOGRAPHY SYSTEM Product Usage: The DX-D 600 system is ... After an upgrade of the software of the Overhead Tube Crane, there were isolated cases in which t... Class II Agfa-Gevaert, N.V.
Dec 4, 2018 Randox CALCIUM (Ca) Colorimetric Method RX Series Cat. No. CA 3871, R1. Ars... Update to the carryover avoidance technical bulletin to introduce additional steps for reagent ca... Class II Randox Laboratories Ltd.
Dec 3, 2018 Fructosamine Control 1, FR2994 This product is intended for in vitro use ... The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 ... 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.