Browse Device Recalls

950 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 950 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 950 FDA device recalls in MI.

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DateProductReasonClassFirm
Apr 24, 2019 PICC Line Accessory Kit CVI4285 Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... Class II Centurion Medical Products Corporation
Apr 24, 2019 OR VANTEX 7FR 3L 16CM CVC ECVC6665 Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... Class II Centurion Medical Products Corporation
Apr 24, 2019 PEDIATRIC PICC INSERTION TRAY CVI4450A Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... Class II Centurion Medical Products Corporation
Apr 18, 2019 Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 8... The gas flow rate output of the EPGS may be inaccurate due to a defect in the internal flowmeter. Class II Terumo Cardiovascular Systems Corporation
Apr 18, 2019 Skytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP Steam P... Weld attaching the air heater assembly to the main sterilizer unit has shown signs of fatigue/fai... Class II Skytron, Div. The KMW Group, Inc
Mar 29, 2019 Sterile Nail Nipper, Barrel Spring (I68400), Sterile Compromised seal on the sterile barrier pouch. Class II Centurion Medical Products Corporation
Mar 29, 2019 Sterile Nail Clipper Concave Edge (67710) Compromised seal on the sterile barrier pouch. Class II Centurion Medical Products Corporation
Mar 19, 2019 Performance Series Sagittal Blade, Catalog Number 6125-127-100 Product Usa... During manufacture, packaging materials for a small portion of the lot may not have been properly... Class II Stryker Instruments Div. of Stryker Corporation
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
Nov 20, 2018 Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000 The power load floor plates which hold the ambulance cot anchors in place during patient transpor... Class II Stryker Medical Division of Stryker Corporation
Oct 17, 2018 Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Elec... An intermittent failure which causes a blender initialization fault upon start-up or during an EP... Class II Terumo Cardiovascular Systems Corporation
Oct 10, 2018 Naera Hospital Bassinet, Model No. 4402 It was identified that the volume of air inside the mattress may expand in regions of high altitu... Class II Stryker Medical Division of Stryker Corporation
Oct 8, 2018 The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option The beds with the high rail side rail option may not be complaint with IEC 60601-2-52/C1:2010. T... Class II Stryker Medical Division of Stryker Corporation
Oct 8, 2018 The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option The beds with the high rail side rail option may not be complaint with IEC 60601-2-52/C1:2010. T... Class II Stryker Medical Division of Stryker Corporation
Sep 13, 2018 Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#:... The service manual was not updated at the time of the release of software version 1.30. Class II Terumo Cardiovascular Systems Corporation
Sep 6, 2018 Altrix¿ Precision Temperature Management System Model: 8001Product Usage: T... Users may experience alarm fatigue due to frequent alarming relating to patient temperature devia... Class II Stryker Medical Division of Stryker Corporation
Aug 28, 2018 Terumo 100/120V AC, Advanced Perfusion System Platform (APS) for use in cardi... Screws on a Terumo¿ Advanced Perfusion System 1 Power Manager Board (the base unit circuit board... Class II Terumo Cardiovascular Systems Corporation
Aug 28, 2018 Terumo 220/240V AC, Advanced Perfusion System Platform (APS) for use in cardi... Screws on a Terumo¿ Advanced Perfusion System 1 Power Manager Board (the base unit circuit board... Class II Terumo Cardiovascular Systems Corporation
Aug 22, 2018 Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING, 4" X 5", 10 Pads, Catalogu... The sterilization process used was unqualified. Class II Safe N Simple, LLC
Aug 22, 2018 Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING ADHESIVE BORDER, 4" X 5", 1... The sterilization process used was unqualified. Class II Safe N Simple, LLC
Aug 13, 2018 IsoFlex LAL Support Surface, Model Number 2860 Product Usage: : The Is... Certain 2860 IsoFlex LAL support surfaces were assembled with a non-conforming fire barrier. Class II Stryker Medical Division of Stryker Corporation
Aug 10, 2018 Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CA... Vials of the autoHDL/LDL Calibrator were shipped without a vial label. Class III Medtest Holdings, Inc.
Aug 2, 2018 Campylobacter Blood Free Selective Medium, PN 7527A Used with cefoperazon... The product is labeled with an incorrect expiration date. Class III Acumedia Manufacturers, Inc.
Aug 2, 2018 Palcam Agar Base, Acumedia, PN 7669, Product Usage - Dehydrated culture media... Expiration date on the label is incorrect. Correct expiration date was November 30, 2020 and labe... Class III Acumedia Manufacturers, Inc.
Jul 18, 2018 Retrograde Cardioplegia Cannula, Model Number RMG-0015S The Retrograde Ca... The device was built with the rigid insertion stylet instead of the flexible stylet. Class II Surge Medical Sales, LLC (DBA Surge Cardiovascu...
Jul 2, 2018 iTOVi Tracker/Scanner, Model Nos. ITS10 and ITS15 Intended to rank galvanic ... The device and its accessories may not have been manufactured according to current Good Manufactu... Class II Hudson Scientific LLC
Jun 26, 2018 Monitor with one Blood Parameter Module and one HSat Probe; 500AHCT Monitor ... H/Sat Hybrid Intensity Shift has been seen in a subset of the H/Sat population, which has resulte... Class II Terumo Cardiovascular Systems Corporation
Jun 26, 2018 CDI Blood parameter monitoring system 500 H/SAT, Part No. 145883 Product U... H/Sat Hybrid Intensity Shift has been seen in a subset of the H/Sat population, which has resulte... Class II Terumo Cardiovascular Systems Corporation
Jun 4, 2018 EZ Single Cytofunnel Brown, A78710004 Product Usage: The EZ Single Cytofu... Mislabeled product Class III Richard-Allan Scientific Company
May 24, 2018 STAT-Check MANUAL RESUSCITATOR / VENTILATOR, REF SC9200MBP-1 There is a potential for the patient port retaining ring to not fully seat allowing the patient p... Class II Sun Med, LLC
May 24, 2018 MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, PEE... There is a potential for the patient port retaining ring to not fully seat allowing the patient p... Class II Sun Med, LLC
May 24, 2018 MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FIL... There is a potential for the patient port retaining ring to not fully seat allowing the patient p... Class II Sun Med, LLC
May 24, 2018 MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, CO2... There is a potential for the patient port retaining ring to not fully seat allowing the patient p... Class II Sun Med, LLC
May 24, 2018 MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, FILT... There is a potential for the patient port retaining ring to not fully seat allowing the patient p... Class II Sun Med, LLC
May 24, 2018 MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK 5, BAG RESERVOIR, PE... There is a potential for the patient port retaining ring to not fully seat allowing the patient p... Class II Sun Med, LLC
May 24, 2018 MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR AND ... There is a potential for the patient port retaining ring to not fully seat allowing the patient p... Class II Sun Med, LLC
May 24, 2018 MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, FILT... There is a potential for the patient port retaining ring to not fully seat allowing the patient p... Class II Sun Med, LLC
May 24, 2018 MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, PEEP... There is a potential for the patient port retaining ring to not fully seat allowing the patient p... Class II Sun Med, LLC
May 24, 2018 MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR AND 7... There is a potential for the patient port retaining ring to not fully seat allowing the patient p... Class II Sun Med, LLC
May 24, 2018 MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FIL... There is a potential for the patient port retaining ring to not fully seat allowing the patient p... Class II Sun Med, LLC
May 24, 2018 MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, PEEP... There is a potential for the patient port retaining ring to not fully seat allowing the patient p... Class II Sun Med, LLC
May 24, 2018 MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FIL... There is a potential for the patient port retaining ring to not fully seat allowing the patient p... Class II Sun Med, LLC
May 24, 2018 MEDLINE ADULT MANUAL RESUSCITATOR WITH LARGE ADULT MASK, TUBE RESERVOIR, FILT... There is a potential for the patient port retaining ring to not fully seat allowing the patient p... Class II Sun Med, LLC
Apr 7, 2018 DriSate¿ Product Code DR-145 The acid concentrate powders and liquids are ... A subassembly component (dextrose bag) within this case product contained small amounts of sodium... Class II Rockwell Medical, Inc
Mar 16, 2018 Terumo HX2 Temperature Management System, Catalog No. 809810 The Terumo HX... Update to cooler-heater cleaning instructions. Class II Terumo Cardiovascular Systems Corporation
Mar 16, 2018 Sarns TCM, Catalog No. 15747 The Sarns TCM is indicated for controlling ... Update to cooler-heater cleaning instructions. Class II Terumo Cardiovascular Systems Corporation
Mar 16, 2018 Sarns TCM II, Catalog Numbers: 4415; 4416;164925; 164930;164935;164940 UDI 00... Update to cooler-heater cleaning instructions. Class II Terumo Cardiovascular Systems Corporation
Mar 12, 2018 Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000, UDI: 076... The power load floor plates which hold the ambulance cot anchors in place during patient transpor... Class II Stryker Medical Division of Stryker Corporation
Mar 9, 2018 6376 M-1 Cot Fastener, catalog no. 6376000000 The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect i... Class II Stryker Medical Division of Stryker Corporation
Mar 9, 2018 6381 M-1 Cot Fastener, catalog no. 6381000000 The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect i... Class II Stryker Medical Division of Stryker Corporation

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.