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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
Aug 25, 2020 Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32, Catalog Nu... Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble dete... Class II Terumo Cardiovascular Systems Corporation
Aug 12, 2020 Stryker IsoAir 2.0 support surface-provides pressure redistribution and is in... Connector between support surface and pump may be out of tolerance resulting in difficulty in rem... Class II Stryker Medical Division of Stryker Corporation
Jul 2, 2020 PAPR (Powered Air-Purifying Respirator) - Model# WLPAPR20W1 The rivets that secure the elastic headband to the face shield have the potential to be mis-assem... Class II Whirlpool Corporation
Apr 7, 2020 Stryker Power-PRO TL cot-powered ambulance cot Model Number 6550 - Product... Ambulance Cots may not meet crash test standard BS EN 1789 Class II Stryker Medical Division of Stryker Corporation
Mar 26, 2020 Neptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 - Product Us... Due to a distribution error, product from the affected lot was shipped expired. Class II Stryker Instruments Div. of Stryker Corporation
Mar 10, 2020 SkyVision SDS System - Video Integration Model: GC-SDS-BSCB-200 - Product Us... Intermittent failure of a signal being sent to a monitor from the touch panel display causing the... Class II Skytron, Div. The KMW Group, Inc
Mar 5, 2020 Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single mon... Potential for the weld to fail at the pivot point of the monitor bracket. This weld failure could... Class II Skytron, Div. The KMW Group, Inc
Jan 22, 2020 Triton Canister System (finished part numbers FG 12009, for 3L canisters, and... Some Canister Scanning Labels used to calibrate the Triton Canister System have a color variance.... Class II Stryker Instruments Div. of Stryker Corporation
Jan 13, 2020 Telescopic Smoke Evac Pencil, PB, Coated, Product No. SHKTSPCL. The product ... Hairline fractures in a component could allow electrical current to arc out of the device, result... Class II Stryker Instruments Div. of Stryker Corporation
Jan 13, 2020 Telescopic Uncoated (Push Button), Product No. SHK TSPL. The product is a Bo... Hairline fractures in a component could allow electrical current to arc out of the device, result... Class II Stryker Instruments Div. of Stryker Corporation
Jan 13, 2020 SafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004. The pr... Hairline fractures in a component could allow electrical current to arc out of the device, result... Class II Stryker Instruments Div. of Stryker Corporation
Jan 10, 2020 Terumo Advanced Perfusion System 1 Roller Pump, 6 Inch, Catalog Number 816571... These roller pumps were assembled with pump shafts that may fail at the location of the thread wh... Class II Terumo Cardiovascular Systems Corporation
Jan 10, 2020 Terumo Advanced Perfusion Assembly Pump Guts, 6 Inch, Catalog Number 801798 -... These roller pumps were assembled with pump shafts that may fail at the location of the thread wh... Class II Terumo Cardiovascular Systems Corporation
Jan 10, 2020 Terumo Advanced Perfusion System 1 Roller Pump, 4 Inch, Catalog Number 816570... These roller pumps were assembled with pump shafts that may fail at the location of the thread wh... Class II Terumo Cardiovascular Systems Corporation
Jan 10, 2020 Terumo Advanced Perfusion Assembly Pump Guts, 4 Inch, Catalog Number 801805 -... These roller pumps were assembled with pump shafts that may fail at the location of the thread wh... Class II Terumo Cardiovascular Systems Corporation
Dec 23, 2019 Nikon Metrology XTH cabinet x-ray Systems which includes variations STH225, X... The manufacturer identified a risk that their products might fail to comply with the cabinet x-ra... Class II Nikon Metrology
Dec 11, 2019 Centurion-LVAD Kits DM1005 DAILY LVAD MAINTENANCE KIT DM280A LVAD MANAGEMEN... Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion- Pelvic Exam Kits DYNDE1037 PELVIC EXAM TRAY,UNIVERSITY H 2019032... Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion- SPEC0002B ARTHROGRAM TRAY SPEC0002B ARTHROGRAM TRAY SPEC0004C A... Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion-Irrigation Kit IG25STSS IRRIGATION GUN &VALVE SET W/SPLASHSHIELD Y Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion- Pathology Container 1150ST STERILE GRADUATED CONTAINER, 32 OZ. 1... Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion-_General Surgery Trays DYNDA1127A RADIOLOGY CUT DOWN TRAY #1 DYND... Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion-General Surgery Convenience Kits DYNDH1033B SUBCLAVIAN ON/OFF KIT ... Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion-BIOPSY TRAY BT205A MINOR SET UP BIOPSY TRAY BT345A HH PACK BIOPSY Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion- I86625 DEBRIDEMENT TRAY Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion-Drive Kits DM1005 DAILY LVAD MAINTENANCE KIT DM280A LVAD MANAGEME... Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion PICC : CVI2650 ANGIO TRAY CVI3610 CENTRAL LINE INSERTION BUNDLE ... Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion-Incision /Drainage Tray ID1235A ESKENAZI INCISION & DRAINAGE TRAY ... Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion-Trays EBSI1021 VALVE CHANGE KIT- DOUBLE Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion- UVT1045 UMBILICAL ARTERY TRAY UVT1055 UVC KIT UVT1065 UMBILICA... Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion Neonatal PICC Tray: CVI2310 NEONATAL PICC INSERTION TRAY CVI2550 ... Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion-Skin Prep Tray DYNDP1015 SKIN PREP TRAY Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion-Suture Tray DYNDR1210A SUTURING TRAY Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion- PT225 PAIN MANAGEMENT TRAY Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion-Infant Feeding Kit IFK840 INFANT FEEDING KIT (8 FR X 40 IN) Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion-Medicine Cup GMC205 GLASS MEDICINE CUP 2 OUNCE STERILE Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion- Trach Kits TC6282G TRACHEOSTOMY CARE TRAY TC7170 LATEX FREE TRAC... Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion-Skin Prep Trays SP1180 DRY PREP SET SP200 SKIN SCRUB TRAY SP41... Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion- P151659 BIOPSY TRAY P243133 LATEX TUBING PACK P243133 LATEX TU... Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion- Laceration Trays DYNDL1073 LACERATION TRAY DYNDL1152A LACERATION... Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion Dental Kits DH775 PREMIUM DENTAL EXAM TRAY DYKA1169B DENTAL KIT Y... Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion-Surgical trays DYNJ04079Z CIRCUMCISION TRAY STERILE DYNJ08835 DE... Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion-Surgical Tray MNS10255 DELIVERY TRAY MNS10255 DELIVERY TRAY MNS1... Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion- DRESSING CHANGE KIT BSICVC1005A CVC DRESSING CHANGE KIT NICU ... Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion-Suture Trays SUT10140 SUTURE TRAY SUT10290 LACERATION TRAY SUT10... Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion-Pitcher Kit GR100150ST GRADUATED PITCHER STERILE 1000 CC Y 2018121... Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion Circumsion Trays as follows: Kit Code Product ... Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion IVS3505 ULTRASOUND GUIDED PIV KIT Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion- Nasal Speculum NSP500ST STERILE NASAL SPECULUM Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion- Dressing Tray M101156A DRESSING TRAY M101167A DRESSING TRAY M10... Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products 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.