Browse Device Recalls

929 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 929 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 929 FDA device recalls in MO.

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DateProductReasonClassFirm
Jan 3, 2020 Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows:... ROi CPS, LLC manufactured custom procedure packs using Clearlink Continu-Flo devices which were s... Class II ROi CPS LLC
Dec 31, 2019 Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw ... Due to a production error, the weld seam of the "Locking screw for crosslink, screw-to-screw" can... Class II ulrich medical USA Inc
Nov 22, 2019 Monaco Radiation Treatment Planning System (RTP) System Monaco is using the incorrect energy when optimizing and calculating dose. Class II Elekta Inc
Nov 18, 2019 Elasto-Gel Absorbent Wound Dressing, Item DR8000. 5 Dressings 4" x 4". Ster... Elasto-Gel Wound Dressing may be contaminated with mold. Class II Southwest Technologies Inc
Oct 30, 2019 Oral-B, Practitioner Series, 5% Sodium Fluoride Varnish, 500 units (40mL/each... Product shelf life may be shorter than that indicated on the label. Class II Young Dental Manufacturing Co, LLC
Oct 22, 2019 BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation Following Customers complaints, investigations have been initiated on potentially false results o... Class II Biomerieux Inc
Sep 4, 2019 Monaco RTP System, 5.40 Unity, radiation treatment planning system Product... It is possible that the forced electron density settings will be changed for some structures unin... Class II Elekta Inc
Sep 4, 2019 Monaco RTP System, 5.50/5.51, radiation treatment planning system Product ... It is possible that the forced electron density settings will be changed for some structures unin... Class II Elekta Inc
Jul 3, 2019 Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Plann... When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of... Class II Elekta Inc
Mar 21, 2019 Regard ¿ custom surgical pack labeled as "LAP - FLOL LADY OF ANGELS" includin... Resource Optimization & Innovation (ROi) has received a recall notice from Stryker regarding tube... Class II ROi Consolidated Service Center (CSC)
Mar 21, 2019 Regard ¿ custom surgical pack labeled as "LAPAROSCOPIC - OSU" including recal... Resource Optimization & Innovation (ROi) has received a recall notice from Stryker regarding tube... Class II ROi Consolidated Service Center (CSC)
Mar 8, 2019 ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the ... Certain Torque Limiting Handles in the field are beyond their 3 year calibration life. Class II ulrich medical USA Inc
Aug 8, 2018 Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined Mid-... The back cap separates from the body of the vitrectomy cutter. Class II Bausch & Lomb Inc
Aug 8, 2018 Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Mid... The back cap separates from the body of the vitrectomy cutter. Class II Bausch & Lomb Inc
Aug 8, 2018 Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Combined Mid-... The back cap separates from the body of the vitrectomy cutter. Class II Bausch & Lomb Inc
Aug 8, 2018 Bausch + Lomb Stellaris Elite 25 GA Vit Cutter, Model BL5628, 7500 cpm, packa... The back cap separates from the body of the vitrectomy cutter. Class II Bausch & Lomb Inc
Aug 8, 2018 Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Combined Wide... The back cap separates from the body of the vitrectomy cutter. Class II Bausch & Lomb Inc
Aug 8, 2018 Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Mid... The back cap separates from the body of the vitrectomy cutter. Class II Bausch & Lomb Inc
Aug 8, 2018 Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined Wide... The back cap separates from the body of the vitrectomy cutter. Class II Bausch & Lomb Inc
Aug 8, 2018 Bausch + Lomb Stellaris Elite 20 GA Vit Cutter, Model BL5626, 7500 cpm, packa... The back cap separates from the body of the vitrectomy cutter. Class II Bausch & Lomb Inc
Aug 8, 2018 Bausch + Lomb Stellaris Elite 23 GA Vit Cutter, Model BL5627, 7500 cpm, packa... The back cap separates from the body of the vitrectomy cutter. Class II Bausch & Lomb Inc
Aug 8, 2018 Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Wid... The back cap separates from the body of the vitrectomy cutter. Class II Bausch & Lomb Inc
Aug 8, 2018 Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Wid... The back cap separates from the body of the vitrectomy cutter. Class II Bausch & Lomb Inc
Aug 8, 2018 Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Mid... The back cap separates from the body of the vitrectomy cutter. Class II Bausch & Lomb Inc
Aug 8, 2018 Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Wid... The back cap separates from the body of the vitrectomy cutter. Class II Bausch & Lomb Inc
Mar 20, 2018 First aid/emergency kits containing Honeywell eyewash: CSM kit number Kit/ca... Firm is recalling first aid/emergency kits and cabinets which contain Honeywell Eyewash (3 lots) ... Class II Certified Safety Mfg Inc
Mar 7, 2018 Edwards Lifesciences Femoral Venous Cannula, 20F X 55CM, resterilized. The expiration date on the device labeling exceeds its actual validated shelf life because the st... Class II SPS Sterilization, Inc
Mar 7, 2018 Edwards Lifesciences Aortic Perfusion Cannula, 24F x 30CM, resterilized. The expiration date on the device labeling exceeds its actual validated shelf life because the st... Class II SPS Sterilization, Inc
Mar 7, 2018 Edwards Lifesciences Optisite Arterial Perfusion Cannula, 22F X 24CM, resteri... The expiration date on the device labeling exceeds its actual validated shelf life because the st... Class II SPS Sterilization, Inc
Mar 7, 2018 Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Self-Expanding... The expiration date on the device labeling exceeds its actual validated shelf life because the st... Class II SPS Sterilization, Inc
Mar 7, 2018 Edwards Lifesciences Femoral Venous Cannula, 18FR, resterilized. The expiration date on the device labeling exceeds its actual validated shelf life because the st... Class II SPS Sterilization, Inc
Mar 7, 2018 Edwards Lifesciences EZ Glide Aortic Cannula, 24F x 37.6CM, resterilized. The expiration date on the device labeling exceeds its actual validated shelf life because the st... Class II SPS Sterilization, Inc
Mar 7, 2018 Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding St... The expiration date on the device labeling exceeds its actual validated shelf life because the st... Class II SPS Sterilization, Inc
Mar 7, 2018 Vascular Solutions Venture Rx Catheter, 6F, resterilized. The expiration date on the device labeling exceeds its actual validated shelf life because the st... Class II SPS Sterilization, Inc
Mar 7, 2018 Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Transhepatic B... The expiration date on the device labeling exceeds its actual validated shelf life because the st... Class II SPS Sterilization, Inc
Mar 7, 2018 Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding St... The expiration date on the device labeling exceeds its actual validated shelf life because the st... Class II SPS Sterilization, Inc
Mar 7, 2018 Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent, 22... The expiration date on the device labeling exceeds its actual validated shelf life because the st... Class II SPS Sterilization, Inc
Mar 7, 2018 Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 38FRX40C... The expiration date on the device labeling exceeds its actual validated shelf life because the st... Class II SPS Sterilization, Inc
Mar 7, 2018 Boston Scientific Wallstent Endoprosthesis Tracheobronchial Transhepatic Bili... The expiration date on the device labeling exceeds its actual validated shelf life because the st... Class II SPS Sterilization, Inc
Mar 7, 2018 Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 34F (11.... The expiration date on the device labeling exceeds its actual validated shelf life because the st... Class II SPS Sterilization, Inc
Mar 7, 2018 Edwards Lifesciences Avid Dual Stage Venous Drainage Cannula, 29/37F (9.6/12.... The expiration date on the device labeling exceeds its actual validated shelf life because the st... Class II SPS Sterilization, Inc
Jan 23, 2018 bioM¿rieux VITEK 2 NH ID Test Kit Product Usage: Is an automated system c... Missing desiccant. Class II Biomerieux Inc
Dec 28, 2017 HYPOTHERMIA MITTS Supportive in Cancer, packaged under the following brands: ... Hypothermia mitts, hypothermia slippers, and hypothermia caps on the market are misbranded for us... Class II Southwest Technologies Inc
Dec 28, 2017 HYPOTHERMIA SLIPPERS Supportive in Cancer, packaged under the following brand... Hypothermia mitts, hypothermia slippers, and hypothermia caps on the market are misbranded for us... Class II Southwest Technologies Inc
Dec 28, 2017 HYPOTHERMIA CAP Supportive in Cancer, packaged under the following brands: (... Hypothermia mitts, hypothermia slippers, and hypothermia caps on the market are misbranded for us... Class II Southwest Technologies Inc
Nov 3, 2017 Handicare P600 Series Patient Lift Product Usage: A device used to lift and... Premature strap wear and breakage at maximum weight conditions (625 lbs.). Class II Handicare Usa Inc
Nov 3, 2017 Handicare C Series Patient Lift Product Usage: A device used to lift and ... Premature strap wear and breakage at maximum weight conditions (625 lbs.). Class II Handicare Usa Inc
Oct 11, 2017 VITEK2 GP-ID, REF 21342 IVD Customers have reported, and an internal investigation has confirmed, occurrences of atypical neg... Class II Biomerieux Inc
Sep 25, 2017 Regard Custom Surgical Pack Packs contain surgical instruments and accesso... Resource Optimization & Innovation, LLC (ROi) received a recall notice from BD for an incorrect l... Class II Resource Optimization & Innovation Llc
Sep 8, 2017 PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered During internal cycle testing of A-Series lifts Handicare has found that the A-Series lift strap ... Class II Handicare Usa Inc

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.