Browse Device Recalls

38,509 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 38,509 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 38,509 FDA device recalls.

DateProductReasonClassFirm
Oct 29, 2025 Vista set utilized in gravity IV administration sets and pump administration ... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 Blood Administration Set utilized in gravity IV administration sets and pump ... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 CT 5300; Software Version Number: 4.5, 5.0, 5.1; If the screws of tube heat exchanger on the rotating scanner are not tightened well after replaci... Class II Philips North America Llc
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174 Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the i... Class II Medicrea International
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 Outlook set utilized in gravity IV administration sets and pump administratio... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 Extension Set utilized in gravity IV administration sets and pump administrat... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 Extension Set utilized in gravity IV administration sets and pump administrat... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 Extension Set utilized in gravity IV administration sets and pump administrat... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 Infusomat utilized in gravity IV administration sets and pump administration ... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 Anesthesia IV Set utilized in gravity IV administration sets and pump adminis... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 SafeDAY set utilized in gravity IV administration sets and pump administratio... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 Blood Administration Set utilized in gravity IV administration sets and pump ... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 Blood Administration Set utilized in gravity IV administration sets and pump ... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 28, 2025 Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: ... An instrument intended for sequencing DNA libraries with in vitro diagnostic assays is used with ... Class II Illumina, Inc.
Oct 28, 2025 Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product... Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a ... Class II Baxter Healthcare Corporation
Oct 27, 2025 Quick Strip Plastic Sterile Adhesive Bandages, 1" x 3", Medline Item Number N... Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit... Class II Medline Industries, LP
Oct 27, 2025 Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only Screw may loosen or fallout of Hemodialysis system Class II Nipro Medical Corporation
Oct 27, 2025 MEDLINE PERFUSION SYRINGE, REF: DYNJ39223C Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class II Medline Industries, LP
Oct 27, 2025 Curad Quick Strip Fabric Bandages Containing 30 Bandages of 3/4" x 3", Medlin... Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit... Class II Medline Industries, LP
Oct 27, 2025 CURAD Germ-Shield Touch-Free Fabric Bandages, Sterile, 0.75" x 3", 30/Box, Me... Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit... Class II Medline Industries, LP
Oct 27, 2025 Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVE... Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped ... Class II Philips North America
Oct 27, 2025 Fur Friends Plastic Sterile Adhesive Bandages, 0.75" x 3", Medline Item Numbe... Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit... Class II Medline Industries, LP
Oct 27, 2025 Quick Strip Plastic Sterile Adhesive Bandages, 0.75" x 3", Medline Item Numbe... Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit... Class II Medline Industries, LP
Oct 27, 2025 Quick Strip Fabric Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number... Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit... Class II Medline Industries, LP
Oct 27, 2025 Quick Strip Fabric Sterile Adhesive Bandages, 1" x 3", Medline Item Number NO... Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit... Class II Medline Industries, LP
Oct 25, 2025 5008X CAREsystem +CLiC +CDX; Several software anomalies with the potential to impact patient treatment, of which one includes ... Class II Fresenius Medical Care Holdings, Inc.
Oct 24, 2025 Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM20 ... As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... Class II Edan Diagnostics
Oct 24, 2025 Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM50, ... As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... Class II Edan Diagnostics
Oct 24, 2025 Brand Name: EDAN Product Name: Fetal & Maternal Monitor Model/Catalog Numbe... As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... Class II Edan Diagnostics
Oct 24, 2025 MAMMOMAT Revelation; There were instances where the operator table was sold together with a bus-installation kit. The ... Class II Siemens Medical Solutions USA, Inc
Oct 24, 2025 Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: X8, X1... As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... Class II Edan Diagnostics
Oct 24, 2025 Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Numb... As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... Class II Edan Diagnostics
Oct 24, 2025 Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM... As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... Class II Edan Diagnostics
Oct 24, 2025 Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening ... Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which... Class II GE Medical Systems, LLC
Oct 24, 2025 Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM... As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... Class II Edan Diagnostics
Oct 24, 2025 Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3... As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... Class II Edan Diagnostics
Oct 24, 2025 Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3... As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... Class II Edan Diagnostics

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.