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Browse Device Recalls

2,817 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,817 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 2,817 FDA device recalls in 2025.

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DateProductReasonClassFirm
Oct 31, 2025 IntelliVue Patient Monitor MX400. Product Number: 866060. Potential issue where the IntelliVue monitors did not alarm. Class II Philips North America Llc
Oct 31, 2025 Stryker MV3 bariatric bed, Part Number 5900000001 Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because som... Class II Stryker Medical Division of Stryker Corporation
Oct 31, 2025 Stryker Arise 1000EX mattress, Part Number 2236000000 Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because som... Class II Stryker Medical Division of Stryker Corporation
Oct 31, 2025 IntelliVue Patient Monitor MX600. Product Number: 865242. Potential issue where the IntelliVue monitors did not alarm. Class II Philips North America Llc
Oct 31, 2025 IntelliVue MP20. Product Number: M8001A. Potential issue where the IntelliVue monitors did not alarm. Class II Philips North America Llc
Oct 31, 2025 IntelliVue MP5. Product Number: M8105A. Potential issue where the IntelliVue monitors did not alarm. Class II Philips North America Llc
Oct 31, 2025 IntelliVue MP60. Product Number: M8005A. Potential issue where the IntelliVue monitors did not alarm. Class II Philips North America Llc
Oct 31, 2025 IntelliVue Multi Measurement Server X2. Product Number: M3002A. Potential issue where the IntelliVue monitors did not alarm. Class II Philips North America Llc
Oct 31, 2025 Olympus OER-Elite Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended... Class II Aizu Olympus Co., Ltd.
Oct 31, 2025 IntelliVue MP40. Product Number: M8003A. Potential issue where the IntelliVue monitors did not alarm. Class II Philips North America Llc
Oct 31, 2025 IntelliVue Patient Monitor MX100. Product Number: 867033. Potential issue where the IntelliVue monitors did not alarm. Class II Philips North America Llc
Oct 31, 2025 IntelliVue MP80. Product Number: M8008A. Potential issue where the IntelliVue monitors did not alarm. Class II Philips North America Llc
Oct 31, 2025 IntelliVue MP50. Product Number: M8004A. Potential issue where the IntelliVue monitors did not alarm. Class II Philips North America Llc
Oct 31, 2025 IntelliVue MP2. Product Number: M8102A. Potential issue where the IntelliVue monitors did not alarm. Class II Philips North America Llc
Oct 31, 2025 NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP; ... Tape used to secure components within packaging contains latex, despite products being labeled as... Class II Stryker Corporation
Oct 31, 2025 NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's... Tape used to secure components within packaging contains latex, despite products being labeled as... Class II Stryker Corporation
Oct 31, 2025 IntelliVue Patient Monitor MX850. Product Number: 866470. Potential issue where the IntelliVue monitors did not alarm. Class II Philips North America Llc
Oct 31, 2025 IntelliVue Patient Monitor MX500. Product Number: 866064. Potential issue where the IntelliVue monitors did not alarm. Class II Philips North America Llc
Oct 31, 2025 IntelliVue Patient Monitor MX700. Product Number: 865241. Potential issue where the IntelliVue monitors did not alarm. Class II Philips North America Llc
Oct 31, 2025 Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841, Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to p... Class II Philips Ultrasound, LLC
Oct 31, 2025 IntelliVue Patient Monitor MX800. Product Number: 865240. Potential issue where the IntelliVue monitors did not alarm. Class II Philips North America Llc
Oct 31, 2025 IntelliVue MP30. Product Number: M8002A. Potential issue where the IntelliVue monitors did not alarm. Class II Philips North America Llc
Oct 31, 2025 IntelliVue MP90. Product Number: M8010A. Potential issue where the IntelliVue monitors did not alarm. Class II Philips North America Llc
Oct 30, 2025 FlexLab (FLX); Version: FLX-217-10; The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched... Class II Inpeco S.A.
Oct 30, 2025 FlexLab (FLX); Version: FLX-217-40; The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatche... Class II Inpeco S.A.
Oct 30, 2025 Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10 Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 ce... Class II Cepheid
Oct 30, 2025 Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Mod... Potential that the ligation loop was unable to release or detach as expected during use, causing ... Class I Olympus Corporation of the Americas
Oct 30, 2025 Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10 Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 ce... Class II Cepheid
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 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 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 B.BRAUN utilized in gravity IV administration sets and pump administration se... 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 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 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 Burette 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 CARESAFE utilized in gravity IV administration sets and pump administration s... 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 ULTRASITE 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 Caresite utilized in gravity IV administration sets and pump administration s... 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

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.