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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 3, 2025 | Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004. | Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a chec... | Class II | Fresenius Kabi USA, LLC |
| Nov 3, 2025 | Pollen Allergy Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Neurotransmitters Plus | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Adrenal Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Parasite Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Mycoplasma test, IgG and IgM | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Sperm Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | HPV Antigen Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Illegally Marketed | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | GI Microbiome Profile XL | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Allergy test Small | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Allergy Test IgE | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Organic Acids Profile Test Large | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Candida Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Vitamin D-Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Food Intolerance Test Small | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 2, 2025 | MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software... | A software timing and processor communication issue in MiniMed" 780G software version 6.60 may tr... | Class II | Medtronic MiniMed, Inc. |
| Oct 31, 2025 | IntelliVue MP70. Product Number: M8007A. | Potential issue where the IntelliVue monitors did not alarm. | Class II | Philips North America Llc |
| Oct 31, 2025 | NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve... | Tape used to secure components within packaging contains latex, despite products being labeled as... | Class II | Stryker Corporation |
| Oct 31, 2025 | IntelliVue Patient Monitor MX450. Product Number: 866062. | Potential issue where the IntelliVue monitors did not alarm. | Class II | Philips North America Llc |
| Oct 31, 2025 | Olympus OER-Mini | Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended... | Class II | Aizu Olympus Co., Ltd. |
| Oct 31, 2025 | IntelliVue Patient Monitor MX750. Product Number: 866471. | Potential issue where the IntelliVue monitors did not alarm. | Class II | Philips North America Llc |
| Oct 31, 2025 | IntelliVue Patient Monitor MX550. Product Number: 866066. | Potential issue where the IntelliVue monitors did not alarm. | Class II | Philips North America Llc |
| Oct 31, 2025 | Olympus OER-Pro | Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended... | Class II | Aizu Olympus Co., Ltd. |
| Oct 31, 2025 | IntelliVue Multi-Measurement Module X3. Product Number: 867030. | Potential issue where the IntelliVue monitors did not alarm. | Class II | Philips North America Llc |
| 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. |
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.