Medical Device Recalls
RSS ↗7,959 medical device recalls from federal enforcement feeds.
Showing 1,751–1,800 of 7,959
- Class III
Medical Device Recall · November 3, 2025
Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PTC Spacer System Model/Catalog Number: 37-3106SP 12mm W X 12mm L, 6mm H, Parallel; 37-3107SP 12mm W X 12mm L, 7mm H, ParLabeling contains claims that are not consistently present.
- Class II
Medical Device Recall · November 3, 2025
Food Allergy Panel Test (IgE)Distribution without premarket approval/clearance.
- Class II
Medical Device Recall · November 3, 2025
Food Intolerance Test LargeDistribution without premarket approval/clearance.
- Class II
Medical Device Recall · November 3, 2025
Vitamin D2 and D3 TestDistribution without premarket approval/clearance.
- Class II
Medical Device Recall · November 3, 2025
Leaky Gut TestDistribution without premarket approval/clearance.
- Class II
Medical Device Recall · November 3, 2025
Menopause (FSH) 2 TestsDistribution without premarket approval/clearance.
- Class II
- Class II
Medical Device Recall · November 3, 2025
Organic acids TestDistribution without premarket approval/clearance.
- Class II
Medical Device Recall · November 3, 2025
Chlamydia TestDistribution without premarket approval/clearance.
- Class II
Medical Device Recall · November 3, 2025
Cholesterol TestDistribution without premarket approval/clearance.
- Class II
Medical Device Recall · November 2, 2025
MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G insulin pump is indicated for use by patients age 7-80 years with Type 1 diabetes, whoseA software timing and processor communication issue in MiniMed" 780G software version 6.60 may trigger Pump Error 43 and/or Pump Error 41, resulting in suspension of insulin delivery.
- Class II
Medical Device Recall · October 31, 2025
Olympus OER-EliteInform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
- Class II
Medical Device Recall · October 31, 2025
Stryker Medical Division of Stryker Corporation
Stryker MV3 bariatric bed, Part Number 5900000001Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because some of these products have been sold in close proximity, suggesting a potential intent for them to be used together. These products have not been tested for compatibility and thus are not designed to be used together. The combination of both is not recommended by Stryker.
- Class II
Medical Device Recall · October 31, 2025
IntelliVue Patient Monitor MX600. Product Number: 865242.Potential issue where the IntelliVue monitors did not alarm.
- Class II
Medical Device Recall · October 31, 2025
NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product No. NN-1001 13g Illumination Sleeve/FiberTape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
- Class II
Medical Device Recall · October 31, 2025
IntelliVue MP30. Product Number: M8002A.Potential issue where the IntelliVue monitors did not alarm.
- Class II
Medical Device Recall · October 31, 2025
NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP; NN-8001 15x 13 MHP; NN-8002 15x 25 MHP - MINOP; NN-8003 13x10 MHP; NN-8004 13x13 MHP; NN-8005 15x25 MHP GAAB; NTape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
- Class II
Medical Device Recall · October 31, 2025
IntelliVue MP2. Product Number: M8102A.Potential issue where the IntelliVue monitors did not alarm.
- Class II
Medical Device Recall · October 31, 2025
IntelliVue Patient Monitor MX550. Product Number: 866066.Potential issue where the IntelliVue monitors did not alarm.
- Class II
Medical Device Recall · October 31, 2025
IntelliVue Patient Monitor MX450. Product Number: 866062.Potential issue where the IntelliVue monitors did not alarm.
- Class II
Medical Device Recall · October 31, 2025
IntelliVue MP60. Product Number: M8005A.Potential issue where the IntelliVue monitors did not alarm.
- Class II
Medical Device Recall · October 31, 2025
IntelliVue Patient Monitor MX800. Product Number: 865240.Potential issue where the IntelliVue monitors did not alarm.
- Class II
Medical Device Recall · October 31, 2025
Olympus OER-ProInform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
- Class II
Medical Device Recall · October 31, 2025
IntelliVue MP70. Product Number: M8007A.Potential issue where the IntelliVue monitors did not alarm.
- Class II
Medical Device Recall · October 31, 2025
IntelliVue Patient Monitor MX400. Product Number: 866060.Potential issue where the IntelliVue monitors did not alarm.
- Class II
Medical Device Recall · October 31, 2025
IntelliVue Multi-Measurement Module X3. Product Number: 867030.Potential issue where the IntelliVue monitors did not alarm.
- Class II
Medical Device Recall · October 31, 2025
IntelliVue Patient Monitor MX850. Product Number: 866470.Potential issue where the IntelliVue monitors did not alarm.
- Class II
Medical Device Recall · October 31, 2025
IntelliVue Patient Monitor MX750. Product Number: 866471.Potential issue where the IntelliVue monitors did not alarm.
- Class II
Medical Device Recall · October 31, 2025
Olympus OER-MiniInform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
- Class II
Medical Device Recall · October 31, 2025
IntelliVue MP90. Product Number: M8010A.Potential issue where the IntelliVue monitors did not alarm.
- Class II
Medical Device Recall · October 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 perform live imagining.
- Class II
Medical Device Recall · October 31, 2025
IntelliVue Patient Monitor MX700. Product Number: 865241.Potential issue where the IntelliVue monitors did not alarm.
- Class II
Medical Device Recall · October 31, 2025
IntelliVue Patient Monitor MX500. Product Number: 866064.Potential issue where the IntelliVue monitors did not alarm.
- Class II
Medical Device Recall · October 31, 2025
NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook - Greenberg; NN-8025 BrainPath Shephard's Hook - Sugita; NN-8026 BrainPath Shephard's Hook - Budde; NN-8042 BraTape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
- Class II
Medical Device Recall · October 31, 2025
IntelliVue MP50. Product Number: M8004A.Potential issue where the IntelliVue monitors did not alarm.
- Class II
Medical Device Recall · October 31, 2025
IntelliVue MP80. Product Number: M8008A.Potential issue where the IntelliVue monitors did not alarm.
- Class II
Medical Device Recall · October 31, 2025
IntelliVue Patient Monitor MX100. Product Number: 867033.Potential issue where the IntelliVue monitors did not alarm.
- Class II
Medical Device Recall · October 31, 2025
IntelliVue MP40. Product Number: M8003A.Potential issue where the IntelliVue monitors did not alarm.
- Class II
Medical Device Recall · October 31, 2025
IntelliVue Multi Measurement Server X2. Product Number: M3002A.Potential issue where the IntelliVue monitors did not alarm.
- Class II
Medical Device Recall · October 31, 2025
IntelliVue MP5. Product Number: M8105A.Potential issue where the IntelliVue monitors did not alarm.
- Class II
Medical Device Recall · October 31, 2025
IntelliVue MP20. Product Number: M8001A.Potential issue where the IntelliVue monitors did not alarm.
- Class II
Medical Device Recall · October 31, 2025
Stryker Medical Division of Stryker Corporation
Stryker Arise 1000EX mattress, Part Number 2236000000Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because some of these products have been sold in close proximity, suggesting a potential intent for them to be used together. These products have not been tested for compatibility and thus are not designed to be used together. The combination of both is not recommended by Stryker.
- Class I
Medical Device Recall · October 30, 2025
Olympus Corporation of the Americas
Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an Olympus endoscope to deliver a nylon loop snare.Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient anatomy.
- Class II
Medical Device Recall · October 30, 2025
FlexLab (FLX); Version: FLX-217-10;The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels which may result in delayed results or erroneous results. This error occurs if the operators open the printer head of mALX to perform error recoveries or maintenance procedures and do not empty the printer tubes buffer to remove all the secondary sample tubes.
- Class II
Medical Device Recall · October 30, 2025
Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
- Class II
Medical Device Recall · October 30, 2025
Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
- Class II
Medical Device Recall · October 30, 2025
FlexLab (FLX); Version: FLX-217-40;The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels which may result in delayed results or erroneous results, this error occurs if the operators open the printer head of mALX to perform error recoveries or maintenance procedures and do not empty the printer tubes buffer to remove all the secondary sample tubes
- Class II
Medical Device Recall · October 29, 2025
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as thPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Class II
Medical Device Recall · October 29, 2025
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the followPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Class II
Medical Device Recall · October 29, 2025
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as thPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).