Medical Device Recalls

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8,689 medical device recalls from federal enforcement feeds.

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Showing 2,451–2,500 of 8,689

Medical Device Recall · November 3, 2025
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Vitamin D-Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GE Healthcare GmbH
GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
GE HealthCare has become aware that the Patient History tab in ViewPoint 6 versions 6.15.3 and 6.15.4 ultrasound software may not include complete patient medical history information.
Class II
Medical Device Recall · November 3, 2025
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Leaky Gut Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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Chlamydia Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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DHEA Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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Urinary Tract Infection Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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Food Intolerance Test Small
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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D-Dimer Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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Gut Microbiome Test Small
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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8 in 1 STI Test Kit
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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Diabetes HbA1c Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
Orthofix U.S. LLC
Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti Spacer System Model/Catalog Number: 37-6005SP 12mm W X 12mm L, 5mm H, 5¿ Lordotic 37-6005SP 12mm W X 12mm L, 5mm H, 5¿
Labeling contains claims that are not consistently present.
Class III
Medical Device Recall · November 3, 2025
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Iron Deficiency Test (ferritin)
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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Parasite Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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Sperm Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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Lyme Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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GI Microbiome Profile XL
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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Illegally Marketed
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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Drug Test Small (4 substances)
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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Parasite Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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Organic acids Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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Adrenal Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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Cholesterol Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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Neurotransmitters Plus
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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Alcohol (ALC) Test Saliva
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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Pet Allergy Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
Orthofix U.S. LLC
Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog Number: 38-2006SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 6H; 38-2007SP FORZA Ti Spacer, Straight, 0¿, 9W x
Labeling contains claims that are not consistently present.
Class III
Medical Device Recall · November 3, 2025
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Lactose Intolerance Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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PSA Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 2, 2025
Medtronic MiniMed, Inc.
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, whose
A 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
Stryker Corporation
NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product No. NN-1001 13g Illumination Sleeve/Fiber
Tape 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
Aizu Olympus Co., Ltd.
Olympus OER-Elite
Inform 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 Arise 1000EX mattress, Part Number 2236000000
Stryker 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
Stryker Medical Division of Stryker Corporation
Stryker MV3 bariatric bed, Part Number 5900000001
Stryker 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
Philips North America Llc
IntelliVue Patient Monitor MX800. Product Number: 865240.
Potential issue where the IntelliVue monitors did not alarm.
Class II
Medical Device Recall · October 31, 2025
Philips North America Llc
IntelliVue Patient Monitor MX500. Product Number: 866064.
Potential issue where the IntelliVue monitors did not alarm.
Class II
Medical Device Recall · October 31, 2025
Philips North America Llc
IntelliVue MP50. Product Number: M8004A.
Potential issue where the IntelliVue monitors did not alarm.
Class II
Medical Device Recall · October 31, 2025
Philips North America Llc
IntelliVue Patient Monitor MX550. Product Number: 866066.
Potential issue where the IntelliVue monitors did not alarm.
Class II
Medical Device Recall · October 31, 2025
Stryker Corporation
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 Bra
Tape 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
Stryker Corporation
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; N
Tape 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
Philips North America Llc
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
Philips North America Llc
IntelliVue MP2. Product Number: M8102A.
Potential issue where the IntelliVue monitors did not alarm.
Class II
Medical Device Recall · October 31, 2025
Aizu Olympus Co., Ltd.
Olympus OER-Mini
Inform 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
Philips North America Llc
IntelliVue Patient Monitor MX750. Product Number: 866471.
Potential issue where the IntelliVue monitors did not alarm.
Class II
Medical Device Recall · October 31, 2025
Aizu Olympus Co., Ltd.
Olympus OER-Pro
Inform 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
Philips North America Llc
IntelliVue Patient Monitor MX450. Product Number: 866062.
Potential issue where the IntelliVue monitors did not alarm.
Class II
Medical Device Recall · October 31, 2025
Philips North America Llc
IntelliVue Patient Monitor MX400. Product Number: 866060.
Potential issue where the IntelliVue monitors did not alarm.
Class II
Medical Device Recall · October 31, 2025
Philips North America Llc
IntelliVue Patient Monitor MX700. Product Number: 865241.
Potential issue where the IntelliVue monitors did not alarm.
Class II
Medical Device Recall · October 31, 2025
Philips North America Llc
IntelliVue MP90. Product Number: M8010A.
Potential issue where the IntelliVue monitors did not alarm.
Class II
Medical Device Recall · October 31, 2025
Philips North America Llc
IntelliVue MP70. Product Number: M8007A.
Potential issue where the IntelliVue monitors did not alarm.
Class II