Medical device recalls

FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.

About medical device recalls

Medical device recalls are the FDA's highest-volume stream. They cover implantable devices like pacemakers and joint replacements, hospital diagnostics and lab analyzers, surgical instruments, software-as-a-medical-device, and consumer-facing hardware like CPAP machines, blood-pressure cuffs, and glucose monitors. The volume comes from the wide range of products in scope and from the FDA's broad definition of 'corrective action' — software updates, IFU revisions, and labeling corrections all show up as recalls.

For Class I device recalls, the device's defect creates a reasonable risk of serious injury or death — these are the urgent ones. Class II covers issues that may cause temporary or medically reversible harm, often around accuracy or calibration. Class III is for products that don't comply with FDA rules but pose no real safety risk; in practice many software-update letters are Class III.

If you depend on a recalled device for ongoing care, don't disconnect or stop using it before talking to the prescribing clinician — interrupting therapy for a CPAP or a continuous glucose monitor can be more dangerous than the recall it's responding to. Almost every device recall offers a remedy that doesn't require you to surrender the device first.

1601–1625 of 13464

HighFDA (Devices)·Z-0625-2026·2025-12-03
IV Administration Sets: Potential Medication Backflow and Occlusion Risk
B Braun Medical's Caresite injection sites in IV administration sets may allow medication to flow backward from secondary containers into primary containers and prevent proper line priming. Approximately 2.8 million units affected worldwide.
Product
Caresite 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 following with corresponding catalog numbers: 1. Primary Gravity IV Set with 2 CARESITE¿
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0587-2026·2025-12-03
Quantum Intersegmental Table Model Q400 heating malfunction fire risk
Pivotal Health Solutions is recalling the Quantum Intersegmental Table Model Q400 because the heat function may become damaged when patients press on component areas, potentially causing overheating and smoldering of the vinyl cushion.
Product
Quantum Intersegmental Table, Model/Catalog Number: Q400; heated massage table
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0714-2026·2025-12-03
B Braun IV Administration Sets Recalled for Medication Backflow Risk
B Braun Medical recalls 41,400 ULTRASITE IV administration sets worldwide due to potential backflow of medication from secondary IV containers and inability to prime.
Product
ULTRASITE 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 following with corresponding catalog number: 1. IV ADMIN SET W/ 2 ULTRASITE VLV, 10
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0628-2026·2025-12-03
B Braun IV Extension Sets Recalled for Potential Medication Backflow
B Braun Medical Inc is recalling 30,250 Extension Sets used with infusion pumps due to potential medication backflow from secondary IV containers into primary containers and inability to prime the line.
Product
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 following with corresponding catalog number: 1. ET08US EXTENSION SET W/ULTRA Y SITE
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0615-2026·2025-12-03
B.Braun IV Administration Sets Recalled for Medication Backflow Risk
B.Braun IV administration sets used with certain infusion pumps are recalled due to potential medication backflow from secondary containers into primary containers and inability to prime. No illnesses reported.
Product
B.BRAUN 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 following with corresponding catalog number: 1. IV ADMIN SET W/ 60 DROPS/ML,141 in.; Cata
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0600-2026·2025-12-03
Medical Device Illumination Pack Recalled for Undisclosed Latex in Packaging
Stryker Corporation is recalling the NICO Myriad Illumination Pack because tape used in packaging contains latex despite the product being labeled as latex-free. Latex may cause allergic reactions in sensitive individuals.
Product
NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product No. NN-1001 13g Illumination Sleeve/Fiber
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0708-2026·2025-12-03
B Braun Medical IV Administration Sets: Medication Backflow and Occlusion Risk
B Braun Medical Inc is recalling approximately 2,352 Outlook IV administration sets due to potential backflow of medication into primary containers and inability to prime. No injuries have been reported.
Product
Outlook 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 following with corresponding catalog number: 1. OUTLOOK PUMP SET 3 CARESITE LADS 133
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0691-2026·2025-12-03
B. Braun IV Administration Sets Recalled for Medication Backflow Risk
B. Braun Medical Inc is recalling 24,072 IV administration sets used with multiple pump models due to potential backflow of medication from secondary containers into primary containers and inability to prime.
Product
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 the following with corresponding catalog number: 1. IV ADMIN SET, 2 CARESITES,
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0645-2026·2025-12-03
IV Administration Sets Recalled for Potential Medication Backflow and Occlusion Risk
B Braun Medical Inc recalls 407,800 IV administration sets for potential backflow of medication and occlusion. The defect may prevent proper medication delivery in gravity and pump administration systems.
Product
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 the following with corresponding catalog number: 1. IV SET 15DR 5CARESITE 1 ULR
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0649-2026·2025-12-03
B. Braun IV Administration Sets recalled due to medication backflow risk
B. Braun IV Administration Sets used with multiple infusion pumps are being recalled due to potential for medication backflow from secondary into primary IV containers and inability to prime properly.
Product
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 the following with corresponding catalog number: 1. IV ADMIN SET W/15 DR / mL W
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0702-2026·2025-12-03
IV Administration Sets Recalled Due to Backflow and Occlusion Risk
B Braun Medical is recalling IV Administration Sets due to a risk of medication backflow from secondary to primary IV containers and inability to prime. Affected catalog numbers 477002 and 477017 were distributed worldwide.
Product
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 the following with corresponding catalog number: 1. IV ADMIN SET, 15DR, CARESIT
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0697-2026·2025-12-03
IV Administration Sets Risk Medication Backflow and Priming Failure
B Braun Medical IV administration sets used with certain infusion pumps may allow medication to flow backward from secondary containers into primary containers and fail to prime. This could result in incorrect medication delivery.
Product
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 the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML,
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0638-2026·2025-12-03
Extension Set Recall: Risk of Backflow in IV Administration Sets
B. Braun Medical Inc is recalling 32,500 Extension Sets used in IV administration due to potential backflow of medication and inability to prime the infusion lines.
Product
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 following with corresponding catalog number: 1. Caresite Extension Set_Export; Cata
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0711-2026·2025-12-03
IV Administration Set with SafeDAY Recalled Due to Backflow Risk
B Braun Medical Inc is recalling approximately 200,917 IV administration sets with SafeDAY components due to potential medication backflow between IV containers and blockage that may prevent line preparation.
Product
SafeDAY 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 following with corresponding catalog number: 1. IV ADMIN SET 60 DROP W/2 SAFEDAY; Cat
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0580-2026·2025-12-03
Medtronic Catalyft Spinal Implant Cages May Collapse, Risk Neurological Injury
Medtronic's Catalyft spinal interbody cages may lose height or collapse during use, which could lead to implant migration, subsidence, and neurological injury. Updated surgical techniques and instructions are being provided to mitigate this risk.
Product
Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073 CATALYFT PL SHORT 7MM. Model Number: 6068073. 2. SPACER 6068076 CATALYFT PL LONG 7MM, Model Number: 6068076. 3. SPACER 6068093 CATALYFT PL SHORT 9MM, Mo
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0617-2026·2025-12-03
Blood Administration Sets Recalled Due to Medication Backflow and Occlusion Risk
B Braun Medical Inc recalls 24,624 blood administration sets due to potential medication backflow and priming failures. The defect may allow secondary IV medications to flow backward into primary lines, affecting IV therapy delivery.
Product
Blood 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 the following with corresponding catalog number: 1. Y-TYPE BLOOD SET W/ 170
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0637-2026·2025-12-03
Extension Set Recall: Risk of Medication Backflow in IV Administration
B Braun Medical is recalling 61,423 extension sets used with IV pumps due to potential backflow of medication and inability to prime. The recalled sets are distributed worldwide.
Product
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 following with corresponding catalog numbers: 1. ANESTHESIA SET W/ SAFEPORT MANIFOL
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0676-2026·2025-12-03
IV Administration Set Recalled for Medication Backflow and Priming Issues
B Braun Medical Inc is recalling IV Administration Sets due to potential backflow of medication from secondary IV containers into primary containers and inability to prime properly.
Product
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 the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML,
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0724-2026·2025-12-03
Xpert MTB/RIF TB diagnostic test recalled due to stability failure
Cepheid is recalling 9,880 units of the Xpert MTB/RIF TB diagnostic device after product testing failed to meet expected stability criteria, potentially affecting test accuracy.
Product
Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0705-2026·2025-12-03
IV Administration Set Risk of Medication Backflow and Occlusion
B. Braun Medical Inc. recalls AESTHESIA IV Administration Sets due to potential backflow of medication from secondary containers into primary containers and inability to prime. Approximately 4,488 units were distributed worldwide.
Product
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 the following with corresponding catalog number: 1. AESTHESIA IV SET, 127 in.;
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0601-2026·2025-12-03
NICO BrainPath Surgical Instruments Recalled for Undisclosed Latex in Packaging
Stryker is recalling NICO BrainPath neurosurgical instruments because packaging tape contains latex despite products being labeled as latex-free, which could cause allergic reactions in sensitive individuals.
Product
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 BrainPath Shephard's Hook - Greenberg LK;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0616-2026·2025-12-03
Blood Administration Set Recall Due to Backflow and Occlusion Risk
B Braun Medical Inc is recalling Blood Administration Sets (catalog 490196) due to potential backflow of medication between IV containers and inability to prime. The recall affects 7,344 units distributed worldwide.
Product
Blood 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 the following with corresponding catalog number: 1. Y-TYPE BLOOD SET 124 IN.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0582-2026·2025-12-03
Emdogain Dental Device Recalled for Unintended Clinical Use Risk
Straumann USA recalls Emdogain dental devices intended for demonstration purposes only due to risk of unintended patient use. 61 units affected across ten US states.
Product
Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0659-2026·2025-12-03
IV Administration Sets Recalled for Potential Medication Backflow and Occlusion
B Braun Medical Inc recalls IV administration sets used with its infusion pumps due to potential backflow of medication into primary IV containers and inability to prime.
Product
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 the following with corresponding catalog number: 1. IV ADMIN SET 60 DROP/ML, 10
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0670-2026·2025-12-03
IV Administration Sets Recalled for Medication Backflow and Priming Failure Risk
B Braun Medical IV administration sets carry risk of medication backflow into primary containers and inability to prime. Affects approximately 20.7 million units distributed worldwide.
Product
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 the following with corresponding catalog number: 1. IV ADMIN SET 15 DR W/2 SAFE
Category
Medical Device
Distribution
0 states

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