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.

1576–1600 of 13464

HighFDA (Devices)·Z-0608-2026·2025-12-03
B Braun IV Administration Sets Recalled for Medication Backflow Risk
B Braun Medical Inc is recalling 14,712 Anesthesia IV Sets due to potential backflow of medication and priming failure that could affect medication delivery.
Product
Anesthesia IV 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 AD. SET,15 DROPS/ML, W/EXT S
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0654-2026·2025-12-03
IV Administration Sets Recalled for Potential Medication Backflow and Occlusion Risk
B Braun Medical Inc is recalling 1,861,111 IV administration sets used with infusion pumps due to potential medication backflow 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 ANES 15DROP W/2 CARESITE
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0610-2026·2025-12-03
Anesthesia IV Sets Recalled Due to Medication Backflow and Occlusion Risk
B Braun Medical is recalling 10,536 Anesthesia IV Sets that may allow medication to flow backward from secondary IV bags into primary bags or fail to prime properly during use.
Product
Anesthesia IV 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, 15D, 144 IN.; Cat
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0643-2026·2025-12-03
IV Administration Set recalled for potential medication backflow and occlusion
B Braun Medical Inc is recalling 13,870 units of the NF1270A SAFELINE ANESTHESIA IV Administration Set worldwide due to potential backflow of medication from secondary IV 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. NF1270A SAFELINE ANESTHESIA
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0664-2026·2025-12-03
B Braun IV Administration Sets recalled due to medication backflow and occlusion
B Braun is recalling IV administration sets due to potential medication backflow from secondary containers into primary containers and inability to prime. About 11,832 units were distributed worldwide, including the US.
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/ML,2 CA
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0671-2026·2025-12-03
IV Administration Set Recalled for Medication Backflow and Occlusion Risk
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. The defect affects 12,168 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 W/ 15 DROPS/ML
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0630-2026·2025-12-03
B. Braun Medical Extension Sets: Risk of IV Medication Backflow and Occlusion
B. Braun Medical extension sets used in IV administration may allow medication backflow from secondary containers into primary containers or fail to prime, potentially compromising treatment delivery. Approximately 43,452 units affected 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. EXTENSION SET, 18 IN; Catalog Numb
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0710-2026·2025-12-03
RATE FLOW IV Administration Sets Recalled for Medication Backflow Risk
B Braun Medical Inc is recalling RATE FLOW IV administration sets due to potential medication backflow between IV containers and inability to prime. Approximately 150,664 units affected worldwide.
Product
RATE FLOW 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. RATEFLOW ADMIN 15 DROP W/2 CARESITE
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0690-2026·2025-12-03
IV Administration Set Recalled for Medication Backflow and Priming Failure
B Braun Medical Inc is recalling IV administration sets (Catalog 490303) due to potential backflow of medication into primary IV containers and inability to prime. Approximately 32,304 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. IV ADMIN SET,3 CARESITE LAD
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0657-2026·2025-12-03
B Braun IV Administration Sets Recalled for Potential Medication Backflow
B Braun Medical Inc is recalling 224,856 IV Administration Sets due to potential medication backflow from secondary IV containers into primary containers and inability to prime the line. The sets are used with Infusomat Space, Outlook, and Vista Basic pumps.
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-0620-2026·2025-12-03
Blood Administration Set Recalled Due to Backflow and Occlusion Risk
B Braun Medical Inc is recalling blood administration sets due to potential backflow of medication from secondary IV containers into primary containers, and inability to prime. No illnesses have been reported.
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-0704-2026·2025-12-03
IV Administration Set Recalled Due to Potential Medication Backflow and Occlusion
B Braun Medical Inc recalls 122,232 IV Administration Sets due to potential medication backflow 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, 129 IN, 3 CAR
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0652-2026·2025-12-03
B Braun IV Administration Sets: Medication Backflow and Priming Failure
B Braun Medical Inc is recalling 66,792 IV Administration Sets due to potential backflow of medication and inability to prime. The Class II recall affects gravity and pump delivery 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 ADMIN SET HF STOPCOCK,10
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0631-2026·2025-12-03
Extension Set Recalled for Medication Backflow and Priming Failure
B Braun Medical's Extension Sets may allow medication backflow between IV containers and fail to prime. The company recalled 13,128 units 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 number: 1. EXTENSION SET, 25 IN.; Catalog Numb
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0719-2026·2025-12-03
Philips Azurion Medical Imaging System Motorized Movement May Become Unavailable
Philips Azurion 7M20 X-ray imaging systems may experience inconsistent or unavailable motorized movement on the ceiling-mounted FlexArm arm due to bearing lubrication failure affecting 172 units.
Product
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234;
Category
Medical Device
Distribution
28 states
HighFDA (Devices)·Z-0717-2026·2025-12-03
IV Administration Set Recalled for Potential Medication Backflow and Priming Failure
B Braun Medical's IV Administration Sets may allow medication to flow backward from secondary to primary containers and fail to prime. The malfunction could affect medication delivery accuracy in healthcare facilities.
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/ 15DROPS/ML;
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0722-2026·2025-12-03
Cold Form Wrap products recalled for burn and rupture risk from microwave heating
DJO Cold Form Wrap products are recalled because microwave heating instructions can cause the wrap to leak, rupture, or reach temperatures that cause second-degree burns.
Product
Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0663-2026·2025-12-03
B. Braun IV Administration Sets Risk Backflow and Occlusion
B. Braun Medical Inc is recalling IV Administration Sets due to potential backflow of medication 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 W/CARESITE EXT
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0583-2026·2025-12-03
DermaSensor skin cancer detection device may produce incorrect diagnostic results
The FDA is recalling DermaSensor Model 10101 because it may not meet performance specifications, potentially causing incorrect diagnostic results or delayed referrals for patients with suspected skin cancer.
Product
DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0682-2026·2025-12-03
IV Administration Sets Recalled Due to Medication Backflow Risk
B Braun Medical is recalling IV Administration Sets due to potential medication backflow from secondary containers into primary containers and inability to prime the line. Approximately 187,464 units are affected 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 W/15 DROPS/ML,
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0627-2026·2025-12-03
B Braun Extension Sets for IV Pumps: Medication Backflow and Occlusion Risk
B Braun Medical is recalling Extension Sets used in IV administration systems due to potential backflow of medication from secondary IV containers into primary containers, which could also cause 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. AS152V2DLL; Catalog Number: 473309.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0623-2026·2025-12-03
B Braun CARESAFE IV Administration Sets Recalled for Medication Backflow Risk
B Braun Medical is recalling CARESAFE IV administration sets due to potential medication backflow from secondary to primary containers and inability to prime. Approximately 4,438 units are affected worldwide.
Product
CARESAFE 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. CARESAFE IV ADMIN SET w/AIRSTOP, 104 IN
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0619-2026·2025-12-03
Blood Administration Set Recall Due to Backflow and Priming Issues
B Braun Medical Inc is recalling 164,568 Blood Administration Sets due to potential backflow of medication from secondary IV containers into primary containers and inability to prime. The affected sets are used in gravity and pump-based IV administration systems.
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, HAND P
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0685-2026·2025-12-03
IV Administration Sets with Potential Medication Backflow and Priming Issues
B Braun IV administration sets used with gravity and pump infusion systems may allow medication to flow backward from secondary containers into primary containers and prevent proper priming. Discontinue use and contact the manufacturer.
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 ADMN SET W/15 DROP, ULTR
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0622-2026·2025-12-03
IV Burette Sets Recalled Due to Potential Medication Backflow Risk
B Braun Medical Inc is recalling 7,240 Burette Sets used in IV administration due to potential medication backflow from secondary containers and inability to prime. The affected catalog number 490159 was distributed worldwide.
Product
Burette 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. BURETTE SET W/ 2 CARESITE, 134 IN.; C
Category
Medical Device
Distribution
0 states

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