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.

1651–1675 of 13464

HighFDA (Devices)·Z-0653-2026·2025-12-03
IV Administration Set Recalled for Potential Medication Backflow and Priming Failure
B Braun Medical Inc is recalling 18,984 units of IV Administration Sets due to potential backflow of medication from secondary IV lines into primary containers and inability to prime. No adverse events have been reported.
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, 81 IN W/ 32 I
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0701-2026·2025-12-03
IV Administration Set Recalled for Potential Medication Backflow
B. Braun Medical Inc is recalling IV administration sets used with certain infusion pumps due to potential medication backflow from secondary containers into primary containers. The defect affects 9,500 units.
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. NF1500UP, IV ADMINISTRATION
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0673-2026·2025-12-03
IV Administration Sets with Risk of Medication Backflow and Priming Failure
B Braun Medical Inc is recalling 41,016 IV Administration Sets due to potential backflow of medication from secondary containers into primary containers and inability to prime. The defect could affect proper drug delivery through infusion 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, 15DR, CARESIT
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0693-2026·2025-12-03
IV Administration Sets Recalled Due to Backflow and Occlusion Risk
B Braun Medical recalls 41,976 IV administration sets due to potential backflow of medication and inability to prime. The sets are used with multiple pump and gravity infusion systems 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-0660-2026·2025-12-03
IV Administration Set Recalled for Potential Medication Backflow
B Braun Medical Inc is recalling 1,272 units of IV Administration Sets due to potential backflow of medication from secondary containers into primary containers and inability to prime. No illnesses or injuries have been reported.
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 CARESITE, TR
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0641-2026·2025-12-03
IV Administration Set Recalled Due to Medication Backflow and Occlusion Risk
B Braun Medical Inc is recalling IV administration sets due to potential medication backflow from secondary IV containers into primary IV containers and inability to prime. 98,688 units have been 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/ 10 DROPS/ML
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0667-2026·2025-12-03
IV Administration Set Recall: Risk of Medication Backflow and Priming Failure
B Braun recalls 37,656 IV administration sets due to potential medication backflow from secondary containers into primary containers and inability to prime, affecting 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, 16
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0635-2026·2025-12-03
B Braun IV Extension Set Recalled for Medication Backflow and Occlusion Risk
B Braun Medical Inc is recalling 27,480 Extension Sets used in gravity and pump IV administration systems. The sets may allow medication to backflow from secondary containers into primary containers or fail to prime correctly.
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. EXT SET ULTRAPORT STOPCOCK, 37IN.;
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0699-2026·2025-12-03
IV Administration Sets: Potential Medication Backflow and Occlusion
B Braun Medical Inc is recalling IV Administration Sets used with its gravity and pump-based IV systems. The sets may allow medication backflow from secondary containers into primary containers and may fail to prime, affecting about 5,100 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 103 IN.; Catal
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0665-2026·2025-12-03
IV Administration Set Risk of Medication Backflow and Occlusion
B Braun Medical Inc is recalling IV administration sets used with their infusion pumps 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 15DR, 92 IN W/
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0584-2026·2025-12-03
Blood Lead Test System Recalled Due to Mislabeled Calibration Buttons
Magellan Diagnostics is recalling the LeadCare II Blood Lead Test Kit due to mislabeled calibration buttons that could produce inaccurate test results. Approximately 1,774 units distributed nationwide may give falsely elevated or falsely low lead readings.
Product
The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in whole blood. The LeadCare¿ II Test Kit is provided with the following materials: " Sensors (2 Containers of 24 sensors each; 48 tests) " Treatment Reagent Tubes (2 packag
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0723-2026·2025-12-03
Medical Imaging Software Bug Risks Clinical Data Loss
A bug in IntelePACS medical imaging software may delete clinical information when modifying patient studies, potentially impacting clinical decision-making.
Product
IntelePACS - InteleConnect / TechPortal
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0655-2026·2025-12-03
IV Administration Set Poses Risk of Medication Backflow and Delivery Obstruction
B Braun Medical Inc is recalling 80,650 IV administration sets due to potential backflow of medication from secondary to primary IV containers and inability to prime. No injuries have been reported.
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 W/2 CARESITE & 2 ULT
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0609-2026·2025-12-03
IV Administration Sets Recalled for Backflow and Occlusion Risk
B Braun Medical Inc is recalling IV administration sets due to potential backflow of medication between containers and inability to prime the line, which could affect medication delivery in clinical settings.
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 W/15 DROPS/ML, 134
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0588-2026·2025-12-03
Quantum Intersegmental Table Heat Function May Cause Overheating
Pivotal Health Solutions is recalling approximately 464 Quantum Intersegmental Table Model AMQ400H heated massage tables due to risk that heat function components may overheat and cause smoldering and melting of the vinyl cushion.
Product
Quantum Intersegmental Table, Model/Catalog Number: AMQ400H; heated massage table
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0648-2026·2025-12-03
IV Administration Sets Recalled for Backflow Risk and Priming Defect
B. Braun Medical's IV administration sets may allow medication to backflow from secondary containers into primary containers and may be unable to prime. The company is recalling 89,552 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 ANES 15DROP W/2 CARESITE
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0602-2026·2025-12-03
BioFire Respiratory Panel diagnostic kit recalled due to false negative risk
BioFire Diagnostics is recalling 23 kits of its Respiratory Panel 2.1 diagnostic test due to unintended movement of pouch chemistry that may cause false negative results and test control failures.
Product
BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0706-2026·2025-12-03
Outlook IV Pump Sets Recalled for Medication Backflow and Occlusion Risk
B. Braun Medical is recalling 6,672 Outlook pump sets used in IV administration due to potential backflow of medication from secondary containers into primary ones and inability to prime. No illnesses 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,115
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0707-2026·2025-12-03
Outlook IV Administration Sets Recalled for Backflow and Occlusion Risk
B Braun Medical Inc is recalling Outlook IV administration sets used with multiple infusion pumps due to potential medication backflow from secondary to primary IV containers and inability to prime properly.
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 IV SET 15DROP W/3 CARESITE; C
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0669-2026·2025-12-03
IV Administration Sets recalled for medication backflow and occlusion risk
B. Braun Medical Inc. is recalling 190,625 IV administration sets due to potential backflow of medication between containers and inability to prime the line. No injuries have been reported.
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 DROP W/ CAR
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0604-2026·2025-12-03
B Braun IV Administration Sets Recalled for Backflow and Occlusion Risk
B Braun Medical Inc is recalling ADDitIV IV administration sets due to potential backflow of medication from secondary containers into primary containers and inability to prime. Affected units were distributed worldwide including the US, Canada, Germany, Guatemala, and Singapore.
Product
ADDitIV 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. V1782F UNIV IV SET W/0.2 MICRON FILTER; C
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0694-2026·2025-12-03
IV Administration Set Recalled for Potential Medication Backflow and Occlusion Risk
B Braun IV administration sets used with multiple pump models risk medication backflow from secondary into primary IV containers and priming failure. No injuries have been reported.
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 124 IN.; Catal
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0666-2026·2025-12-03
IV Administration Set Recalled for Risk of Medication Backflow and Occlusion
B. Braun Medical is recalling 23,160 IV administration sets used with its infusion pumps 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 W/15 DROPS/ML,
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0698-2026·2025-12-03
IV Administration Sets Recalled for Backflow and Occlusion Risk
IV Administration Sets from B Braun Medical may allow medication to backflow from secondary into primary containers and may fail to prime. This FDA Class II recall affects approximately 98,568 units.
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-0703-2026·2025-12-03
IV Administration Sets Recalled for Potential Medication Backflow Risk
B Braun IV administration sets may allow medication backflow from secondary to primary containers and inability to prime. The FDA issued a Class II recall affecting 31,392 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 AD.SET W/15 DR 128 IN, E
Category
Medical Device
Distribution
0 states

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