Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

1651–1675 of 13446

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
HighFDA (Devices)·Z-0647-2026·2025-12-03
IV Administration Set Recall Due to Backflow and Priming Occlusion Risk
B Braun Medical's IV administration sets may allow medication backflow into primary containers and prevent proper priming. FDA issued a Class II recall for the affected sets used in multiple pump models.
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 15D, 2 B/C VLV, 3
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0640-2026·2025-12-03
IV Administration Sets Risk Medication Backflow and Pump Occlusion Failure
B Braun Medical Inc is recalling multiple IV administration sets used with gravity and pump infusion systems. The sets pose a risk of medication backflow between containers and inability to prime the pump.
Product
Infusomat 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. UNIV.15DROP PUMP SET W/3 SAFELINE LL;
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0675-2026·2025-12-03
IV Administration Set Recalled for Medication Backflow and Priming Issues
B Braun Medical Inc is recalling 65,232 IV Administration Sets used with multiple infusion 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. Catalog Number: 490549; Pri
Category
Medical Device
Distribution
0 states

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1651–1675 of 13446