Hazard

Backflow recalls

128 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 128
Critical: 0
Severe: 0
Most recent: 2026-04-29

Of the 128 backflow recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all backflow recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

101–125 of 128

HighFDA (Devices)·Z-0660-2026·2025-12-03
IV set 490343 recalled over piggyback backflow and priming occlusion
B. Braun Medical is recalling 1,272 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an 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 CARESITE, TR
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0661-2026·2025-12-03
IV set 490309 recalled over backflow into the primary bag
B. Braun Medical is recalling 259,392 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an 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/ 2 CARESITE,
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0685-2026·2025-12-03
IV set 490312 recalled over medication backflow between IV containers
B. Braun Medical is recalling 226,632 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an 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 ADMN SET W/15 DROP, ULTR
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0709-2026·2025-12-03
Outlook set 354212 recalled over piggyback backflow and occlusion risk
B. Braun Medical is recalling 162,648 units outlook sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
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/2 CARESITE; C
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0697-2026·2025-12-03
IV set 480231 recalled over backflow from secondary piggyback containers
B. Braun Medical is recalling 85,176 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an 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-0716-2026·2025-12-03
Outlook set 354214 recalled over backflow and inability to prime
B. Braun Medical is recalling Outlook set catalog number 354214 over the potential for medication backflow from secondary piggyback containers and an inability to prime.
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 15DR W/2 CARESITE FILT
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0663-2026·2025-12-03
IV set 490400 recalled over backflow and inability to prime
B. Braun Medical is recalling 19,104 IV administration sets over the potential for medication backflow from secondary piggyback containers and an 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-0620-2026·2025-12-03
Blood set 480233 recalled over backflow from piggyback containers
B. Braun Medical is recalling 5,448 blood administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
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-0641-2026·2025-12-03
IV set 490357 recalled over backflow from secondary piggyback containers
B. Braun Medical is recalling 98,688 IV administration sets over the potential for medication backflow from secondary piggyback containers and an 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/ 10 DROPS/ML
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0617-2026·2025-12-03
Blood set 490355 recalled over backflow into the primary container
B. Braun Medical is recalling 24,624 units blood administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
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-0616-2026·2025-12-03
Blood set 490196 recalled over piggyback backflow and priming occlusion
B. Braun Medical is recalling 7,344 blood administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
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-0598-2026·2025-12-03
Anesthesia set 490469 recalled over backflow and priming occlusion
B. Braun Medical is recalling 104,784 units anesthesia iv sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001 Product Description: The Galaxy SystemTM and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedure.
Category
Medical Device
Distribution
20 states
HighFDA (Devices)·Z-0651-2026·2025-12-03
Pump administration sets recalled over piggyback backflow and priming failure
B. Braun Medical is recalling 135,000 IV administration sets over the potential for medication backflow from secondary piggyback containers and an 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 SET 3 CARESITE ULTRA ZER
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0675-2026·2025-12-03
Pump IV sets recalled over backflow from piggyback into primary bags
B. Braun Medical is recalling 65,232 IV administration sets over the potential for medication backflow from secondary piggyback containers and an 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
HighFDA (Devices)·Z-0686-2026·2025-12-03
Low volume IV sets recalled over backflow and priming occlusion
B. Braun Medical is recalling 960 IV administration sets over the potential for medication backflow from secondary piggyback containers and an 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 ADMINISTRATION SET, 138
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0688-2026·2025-12-03
IV set 470179 recalled over backflow into the primary bag
B. Braun Medical is recalling 28,344 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an 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/ B/C VALVE,1
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0700-2026·2025-12-03
IV set 490088 recalled over medication backflow and priming failure
B. Braun Medical is recalling iv administration sets, catalog number 490088, over the potential for medication backflow from secondary piggyback containers and an 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. NF1505, IV ADMIN SET W/2 H.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0683-2026·2025-12-03
IV set 354211 recalled over piggyback backflow and occlusion risk
B. Braun Medical is recalling 286,400 IV administration sets over the potential for medication backflow from secondary piggyback containers and an 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 ADM 15 DROP W/3 CARESITE
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2391-2024·2024-07-24
Infusomat UNIV. 15 IV Pump Set Recalled for Backflow Hazard
B. Braun Medical is recalling 32,752 units of the Infusomat UNIV. 15 DR pump tubing set due to potential backcheck valve malfunction that could cause medication backflow between IV containers and medication loss.
Product
Infusomat UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363424
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2397-2024·2024-07-24
IV Infusion Pump Set Valve May Cause Dangerous Medication Backflow
B. Braun's Infusomat pump sets may have faulty backcheck valves causing medication to backflow between IV bags, risking reduced medication delivery and adverse reactions. All units distributed worldwide after August 2023 are affected.
Product
Infusomat UNIV. 15 DROP PUMP SET W 3 CARESITE L.L. Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2404-2024·2024-07-24
IV Infusion Pump Set Recalled for Backflow Risk During Medication Administration
B. Braun Medical is recalling the OUTLOOK PUMP SET 3 IV infusion sets due to a potential backcheck valve malfunction that could cause medication to backflow from secondary containers into primary containers, risking adverse drug reactions and medication loss.
Product
OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490564
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2401-2024·2024-07-24
Infusomat UNIV 60 IV Infusion Pump Set Recalled for Valve Malfunction Risk
B. Braun is recalling Infusomat UNIV 60 IV infusion pump sets due to a backcheck valve defect that could cause medication backflow between IV containers and prevent priming, potentially resulting in adverse drug reactions or medication loss.
Product
Infusomat UNIV 60 DROP PUMP SET, W/2 CARESITE INJ. -Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number : 490104
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2394-2024·2024-07-24
Infusomat SPACE Pump IV Sets Recalled for Backcheck Valve Malfunction
B. Braun's Infusomat SPACE Pump IV sets are recalled due to a potential backcheck valve malfunction that could cause medication backflow and inability to prime. The defect affects approximately 109,464 units distributed in the US and Canada.
Product
Infusomat SPACE PUMP IV SET 15D, 110 IN. -Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 480254
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2393-2024·2024-07-24
IV Infusion Pump Set Backcheck Valve Malfunction Recall
B. Braun Medical recalls Infusomat UNIV. 15 DROP PUMP SET due to backcheck valve malfunction that could cause medication backflow and loss of medication, resulting in adverse drug reactions.
Product
Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363433
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2380-2024·2024-07-24
Infusomat IV Pump Set Recalled for Backcheck Valve Malfunction
The Infusomat 60DROP METRISET PUMP SET may experience backcheck valve malfunction, causing medication to flow backward between IV containers and loss of medication. This could result in adverse drug reactions or inability to administer medication properly.
Product
Infusomat 60DROP METRISET PUMP SET, 3 SAFELINE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 362034
Category
Medical Device
Distribution
Distributed nationwide