FDA (Devices) recall action 97816

B Braun Medical Inc recalled 116 products on 2025-12-03

The FDA (Devices) publishes a recall like this one as 116 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 116 pages.

Products: 116
Announced: 2025-12-03
Critical: 0
Units: 93,637,186

Why these products were recalled

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

76–100 of 116

HighFDA (Devices)··2025-12-03
IV set 490283 recalled over backflow between primary and secondary containers
B. Braun Medical is recalling 65,904 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
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 W/ B/C VALVE 53 in.…
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HighFDA (Devices)··2025-12-03
IV set 490426 recalled over piggyback backflow and occlusion risk
B. Braun Medical is recalling 63,192 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/10 DROPS…
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HighFDA (Devices)··2025-12-03
IV set 470005 recalled over medication backflow and priming failure
B. Braun Medical is recalling 29,900 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 SET 15DR 3 CARESITE…
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HighFDA (Devices)··2025-12-03
IV set 490385 recalled over medication backflow between IV containers
B. Braun Medical is recalling 168,816 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 numbers: 1. IV ADMIN SET, 10…
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HighFDA (Devices)··2025-12-03
IV set 490507 recalled over backflow and inability to prime
B. Braun Medical is recalling 48,672 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 ADMINISTRATION SET WITH…
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HighFDA (Devices)··2025-12-03
IV set 352636 recalled over piggyback backflow and priming occlusion
B. Braun Medical is recalling 20,694,734 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 15 DR W/2…
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HighFDA (Devices)··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…
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0 states
HighFDA (Devices)··2025-12-03
Extension set V5405 recalled over backflow and inability to prime
B. Braun Medical is recalling 300 units extension sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
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/2INJ/FLBL/FML LRLK/CV 34…
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HighFDA (Devices)··2025-12-03
Universal infusion sets recalled over piggyback backflow and priming occlusion
B. Braun Medical is recalling 49,330,370 Infusomat administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
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…
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ModerateFDA (Devices)··2025-12-03
Bronchoscopy robots recalled because the user manual was password protected
Noah Medical is recalling 47 Galaxy Systems because users did not have access to the Instructions for Use and User Manual, which was password protected.
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…
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0 states
HighFDA (Devices)··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…
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HighFDA (Devices)··2025-12-03
IV set 490301 recalled over backflow from secondary piggyback containers
B. Braun Medical is recalling 31,392 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 AD.SET W/15 DR 128 IN…
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0 states
HighFDA (Devices)··2025-12-03
Outlook pump sets recalled over backflow into the primary container
B. Braun Medical is recalling 2,352 Outlook pump 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 PUMP SET 3 CARESITE LADS 133…
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HighFDA (Devices)··2025-12-03
Anesthesia infusion sets recalled over backflow into the primary bag
B. Braun Medical is recalling 19,392 anesthesia IV sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
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, 15 DROPS/ML 125…
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HighFDA (Devices)··2025-12-03
Extension set 490629 recalled over backflow and priming occlusion
B. Braun Medical is recalling 13,128 extension sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
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…
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HighFDA (Devices)··2025-12-03
IV set NF1270A recalled over piggyback backflow and priming occlusion
B. Braun Medical is recalling 13,870 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. NF1270A SAFELINE…
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HighFDA (Devices)··2025-12-03
Anesthesia set 490476 recalled over piggyback backflow and priming occlusion
B. Braun Medical is recalling 19,320 units anesthesia iv sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
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, 2-HIGH FLOW…
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HighFDA (Devices)··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…
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HighFDA (Devices)··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…
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HighFDA (Devices)··2025-12-03
IV set 490427 recalled over piggyback backflow and priming occlusion
B. Braun Medical is recalling 224,856 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…
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0 states
HighFDA (Devices)··2025-12-03
IV set 490504 recalled over piggyback backflow and priming occlusion
B. Braun Medical is recalling 36,936 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…
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Distribution
0 states
HighFDA (Devices)··2025-12-03
IV set 490612 recalled over medication backflow between IV containers
B. Braun Medical is recalling 5,952 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. 15DR 2SAFELINE 1CARESITE…
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HighFDA (Devices)··2025-12-03
IV set 490522 recalled over backflow from secondary piggyback containers
B. Braun Medical is recalling 41,016 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, 15DR…
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0 states
HighFDA (Devices)··2025-12-03
IV set 490408 recalled over backflow between primary and secondary containers
B. Braun Medical is recalling 24,072 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 CARESITES…
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HighFDA (Devices)··2025-12-03
Burette set 490159 recalled over backflow into the primary container
B. Braun Medical is recalling 7,240 burette sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
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.…
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