Reported Dec 3, 2025 · Ongoing

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's…

B Braun Medical Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: B Braun Medical Inc · 824 12th Ave · Bethlehem, PA · 18018-3524

Is this the product you have?

50 of 50 products

Products covered by this recall
Model / number	Product as published
`352636.`	IV ADMIN SET 15 DR W/2 SAFEDAY
`352639.`	IV ADMIN SET 15 DR W/2 SAFEDAY 84 IN.
`352640.`	IV ADMIN SET 15 DROP W/3 SAFEDAY
`352643.`	IV ADMIN 15D W/2 SAFEDAY & 0.2 FILTER
`477003.`	IV ADMIN SET, 105 IN.
`477006.`	IV ADMIN SET 15D, 4 CARESTIE LAD, 145 IN
`477008.`	IV ADMIN SET, 121 IN.
`477012.`	IV ADMIN SET 15D, CARESTIE LAD, 90 IN
`477019.`	IV ADMIN SET, 2 CARESTIE LAD, 15D, 117IN
`477021.`	IV ADMIN SET, 15D, 5CARESITE LAD, 136 IN
`477022.`	IV ADMIN SET 114 IN.
`477023.`	IV ADMIN SET 5 CARESITE LADS, 126 IN.
`477053.`	IV SET 15DR 3 SAFEDAY, 106 IN.
`490513.`	IV ADMIN SET, 15DR, CARESITE LAD, 121 IN
`490521.`	IV ADMIN SET, 15D, 120 IN.
`490527.`	IV ADMIN SET 15D 2 CARESITE LADS, 112IN.
`490529.`	IV ADMIN SET 15 DRP CARESITE SAFEPORT
`490535.`	IV ADMIN SET, 15D, 139 IN.
`490543.`	IV ADMIN SET 15D, CARESITE LAD, 122IN.
`490546.`	IV ADMIN SET 15D 3 CARESITE LADS, 150IN.

Lot codes and dates: 50 of 50 products
Products covered by this recall
Model / number Barcodes Product as published
352636 0404695559459704046955594580 Primary UDI-DI: 04046955594597; Unit of Dose UDI-DI: 04046955594580; Expiration Date: 36mths from Start Date.
352639 0404695559467204046955594665 Primary UDI-DI: 04046955594672; Unit of Dose UDI-DI: 04046955594665; Expiration Date: 36mths from Start Date.
352640 0404695559469604046955594689 Primary UDI-DI: 04046955594696; Unit of Dose UDI-DI: 04046955594689; Expiration Date: 36mths from Start Date.
352643 0404695559475704046955594740 Primary UDI-DI: 04046955594757; Unit of Dose UDI-DI: 04046955594740; Expiration Date: 36mths from Start Date.
477003 0404695520283604046955202829 Primary UDI-DI: 04046955202836; Unit of Dose UDI-DI: 04046955202829; Expiration Date: Earliest Exp of Comp or 36mths.
477006 0404695520275104046955202744 Primary UDI-DI: 04046955202751; Unit of Dose UDI-DI: 04046955202744; Expiration Date: Earliest Exp of Comp or 36mths.
477008 0404695520285004046955202843 Primary UDI-DI: 04046955202850; Unit of Dose UDI-DI: 04046955202843; Expiration Date: Earliest Exp of Comp or 36mths.
477012 0404695520287404046955202867 Primary UDI-DI: 04046955202874; Unit of Dose UDI-DI: 04046955202867; Expiration Date: Earliest Exp of Comp or 36mths.
477019 0404695520314704046955203130 Primary UDI-DI: 04046955203147; Unit of Dose UDI-DI: 04046955203130; Expiration Date: Earliest Exp of Comp or 36mths.
477021 0404695526998304046955269976 Primary UDI-DI: 04046955269983; Unit of Dose UDI-DI: 04046955269976; Expiration Date: Earliest Exp of Comp or 36mths.
477022 0404695527000204046955269990 Primary UDI-DI: 04046955270002; Unit of Dose UDI-DI: 04046955269990; Expiration Date: Earliest Exp of Comp or 36mths.
477023 0404695527002604046955270019 Primary UDI-DI: 04046955270026; Unit of Dose UDI-DI: 04046955270019; Expiration Date: Earliest Exp of Comp or 36mths.
477053 0404695567243104046955672424 Primary UDI-DI: 04046955672431; Unit of Dose UDI-DI: 04046955672424; Expiration Date: Earliest Exp of Comp or 36mths.
490513 0404695513723704046955137220 Primary UDI-DI: 04046955137237; Unit of Dose UDI-DI: 04046955137220; Expiration Date: Earliest Exp of Comp or 36mths.
490521 0404695518525204046955186563 Primary UDI-DI: 04046955185252; Unit of Dose UDI-DI: 04046955186563; Expiration Date: Earliest Exp of Comp or 24mths.
490527 0404695520322204046955203215 Primary UDI-DI: 04046955203222; Unit of Dose UDI-DI: 04046955203215; Expiration Date: Earliest Exp of Comp or 36mths.
490529 0404695520330704046955203291 Primary UDI-DI: 04046955203307; Unit of Dose UDI-DI: 04046955203291; Expiration Date: Earliest Exp of Comp or 24mths.
490535 0404695520340604046955203390 Primary UDI-DI: 04046955203406; Unit of Dose UDI-DI: 04046955203390; Expiration Date: Earliest Exp of Comp or 36mths.
490543 0404695527020004046955270194 Primary UDI-DI: 04046955270200; Unit of Dose UDI-DI: 04046955270194; Expiration Date: Earliest Exp of Comp or 36mths.
490546 0404695527026204046955270255 Primary UDI-DI: 04046955270262; Unit of Dose UDI-DI: 04046955270255; Expiration Date: Earliest Exp of Comp or 36mths.
Page 1 of 3
Amount recalled: 20,694,734 units

This recall covers 116 products

The agency filed one notice per product. You are reading one of them; the other 115 are below.

103 more are in the archive.

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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By hazard

Medical device recalls

Other recalls from B Braun Medical Inc.

25 in total.

All recall categories · Browse the whole archive

Model / number	Barcodes	Product as published
`352636`	`0404695559459704046955594580`	Primary UDI-DI: 04046955594597; Unit of Dose UDI-DI: 04046955594580; Expiration Date: 36mths from Start Date.
`352639`	`0404695559467204046955594665`	Primary UDI-DI: 04046955594672; Unit of Dose UDI-DI: 04046955594665; Expiration Date: 36mths from Start Date.
`352640`	`0404695559469604046955594689`	Primary UDI-DI: 04046955594696; Unit of Dose UDI-DI: 04046955594689; Expiration Date: 36mths from Start Date.
`352643`	`0404695559475704046955594740`	Primary UDI-DI: 04046955594757; Unit of Dose UDI-DI: 04046955594740; Expiration Date: 36mths from Start Date.
`477003`	`0404695520283604046955202829`	Primary UDI-DI: 04046955202836; Unit of Dose UDI-DI: 04046955202829; Expiration Date: Earliest Exp of Comp or 36mths.
`477006`	`0404695520275104046955202744`	Primary UDI-DI: 04046955202751; Unit of Dose UDI-DI: 04046955202744; Expiration Date: Earliest Exp of Comp or 36mths.
`477008`	`0404695520285004046955202843`	Primary UDI-DI: 04046955202850; Unit of Dose UDI-DI: 04046955202843; Expiration Date: Earliest Exp of Comp or 36mths.
`477012`	`0404695520287404046955202867`	Primary UDI-DI: 04046955202874; Unit of Dose UDI-DI: 04046955202867; Expiration Date: Earliest Exp of Comp or 36mths.
`477019`	`0404695520314704046955203130`	Primary UDI-DI: 04046955203147; Unit of Dose UDI-DI: 04046955203130; Expiration Date: Earliest Exp of Comp or 36mths.
`477021`	`0404695526998304046955269976`	Primary UDI-DI: 04046955269983; Unit of Dose UDI-DI: 04046955269976; Expiration Date: Earliest Exp of Comp or 36mths.
`477022`	`0404695527000204046955269990`	Primary UDI-DI: 04046955270002; Unit of Dose UDI-DI: 04046955269990; Expiration Date: Earliest Exp of Comp or 36mths.
`477023`	`0404695527002604046955270019`	Primary UDI-DI: 04046955270026; Unit of Dose UDI-DI: 04046955270019; Expiration Date: Earliest Exp of Comp or 36mths.
`477053`	`0404695567243104046955672424`	Primary UDI-DI: 04046955672431; Unit of Dose UDI-DI: 04046955672424; Expiration Date: Earliest Exp of Comp or 36mths.
`490513`	`0404695513723704046955137220`	Primary UDI-DI: 04046955137237; Unit of Dose UDI-DI: 04046955137220; Expiration Date: Earliest Exp of Comp or 36mths.
`490521`	`0404695518525204046955186563`	Primary UDI-DI: 04046955185252; Unit of Dose UDI-DI: 04046955186563; Expiration Date: Earliest Exp of Comp or 24mths.
`490527`	`0404695520322204046955203215`	Primary UDI-DI: 04046955203222; Unit of Dose UDI-DI: 04046955203215; Expiration Date: Earliest Exp of Comp or 36mths.
`490529`	`0404695520330704046955203291`	Primary UDI-DI: 04046955203307; Unit of Dose UDI-DI: 04046955203291; Expiration Date: Earliest Exp of Comp or 24mths.
`490535`	`0404695520340604046955203390`	Primary UDI-DI: 04046955203406; Unit of Dose UDI-DI: 04046955203390; Expiration Date: Earliest Exp of Comp or 36mths.
`490543`	`0404695527020004046955270194`	Primary UDI-DI: 04046955270200; Unit of Dose UDI-DI: 04046955270194; Expiration Date: Earliest Exp of Comp or 36mths.
`490546`	`0404695527026204046955270255`	Primary UDI-DI: 04046955270262; Unit of Dose UDI-DI: 04046955270255; Expiration Date: Earliest Exp of Comp or 36mths.