CLASS II ONGOING Device recall · Reported 3 Dec 2025 · FDA Enforcement Report

Caresafe utilized in gravity IV administration sets recalled

B Braun Medical is recalling Caresafe utilized in gravity IV administration sets and pump administration sets utilized. The recall was initiated on 29 Oct 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1. Catalog Number: 354302; Primary UDI-DI: 04046955259946; Unit of Dose UDI-DI: 04046955259939. 2. Catalog Number: 354303; Primary UDI-DI: 04046955052424; Unit of Dose UDI-DI: 04046955052417. 3. Catalog Number: 354304; Primary UDI-DI: 04046955259960; Unit of Dose UDI-DI: 04046955259953. 4. Catalog Number: 354305; Primary UDI-DI: 04046955052448; Unit of Dose UDI-DI: 04046955052431. 5. Catalog Number: 354306; Primary UDI-DI: 04046955259984; Unit of Dose UDI-DI: 04046955259977. 6. Catalog Number: 354307; Primary UDI-DI: 04046955052462; Unit of Dose UDI-DI: 04046955052455. 7. Catalog Number: 354308; Primary UDI-DI: 04046955260003; Unit of Dose UDI-DI: 04046955259991. 8. Catalog Number: 354310; Primary UDI-DI: 04046955052929; Unit of Dose UDI-DI: 04046955052905.

Quantity recalled4,438 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0623-2026
FDA event ID: 97816
Recalling firm: B Braun Medical, Bethlehem, PA
Classification: Class II
Status: Ongoing
Recall initiated: 29 Oct 2025
FDA classified: 26 Nov 2025
Reported: 3 Dec 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Infusion Pumps

Timeline

29 Oct 2025	Recall initiated by company
26 Nov 2025	Classified by FDA	+28 days
3 Dec 2025	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

CARESAFE 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. CARESAFE IV ADMIN SET w/AIRSTOP, 104 IN.; Catalog Number: 354302. 2. CARESAFE ADMIN SET w/15um FILTER, 104 IN; Catalog Number: 354303. 3. CARESAFE IV ADMIN SET w/AIRSTOP, 114 IN.; Catalog Number: 354304. 4. CARESAFE ADMIN SET w/15um FILTER, 114 IN; Catalog Number: 354305. 5. CARESAFE IV ADMIN SET w/AIRSTOP, 110 IN.; Catalog Number: 354306. 6. CARESAFE ADMIN SET w/15um FILTER, 110 IN; Catalog Number: 354307. 7. CARESAFE" IV Administration Set with AirStop Filter, Not made with PVC or DEHP, 2 CARESITE¿ Injection Sites, 2 ULTRAPORT¿ High-FlowFour-Way Stopcocks; CARESAFE ANESTH SET W/AIRSTOP, 134 IN.; Catalog Number: 354308. 8. CARESAFE ANESTH SET w/15um FILTER,134IN.; Catalog Number: 354310.

Where it was distributed

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

Questions about this recall

Why was it recalled?

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

Which lots are affected?

1. Catalog Number: 354302; Primary UDI-DI: 04046955259946; Unit of Dose UDI-DI: 04046955259939. 2. Catalog Number: 354303; Primary UDI-DI: 04046955052424; Unit of Dose UDI-DI: 04046955052417. 3. Catalog Number: 354304; Primary UDI-DI: 04046955259960; Unit of Dose UDI-DI: 04046955259953. 4. Catalog Number: 354305; Primary UDI-DI: 04046955052448; Unit of Dose UDI-DI: 04046955052431. 5. Catalog Number: 354306; Primary UDI-DI: 04046955259984; Unit of Dose UDI-DI: 04046955259977. 6. Catalog Number: 354307; Primary UDI-DI: 04046955052462; Unit of Dose UDI-DI: 04046955052455. 7. Catalog Number: 354308; Primary UDI-DI: 04046955260003; Unit of Dose UDI-DI: 04046955259991. 8. Catalog Number: 354310; Primary UDI-DI: 04046955052929; Unit of Dose UDI-DI: 04046955052905.

Where was it sold?

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

100 other products · FDA event 97816

This product is part of a recall event; the main page for the event is Blood Administration Set utilized recalled by B Braun Medical.

Reported	Class	Recall	Company	Reason	Where
3 Dec 2025	CLASS II	Blood Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	Blood Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	SafeDAY set utilized in gravity IV administration sets recalled	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	Anesthesia IV Set utilized in gravity IV administration recalled	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	Infusomat utilized in gravity IV administration sets recalled	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	Extension Set utilized in gravity IV administration sets recalled	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	Extension Set utilized in gravity IV administration sets recalled	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	Extension Set utilized in gravity IV administration sets recalled	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	Outlook set utilized in gravity IV administration sets recalled	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	Blood Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	Vista set utilized in gravity IV administration sets recalled	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	Extension Set utilized in gravity IV administration sets recalled	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	Extension Set utilized in gravity IV administration sets recalled	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	ADDitIV utilized in gravity IV administration sets recalled	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	Burette Set utilized in gravity IV administration sets recalled	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	Anesthesia IV Set utilized in gravity IV administration recalled	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	Extension Set utilized in gravity IV administration sets recalled	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	ADDitIV utilized in gravity IV administration sets recalled	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	Caresite utilized in gravity IV administration sets recalled	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	Caresite utilized in gravity IV administration sets recalled	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	Blood Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	Anesthesia IV Set utilized in gravity IV administration recalled	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	Anesthesia IV Set utilized in gravity IV administration recalled	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	Safeline set utilized in gravity IV administration sets recalled	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	Extension Set utilized in gravity IV administration sets recalled	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	Outlook set utilized in gravity IV administration sets recalled	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	Extension Set utilized in gravity IV administration sets recalled	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	Anesthesia IV Set utilized in gravity IV administration recalled	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	ADDitIV utilized in gravity IV administration sets recalled	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	Rate Flow set utilized in gravity IV administration sets recalled	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	Anesthesia IV Set utilized in gravity IV administration recalled	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	Outlook set utilized in gravity IV administration sets recalled	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	Extension Set utilized in gravity IV administration sets recalled	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	Extension Set utilized in gravity IV administration sets recalled	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	Anesthesia IV Set utilized in gravity IV administration recalled	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	Extension Set utilized in gravity IV administration sets recalled	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	Anesthesia IV Set utilized in gravity IV administration recalled	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	Outlook set utilized in gravity IV administration sets recalled	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	Caresite utilized in gravity IV administration sets recalled	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	Ultrasite set utilized in gravity IV administration sets recalled	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	IV Administration Set utilized recalled by B Braun Medical	B Braun Medical	Other	PA
3 Dec 2025	CLASS II	Burette Set utilized in gravity IV administration sets recalled	B Braun Medical	Other	PA

More recalls from B Braun Medical

All 447

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Drug	CLASS I	0.9% Sodium Chloride Injection, USP Partial Fill recalledSodium Chloride	B Braun Medical	Particulate Matter	Nationwide
9 Sep 2026Device	CLASS II	Extension Set Discofix Four Way Stopcock recalled by B Braun Medical	B Braun Medical	Other	Nationwide
2 Sep 2026Drug	CLASS I	Lactated Ringer's Injection USP Excel container recalledLactated Ringers	B Braun Medical	Particulate Matter	Nationwide
10 Jun 2026Device	CLASS I	Design Options Spinal Tray Spinal Needle Anesthesia recalled	B Braun Medical	Processing Deviation	Nationwide
10 Jun 2026Device	CLASS II	Sesk Upmc Double Catheter Tray recalled by B Braun Medical	B Braun Medical	Device Malfunction	Nationwide

Other Infusion Pumps recalls

All 549

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS I	BD Alaris Pump Infusion Sets 10561554* recalled by BD Switzerland Sarl	BD Switzerland Sarl	Other	Nationwide
23 Sep 2026Device	CLASS II	IV Non-Dedicated Gravity Administration Sets with drip chambers recalled	ICU Medical	Foreign Material	Nationwide
23 Sep 2026Device	CLASS II	Plum administration sets recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide
9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide