CLASS II ONGOING Device recall · Reported 11 Mar 2026 · FDA Enforcement Report

BBraun Medical Winged INF recalled

B Braun Medical is recalling BBraun Medical Winged INF, distributed nationwide in the US. The recall was initiated on 2 Feb 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel/Catalog Number: 7B3050; Primary-DI 4046964341298, Unit of Use- DI 4046964341274; Lot 0062006430, Exp 30APR2032; Lot 0062006470, Exp 30JUN2032; Lot 0062006471, Exp 31MAY2032; Lot 0062014964, Exp 31JUL2032; Lot 0062014965, Exp 31JUL2032; Lot 0062014966, Exp 30SEP2032; Lot 0062027579, Exp 31AUG2032.

Quantity recalled105550 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-1481-2026
FDA event ID: 98380
Recalling firm: B Braun Medical, Bethlehem, PA
Classification: Class II
Status: Ongoing
Recall initiated: 2 Feb 2026
FDA classified: 2 Mar 2026
Reported: 11 Mar 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Breast Implants

Timeline

2 Feb 2026	Recall initiated by company
2 Mar 2026	Classified by FDA	+28 days
11 Mar 2026	Published in enforcement report	+9 days

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

Reason for recall

The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B3050 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids. Component: N/A

Where it was distributed

Worldwide - US Nationwide distribution in the state of TX and the country of Costa Rica.

Nationwide Texas

Questions about this recall

Why was it recalled?

The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.

Which lots are affected?

Model/Catalog Number: 7B3050; Primary-DI 4046964341298, Unit of Use- DI 4046964341274; Lot 0062006430, Exp 30APR2032; Lot 0062006470, Exp 30JUN2032; Lot 0062006471, Exp 31MAY2032; Lot 0062014964, Exp 31JUL2032; Lot 0062014965, Exp 31JUL2032; Lot 0062014966, Exp 30SEP2032; Lot 0062027579, Exp 31AUG2032.

Where was it sold?

Worldwide - US Nationwide distribution in the state of TX and the country of Costa Rica.

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

2 other products · FDA event 98380

This product is part of a recall event; the main page for the event is B. Braun Winged INF SET recalled by B Braun Medical.

Reported	Class	Recall	Company	Reason	Where
11 Mar 2026	CLASS II	B. Braun Winged INF SET recalled by B Braun Medical	B Braun Medical	Device Malfunction	Nationwide
11 Mar 2026	CLASS II	B. Braun Winged Infusion, Single PK recalled by B Braun Medical	B Braun Medical	Device Malfunction	Nationwide

More recalls from B Braun Medical

All 447

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9 Sep 2026Device	CLASS II	Extension Set Discofix Four Way Stopcock recalled by B Braun Medical	B Braun Medical	Other	Nationwide
3 Sep 2026Drug	ANNOUNCED	B. Braun 0.9% Sodium Chloride Injection USP, in a PAB Container recalledB. Braun	B. Braun Medical	Particulate Matter	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 Breast Implants recalls

All 29

Reported	Class	Recall	Company	Reason	Where
8 Apr 2026Device	CLASS II	Artoura Breast Tissue Expanders Reference Numbers recalled	Mentor Texas	Device Malfunction	Nationwide
8 Apr 2026Device	CLASS II	Artoura Breast Tissue Expanders Reference Numbers recalled	Mentor Texas	Device Malfunction	Nationwide
8 Apr 2026Device	CLASS II	Artoura Breast Tissue Expanders Reference Numbers recalled	Mentor Texas	Device Malfunction	Nationwide
11 Mar 2026Device	CLASS II	B. Braun Winged Infusion, Single PK recalled by B Braun Medical	B Braun Medical	Device Malfunction	Nationwide
11 Mar 2026Device	CLASS II	B. Braun Winged INF SET recalled by B Braun Medical	B Braun Medical	Device Malfunction	Nationwide