PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga — Class II medical device recall Z-0116-2026

Ongoing recall by B BRAUN MEDICAL INC, reported 2025-10-15, distributed nationwide. Potential for the lid of the catheter connector to be in the incorrect position.

Recall number	`Z-0116-2026`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	B BRAUN MEDICAL INC, Allentown, PA, United States
Recall initiated	2025-09-18
Classified	2025-10-09
Reported by FDA	2025-10-15
Distributed	Nationwide (US)
Quantity	48,110 units
UPC / GTIN / UDI-DI	`04046955899456`, `04046955899463`
Lot numbers	`0062010541`, `0062010542`, `0062010543`, `0062010545`, `0062010546`, `0062010547`, `0062010548`, `0062010549`, `0062010550`, `0062010743`, `0062013041`, `0062013042`, `0062013043`, `0062013044`, `0062013045`, `0062013046`, `0062013047`, `0062013049`, `0062015110`, `0062015112`, `0062015113`, `0062015114`
Model numbers	`332079`
Expiration dates	`2026-07-31`

Product

PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFC. Product Description: CE17TKFC EPIDURAL TRAY W/ 17GA TUOHY.

Reason for recall

Potential for the lid of the catheter connector to be in the incorrect position.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0116-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.