Z-0125-2026Class II

Combined Spinal and Epidural Anesthesia Tray 2, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle...

Name: Z-0125-2026 Combined Spinal and Epidural Anesthesia Tray 2, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle...
Creator: B Braun Medical Inc
Published: 2025-09-18
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2025-09-18 / Open, Classified / root cause: manufacturing process

FDA source

B BRAUN MEDICAL INC began a recall of Combined Spinal and Epidural Anesthesia Tray 2, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga. x 5 in. (12.7 cm) Spinal Needle, and... on 2025-09-18. FDA classified it as Class II and gives the reason as "Potential for the lid of the catheter connector to be in the incorrect position". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0125-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-18
Posted: 2025-10-09
Recalling firm: B Braun Medical Inc
Product: Combined Spinal and Epidural Anesthesia Tray 2, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga. x 5 in. (12.7 cm) Spinal Needle, and 19 Ga. Closed Tip PERIFIX FX Springwound Epidural Catheter. Product Code: SESK. Product Description: SESK COMBINED SPINAL AND EPIDURAL TRAY 2.
Product code: OGE Epidural Anesthesia Kit
Reason for recall: Potential for the lid of the catheter connector to be in the incorrect position.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: B Braun notified consignees on about 09/18/2025 via USPS certified mailed URGENT MEDICAL DEVICE CORRECTION NOTIFICATION. Consignees were instructed to, where possible, have a second kit or additional catheter connector available at the point of use and upon opening the kit, verify the correct catheter connector is present. If the affected component is detected, discard and do not use. Consignees were also instructed to review the Medical Device Correction Notification and ensure all users in your organization and other concerned persons are informed, if affected units have been further distributed, notify customers, post the notification where affected units are stored, and complete and return the "Urgent Medical Device Correction Acknowledgement Form." Additionally, if consignees have identified affected units in inventory, they may order one case (50 pieces) of affected sterilized single use catheter connectors to have on hand.
Quantity in commerce: 60 units
Distribution: Nationwide distribution to AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV.
Product codes and lots: REF: 530185; Product Code: SESK; UDI-DI (Primary): 04046955625147; UDI-DI (Unit of Use): 04046955625130; Lot Number: 0062003227. Expiration Date: 07/31/2026.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0125-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0114-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-15	2025-10-09
Z-0115-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-15	2025-10-09
Z-0116-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-15	2025-10-09
Z-0117-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-15	2025-10-09
Z-0118-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-15	2025-10-09
Z-0119-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-15	2025-10-09
Z-0120-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-15	2025-10-09
Z-0121-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-15	2025-10-09
Z-0122-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-15	2025-10-09
Z-0123-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-15	2025-10-09
Z-0124-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-15	2025-10-09
Z-0125-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-15	2025-10-09
Z-0126-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-15	2025-10-09

Product code OGE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)