Z-1319-2026Class I

Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 Electrodes 2-8-2mm Spacing w/AutoID...

Name: Z-1319-2026 Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 Electrodes 2-8-2mm Spacing w/AutoID...
Creator: Medline Industries, LP
Published: 2025-12-22
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2025-12-22 / Open, Classified

FDA source

Medline Industries, LP began a recall of Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 Electrodes 2-8-2mm Spacing w/AutoID w/ EZ Steer BD710DF282CRH; Webster CS Catheter 10... on 2025-12-22. FDA classified it as Class I and gives the reason as "These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1319-2026
Classification: Class I
Status: Open, Classified
Initiated: 2025-12-22
Posted: 2026-02-06
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 Electrodes 2-8-2mm Spacing w/AutoID w/ EZ Steer BD710DF282CRH; Webster CS Catheter 10 Electrodes, 2-8-2mm Spacing w/ EZ Steer BD710DF282RRH BD710FJ282RRH; Webster CS Catheter 10 Electrodes, 2-8-2mm Spacing w/AutoID w/ EZ Steer BD710FJ282CRH;
Product code: NLH Catheter, Recording, Electrode, Reprocessed
Reason for recall: These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
FDA root cause: Under Investigation by firm
Action: On December 22, 2025, the firm issued Urgent Medical Device Recall letters as a follow-up to an earlier action in 2025 for the same issue, but newly identified item numbers and lots of previously identified item numbers. Notably, the products associated with the new/updated action are to be destroyed by the customer on-site for credit, and not returned to the manufacturer. ***Updated 5/18/26*** The firm issued an expanded notification on 5/15/26 which expanded the action to include on additional lot of product. These devices were not expired at the time of the original notification but have since expired.
Quantity in commerce: 228
Distribution: Distribution US nationwide.
Product codes and lots: BD710DF282CRH UDI-DI 10197344044023 Lots EP250429 EP250808; BD710DF282RRH UDI-DI 10197344044030 Lots EP250429 EP250808; BD710FJ282RRH UDI-DI 10197344044054 Lots EP250429 EP250808; BD710FJ282CRH UDI-DI (case) 40197344044048 (ea) 10197344044047 Lots EP250429 EP250808

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1319-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1319-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-06
Z-1320-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-06
Z-1321-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-06
Z-1322-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-06
Z-1323-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-06
Z-1324-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-06
Z-1325-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-06

Product code NLH

K241224Class IIMedline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT)Surgical Instrument Service and Savings Inc.(Dba Medline Ren / cleared 2024-11-15

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)