Medline Industries, LP recalls Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 Electrodes…
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
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
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;
Lot / code information
- UDI
- 10197344044023 Lots EP250429 EP250808; BD710DF282RRH
- UDI
- 10197344044030 Lots EP250429 EP250808; BD710FJ282RRH
- UDI
- 10197344044054 Lots EP250429 EP250808; BD710FJ282CRH
- UDI
- (case) 40197344044048 (ea) 10197344044047 Lots EP250429 EP250808
What the firm is doing
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.
DistributionShow detailsHide
Distribution US nationwide.
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1319-2026
- FDA 510(k) clearance · K241224The device's official FDA premarket clearance record
- FDA device classification · NLHOfficial FDA classification for this device type
- CFR regulation · 21 CFR 870.1220The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Medline Industries, LPSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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