RegWardenFDA facility compliance records
Recall

Class II — TELEFLEX LLC

Recalling firmTeleflex
Registered facilityView this company's 9 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusOngoing
ReasonProduct may not be sterile
ProductTeleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140 (IPN050116). Urinary catheter.
Quantity7200 catheters
DistributionTN, CA, NC, TX, FL, OH, MO, IL, OR
Initiated2022-09-20
Classified2022-11-11
Recall numberZ-0227-2023
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — TELEFLEX LLC (Z-0227-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90962/

Not open yet

Alerts for Teleflex

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.