RecallRadar

FDA Device recall Z-0833-2022

(a) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 10 mm, 30 degrees 7", 17.5 cm, Catalog #88-5910

On 2022-04-06 the FDA classified a Class II recall of (a) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 10 mm, 30 degrees 7", 17.5 cm, Catalog #88-5910 by Carefusion 2200, citing the finished device package did not contain the IFU.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0833-2022
ClassificationClass II
Statusterminated
Initiated2022-02-23
Published2022-04-06
Last updated2026-09-13 11:56 UTC
CompanyCarefusion 2200
DistributionUS

Product

(a) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 10 mm, 30 degrees 7", 17.5 cm, Catalog #88-5910; (b) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 5 mm, 30 degrees 7", 17.5 cm, Catalog #88-5920; (c) CareFusion Snowden-Pencer MIS, Endoplastic Fitting, Storz Scope, Catalog #88-9808; and (d) CareFusion Snowden-Pencer MIS, Endoplastic Fitting, Wolf Scope, Catalog #88-9809.

Reason

The finished device package did not contain the IFU.

Identifiers

code_info
(a) Catalog #88-5910 - Lot numbers C17XRD and K17XRD, UDI 10885403153341; (b) Catalog #88-5920 - Lot numbers XRDX02, XR…(a) Catalog #88-5910 - Lot numbers C17XRD and K17XRD, UDI 10885403153341; (b) Catalog #88-5920 - Lot numbers XRDX02, XRDZ07, K17XRD, C18XRD, G18XRD, C19XRD, D20XRD, G20XRD, J19XRD, K19XRD; UDI 10885403153358; (c) Catalog #88-9808 - Lot numbers XRDV09, G20XRD, 864909; UDI 10885403155314; and (d) Catalog #88-9809 - Lot numbers XRDV09, XRDV10, XRDX06, B18XRD, D18XRD, G20XRD; UDI 10885403155321.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0833-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.