RecallRadar

FDA Device recall Z-1612-2022

Fischer Cone Biopsy Excisor EXCISOR, CONE FISCHER BIOPSY WD ANGL SM (5/BX) Model Number: 900-157

On 2022-08-31 the FDA classified a Class II recall of Fischer Cone Biopsy Excisor EXCISOR, CONE FISCHER BIOPSY WD ANGL SM (5/BX) Model Number: 900-157 by Mckesson Medical Surgical Corporate Office, citing facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1612-2022
ClassificationClass II
Statusongoing
Initiated2022-05-25
Published2022-08-31
Last updated2026-09-13 11:56 UTC
CompanyMckesson Medical Surgical Corporate Office
DistributionUS

Product

Fischer Cone Biopsy Excisor EXCISOR, CONE FISCHER BIOPSY WD ANGL SM (5/BX) Model Number: 900-157

Reason

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

Identifiers

code_infoGTIN: 00888937003765; 20888937003769

Status history

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

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1612-2022%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.