Device recall

Z-1366-2021: SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult

FDA device recall · Class II · Sharp Medical Products

Key facts

Recall number (Z-number) Z-1366-2021
Recall event 87432
Product SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult
Product code GCJ
Recalling firm Sharp Medical Products
Recall class Class II
Status Terminated
Termination date Feb 17, 2023
510(k) numbers K150549
FEI number 3017828726

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)