FDA Medical Device Recalls (openFDA)
Stradis Medical, LLC dba Stradis Healthcare: NARMD MEDICAL DEPOT Forceps - Kelly Straight 5.5"; Part Number: ZZ-0700
- Recall number
- Z-1553-2022
- Recalling firm
- Stradis Medical, LLC dba Stradis Healthcare
- Product
- NARMD MEDICAL DEPOT Forceps - Kelly Straight 5.5"; Part Number: ZZ-0700
- Status
- Open, Classified
- Initiated
- 2022-07-25
- Posted
- not on file
- Terminated
- not on file
- Reason
- The sterile barrier may be compromised.
- Root cause
- Under Investigation by firm
- Action
- Stradis notified its sole consignee on 07/25/2022 by email. The notice explained the reason for the recall and the hazard, and requested the consignee contact customer service to arrange for the return and credit of the affected product. Should the product be further distributed, the consignee was directed to notify its customers within 48 hours of receipt of the notice. Those customers were directed to contact Stradis directly to arrange return and credit.
- Quantity
- 825 units
- Distribution
- US Nationwide distribution in the state of SC.
- Lot, serial or model codes
- SKU/Part Number: ZZ-0700; Lots: 22145487092 and 22154486659 UDI/DI: M752ZZ07000
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HTD
- Firm FEI
- 1000111025
- Firm city
- Peachtree Corners
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28