FDA Medical Device Recalls (openFDA)
Adept-Med International Inc: Adept-Med brand Glassman Viscera Retainer FISH Sterile, Item Numbers: 3204, 3202, 3203, 3202, 3201, 3200, 3206; Product is manufactured and distributed by Adept-Med International, Inc., 665 Pleasant Valley Rd., Diamond Springs, CA 95619
- Recall number
- Z-1156-06
- Recalling firm
- Adept-Med International Inc
- Product
- Adept-Med brand Glassman Viscera Retainer FISH Sterile, Item Numbers: 3204, 3202, 3203, 3202, 3201, 3200, 3206; Product is manufactured and distributed by Adept-Med International, Inc., 665 Pleasant Valley Rd., Diamond Springs, CA 95619
- Status
- Terminated
- Initiated
- 2004-08-17
- Posted
- 2006-06-22
- Terminated
- 2006-12-28
- Reason
- Devices for which sterility may be compromised as evidenced by a loss of package integrity.
- Root cause
- Other
- Action
- On 8/13/04, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned.
- Quantity
- 7,600 units
- Distribution
- Nationwide-The product was released for distribution to 249 consignees in US. The firm identified 242 hospitals and 7 distributors. The recall was appropriately extended to the consumer/user level; i.e., the wholesalers/distributors, pharmacists, hospitals who received the recalled product.
- Lot, serial or model codes
- 1104, 1204, 11203, 11103, 11503, 11403, 10503
- 510(k) numbers
- ["K802806","K870809"]
- PMA numbers
- not on file
- Product code
- GZC
- Firm FEI
- 3000718212
- Firm city
- Diamond Springs
- Firm state
- CA
- 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