FDA Medical Device Recalls (openFDA)
Alto Development Corp: Surgical punch; sealed pouches packed in punch shelf box Intended for use by trained surgeons to create circular cuts in soft tissue or openings in soft vessel walls during surgical procedures.
- Recall number
- Z-0813-2018
- Recalling firm
- Alto Development Corp
- Product
- Surgical punch; sealed pouches packed in punch shelf box Intended for use by trained surgeons to create circular cuts in soft tissue or openings in soft vessel walls during surgical procedures.
- Status
- Terminated
- Initiated
- 2017-10-23
- Posted
- not on file
- Terminated
- 2019-04-30
- Reason
- Surgical punches are being recalled due to potential packaging damage which may have occurred during transportation resulting in loss of sterility.
- Root cause
- Package design/selection
- Action
- A&E Medical sent an Recall Notice Action Required letter dated October 20, 2017. Surgical Punches are being recalled due to potential packaging damage which may have occurred during transportation resulting in a loss of sterility. Recent testing identified certain shipping configurations which may cause damage to the sterile barrier pouch if the Surgical Punches experience excessive movement from multiple drops during transport A&E is recalling all product currently on the market. Customer and Distributor Letters were sent with Acknowledgement Form. Product will be quarantined pending rework. For further questions, please call (800) 323-4035.
- Quantity
- 411,486 units
- Distribution
- Worldwide Distribution - USA Distribution
- Lot, serial or model codes
- 080-271 (9108 units); 080-351 (41712 units); 080-401(219954 units); 080-403 (1368 units); 080-451 (83190 units); 080-481 (32556 units); 080-501 (23598 units)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRY
- Firm FEI
- 2242056
- Firm city
- Wall Township
- Firm state
- NJ
- 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