Alto Development Corp Recalls Surgical Punches Due to Packaging Damage
Alto Development Corp is recalling surgical punches because packaging damage during transport may have compromised sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (loss of sterility in surgical instruments) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Alto Development Corp is recalling surgical punches due to potential packaging damage that may have occurred during transportation. This damage could have resulted in a loss of sterility for the devices.
The recalled products are surgical punches intended for use by trained surgeons to create circular cuts in soft tissue or openings in soft vessel walls during surgical procedures. The devices are packed in sealed pouches within a punch shelf box. Alto Development Corp is the recalling firm.
The source text does not specify the number of affected units, specific lot numbers, or the geographic distribution of the recall. Consumers and healthcare facilities should check with their supplier or the manufacturer for specific guidance on handling these devices.
The recalled product
- 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.
- Manufacturer
- Alto Development Corp
- Affected units
- 411,486
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- 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)
Distribution
Distribution scope not specified by the agency.
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