Surgical access port kits recalled over trays that may crack
Intuitive Surgical is recalling 41,526 da Vinci SP Access Port Kits because the Access Port System tray may develop cracks, potentially resulting in a sterility breach.
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: Scored 3 under the risk-of-harm criterion: the firm states cracks in the tray may result in a sterility breach, and no injuries are reported.
Plain-English summary
The da Vinci SP Access Port Kit, Large Incision, reference numbers 430073 (2.7-4cm) and 430075 (2.7-7cm), is being recalled by Intuitive Surgical, Inc.
The reason given in the enforcement record is that the Access Port System tray may develop cracks, potentially resulting in a sterility breach.
The record lists 41,526 units, with REF 430073 carrying UDI 00886874119549 and lot numbers listed in the enforcement record. Distribution was worldwide, including nationwide in the United States across Alabama, Arizona, California, Colorado and Connecticut among other states. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Facilities should quarantine affected lots and follow Intuitive Surgical's instructions.
The recalled product
- Product
- da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 41,526
Distribution
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