Oral Surgery Tray Kit Recalled for Potential Sterility Breach
ACE Surgical Supply oral surgery tray kits are recalled because the outer packaging may be incompletely sealed, potentially compromising sterility. The kits were distributed throughout the United States and Canada.
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: This is an FDA Class II recall involving a sterile medical device used in surgical procedures. No illnesses or injuries have been reported. The hazard is potential sterility loss from incomplete packaging seals, which represents a risk to patient safety but has not yet resulted in reported harm.
Plain-English summary
ACE Surgical Supply 17539 CUSTOM KIT STERILE oral surgery tray (Item No. 003-3880), manufactured by Stradis Medical, LLC dba Stradis Healthcare, is subject to this recall. These sterile kits are used in oral surgical procedures. The outer packaging of these kits may be incompletely sealed, which could result in a breach of the kit's sterility.
The affected product was distributed nationwide throughout the United States and to Canada. The recall applies to kits with lot number 22242490999. During the manufacturing process, certain conditions may have resulted in incomplete sealing of the outer bag.
The recalled product
- Product
- ACE Surgical Supply, 17539 CUSTOM KIT STERILE Item No.003-3880, oral surgery tray
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Affected units
- 10
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 (3)
- UDI/DI (case) M75200338800
- UDI/DI (kit)M75200338800
- Serial/Lot Numbers: 22242490999
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 78 recalled by Stradis Medical, LLC dba Stradis Healthcare under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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