Dental Surgical Pack Recalled Due to Incomplete Sterile Seal
Stradis Medical is recalling a dental surgical pack because the outer bag may be incompletely sealed, potentially compromising sterility. Affected units should not be used.
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: FDA Class II classification applies. No illnesses or injuries have been reported. However, this is a sterile surgical product where compromised sterility presents a potential risk of serious infection if contaminated instruments are used in procedures, qualifying it as a risk-of-harm product without reported injury.
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare is recalling the DENTAL SURGICAL PACK (Item No. 41236SDSP) due to manufacturing conditions that may result in an incompletely sealed outer bag.
The incomplete seal may result in a breach of the sterility of the surgical kit. Sterile surgical packs are designed to maintain a bacteria-free environment for procedures. A compromised seal could allow contamination of the instruments prior to use.
The recalled product was distributed nationwide in the United States and in Canada. The affected lot is identified by Serial/Lot Number 22235489632.
Healthcare facilities and users who have received this product should cease use immediately and contact Stradis Medical for instructions on replacement or disposal.
The recalled product
- Product
- Surgical room, DENTAL SURGICAL PACK, Item No.41236SDSP
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Affected units
- 20
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) M75241236SDSP1
- UDI/DI (kit)M75241236SDSP0
- Serial/Lot Numbers: 22235489632
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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