Sterile Procedural Trays Recalled Due to Potential Packaging Compromise
Medline Industries recalls sterile pelviscopy trays because blades inside may puncture the protective foil packaging, potentially compromising sterility. 316 units distributed worldwide are affected.
What this means for you
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 a Class II recall involving a risk-of-harm product (sterile surgical instruments) where potential for injury exists due to sterility compromise, but no illnesses or injuries have been reported. The hazard—blade puncture of protective packaging—poses a theoretical but significant risk to patient safety.
Plain-English summary
Medline Industries, LP is recalling sterile pelviscopy procedural trays labeled as PELVISCOPY PACK and D-PELVISCOPY. The recall was issued because sterile blades within the kits have the potential to puncture the outer foil layer of the sterile packaging.
The affected trays were distributed worldwide, including to the United States, Canada, Japan, Mexico, Panama, Turks & Caicos, and the United Arab Emirates. A total of 109 cases containing 316 units are subject to this recall. The affected lots are PELVISCOPY PACK (Item Number DYNJ82555, Lot 22HBQ035) and D-PELVISCOPY (Item Number DYNJ900628I, Lot 22JDB340).
Compromised packaging could allow contamination of sterile instruments before use. Healthcare facilities and users should verify whether they have received affected units by checking item numbers and lot numbers against the recall information.
The recalled product
- Product
- Sterile Procedural Trays, labeled as the following: a. PELVISCOPY PACK b. D-PELVISCOPY
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
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 (10)
- a. PELVISCOPY PACK
- Item Number: DYNJ82555
- Case UDI/GTIN: 40195327198252
- Unit UDI/GTIN: 10195327198251
- Lot Number: 22HBQ035
- b. D-PELVISCOPY
- Item Number: DYNJ900628I
- Case UDI/GTIN: 40195327224142
- Unit UDI/GTIN: 10195327224141
- Lot Number: 22JDB340
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 38 recalled by MEDLINE INDUSTRIES, LP - Northfield 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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