Medline Sterile Procedural Trays Recalled Due to Blade Puncture Risk
Medline Industries is recalling sterile procedural trays (Rhinoplasty Pack, OSC Otology Pack-LF, and Rhyzotomy) distributed worldwide because sterile blades within the kits may puncture the outer foil layer of sterile packaging, potentially compromising sterility.
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 an FDA Class II recall involving surgical instruments where a manufacturing defect (blade puncture risk) could compromise product sterility. While no injuries or illnesses have been reported, the potential for loss of sterility in surgical instruments poses a significant risk to patient safety.
Plain-English summary
Medline Industries, LP is recalling three sterile procedural trays: Rhinoplasty Pack (Item Number DYNJ27333F, Lot 22JMD960), OSC Otology Pack-LF (Item Number DYNJ37384D, Lot 22HBY172), and Rhyzotomy (Item Number DYNJ902288G, Lots 22JBU356 and 22JBT657). The recall affects 86 cases containing 152 total units.
The sterile blades within these kits have the potential to puncture the outer foil layer of the sterile packaging. A breach in the sterile barrier could compromise the sterility of the surgical instruments.
Affected products have been distributed worldwide, including throughout the United States, Canada, Japan, Mexico, Panama, Turks & Caicos, and the United Arab Emirates.
The recalled product
- Product
- Sterile Procedural Trays, labeled as the following: a. RHINOPLASTY PACK b. OSC OTOLOGY PACK-LF c. RHYZOTOMY
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- puncture-risk
- sterility-compromise
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 (16)
- a. RHINOPLASTY PACK
- Item Number: DYNJ27333F
- Case UDI/GTIN: 40888277055293
- Unit UDI/GTIN: 10888277055292
- Lot Number: 22JMD960
- b. OSC OTOLOGY PACK-LF
- Item Number: DYNJ37384D
- Case UDI/GTIN: 40193489306898
- Unit UDI/GTIN: 10193489306897
- Lot Number: 22HBY172
- c. RHYZOTOMY
- Item Number: DYNJ902288G
- Case UDI/GTIN: 40193489885126
- Unit UDI/GTIN: 10193489885125
- Lot Number: 22JBU356
- 22JBT657
Distribution
Distributed nationwide across the United States.
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