[pending] Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40m
Pending LLM rewrite. Source: FDA_DEVICE Z-1884-2025.
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: Pending LLM scoring against the rubric.
Plain-English summary
Potential for breach of Tyvek seals.
The recalled product
- Product
- Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40mm, 1 EACH; Model Number: 25001040E b. Male-Female Midsection, 50mm, 1 EACH; Model Number: 25001050E c. Male-Female Midsection, 60mm, 1 EACH; Model Number: 25001060E d. Mal
- Manufacturer
- Onkos Surgical, Inc.
- Category
- Medical Device — Devices
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 (20)
- a. Model Number: 25001040E
- UDI-DI: B27825001040E0
- Lot Numbers: 1802695
- 1813688
- 1823008
- 1833874
- 1841365
- 1844552
- 1855654
- 1855799
- 1856873
- 1856874
- 1860075
- 1860076
- 1880172
- 1880173
- 1880174
- 1880175
- 1880176
- 1880177
Distribution
Distributed in 18 states:
- AZ
- FL
- GA
- HI
- IL
- KS
- KY
- LA
- MD
- MS
- NC
- NE
- NJ
- OH
- PA
- TX
- WA
- WI
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