Halyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
GRI Medical is recalling Halyard Laparoscopy Comprehensive Pack II kits because they contain a latex urethral catheter despite being labeled as latex-free.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall involves a labeling error where latex was present in products labeled as latex-free, a hazard that may cause temporary or medically reversible adverse health consequences. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
GRI Medical & Electronic Technology Co., Ltd. is recalling 396 kits of the Halyard Laparoscopy Comprehensive Pack II (REF: 49332). The recall was initiated because the laparoscopy packs, which are labeled as "latex free," were found to contain a latex urethral catheter.
The affected products were distributed nationwide in the state of Mississippi. The recall covers specific lot numbers: GL25271CXA, GL25296CXA, and GL26076CXA, all with expiry dates in 2029. The UDI-DI codes for the units are 10680651493320 and 30680651493324.
Healthcare facilities and consumers should stop using these specific kits and contact the recalling firm for instructions on how to return or dispose of the product. This recall is classified as Class II by the FDA.
The recalled product
- Product
- HALYARD Laparoscopy Comprehensive Pack II REF: 49332
- Manufacturer
- GRI Medical & Electronic Technology Co., Ltd.
- Affected units
- 396
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 (4)
- UDI-DI: 10680651493320 (unit level)
- 30680651493324 (case level) Lot Numbers: GL25271CXA-Expiry Date: 2029/3/30
- GL25296CXA-Expiry Date: 2029/3/30
- GL26076CXA-Expiry Date: 2029/5/31
Distribution
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