Medline Medical Procedure Kits Recalled for Canister Fitting Issues
Medline is recalling 22,891 medical procedure kits because of a slight dimensional variation that may cause difficulty fitting into the outer canister.
What this means for you
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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard consists of a slight dimensional variation affecting fit into a storage canister, which is a functional issue rather than a direct safety threat. Per the rubric, functional issues without reported harm in Class II recalls are classified as Moderate.
Plain-English summary
Medline Industries, LP is recalling multiple medical procedure kits due to a slight dimensional variation that has the potential for increased difficulty fitting into the outer canister. The recalled kits include procedures for cystoscopy, endoscopy, and laparoscopy, with 22,891 units distributed worldwide.
The affected kits have been distributed throughout the United States and internationally to Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, and Singapore. Healthcare providers and facilities should verify whether they have received any of the affected kits by checking the reference numbers and lot numbers provided in the FDA recall notice.
Healthcare providers should contact Medline Industries, LP or the FDA for instructions on returning or replacing the affected procedure kits.
The recalled product
- Product
- Medline medical procedure kits labeled as follows: a) CYSTO, REF DYNJ905000D; b) ENDO KIT, REF DYKE1462A; c) ENDOSCOPY KIT, REF DYKE1431B; d) ENDOSCOPY KIT, REF DYKE1623B; e) GENERAL LAPAROSCOPY, REF DYNJ902385I; f) GENERAL LAPAROSCOPY, REF DYNJ905508G; g) GENERAL
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- fitting-issue
- dimensional-variation
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) REF DYNJ905000D
- UDI/DI 40195327316908 (case)
- 10195327316907 (unit)
- Lot Numbers: 23BBG363
- 23CBN659
- 23GBH840
- 23HBE163
- 23IBJ724
- 23KBW116
- b) REF DYKE1462A
- UDI/DI 40889942620167 (case)
- 10889942620166 (unit)
- Lot Numbers: 22FDC042
- 22JDB988
- 22LBJ315
- 23BBL256
- 23CBU426
- 23EBH275
- 23FBK205
- 23IBF933
Distribution
Distributed nationwide across the United States.
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