Medline Medical Procedure Kits Recalled for Dimensional Variation in Canister Fitting
Medline Industries is recalling 75,098 medical procedure kits due to slight dimensional variations that may cause difficulty fitting into their outer canisters. No injuries or illnesses have been reported.
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 medical device recall involving dimensional variations that may affect assembly or fitting. No injuries or illnesses have been reported, and the hazard is functional and potential rather than an immediate safety risk. This aligns with Moderate severity for a device recall without reported harm.
Plain-English summary
Medline Industries, LP is recalling multiple medical procedure kits due to a slight dimensional variation. This variation has the potential to increase difficulty when fitting these kits into their outer canisters.
The recall affects 75,098 units of 17 different kit types distributed worldwide, including throughout the United States and to Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, and Singapore. Affected kits can be identified by their specific reference numbers and lot numbers as detailed in the official recall notice.
No injuries or illnesses have been reported in connection with this issue. Healthcare facilities and individuals who have received any of the affected kits should verify whether their products are included in the recall by checking their kit reference numbers and lot numbers. Contact Medline Industries directly for instructions on product replacement or other remedial measures.
The recalled product
- Product
- Medline medical procedure kits labeled as follows: a) AAA CDS, REF CDS984011C; b) CAN KIT, REF DYKM1184; c) DENTAL CDS, REF CDS984010B; d) EGD KIT, REF DYK1253578F; e) EGD REG KIT, REF DYKE1830; f) ENDO KIT, REF DYKE1516A; g) ERCP REG KIT, REF DYKM2127; h) GI P
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- dimensional-variation
- fitting-difficulty
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 CDS984011C
- UDI/DI 40889942325796 (case)
- 10889942325795 (unit)
- Lot Numbers: 22EBC452
- 22FBX932
- 22GBR344
- 22HBG632
- 22JBR362
- 22KBE842
- 23EBU748
- 23KBF372
- b) REF DYKM1184
- UDI/DI 40888277877024 (case)
- 10888277877023 (unit)
- Lot Numbers: 22FMF770
- 22HMF787
- 22IMH596
- 22KMH402
- 22LMG049
- 23AMH718
Distribution
Distributed nationwide across the United States.
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