Medline Medical Procedure Kits Recalled for Dimensional Variation Affecting Fit
Medline is recalling 964 units of multiple medical procedure kits due to slight dimensional variations that may cause difficulty fitting components into the outer canister. No injuries or illnesses have been reported.
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: FDA Class II medical device recall involving a functional/dimensional defect on surgical procedure kits. While no injuries or illnesses have been reported and the hazard is potential rather than realized, the risk-of-harm nature of surgical equipment with assembly defects warrants High severity.
Plain-English summary
Medline Industries is recalling 964 units of various medical procedure kits, including GYN CDS, GYN LAP, GYN LAPAROSCOPY, LAP ROBOTIC, and LAPAROSCOPY-ROBOT models. The kits are identified by specific reference numbers and associated lot numbers provided by the manufacturer.
The kits are being recalled due to a slight dimensional variation in the components. This variation has the potential to cause increased difficulty when fitting the kits into the outer canister. No injuries or illnesses have been reported as of this notice.
The recalled kits were distributed worldwide, including throughout the United States and to Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, and Singapore. Healthcare facilities and providers who have received these kits should contact Medline Industries for instructions on product return or replacement.
The recalled product
- Product
- Medline medical procedure kits labeled as follows: a) GYN CDS, REF DYNJ905499B; b) GYN LAP, REF DYNJ909936; c) GYN LAPAROSCOPY, REF DYNJ902371J; d) GYN LAPAROSCOPY, REF DYNJ905509F; e) GYN LAPAROSCOPY II, REF DYNJS2030F; f) LAP ROBOTIC, REF DYNJ902384K; g) LAPAROSC
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- dimensional-variation
- fit-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 DYNJ905499B
- UDI/DI 40195327316915 (case)
- 10195327316914 (unit)
- Lot Numbers: DYNJ905499B
- DYNJ905499B
- b) REF DYNJ909936
- UDI/DI 40195327511204 (case)
- 10195327511203 (unit)
- Lot Numbers: 23JBI037
- 23KBP829
- c) REF DYNJ902371J
- UDI/DI 40195327505821 (case)
- 10195327505820 (unit)
- Lot Numbers: 23JBU910
- 23LBM411
- d) REF DYNJ905509F
- UDI/DI 40195327269082 (case)
- 10195327269081 (unit)
- Lot Numbers: 22LMF016
- 23CMH468
Distribution
Distributed nationwide across the United States.
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