Quick summary
Quick summary: Medline Convenience Kits Containing Select Polycarbonate Colored Syringes. Reason: Unauthorised device. Category: General hospital and personal use. Date: 2026-04-30.
Public recall detail
Medline Convenience Kits Containing Select Polycarbonate Colored Syringes
2026-04-30
General hospital and personal use
Unauthorised device
Recommended action
Recommended action: compare your product with the official notice and follow the instructions published by the official source.
Recall details
Quick summary: Medline Convenience Kits Containing Select Polycarbonate Colored Syringes. Reason: Unauthorised device. Category: General hospital and personal use. Date: 2026-04-30.
Official details
Affected product details
Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.
BrandMedline Industries, Lp
ProductMedline Convenience Kits Containing Select Polycarbonate Colored Syringes
IssueMedical devices - Unauthorised device
Recall classType II
IdentificationRA-82000
Affected products
ProductPCI Pack
LotMore than 10 numbers, contact manufacturer.
ModelDYNJ41941D
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionPCI Pack
ProductEnsemble Gyneco Scopie
Lot24ABS765
ModelDYNJ53744B
Serial number24ABS765
DescriptionEnsemble Gyneco Scopie
ProductEnsemble Hemorroides
Lot24ABR871
ModelDYNJ56311A
Serial number24ABR871
DescriptionEnsemble Hemorroides
ProductLavh GRH LF
Lot24ABT556
ModelDYNJ41792G
Serial number24ABT556
DescriptionLavh GRH LF
ProductGyne Laparotomy Pack
Lot21FBM893
ModelDYNJ49593A
Serial number21FBM893
DescriptionGyne Laparotomy Pack
Issue
Specific item(s) and lot(s) of Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes are recalled, after identifying unapproved design changes to the products outside of the 510(k) cleared by FDA. Customers must discard the affected products, but all remaining products inside of the kit may be used.
What you should do
- Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - General hospital and personal use
CompaniesMedline Industries, LP Three Lakes Drive, Northfield, Illinois, United States, 60093
Recall date2026-04-20
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-82000
Background{}
CompaniesMedline Industries, LP Three Lakes Drive, Northfield, Illinois, United States, 60093
AudiencesHealthcare
Source updated2026-04-30
Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.
FAQ
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Product images
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