LeMaitre Vascular Cholangiogram Catheter Recalled for Missing Latex Labeling
LeMaitre Vascular is recalling 250 units of Reddick Cholangiogram Stiffer Catheters because the latex warning symbol was not printed on the packaging.
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 a minor labeling error (missing latex symbol) classified as FDA Class II, which aligns with the Moderate severity criteria for low-risk contamination or labeling issues without reported injuries.
Plain-English summary
LeMaitre Vascular, Inc. is recalling 250 units of the Reddick Cholangiogram Stiffer Catheter with introducer (REF # e2400-53). The recall is due to a labeling error where the Contains Latex symbol was not printed on the box label or the sterile inner product pouch.
The affected lots are RED1747 (exp. 2018-09), RED1754 (exp. 2018-12), RED1763 (exp. 2019-03), and RED1770 (exp. 2019-05). These products were distributed worldwide, including in the United States, Austria, Belgium, France, Germany, Italy, Luxembourg, Morocco, Saudi Arabia, Singapore, Spain, Switzerland, the UAE, and the UK.
Healthcare facilities and distributors should stop using the affected devices and contact LeMaitre Vascular for instructions on return or disposal. Patients who have had these devices implanted should consult their healthcare provider if they have a known latex allergy.
The recalled product
- Product
- LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (eIFU) REF # e2400-53
- Manufacturer
- LeMaitre Vascular, Inc.
- Category
- Medical Device — Catheter
- Affected units
- 250
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by LeMaitre Vascular, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 12 products in this recall →Related recalls
Same manufacturer · LeMaitre Vascular, Inc.
See all →- ModerateArtegraft vascular graft recalled over incorrect lot outer packaging labeling
FDA (Devices) · 2026-03-25
- ModerateCollagen vascular graft recalled after being packed in wrong size packaging
FDA (Devices) · 2025-10-29
- ModerateCollagen vascular grafts recalled over incorrect labels missing CE and UKCA marks
FDA (Devices) · 2025-10-15
- ModerateCollagen vascular grafts recalled over unapproved bovine raw material supplier
FDA (Devices) · 2025-10-08
- SevereTufTex Over-the-Wire Embolectomy Catheter incomplete sterile barrier
FDA (Devices) · 2025-05-21
Same hazard · latex allergy
See all →- ModerateDJO Nylatex Wraps Recalled for Missing Latex Warning Labels
FDA (Devices) · 2020-07-22
- HighCustom Healthcare Systems Recalls Inpatient Dialysis Kits Due to Latex
FDA (Devices) · 2020-02-05
- ModerateMerit Medical Systems Recalls Custom Procedure Kits Due to Latex Labeling Error
FDA (Devices) · 2019-10-09
- HighCardinal Health Recalls ChemoPlus Chemo Spill Kits Due to Latex
FDA (Devices) · 2019-05-15
- HighCardinal Health Recalls ChemoPlus Goggles Due to Latex Mislabeling
FDA (Devices) · 2019-05-15