Applied Medical Recalls Biliary Catheters Due to Packaging Particulate Matter
Applied Medical is recalling specific lots of biliary catheters because packaging particulate matter may reside on the product.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: The recall is classified as FDA Class II, and the hazard involves potential packaging particulate matter without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Applied Medical Resources Corp is recalling specific lot numbers of its biliary catheters, including models A4752, A4754, A4762, CB052308, CB054008, and CB062313. The recall involves 40,238 units distributed worldwide, including the United States and numerous international markets.
The recall was initiated because the catheters may have a potential for packaging particulate matter to reside on the product. These devices are indicated for the removal of stones and ductal debris from the biliary system.
Healthcare facilities and distributors should stop using the affected units and contact Applied Medical Resources Corp for further instructions on the recall.
The recalled product
- Product
- Biliary Catheters (Models A47XX and CB0XXXXX): Model Numbers & Description: A4752, SYNTEL BILIARY 5F-23CM CATHETER; A4754, SYNTEL BILIARY 5F-40CM CATHETER; A4762, SYNTEL BILIARY 6F-23CM CATHETER; CB052308, SYNTEL BILIARY 5F-23CM CATH; CB054008, SYNTEL BILIARY 5F-40CM…
- Manufacturer
- Applied Medical Resources Corp
- Affected units
- 40,238
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 (2)
- Model Numbers: Lot Numbers A4752: 1165670. A4754: 1156762. A4762: 1155852
- 1165674. CB052308: 1164350. CB054008: 1164305. CB062313: 1164306.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Applied Medical Resources Corp 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 3 products in this recall →Related recalls
Same manufacturer · Applied Medical Resources Corp
See all →- ModerateLaparoscopic trocars recalled over a potentially extended blade obturator length
FDA (Devices) · 2026-01-14
- HighEpix Universal Clip Applier Recalled for Potential Clip Loading Failure
FDA (Devices) · 2024-04-03
- HighEpix Universal Clip Applier Recalled for Clip Load Failure Risk
FDA (Devices) · 2024-04-03
- HighApplied Medical Resources Recalls Clip Applier Kits Due to Tissue Damage Risk
FDA (Devices) · 2020-06-03
- HighApplied Medical Recalls Epix latis GRASPER Due to Tissue Damage Risk
FDA (Devices) · 2020-06-03
Same hazard · foreign object
See all →- ModerateMezzetta Golden Greek Peperoncini Recalled for Potential Mouse Contamination
FDA (Food) · 2026-10-14
- SevereUnited and Good & Gather Light Brown Sugar Recalled for Wheat Contamination
FDA (Food) · 2026-09-30
- SevereBaxter Recalls Dextrose Injection Bags Due to Stainless Steel Particulate Matter
FDA (Drugs) · 2026-09-16
- ModerateBionpharma Recalls Doxylamine Succinate Tablets Due to Foreign Material Presence
FDA (Drugs) · 2026-09-09
- SevereTeva Recalls Trazodone Hydrochloride Tablets Due to Foreign Material
FDA (Drugs) · 2026-09-09
Similar recalls
- SevereBoston Scientific Recalls Biliary Drainage Catheters Due to Fragmentation Risk
FDA (Devices) · 2015-04-08
- HighBoston Scientific Recalls Expel Drainage Catheters Due to Fragmentation Risk
FDA (Devices) · 2015-04-08
- HighMerit Medical Systems Recalls Biliary Locking Drainage Catheters Due to Breakage
FDA (Devices) · 2013-02-27
- SevereCustomed Recalls Umbilical Vessel Catheter Kits Due to Packaging Integrity Concerns
FDA (Devices) · 2014-09-10
- ModerateBoston Scientific Recalls Guidezilla II Catheters Due to Missing Coating
FDA (Devices) · 2019-12-04
- SevereBoston Scientific Recalls SpyScope DS Biliary Catheters Due to Sleeve Defect
FDA (Devices) · 2018-03-28