Prodimed Combicath Catheters Recalled Due to Sterility Assurance Concerns
Prodimed Plastimed Division is recalling Combicath catheters for mini bronchoalveolar lavage because of a lack of assurance of sterility.
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 3/5 (High).
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: The recall is classified as FDA Class II, and the hazard involves a lack of sterility assurance for an invasive medical device, which poses a risk of harm even without reported injuries.
Plain-English summary
Prodimed Plastimed Division is recalling Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL). The specific product model is COMBICATH PE 85 cm x 4.0 mm, catalog number 58124 40US. The recall involves 39,800 units distributed nationwide, covering all lots within their expiry dates.
The recall was initiated due to a lack of assurance of sterility. This means the manufacturer cannot guarantee that the catheters are sterile, which is a critical requirement for medical devices used in invasive procedures.
Healthcare providers and facilities that have purchased these catheters should stop using them and contact Prodimed Plastimed Division for further instructions on how to return or dispose of the affected units.
The recalled product
- Product
- Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 85 cm x 4.0 mm 58124 40US
- Manufacturer
- Prodimed Plastimed Division
- Category
- Medical Device — Catheters
- Affected units
- 39,800
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 (1)
- All lots within expiry
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Prodimed Plastimed Division 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 6 products in this recall →Related recalls
Same manufacturer · Prodimed Plastimed Division
See all →- HighProdimed Combicath Paediatric Catheters Recalled for Sterility Assurance Issues
FDA (Devices) · 2020-07-15
- HighProdimed Combicath Catheters Recalled for Sterility Assurance Concerns
FDA (Devices) · 2020-07-15
- SevereProdimed Combicath Paediatric Catheters Recalled Due to Sterility Assurance Issues
FDA (Devices) · 2020-07-15
- HighProdimed Combicath catheters recalled due to sterility assurance concerns
FDA (Devices) · 2020-07-15
- SevereProdimed Combicath Catheters Recalled for Sterility Assurance Concerns
FDA (Devices) · 2020-07-15
Same hazard · sterility
See all →- SevereFDA Recalls Tri-MIX Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Leader Advanced Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tri-MIX Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Leader Ultra Lubricating Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
Similar recalls
- HighBoston Scientific Recalls Flexima APDL Drainage Catheter Systems Due to Sterility Risk
FDA (Devices) · 2024-09-25
- HighMedline Sterile Convenience Kits Recalled for Weak Breather Pouch Seals
FDA (Devices) · 2025-04-23
- SevereCustomed Umbilical Vessel Catheter Kits Recalled for Compromised Sterility
FDA (Devices) · 2014-12-10
- HighFlexima Biliary Catheter System Kits recalled for potential sterile barrier failure
FDA (Devices) · 2024-09-25
- SevereCustomed Recalls Minor Laparotomy Packs Due to Packaging Integrity Concerns
FDA (Devices) · 2014-09-10
- SevereCustomed Recalls Umbilical Vessel Catheter Kits Due to Packaging Integrity Concerns
FDA (Devices) · 2014-09-10