Prodimed Combicath Catheters Recalled for Sterility Assurance Concerns
Prodimed Plastimed Division is recalling 7,220 Combicath catheters for mini bronchoalveolar lavage due to 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 involves a medical device with a lack of sterility assurance, which poses a risk of harm (infection) even though specific injury reports are not detailed in the source text. This aligns with the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Prodimed Plastimed Division is recalling 7,220 units of Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL). The specific product code is 58216 27US, and the recall includes all lots within their expiry dates. The distribution of these devices was nationwide.
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 like bronchoalveolar lavage.
Healthcare providers and facilities that have received these products should stop using them immediately. Patients who have already used these catheters should contact their healthcare provider if they have concerns about potential infection or other adverse effects.
The recalled product
- Product
- Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 60 cm x 2.7 mm Product Code: 58216 27US
- Manufacturer
- Prodimed Plastimed Division
- Category
- Medical Device — Catheters
- Affected units
- 7,220
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 Due to 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 · infection risk
See all →- SevereSteris VERIFY Biological/Integrator Challenge Pack Recall for Sterilization Monitoring Failure
FDA (Devices) · 2026-10-14
- HighFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- HighRecall of Medical Convenience Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- SevereFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- HighMedline Neurological Surgery Kits Recalled for Endotoxin Variability
FDA (Devices) · 2026-09-30
Similar recalls
- SevereCustomed Umbilical Vessel Catheter Kits Recalled for Compromised Sterility
FDA (Devices) · 2014-12-10
- SevereCustomed Laparotomy Basic Packs Recalled for Sterility Compromise
FDA (Devices) · 2014-12-10
- CriticalCustomed Minor Laparotomy Packs Recalled Due to Compromised Sterility
FDA (Devices) · 2014-12-10
- CriticalCustomed Minor Laparotomy Packs Recalled for Sterility Compromise
FDA (Devices) · 2014-12-10
- SevereCustomed Recalls Umbilical Vessel Catheter Kits Due to Packaging Integrity Concerns
FDA (Devices) · 2014-09-10
- HighBard Access Systems Recalls PowerPICC Provena Catheters Due to Possible Leaks
FDA (Devices) · 2018-02-14