Teleflex Medical Recalls Rectal Catheters Due to Missing Latex Warning
Teleflex Medical Europe Ltd is recalling 6,340 rectal catheters because the packaging lacks a required warning that the product contains natural rubber latex.
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, but the hazard is a labeling error (missing latex warning) rather than a direct contamination or structural defect. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries fall under Moderate severity.
Plain-English summary
Teleflex Medical Europe Ltd is recalling 6,340 units of Rectal Balloon Catheters (Product Code 580114) distributed nationwide in the United States. The recall was initiated because the product packaging is missing the required statement: "Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions."
The affected products are used to measure abdominal pressure as the bladder fills. The recall covers specific batch numbers, including 13DE17, 13EE22, and 13FE24, among others listed in the agency record. The FDA has classified this recall as Class II.
Healthcare facilities and consumers should check their inventory for these specific batch numbers. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations. Patients with known latex allergies should consult their healthcare provider if they have used these devices.
The recalled product
- Product
- Rectal Catheters; Product Code Equivalent Code 580114 580114 Product Usage: Rectal Balloon Catheter is inserted into the rectum to measure the abdominal pressure as bladder filled.
- Manufacturer
- Teleflex Medical Europe Ltd
- Category
- Medical Device — Catheters
- Affected units
- 6,340
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Teleflex Medical Europe Ltd 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 4 products in this recall →Related recalls
Same manufacturer · Teleflex Medical Europe Ltd
See all →- HighRUSCH Endotracheal Tubes Recalled for Potential Cuff Inflation Malfunction
FDA (Devices) · 2021-08-25
- HighRUSCH Flexi-Set Endotracheal Tube Cuff May Inflate Without Pilot Balloon Response
FDA (Devices) · 2021-08-25
- HighRUSCH Slick Set Cuffed Endotracheal Tubes Recalled for Improper Cuff Inflation
FDA (Devices) · 2021-08-25
- HighRUSCH Endotracheal Tube Cuff Inflation Malfunction Without Pilot Balloon Indication
FDA (Devices) · 2021-08-25
- HighTeleflex Universal Shears Recalled Due to Handle Melting During Sterilization
FDA (Devices) · 2018-07-04
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
Similar recalls
- ModerateTeleflex Recalls Soft Rubber Bladder Catheters Due to Missing Latex Warning
FDA (Devices) · 2014-09-24
- ModerateTeleflex Recalls RUSCH Easy Cath Coude Kits Due to Incorrect Catheter Type
FDA (Devices) · 2014-06-18
- ModerateTeleflex Medical Recalls RUSCH LaserTube Tracheal Tubes for Missing Latex Warning
FDA (Devices) · 2014-07-02
- ModerateC.R. Bard Recalls Foley Catheters Due to Labeling Error
FDA (Devices) · 2016-04-20
- LowTeleflex RuSCH Male External Catheter Recalled for Incorrect Sterility Labeling
FDA (Devices) · 2020-01-22
- HighTeleflex Recalls Taut Operative Cholangiogram Catheters Due to Missing Metal Support Tube
FDA (Devices) · 2014-06-18