Baxter 15 L Cycler Drainage Bag Recalled for Potential Drain Tube Leakage
Baxter Healthcare is recalling 15 L Cycler Drainage Bags because the tube clamp may not fully close, potentially causing leakage.
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: The recall is classified as FDA Class II, and the hazard is a mechanical defect (leakage) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Baxter Healthcare Corp is recalling 15 L Cycler Drainage Bags used as peritoneal dialysis accessories with Baxter Cycler Tubing sets. The recall involves 3,085,080 units distributed worldwide, including the United States, Canada, Australia, and numerous other countries.
The recall was initiated because the large tube clamp used to close the drain tube may not fully close the tube. This defect may result in leakage of the drainage fluid.
Consumers and healthcare providers should check their inventory for the specific lot numbers listed in the official recall notice. If the product is found, it should be stopped from use and returned to Baxter Healthcare Corp for instructions on replacement or refund.
The recalled product
- Product
- 15 L Cycler Drainage Bag Product Usage: For use with Baxter Cycler Tubing sets as a peritoneal dialysis accessory.
- Manufacturer
- Baxter Healthcare Corp
- Category
- Medical Device — Dialysis
- Hazard
- Affected units
- 3,085,080
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 (20)
- Lot numbers: H12K20044
- H12K20085
- H12K21026
- H13B04052
- H13B04086
- H13B05042
- H13B05067
- H13B06073
- H13B07063
- H13B13087
- H13B14069
- H13B14085
- H13B15066
- H13B18029
- H13B18084
- H13B20108
- H13B22013
- H13B22062
- H13B23060
- H13B24043
Distribution
Related recalls
Same manufacturer · Baxter Healthcare Corp
See all →- HighBaxter Amia Automated Peritoneal Dialysis Set Recalled for Flow Issues
FDA (Devices) · 2017-09-20
- ModerateBaxter Recalls SIGMA Spectrum Infusion Pump Rear Case Assemblies
FDA (Devices) · 2016-12-07
- ModerateBaxter Recalls Sigma Spectrum Infusion Pumps Due to Speaker Failure Risk
FDA (Devices) · 2016-12-07
- ModerateBaxter SIGMA Spectrum Infusion Pump Recall for Speaker Failure
FDA (Devices) · 2016-12-07
- HighBaxter Recalls Revaclear MAX Dialyzers Due to Potential Particulate Matter
FDA (Devices) · 2016-11-16
Same hazard · leakage
See all →- HighConvaTec Esteem Body Soft Convex Urostomy Pouches Recalled for Leakage
FDA (Devices) · 2026-08-26
- SevereStryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77522
FDA (Devices) · 2026-08-05
- HighICU Medical Recalls Hotline Fluid Warming Sets Due to Leakage Risk
FDA (Devices) · 2026-07-29
- SevereABIOMED Introducer Kit 23 Fr heart pump accessory leakage risk
FDA (Devices) · 2026-07-22