Baxter Recalls 0.2 Micron Filters Due to Missing Membrane
Baxter Corporation is voluntarily recalling 0.2 Micron Filters because the filter membrane may be missing, allowing particulate matter to pass through.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Baxter Healthcare Corporation is issuing a voluntary product recall for all unexpired lots of the 50mm 0.2 Micron Filter (Product Code: H93835) due to the potential for the filter membrane layer to be missing and for particulate matter to…"
Plain-English summary
Baxter Healthcare Corporation is issuing a voluntary product recall for all unexpired lots of the 50mm 0.2 Micron Filter (Product Code: H93835). The recall is due to the potential for the filter membrane layer to be missing and for particulate matter to be present in the solution.
The affected product is a bacteria and particulate filter for aqueous solutions that attaches to a standard Baxter Pharmacy Pump Tube Set. The recall covers 202,647 units distributed worldwide, including the United States and several European countries such as Austria, Belgium, and Germany.
Consumers and healthcare facilities should stop using the affected filters and contact Baxter Corporation for further instructions or a replacement.
The recalled product
- Product
- 0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.
- Manufacturer
- Baxter Corporation Englewood
- Affected units
- 202,647
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 unexpired lots-Product Code: H93835
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Baxter Corporation Englewood
See all →- ModerateBaxter RAPIDFILL Syringe Strips Recalled for Shelf Life Packaging Claim
FDA (Devices) · 2016-02-10
- HighBaxter ABACUS Software Recalled for Potential TPN Formula Loading Errors
FDA (Devices) · 2015-05-27
- ModerateBaxter Recalls Syringe Tip Caps for Missing Latex Symbol
FDA (Devices) · 2015-03-11
- ModerateBaxter Recalls Self-Righting Luer Tip Caps Due to Validation Timing
FDA (Devices) · 2014-12-31
- ModerateBaxter Abacus 3.1 Pharmacy Calculator Software Field Correction
FDA (Devices) · 2014-07-02
Same hazard · contamination
See all →- SevereFDA Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- ModerateAVID Medical Recalls 15 Laparoscopic Prostatectomy Kits for Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls 23 ABD Hysterectomy Kits Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- ModerateAVID Medical Recalls GYN Laparoscopy Kits for Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateBaxter Recalls Buretrol Solution Sets Due to Chamber Separation
FDA (Devices) · 2014-09-17
- HighBaxter Prismaflex Dialysis Membranes Recalled for Sterilization Failure
FDA (Devices) · 2021-09-08
- SevereBaxter Recalls 5% Dextrose Injection Due to Particulate Matter
FDA (Drugs) · 2014-03-26
- SevereBaxter Recalls Clearlink Buretrol Solution Sets Due to Valve Malfunction
FDA (Devices) · 2012-10-17
- HighBaxter Recalls Famotidine Injection Due to Plastic and Rubber Particulate Matter
FDA (Drugs) · 2014-12-17
- HighBaxter Recalls Revaclear MAX Dialyzers Due to Potential Particulate Matter
FDA (Devices) · 2016-11-16