Kimberly-Clark Recalls KIMGUARD Container Filters Due to Sterility Concerns
Kimberly-Clark is recalling KIMGUARD Container Filters because thin areas in some units may compromise the sterile barrier.
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 risk-of-harm product (medical device) where the sterile barrier may be compromised, but no injuries or illnesses have been reported.
Plain-English summary
Kimberly-Clark Corporation is recalling KIMGUARD Container Filters, which are intended to enclose medical devices for sterilization. The recall involves specific round and square filter sizes distributed worldwide, including the United States, Canada, Australia, and several other countries.
The recall is being conducted because some individual container filter units might contain thin areas. These thin areas may potentially compromise the filter's ability to maintain a sterile barrier.
Health care providers and consumers should stop using the affected KIMGUARD Container Filters. The specific product codes and case lot numbers are listed in the official recall notice.
The recalled product
- Product
- KIMGUARD Container Filters, 7.5in (19cm), Round and 9in. X 9in. (23cm x 23cm), Square. Intended to be used to enclose another medical device that is to be sterilized by a health care provider.
- Manufacturer
- Kimberly-Clark Corporation
- Hazard
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)
- Product Code 68507 (Round) Case Lot Numbers MF1284XXX
- MF1287XXX
- MF1294XXX
- MF1316XXX
- MF2012XXX
- MF2055XXX
- MF2086XXX
- MF2098XXX
- MF2115XXX
- MF2146XXX
- MF2178XXX
- MF2188XXX
- MF2196XXX
- MF2210XXX
- MF2228XXX
- MF2243XXX
- MF2264XXX
- MF2271XXX
- MF2285XXX
- MF2328XXX
Distribution
Related recalls
Same manufacturer · Kimberly-Clark Corporation
See all →- ModerateKimberly-Clark Recalls Scott Moisturizing Foam Hand Sanitizer Due to Labeling Error
FDA (Drugs) · 2021-04-14
- SevereKimberly-Clark Recalls U by Kotex Sleek Tampons for Structural Defect
FDA (Devices) · 2019-01-23
- HighKimberly-Clark Recalls U by Kotex Sleek Tampons for Structural Defect
FDA (Devices) · 2019-01-23
- HighU by Kotex Sleek Regular Tampons Recalled for Potential Breakage
FDA (Devices) · 2019-01-23
- HighKimberly-Clark Recalls U by Kotex Sleek Tampons for Structural Defect
FDA (Devices) · 2019-01-23
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- HighKimberly-Clark Recalls Sterile Surgical Gowns Due to Potential Seal Failure
FDA (Devices) · 2012-11-14
- LowKimberly-Clark Recalls Non-Commercial Sterile Surgical Gowns
FDA (Devices) · 2012-09-26
- HighKimberly-Clark Recalls MicroCool Sterile Surgical Gowns Due to Seal Defects
FDA (Devices) · 2012-11-14
- ModerateStryker Quikflap Burr Hole Cover Recall Due to Packaging Compromise
FDA (Devices) · 2018-09-05
- SevereKimberly-Clark Recalls U by Kotex Sleek Tampons for Structural Defect
FDA (Devices) · 2019-01-23
- HighCardinal Health Recalls Sterile Needle Counters Due to Packaging Defects
FDA (Devices) · 2013-04-03