Safe N Simple Recalls Hydrogel Wound Dressings Due to Sterilization Issues
Safe N Simple, LLC is recalling 125 cases of Simpurity Hydrogel Absorbent Sheet Wound Dressings because the sterilization process used was unqualified. The affected products were distributed in California.
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 source text does not report any illnesses, injuries, or hospitalizations. The hazard is a process qualification issue (unqualified sterilization) rather than a confirmed contamination event with reported harm, fitting the 'voluntary precautionary' or 'low-risk contamination' criteria for a Moderate score.
Plain-English summary
Safe N Simple, LLC is recalling 125 cases of Simpurity Hydrogel Absorbent Sheet Wound Dressings with an adhesive border. The specific product is the 4" x 5" size, sold in packs of 12 pads, with catalogue number SNS58345. The recall involves lot number 18060564.
The recall was initiated because the sterilization process used for these products was unqualified. This means the process was not validated to ensure the products were sterile as intended. The affected units were distributed in California.
Consumers who have purchased this product should stop using it and contact Safe N Simple, LLC for further instructions or a refund. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING ADHESIVE BORDER, 4" X 5", 12 Pads, Catalogue number SNS58345
- Manufacturer
- Safe N Simple, LLC
- Category
- Medical Device — Wound Care
- Hazard
- Affected units
- 125
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)
- lot number 18060564
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Safe N Simple, LLC 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 2 products in this recall →Related recalls
Same manufacturer · Safe N Simple, LLC
See all →- ModerateSimpurity Hydrogel Wound Dressing Recalled Due to Unqualified Sterilization Process
FDA (Devices) · 2018-11-14
- HighSafe N Simple Ostomy Skin Barrier Wipes Recalled for Bacterial Contamination
FDA (Devices) · 2018-07-04
- ModerateSafe N Simple Recalls DermaPro Waterproof Silicone Tape for Adhesion Issues
FDA (Devices) · 2018-06-20
Same hazard · sterilization failure
See all →- SevereSteris VERIFY Biological Indicator Recall Due to Spore Population Concerns
FDA (Devices) · 2026-10-14
- HighSteris VERIFY Dual Species Biological Indicator Recall for Spore Population Issues
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological Steam Test Pack Recalled for Spore Population Defect
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological/Integrator Challenge Pack Recall for Spore Population Defect
FDA (Devices) · 2026-10-14
- SevereSteris Recalls VERIFY Biological Steam Test Packs Due to Spore Population Concerns
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateAndover Healthcare Recalls Sterile Co-Flex Med Wound Dressings Due to Packaging Seal Defects
FDA (Devices) · 2019-10-30
- HighRecall of Sterile Wound Dressings Due to Compromised Sterility Barrier
FDA (Devices) · 2017-04-12
- HighAndover Healthcare Recalls Sterile Co-Flex NL Wound Dressings Due to Packaging Seal Issues
FDA (Devices) · 2019-10-30
- HighAndover Healthcare Recalls Sterile Co-Flex NL Wound Dressings Due to Packaging Defect
FDA (Devices) · 2019-10-30
- HighAndover Healthcare Recalls Sterile Co-Flex Med Wound Dressings
FDA (Devices) · 2019-10-30
- HighMediHoney non-adhesive hydrogel dressings recalled over sterile barrier packaging failures
FDA (Devices) · 2025-09-10