Stradis Healthcare Cotton Applicator 3 inch kits recalled due to incomplete bag sealing
Stradis Healthcare is recalling cotton applicator 3 inch kits used in medical and surgical procedures due to incomplete outer bag sealing that may compromise kit sterility. Kits were distributed nationwide in the U.S. and Canada.
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: FDA Class II medical device with a sterility defect that poses a risk of infection in medical procedures, but no illnesses or injuries have been reported. This qualifies as a risk-of-harm product where injury has not yet been reported, per the rubric.
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare is recalling cotton applicator 3 inch kits (Item No. 505-010) distributed nationwide in the United States and Canada. These kits are used in medical and surgical procedures.
The recall was issued because the kits underwent manufacturing conditions that may have resulted in the outer bag being incompletely sealed. An incomplete seal may allow a breach in the sterility of the kit, which is essential for safe medical and surgical use.
Affected lots include Serial/Lot Numbers 22269491064, with UDI/DI (case) M7525050101 and UDI/DI (kit) M7525050100. Healthcare facilities and medical professionals who have these kits should cease use and contact the manufacturer for instructions or replacement.
The recalled product
- Product
- STRADIS HEALTHCARE, COTTON APPLICATOR 3" Item No.505-010,
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Affected units
- 100
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 (3)
- UDI/DI (case) M7525050101
- UDI/DI (kit)M7525050100
- Serial/Lot Numbers: 22269491064
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 78 recalled by Stradis Medical, LLC dba Stradis Healthcare 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 78 products in this recall →Related recalls
Same manufacturer · Stradis Medical, LLC dba Stradis Healthcare
See all →- HighStradis Healthcare Venous Access Pack Recalled for Potential Sterility Breach
FDA (Devices) · 2022-12-21
- HighGeneral Surgery Procedure Kit Recalled for Sterility Concerns
FDA (Devices) · 2022-12-21
- HighStradis Healthcare Vein RF Pack surgical trays recalled for incomplete outer bag seal
FDA (Devices) · 2022-12-21
- HighSurgical Procedure Trays Recalled for Potential Sterility Breach
FDA (Devices) · 2022-12-21
- HighSurgical Procedure Kits Recalled by Stradis Healthcare for Sealing Defect
FDA (Devices) · 2022-12-21
Same hazard · sterility breach
See all →- HighMedline Open Heart A Pack Kits Recalled for Sterility Concerns
FDA (Devices) · 2026-09-23
- HighAVID Medical Recalls Halyard IV Start Kits Due to Seal Defects
FDA (Devices) · 2026-09-16
- SevereMedline Ultrasound Breast Pack Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- SevereMedline C-Section Prep Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- HighMedline Convenience Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
Similar recalls
- HighSurgical Suture Kit Recalled for Uncertain Sterile Barrier Integrity
FDA (Devices) · 2022-06-01
- HighSurgical kit recall due to outer bag perforation and sterility risk
FDA (Devices) · 2022-04-13
- HighPICC Kit Recall: Outer Bag Pinhole Leaks May Compromise Sterility
FDA (Devices) · 2023-01-18
- HighStradis Healthcare Foley Catheter Insertion Tray Recalled for Sterility Breach Risk
FDA (Devices) · 2023-01-18
- HighStradis Healthcare TCTR Convenience Kit recalled for potential sterility compromise
FDA (Devices) · 2023-01-18
- HighVYGON Dressing Change Kit Recalled for Potential Seal Integrity Issues
FDA (Devices) · 2022-09-14