Foundation Kit Tenaculum Devices Recalled for Manufacturing Non-Compliance
Stradis Medical recalled 790 Foundation Kits because the manufacturer cannot confirm tenaculum devices met design and manufacturing standards.
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 recall for manufacturing and design standards non-compliance. This constitutes a risk-of-harm product where no injuries have been reported, meeting the criteria for High severity.
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare is recalling the Foundation Kit, which includes tenaculum devices used in medical procedures. The recall was initiated because the manufacturer is unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
A total of 790 kits have been affected by this recall. These kits were distributed nationwide to healthcare facilities in VA, SC, CA, PA, MA, FL, TN, NJ, GA, AZ, IL, OH, OK, WA, NY, NV, MO, MD, IN, TX, CO, RI, NC, KY, MT, VI, KS, MI, AK, ID, SD, UT, and internationally to Canada.
No injuries or illnesses related to this product have been reported. Healthcare facilities and other recipients of this product should contact the manufacturer for instructions regarding the return or destruction of affected units.
The recalled product
- Product
- Foundation Kit
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Affected units
- 790
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)
- Part Number: A10
Distribution
Part of a larger recall action
This product is one of 6 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 6 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 Kits Recalled by Stradis Healthcare for Sealing Defect
FDA (Devices) · 2022-12-21
- HighStradis Healthcare Curved Tip Syringes Recalled Due to Incomplete Sterile Sealing
FDA (Devices) · 2022-12-21
Same hazard · manufacturing defect
See all →- ModerateBoston Scientific Recalls NaviFlex LW Pusher and Advx Panc. Stent
FDA (Devices) · 2026-10-21
- ModerateCook Williams Cystoscopic Injection Needles Recalled for Manufacturing Defect
FDA (Devices) · 2026-10-21
- ModerateNeuronetics Recalls NeuroStar Advanced Therapy Systems Due to Non-Conforming Cables
FDA (Devices) · 2026-10-21
- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-10-14
- ModerateCustom Interventional Pain Management Recalls Mastisol Skin Adhesive Trays
FDA (Devices) · 2026-10-07
Similar recalls
- HighStradis Healthcare Medical Vein Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2022-12-21
- HighSurgical Suture Kit Recalled for Uncertain Sterile Barrier Integrity
FDA (Devices) · 2022-06-01
- HighStradis Healthcare Introducer Kit Micro recalled for potential sterility compromise
FDA (Devices) · 2022-12-21
- HighFluid Filter Transfer Kit Recalled Over Potential Sterility Breaches
FDA (Devices) · 2023-01-18
- HighMedical Paracentesis Kit Recalled Over Sterilization Assurance Failure
FDA (Devices) · 2024-10-02
- HighStradis Healthcare Thoracic Surgery Kits Recalled for Sterility Risk
FDA (Devices) · 2022-12-21