Quick Facts at a Glance
- Recall Date
- November 6, 2025
- Hazard Level
- HIGH
- Brand
- Bard Peripheral Vascular
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Bard Peripheral Vascular
- Product type
- Catheter Drainage Tray
- Model numbers
- UDI/Lot/Expiration: (01)10885403108365(17)271130(10)0001623320/0001623320/20271130, (01)10885403108365(17)271130 (10)0001623069/0001623069/20271130
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 6, 2025
Reported by FDA DEVICE
December 17, 2025
RecallRadar source check
December 24, 2025
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Acute drainage catheters, indicated for use in removing fluid during acute drainage/aspiration procedure, manufactured with safety indicators that erroneously show catheter in sharp position when catheter is in blunt position, which may lead users to believe device is not yet in pleural or peritoneal space when it is, may cause discomfort, delay to treatment, injury to internal organs or vessels.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Bard Peripheral Vascular Inc or your healthcare provider for instructions. Notification method: N/A
About This Product
The Safe-T-Centesis Catheter Drainage Tray is a medical device designed for the removal of fluid during acute drainage procedures. Healthcare providers commonly use it in hospitals and clinics to manage patient conditions.
Why This Is Dangerous
The device's safety indicators can falsely indicate that the catheter is in a sharp position when it is actually blunt. This can mislead users, posing risks of internal injuries during procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall poses a high risk of serious injury during medical procedures, leading to potential discomfort and treatment delays for patients.
Practical Guidance
How to identify if yours is affected
- Locate the model number and lot number on the packaging or device.
- Check if your catheter matches the affected models listed in the recall.
- Consult your healthcare provider if you are unsure about your product.
Where to find product info
Look for the model and lot numbers on the catheter packaging or the device itself, typically printed on a label or sticker.
What timeline to expect
Expect a refund or replacement process to take approximately 4-6 weeks.
If the manufacturer is unresponsive
- Document your communications with the manufacturer.
- Consider reaching out to your healthcare provider for assistance.
- File a complaint with the FDA if necessary.
How to prevent similar issues
- Always verify if a medical device has been recalled before use.
- Check for safety certifications and indicators on medical devices.
- Consult with healthcare professionals about the reliability of medical devices.
Documentation advice
Keep records of your purchase, including receipts, communications with the manufacturer, and any related medical documentation.
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Product Details
The recall covers Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T. It includes lot numbers (01)10885403108365(17)271130(10)0001623320 and (01)10885403108365(17)271130(10)0001623069. These products were distributed in California, Minnesota, Indiana, Michigan, and Louisiana.
Key Facts
- Recall date: November 6, 2025
- Distribution: Nationwide in CA, MN, IN, MI, LA
- Quantity recalled: 1,240 units
- Potential for serious injury
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Safety Guide
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