CLASS II ONGOING Device recall · Reported 17 Dec 2025 · FDA Enforcement Report
Safe-T-Centesis Catheter Drainage Tray recalled
Bard Peripheral Vascular is recalling Safe-T-Centesis Catheter Drainage Tray, distributed nationwide in the US. The recall was initiated on 6 Nov 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0887-2026
- FDA event ID
- 97864
- Recalling firm
- Bard Peripheral Vascular, Tempe, AZ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Nov 2025
- FDA classified
- 5 Dec 2025
- Reported
- 17 Dec 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 6 Nov 2025 | Recall initiated by company | |
| 5 Dec 2025 | Classified by FDA | +29 days |
| 17 Dec 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,
Where it was distributed
US Nationwide distribution in the states of CA, MN, IN, MI, LA.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI/Lot/Expiration: (01)10885403108365(17)271130(10)0001623320/0001623320/20271130; (01)10885403108365(17)271130 (10)0001623069/0001623069/20271130
Where was it sold?
US Nationwide distribution in the states of CA, MN, IN, MI, LA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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