Reported Jul 8, 2026 · Ongoing
OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 0110885403284748 PIG1260T SAFE-T-CENTESIS TRAY 6FR X 16CM UDI-DI…
Bard Access Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bard Access Systems, Inc. · 605 N 5600 W · Salt Lake City, UT · 84116-3738
Is this the product you have?
OTP5000 THORA/PARA TRAY5FR
- NON-VALVED UDI-DI Code0110885403284748 PIG1260T SAFE-T-CENTESIS
- TRAY 6FR X 16CM UDI-DI Code0110885403108365 TPT1000 THORACENTESIS/PARACENTESIS
- TRAY UDI-DI Code0110885403108488 The Acute Drainage devices are indicated for use in removing fluid from either the pleural or peritoneal spaces during an acute drainage / aspiration procedure
- Lot codes and dates
3 of 3 products
Products covered by this recall # Product as published 1 Lot Number: REKY3402 PIG1260T SAFE-T-CENTESIS TRAY 6FR X 16CM UDI-DI Code: 0110885403108365 2 Lot Number: REKY3397 TPT1000 THORACENTESIS/PARACENTESIS TRAY UDI-DI Code: 0110885403108488 3 Lot Number: REKY3386 - Amount recalled
- 9,500
This recall covers 14 products
The agency filed one notice per product. You are reading one of them; the other 13 are below.
1 more are in the archive.
Where it was sold
Why it was recalled
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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