Bard Access Systems Recalls Acute Drainage Trays
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Bard Access Systems, Inc. is recalling 9,500 units of three acute drainage device trays nationwide due to lidocaine ampoules manufactured under deficient practices.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 7, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevices.
What Happened Bard Access Systems, Inc. initiated a voluntary recall of certain acute drainage devices because the included lidocaine ampoules were manufactured under deficient manufacturing practices by the supplier.
Which Products Are Affected
- OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED (UDI-DI: 0110885403284748, Lot: REKY3402)
- PIG1260T SAFE-T-CENTESIS TRAY 6FR X 16CM (UDI-DI: 0110885403108365, Lot: REKY3397)
- TPT1000 THORACENTESIS/PARACENTESIS TRAY (UDI-DI: 0110885403108488, Lot: REKY3386)
A total of 9,500 units are affected. Distribution includes U.S. nationwide (AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY) and Belgium.
What You Should Do The recall is voluntary and firm-initiated. Consumers with affected products should contact Bard Access Systems, Inc. for additional guidance.
Why This Matters This Class II recall involves devices indicated for fluid removal from pleural or peritoneal spaces and affects distribution across the United States and internationally.
Source FDA recall number Z-2655-2026, report date 20260708.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,227 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 7, 2026.
Frequently Asked Questions
Common questions about this FDA recall.