Bard Access Systems Soft Tissue Biopsy Trays Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Bard Access Systems, Inc. is recalling 11,990 units of two Soft Tissue Biopsy Tray models due to a supplier recall of lidocaine ampoules.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 8, 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, Devices.
What Happened
Bard Access Systems, Inc. initiated a voluntary recall of certain Soft Tissue Biopsy Trays because the included lidocaine ampoules were manufactured under deficient practices by the supplier.
Which Products Are Affected
- 4380 ECONOMY SOFT TISSUE BIOPSY TRAY, UDI-DI Code: 0110885403108563, Lot Number: REKY3390
- 4382A SOFT TISSUE BIOPSY TRAY, UDI-DI Code: 0110885403108501, Lot Numbers: REKY3393, REJZ0942, REJZ0943
A total of 11,990 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
Consumers should follow instructions provided in the firm's notification letter.
Why This Matters
The Class II recall involves devices indicated for collection of aspirate tissue such as liver or kidney samples.
Source
FDA recall number Z-2668-2026. https://www.fda.gov
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 (1,034 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 8, 2026.
Frequently Asked Questions
Common questions about this FDA recall.