The Recall Desk
SevereFDA (Devices)·Z-2365-2026·Announced 2026-06-24

Arrow biopsy system comprehensive kits contain recalled supplier drugs

Arrow Biopsy System Comprehensive Kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 14,840 units affected.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I recall, which the rubric floors at Severe; no death is reported in the source, so it does not escalate to Critical.

Plain-English summary

Arrow International is recalling Biopsy System Comprehensive Kits, covering REF ASK-09458-AH, ASK-09458-COC, ASK-09458-EUH, ASK-09458-SD and ASK-09458-VU. The action covers 14,840 units.

Lidocaine, bupivacaine and 0.9% sodium chloride, the subject of a supplier recall, were included in the kits and sets. According to the manufacturer, the supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries. The FDA classified the action as Class I, its most serious classification.

Distribution was nationwide in the United States across a large number of states. The kits are supplied to healthcare facilities rather than sold to consumers.

Facilities should identify affected stock using the REF numbers, UDI-DI codes and lot numbers in the recall notice, quarantine it, and follow the instructions issued by Arrow International.

The recalled product

Product
Description/REF: BIOPSY SYSTEM COMPREHENSIVE KIT/ASK-09458-AH, ASK-09458-COC, ASK-09458-EUH, ASK-09458-SD, ASK-09458-VU
Manufacturer
ARROW INTERNATIONAL, LLC
Category
Medical Device — Biopsy kit
Hazard
  • contained-drug-recall
  • sterility-assurance
  • drug-ineffectiveness
  • class-i

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • REF(Material)/UDI-DI/Lot(Batch): ASK-09458-AH/10801902203172
  • 10801902193275
  • 10801902203172/33F24C0359
  • 33F24C1122
  • 33F24E0323
  • 33F24F0780
  • 33F24K0397
  • 33F25A0208
  • 33F25B0518
  • 33F25D0001
  • 33F25D0338
  • 33F25D0465
  • 33F25E0528
  • 33F25H0610
  • 33F25J0353
  • 33F25K0076
  • 33F25K0091
  • 33F25M0173
  • 33F26A1538
  • 33F26B0819

Distribution

Distributed nationwide across the United States.

Related recalls

Same category