Z-2365-2026 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 24, 2026
- Initiation Date
- April 21, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,840
Product Description
Description/REF: BIOPSY SYSTEM COMPREHENSIVE KIT/ASK-09458-AH, ASK-09458-COC, ASK-09458-EUH, ASK-09458-SD, ASK-09458-VU
Reason for Recall
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. 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.
Distribution Pattern
US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.
Code Information
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, 33F24H0227; ASK-09458-COC/10801902193275, 10801902221084, 10801902216394/33F24K0755, 33F25C0380, 33F25D0590, 33F25H0583, 33F25J0354, 33F25K0125, 33F25M0243, 33F25M0393, 33F26A1535, 33F26B0404, 33F24F0732; ASK-09458-EUH/10801902193275, 10801902216394/33F24L0908, 33F25E0715, 33F25F0096, 33F25G0215, 33F25J0144, 33F25M0118, 33F26A1515, 33F26B0862, 33F24H0125; ASK-09458-SD/10801902193275, 10801902215014/33F25D0398, 33F25F0165, 33F25M0692, 33F26C0488; ASK-09458-VU/10801902217261, 10801902193275, 10801902217261, 10801902193275/33F24C0832, 33F24D0624, 33F24F0650, 33F24K0752, 33F24L0916, 33F25D0534, 33F25E0531, 33F25F0141, 33F25H0588, 33F25K0127, 33F25M0177, 33F26B0134, 33F26B0477, 33F26C0487, 33F24H0099