FDA Medical devices recall ·
REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-2364-2026
- Date
- (initiated April 21, 2026)
- Company / brand
- Arrow International, LLC
3015 Carrington Mill Blvd, Morrisville, NC, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 205,685
- Hazard tags
- Sterility Injury risk
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Description/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1; STIMUCATH SFTY KIT: 19G CTH, 17Gx4CM NDL/AB-19604-KS; STIMUCATH SFTY KIT: 19G CTH, 17Gx8CM NDL/AB-19608-KS; STIMUCATH SFTY KIT: 20G CTH, 18Gx8CM NDL/AB-20608-KS; STIMUCATH KIT: 19G CATH, 17G x 9CM NDL/AB-05060-PK; FLEXBLOCK ULTRASOUND KIT: 17Gx9CM NS NDL/ASK-19609-VCU; CONTINUOUS NERVE BLOCK KIT/ASK-19600-CC2; CONTINUOUS NERVE BLOCK KIT 19 GA X 60/ASK-19608-CC; CONTINUOUS NERVE BLOCK KIT 19GA X 60CM/ASK-19608-KP; CONTINUOUS NERVE BLOCK KIT 19GA X 60CM/ASK-19608-SHC; FLEXBLOCK KIT:ECHO CATH, 17Gx8CM STM NDL/FB-19608-K; FLEXBLOCK ULTRASOUND KIT: 17Gx8CM STM ND/FB-19608-KU; FLEXBLOCK KIT:ECHO CATH, 17Gx9CM NS NDL/FB-19609-K; FLEXBLOCK ULTRASOUND KIT: 17Gx9CM NS NDL/FB-19609-KU; CONTINUOUS PERIPHERAL NERVE BLOCK KIT/ASK-19608-US1; EPIDURAL CATHETERIZATION KIT/ASK-05001-SLR1; EPIDURAL CATHETERIZATION KIT/MH-05001; EPIDURAL CATHETERIZATION KIT/WJ-05401; SPINAL ANES/EPIDURAL CATH 19GA X 90CM/ASK-05501-USC1; EPIDURAL NEEDLE KIT/LG-03000; EPIDURAL ANESTHESIA KIT/MTO-03000-VM; EPIDURAL ANESTHESIA KIT/SM-03001; Anesthesia conduction kit/FB-19611-K
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
REF(Material)/UDI-DI/Lot(Batch): ASK-04001-SUH-S/10801902210217, 10801902193275/33F25C0766, 33F25E0112, 33F25G0101, 33F25H0058, 33F25H0725, 33F25J0862, 33F25M0836, 33F25F0160; ASK-04001-VM1/10801902210217, 10801902202106, 10801902193275/33F24L0599, 33F26A0962, 33F24G0280; AB-19604-KS/10801902210217, 10801902209471/33F24L0608, 33F25G0474, 33F25J0814, 33F25M0887, 33F24D0064; AB-19608-KS/10801902210217, 10801902209471/33F24E0312, 33F24F0295, 33F24G0316, 33F24K0082, 33F24L0714, 33F25E0027, 33F25E0904, 33F25H0003, 33F25J0815, 33F25L0337, 33F26B0498, 33F24E0314; AB-20608-KS/)10801902210217/33F25H0004, 33F25J0816, 33F24D0437; AB-05060-PK/10801902209433, 10801902210217/33F24D0002, 33F24E0029, 33F24G0315, 33F24J0484, 33F24K0081, 33F25A0451, 33F25C0747, 33F25E0026, 33F25J0646, 33F24E0028; ASK-19609-VCU/10801902210217, 10801902206876, 10801902214291/33F24E0536, 33F24J0630, 33F24L0605, 33F25C0179, 33F25E0220, 33F25H0140, 33F26B1003, 33F24D0628; ASK-19600-CC2/10801902210057, 10801902210217, 10801902210064/33F24D0393, 33F24E0533, 33F24G0494, 33F24K0251, 33F24L0665, 33F25C0177, 33F25E0217, 33F25H0138, 33F24C0230; ASK-19608-CC/10801902210217, 10801902210064, 10801902202236/33F24G0309, 33F24K0252, 33F24L0639, 33F25B0691, 33F25C0178, 33F25C0761, 33F25E0218, 33F25E1022, 33F25H0750, 33F25J0918, 33F26B0230, 33F24D0394; ASK-19608-KP/10801902210217/33F24G0495, 33F24G0086; ASK-19608-SHC/10801902210217, 40801902202220, 10801902202243/33F24G0496, 33F24J0629, 33F24K0253, 33F24L0573, 33F25A0571, 33F25C0
Distribution
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.
States: Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri Mississippi Montana North Carolina North Dakota Nebraska New Hampshire New Jersey New Mexico Nevada New York Ohio Oklahoma Oregon Pennsylvania Puerto Rico Rhode Island South Carolina South Dakota Tennessee Texas Utah Virginia Vermont Washington Wisconsin West Virginia Wyoming
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-2364-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.