FDAFDA · Food and drugs·Recall number Z-3254-2026
Presource Convenience Kits: 1) KIT, PRE OP , Catalog Number: AMN548616A; 2) KIT, NICU ADMIT NEW HAN , Catalog Number: BA1DH0116B; 3) KIT, PRE PROCEDURE , Catalog Number: IVSJV8302E; 4) KIT, IV SUPPLIES , Catalog Number: IVS3223531; 5) KIT, IV SUPPLIES , Catalog Number: IVS3223532; 6) KIT, IV SUPPLIES , Catalog Number: IVS3223533; 7) KIT, IV SUPPLIES , Catalog Number: IVS3223534; 8) KIT, IV SUPPLIES , Catalog Number: IVS3223535; 9) KIT, IV SUPPLIES , Catalog Number: IVS322358M; 10) KIT, IV SUPPLIES , Catalog Number: IVS322358N; 11) KIT, IV SUPPLIES , Catalog Number: IVS322358O; 12) KIT, PATIENT ADMISSIONS , Catalog Number: AMN333032A; 13) KIT, C SECTION , Catalog Number: MAT42267AL; 14) KIT, C SECTION , Catalog Number: MAT4226725; 15) KIT, VAGINAL DELIVERY , Catalog Number: MAT422677G; 16) KIT, VAGINAL DELIVERY , Catalog Number: MAT4226792; 17) KIT, VAGINAL DELIVERY , Catalog Number: MAT4226793; 18) KIT, VAGINAL DELIVERY , Catalog Number: MAT4226794; 19) KIT, VAGINAL DELIVERY , Catalog Number: MAT4226795
Published September 30, 2026 · Recall initiated: August 10, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated applicator could result in no patient harm or may lead to localized skin or soft tissue infection. Less commonly, systemic infection or other infectious complications may occur.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cardinal Health 200, LLC
- Distributor
- US Nationwide distribution in the states of FL, KY, MO, NC, OH, TX.
- Lot
- 1) AMN548616A, UDI-DI: 10197106721834(each), 10197106721834(case), Lot Number: 4249818 ; 2) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5124984 ; 3) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5129488 ; 4) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5129488 ; 5) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5188103 ; 6) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5188103 ; 7) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5211212 ; 8) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5155824 ; 9) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5211985 ; 10) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5279226 ; 11) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5155824 ; 12) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5188103 ; 13) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5211212 ; 14) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5246952 ; 15) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5279226 ; 16) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5279226 ; 17) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 6062168 ; 18) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5155824 ; 19) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5279226 ; 20) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 6062168 ; 21) BA1DH0116B, UDI-DI: 0(each), 0(case), Lot Number: 6051588 ; 22) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5124984 ; 23) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5124984 ; 24) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5129488 ; 25) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5124984 ; 26) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5129488 ; 27) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5129488 ; 28) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5188103 ; 29) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5195818 ; 30) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5211907 ; 31) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5211985 ; 32) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5211212 ; 33) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5211985 ; 34) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5279226 ; 35) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5129488 ; 36) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5211985 ; 37)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Related recalls
- FDAPresource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, GYN LAPAROSCOPY NEW HAN , Cata…October 7, 2026
- FDAPresource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT,GU DAVINCI , Cata…October 7, 2026
- FDAPresource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAVH , Cata…October 7, 2026
- FDAPresource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAP CHOLE , Cata…October 7, 2026
- FDAnGenuity Patient Monitor with Capnography (ETCO2) CAT 8100E1-ST-US, CAT 8100E1-US, CAT 8100EP1, CAT 8100EP…September 30, 2026
- FDAPresource Convenience Kits: 1) KIT, USGPIV , Catalog Number: PVMHIVMHD; 2) KIT, USGPIV …September 30, 2026
- FDAAutomated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1…September 30, 2026
- FDAREF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 SeriesSeptember 30, 2026
Questions about this recall
Was Presource Convenience Kits: 1) KIT, PRE OP , Catalog Number: AMN548616A; 2) KIT, NICU ADMIT NEW HAN , Catalog Number: BA1DH0116B; 3) KIT, PRE PROCEDURE , Catalog Number: IVSJV8302E; 4) KIT, IV SUPPLIES , Catalog Number: IVS3223531; 5) KIT, IV SUPPLIES , Catalog Number: IVS3223532; 6) KIT, IV SUPPLIES , Catalog Number: IVS3223533; 7) KIT, IV SUPPLIES , Catalog Number: IVS3223534; 8) KIT, IV SUPPLIES , Catalog Number: IVS3223535; 9) KIT, IV SUPPLIES , Catalog Number: IVS322358M; 10) KIT, IV SUPPLIES , Catalog Number: IVS322358N; 11) KIT, IV SUPPLIES , Catalog Number: IVS322358O; 12) KIT, PATIENT ADMISSIONS , Catalog Number: AMN333032A; 13) KIT, C SECTION , Catalog Number: MAT42267AL; 14) KIT, C SECTION , Catalog Number: MAT4226725; 15) KIT, VAGINAL DELIVERY , Catalog Number: MAT422677G; 16) KIT, VAGINAL DELIVERY , Catalog Number: MAT4226792; 17) KIT, VAGINAL DELIVERY , Catalog Number: MAT4226793; 18) KIT, VAGINAL DELIVERY , Catalog Number: MAT4226794; 19) KIT, VAGINAL DELIVERY , Catalog Number: MAT4226795 recalled?
Yes. FDA published recall Z-3254-2026 on September 30, 2026. Reported hazard: The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated applicator could result in no patient harm or may lead to localized skin or soft tissue infection. Less commonly, systemic infection or other infectious complications may occur.
What should I do if I have this product?
Voluntary: Firm initiated · Letter
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.
Recalert also tracks expiration dates so you can sell stock before it becomes a loss.