RegWardenFDA facility compliance records
Recall

Class II — Allison Medical, Inc.

Recalling firmALLISON MEDICAL, INC.
Registered facilityALLISON MEDICAL, INC. (the firm's only registered facility)
ClassificationClass II
StatusCompleted
ReasonSyringe without needle may have a green substance on the plunger. Substance found to be nontoxic but its effect on drug potency or interaction is unknown.
ProductCarePoint 60 mL Syringe Without Needle, REF: 04-7560
Quantity2,004 Boxes
DistributionUS: IA, LA, MS, FL, PR; OUS: BARBADOS
Initiated2020-09-03
Classified2022-12-13
Recall numberZ-0478-2023
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Allison Medical, Inc. (Z-0478-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91092/

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