Data Foundry

Medical device recalls 2019

20" 2-Needle 26-Gauge 6mm HlgH-Flo Subcutaneous Safety Needle Sets"… — Class II medical device recall Z-0051-2020

Terminated recall by Repro-Med Systems, Inc., reported 2019-10-16, distributed nationwide. Mislabeled needle lengths

Recall numberZ-0051-2020
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmRepro-Med Systems, Inc., Chester, NY, United States
Recall initiated2019-08-20
Classified2019-10-07
Reported by FDA2019-10-16
Terminated2020-05-29
DistributedNationwide (US)
Quantity1,990 pouches
Reason classeslabeling
UPC / GTIN / UDI-DI00659443000292
Lot numbersN.78648

Product

20" 2-Needle 26-Gauge 6mm HlgH-Flo Subcutaneous Safety Needle Sets" Product # RMS22606 - Product Usage: RMS HlgH-Flo Subcutaneous Safety Needle Sets are intended for the delivery of medication to the subcutaneous tissue.

Reason for recall

Mislabeled needle lengths

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0051-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.