Z-0266-2023Class II

InControl Insulin Syringes, Short Needle, 29 Gauge, 1CC

Name: Z-0266-2023 InControl Insulin Syringes, Short Needle, 29 Gauge, 1CC
Creator: Allison Medical, Inc.
Published: 2018-01-19
License: https://open.fda.gov/license/

Allison Medical, Inc. / initiated 2018-01-19 / Completed / root cause: labeling and UDI

FDA source

Allison Medical, Inc. began a recall of InControl Insulin Syringes, Short Needle, 29 Gauge, 1CC on 2018-01-19. FDA classified it as Class II and gives the reason as "Insulin syringe retail packages incorrectly labeled as "Short Needle"". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0266-2023
Classification: Class II
Status: Completed
Initiated: 2018-01-19
Posted: 2022-11-18
Recalling firm: Allison Medical, Inc.
Product: InControl Insulin Syringes, Short Needle, 29 Gauge, 1CC
Product code: FMF Syringe, Piston
Reason for recall: Insulin syringe retail packages incorrectly labeled as "Short Needle".
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: On 01/19/2018, The recalling firm notified their customer of the recall.
Quantity in commerce: 1,500 Boxes (150,000 syringes)
Distribution: Texas
Product codes and lots: UDI/Lot/Expiration: 00041220791484/ 170407/ 2022-03-31

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0266-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0266-2023	Class II	Completed	Voluntary: Firm initiated	2022-11-30	2022-11-18

Product code FMF

K191531Class IISure-Fine Insulin SyringesShina Med Corporation / cleared 2019-09-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)