Z-1478-2023Class II

injeTAK Adjustable Tip Needles Needle Sheath diameter 6Fr with 35-50cm in length Stainless-stell needle...

Name: Z-1478-2023 injeTAK Adjustable Tip Needles Needle Sheath diameter 6Fr with 35-50cm in length Stainless-stell needle...
Creator: Labories Medical Technologies
Published: 2023-02-07
License: https://open.fda.gov/license/

Abbott Medical / initiated 2023-02-07 / Open, Classified / root cause: manufacturing process

FDA source

Labories Medical Technologies began a recall of injeTAK Adjustable Tip Needles Needle Sheath diameter 6Fr with 35-50cm in length Stainless-stell needle cannula is 25 gauge on 2023-02-07. FDA classified it as Class II and gives the reason as "The packaging may be damaged, compromising the sterile barrier". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1478-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-07
Posted: 2023-04-28
Recalling firm: Abbott Medical
Product: injeTAK Adjustable Tip Needles Needle Sheath diameter 6Fr with 35-50cm in length Stainless-stell needle cannula is 25 gauge
Product code: FBK Endoscopic Injection Needle, Gastroenterology-Urology
Reason for recall: The packaging may be damaged, compromising the sterile barrier.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: A customer letter dated February 7, 2023 was issued to impacted consignees. The letter asks consignees to examine their inventory for affected product lots and to complete a response card to the recalling firm. Return of impacted product will be coordinated with Laborie Medical Technologies.
Quantity in commerce: 415,480 units
Distribution: Worldwide distribution.
Product codes and lots: Model DIS199, UDI-DI (GTIN): 00627825000017 Lots: D198592, D211823, D19C094, D211825, D197765, D215573, D19B105, D214446, D19C097, D213099, D19C742, D214448, D201666, D213385, D202622, D216690, D203779, D217602, D204597, D21A632, D198638, D21B406, D204100, D219650, D201620, D221275, D207081, D218636, D205443, D21C155, D205441, D221088, D205445, D222083, D207623, D223087, D20A091, D224083, D20C092, D224386, D208579, D225586, D20C094, D225589, D20A092, D227088, D20B085, D226108, D211094, D228087 Model DIS201, UDI-DI (GTIN): 00627825000024 Lots: D19B109, D214447, D199716, D211094, D19B106, D214449, D19C789, D215574, D19C788, D216689, D19C098, D219083, D19C743, D217081, D201667, D218089, D203778, D21B407, D202623, D21B081, D204598, D21A082, D205444, D221277, D205440, D21C156, D203783, D221089, D205442, D221276, D204101, D222084, D203780, D224084, D207624, D221087, D207082, D222082, D208580, D223088, D205446, D226109, D20B086, D224387, D20A093, D227089, D20C095, D228088, D20C093, D226107, D211824, D228197, D211095, D229088, D211826, D22A099, D213100, D22A719, D213386, D229086

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1478-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1478-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-10	2023-04-28

Product code FBK

K090830Class IILaborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid TipLaborie Medical Technologies, Ltd. / cleared 2009-07-21

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)