Z-1138-2025Class II

stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal Blades

Name: Z-1138-2025 stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal Blades
Creator: Stryker Corporation
Published: 2025-01-08
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2025-01-08 / Open, Classified / root cause: manufacturing process

FDA source

Stryker Corporation began a recall of stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal Blades on 2025-01-08. FDA classified it as Class II and gives the reason as "Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece". 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-1138-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-01-08
Posted: 2025-02-11
Recalling firm: Stryker Corp.
Product: stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal Blades
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Stryker issued an URGENT MEDICAL DEVICE recall notice to its consignees on 01/08/2025 via FedEx. The notice explained the issue, potential risk, and requested the affected items be quarantined pending return. Stryker will issue a shipping label to the consignee once the response form has been received. Distributors were directed to forward the notice to all those to whom the affected devices were distributed.
Quantity in commerce: 622 units
Distribution: Worldwide distribution.
Product codes and lots: GTIN 04546540046482, Lot Number 22298017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1138-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1138-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-19	2025-02-11
Z-1139-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-19	2025-02-11

Product code GEI

K143145Class IISafeAir Smoke PencilLina Medical Aps / cleared 2014-12-04

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)