Z-2620-2025Class II

Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034

Name: Z-2620-2025 Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034
Creator: Stryker Communications
Published: 2025-07-15
License: https://open.fda.gov/license/

STRYKER Communications, Inc. / initiated 2025-07-15 / Open, Classified

FDA source

Stryker Communications began a recall of Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034 on 2025-07-15. FDA classified it as Class II and gives the reason as "Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2620-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-15
Posted: 2025-09-24
Recalling firm: STRYKER Communications, Inc.
Product: Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034
Product code: FSY Light, Surgical, Ceiling Mounted
Reason for recall: Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur.
FDA root cause: Component change control
Action: On 7/15/2025, recall notices were mailed or hand delivered to customers who were asked to do the following: Inform individuals within your organization who need to be aware of this action. 2. A Stryker representative will be in contact with your account to schedule a field service visit at your earliest convenience to complete the following: a. Deinstall impacted Oculan light(s) and reinstall with SLX lights to ensure your operating room stays in use. b. Upon product remediation and availability, Stryker will return to reinstall Oculan within your operating room(s). Your local Stryker representative will provide timing updates as they are available. 3. Complete and return the Business Reply Form to [email protected] 4. Maintain awareness of this communication internally until all required actions have been completed within your facility.
Quantity in commerce: 40
Distribution: US Nationwide distribution in the states of TX, IL, NY, UT, OR, AZ, VT, NY, IL, MN.
Product codes and lots: UDI-DI: 07613327296167 and 07613327651317 REF/Serial Numbers: CH00000001/7000010116, 7000010117, 7000010118, 7000010119, 7000010120, 7000010121, 7000010122, 7000010123, 7000010124, 7000010125, 7000010141, 7000010142, 7000010177, 7000010178, 7000010148, 7000010149, 7000010157, 7000010137, 7000010175, 7000010176, 7000010145, 7000010146, 7000010147, 7000010309, 7000010305, 7000010307, 7000010296, 7000010143, 7000010150, 7000010151, 7000010155. P60034/1000022, 1000023, 1000024, 1000016, 1000017, 1000018, 1000019, 1000020, 1000021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2620-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2620-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-10-01	2025-09-24

Product code FSY

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)