Z-1688-2026Class II

Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001

Name: Z-1688-2026 Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001
Creator: Stryker Communications
Published: 2026-02-23
License: https://open.fda.gov/license/

STRYKER Communications, Inc. / initiated 2026-02-23 / Open, Classified

FDA source

Stryker Communications began a recall of Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001 on 2026-02-23. FDA classified it as Class II and gives the reason as "Surgical light assembly may not adequate support the weight of the ceiling cover". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1688-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-02-23
Posted: 2026-03-27
Recalling firm: STRYKER Communications, Inc.
Product: Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001
Product code: FSY Light, Surgical, Ceiling Mounted
Reason for recall: Surgical light assembly may not adequate support the weight of the ceiling cover.
FDA root cause: Unknown/Undetermined by firm
Action: On February 23, 2026 Stryker issued "Urgent: Medical Device Recall" via E-Mail to affected consignees. Stryker ask consignees to take the following actions: 1. Inform individuals within your organization who need to be aware of this action. 2.Check your internal inventory to locate the product. 3.Please complete, Business Reply Form, as an acknowledgement of this notice and return the completed form via email to [email protected]. Response is required. 4. A representative will contact affected accounts to schedule a field service visit to complete an inspection and replacement of the affected component. 5. Maintain awareness of this communication internally until all required actions have been completed within your facility. 6. Inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients appropriately.
Quantity in commerce: 6170 units
Distribution: Worldwide - US Nationwide distribution.
Product codes and lots: UDI: 07613327296167; All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1688-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1688-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-03-27

Product code FSY

K120392Class IIChromophare F 628 and F 528Berchtold GmbH & Co. KG / cleared 2012-02-16

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)