Chromophare Surgical Light (Stryker) – Mounting Stability Risk (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Chromophare Surgical Light System , REF CH00000001
Brand
Stryker Communications
Lot Codes / Batch Numbers
S/N:03857056/ UDI: 07613327296167
Products Sold
S/N:03857056/ UDI: 07613327296167
Stryker Communications is recalling Chromophare Surgical Light System , REF CH00000001 due to Due to insufficient mounting force the stability of surgical light system cannot be guaranteed.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to insufficient mounting force the stability of surgical light system cannot be guaranteed.
Recommended Action
Per FDA guidance
On February 19, 2024, Stryker issued a Urgent Medical Device Recall notification via XXX. In addition to notifying consignees about the recall. Stryker asked consignees to take the following actions: Inform individuals within your organization who need to be aware of this action. 2. Check your internal inventory to locate the product listed in the product affected grid. If affected product is found, segregate and do not use the product. 3. Complete and sign the enclosed Business Reply Form on Attachment A and return to CommunicationsRA1@stryker.com. 4. A Sales Representative or Field Service Technician will be in contact with your facility to schedule a service visit to perform the recall activities. 5. Maintain awareness of this communication internally until all required actions have been completed within your facility. Response is required.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026