Class II U.S. Food and Drug Administration

Stryker Communications Chromophare Surgical Light System, REF: CH00000001 recall: Surgical lights have stress lines forming on the powder coating

Recall published 1+ years ago

Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur.

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2620-2025
Published
October 1, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Stryker Communications
Product type
Medical devices
Units affected
40
Distribution
Nationwide
Made in
United States
Lot / code info
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
UPC codes
07613327296167, 07613327651317

Products covered by this recall

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

Check your product

The notice names 8 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 07613327296167
  • 07613327651317

Model or item number

On the rating label, the box or the instruction sheet.

  • CH00000001
  • P60034 — UDI-DI

Serial number

On the rating plate, often next to the date of manufacture.

  • CH00000001
  • 7000010116
  • 7000010117
  • 700001

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Stryker Communications — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: Stryker Communications — 571 Silveron Blvd, Flower Mound, TX, 75028

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Stryker Communications medical devices recalled?

Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur. Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 07613327296167, 07613327651317; model number CH00000001, P60034 — UDI-DI. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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