Recall Record: Class II Recall: ALYON Surgical Lighting System by Steris Corporation

Key facts

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Steris Corporation and the affected product is described in FDA's record as: ALYON Surgical Lighting System. FDA's stated reason for the recall is: The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.. The recall is tracked under FDA recall number Z-2450-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended. Adverse events believed to be related to a recalled product can be reported to FDA's MedWatch program, which FDA uses to monitor safety signals after a recall is opened.

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- ALYON Surgical Lighting System -- and the recall number Z-2450-2026. If it matches, stop using or distributing it and contact Steris Corporation or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

Steris Corporation’s FDA history

Argus HQ has recorded 3 total FDA actions tied to Steris Corporation: 0 warning letters, 3 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What was recalled and why?

Steris Corporation recalled ALYON Surgical Lighting System. FDA's record states the reason for recall as: The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.. The recall is logged under FDA recall number Z-2450-2026 with a Class II classification.

How serious is this recall?

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.

What should someone who has this product do?

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (ALYON Surgical Lighting System) and recall number Z-2450-2026, then follow Steris Corporation's recall instructions.

Has Steris Corporation had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 3 total FDA actions tied to Steris Corporation, including 3 recalls and 0 warning letters.

Related enforcement actions