Skytron, Div. The KMW Group, Inc Skytron Infinity Series surgical light, 4 bulbs in 1 - 22' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF54, IF54EL, IF54LH and IF54S. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Skytron Infinity Series surgical light, 4 bulbs in 1 - 22' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF54, IF54EL, IF54LH and IF54S.
Brand
Skytron, Div. The KMW Group, Inc
Lot Codes / Batch Numbers
Each lighthead bears a unique serial number. For units with model numbers beginning in IF54, 96, 97, 98, 99, 00 or 01 (example: xx98xxx).
Products Sold
Each lighthead bears a unique serial number. For units with model numbers beginning in IF54, all serial numbers with the following numbers in the third and fourth positions of the numerical series: 95, 96, 97, 98, 99, 00 or 01 (example: xx98xxx).
Skytron, Div. The KMW Group, Inc is recalling Skytron Infinity Series surgical light, 4 bulbs in 1 - 22' diameter lighthead, Manufactured by Dai-i due to If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.
Recommended Action
Per FDA guidance
The firm initially notified consignees of this problem on 11/23/1999 and again on 11/01/2002 and most lights have already been corrected. Remaining consignees with lights in need of correction were notified of the problem via letter dated 1/8/07 and instructed to contact the distributor to have their lights inspected and modified.
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