Skytron, Div. The KMW Group, Inc Skytron Infinity series (also called Astro series) minor surgery light, 3 bulbs in 1 - 19' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Japan; Models IN19, IN19EL, IN19LH and IN19S. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Skytron Infinity series (also called Astro series) minor surgery light, 3 bulbs in 1 - 19' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Japan; Models IN19, IN19EL, IN19LH and IN19S.
Brand
Skytron, Div. The KMW Group, Inc
Lot Codes / Batch Numbers
Each lighthead bears a unique serial number. For units with model numbers beginning with IN 19, 96, 97
Products Sold
Each lighthead bears a unique serial number. For units with model numbers beginning with IN 19, all seven digit serial numbers with the following numbers in the third and fourth positions of the numerical series: 95, 96, 97, 98 or 99 (example: xx95xxx) plus all eight serial numbers with a 0 in the fifth position (example: xxxx0xxx).
Skytron, Div. The KMW Group, Inc is recalling Skytron Infinity series (also called Astro series) minor surgery light, 3 bulbs in 1 - 19' diameter 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