openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 2
Stryker SmartLife Large Aseptic Housing REF 7126-120-000 Rx Only The SmartLife" Aseptic Housings are designed to be used in conjunction with the SmartLife Non-Sterile Batteries to provide power for System 7 Handpieces, Cordless Driver 4 Handpiece, and Sabo2 Sagittal Saw Handpiece.
The SmartLife Aseptic Housings are being recalled in that the top section of the housing may separate from the bottom section due to insufficient welding.
These labels are deterministic app interpretations, not FDA categories.
The SmartLife Aseptic Housings are being recalled in that the top section of the housing may separate from the bottom section due to insufficient welding.
Code information
Part Number 7126-120-000; All lot numbers from 13027 to 14093
Distribution pattern
Worldwide Distribution: US (nationwide) WI, MD, NY, NM, AZ, GA, CA, MN, DE, PA, TX, MT, MI, KS, KY, WY, IL; and countries of: Australia, Canada, Sweden, Netherlands, France Switzerland, India, Japan, Poland, South Africa, England, and Hong Kong.
device · product 2 of 2
Stryker SmartLife Small Aseptic Housing REF 7222-120-000 Rx Only The SmartLife" Aseptic Housings are designed to be used in conjunction with the SmartLife Non-Sterile Batteries to provide power for System 7 Handpieces, Cordless Driver 4 Handpiece, and Sabo2 Sagittal Saw Handpiece.
The SmartLife Aseptic Housings are being recalled in that the top section of the housing may separate from the bottom section due to insufficient welding.
These labels are deterministic app interpretations, not FDA categories.
The SmartLife Aseptic Housings are being recalled in that the top section of the housing may separate from the bottom section due to insufficient welding.
Code information
Part Number 7222-120-000; All lot numbers from 13072 to 14121
Distribution pattern
Worldwide Distribution: US (nationwide) WI, MD, NY, NM, AZ, GA, CA, MN, DE, PA, TX, MT, MI, KS, KY, WY, IL; and countries of: Australia, Canada, Sweden, Netherlands, France Switzerland, India, Japan, Poland, South Africa, England, and Hong Kong.
