Sandhill Scientific, Inc Schuster Anorectal Manometry Probe. Labeling applied to the ballon pouch reads in part: ''SANDHILL SCIENTIFIC SCHUSTER ANORECTAL MANOMETRY PROBE Rectosphincteric Manometry Balloon Probe Manufactured by: SANDHILL SCIENTIFIC, INC. HIGHLANDS RANCH, COLORADO USA P/N: A86-4050. *** Size: Adult ... CAUTION: Balloon are made of latex rubber. *** Do not use if latex sensitivity exists.' Additional labeling found on the pouch reads in part: 'Cat. 92510 Convertors Self-Seal Pouch 51/4'x10' *** Latex F Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Schuster Anorectal Manometry Probe. Labeling applied to the ballon pouch reads in part: ''SANDHILL SCIENTIFIC SCHUSTER ANORECTAL MANOMETRY PROBE Rectosphincteric Manometry Balloon Probe Manufactured by: SANDHILL SCIENTIFIC, INC. HIGHLANDS RANCH, COLORADO USA P/N: A86-4050. *** Size: Adult ... CAUTION: Balloon are made of latex rubber. *** Do not use if latex sensitivity exists.' Additional labeling found on the pouch reads in part: 'Cat. 92510 Convertors Self-Seal Pouch 51/4'x10' *** Latex F
Brand
Sandhill Scientific, Inc
Lot Codes / Batch Numbers
Product model # A86-4050. All lot numbers.
Products Sold
Product model # A86-4050. All lot numbers.
Sandhill Scientific, Inc is recalling Schuster Anorectal Manometry Probe. Labeling applied to the ballon pouch reads in part: ''SANDHILL due to The product is mislabeled. The labeling on the front of the packaging states that product contains latex. However, the back of the package contains . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The product is mislabeled. The labeling on the front of the packaging states that product contains latex. However, the back of the package contains a latex- free symbol.
Recommended Action
Per FDA guidance
Consignees were notified by letter on 12/13/2005.
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 noticeDistribution
As reported by FDA
CA, CO, GA, ID, IL, IN, IA, KS, LA, MD, MO, NE, NJ, NM, OR, PA, TN, TX, VT, VA, WA, WV
Page updated: Jan 10, 2026