Generic Medical Devices GMD UNIVERSAL URINARY INCONTINENCE SLING, Rx ONLY Product Code 1020-18. Intended for use in women as a suburethral sling for the treatment of stress urinary incontinence resulting from either urethral hypermobility and/or intrinsic sphincter deficiency. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
GMD UNIVERSAL URINARY INCONTINENCE SLING, Rx ONLY Product Code 1020-18. Intended for use in women as a suburethral sling for the treatment of stress urinary incontinence resulting from either urethral hypermobility and/or intrinsic sphincter deficiency.
Brand
Generic Medical Devices
Lot Codes / Batch Numbers
Lot number 21664
Products Sold
Lot number 21664
Generic Medical Devices is recalling GMD UNIVERSAL URINARY INCONTINENCE SLING, Rx ONLY Product Code 1020-18. Intended for use in women a due to Product that is approved only for use outside the U.S. was shipped to two customers in the U.S.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product that is approved only for use outside the U.S. was shipped to two customers in the U.S.
Recommended Action
Per FDA guidance
On June 17, 2009 the recalling firm called the consignees and arranged for the unused product to be returned. On July 13, 2009 the firm sent a notification letter to the consignee that had implanted 1 of the devices.
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
NJ, PA
Page updated: Jan 10, 2026