Some lots of women’s endoscopy and urology health devices, such as feeding tube parts, pelvic floor repair kits, and incontinence products made by Boston Scientific are being recalled by the Food and Drug Administration (FDA) because they were stolen prior to being sterilized sometime between April 8, 2011 and April 11, 2011. These devices are non-sterile and may cause serious health problems for patients including post-operative infections.

The devices are imprinted with the word “sterile” but they have not been sterilized. They may have been sold to hospitals and clinics, likely at a discounted rate. Customers are being advised to check their inventories for the recalled lots, and to continue to monitor incoming shipments for the affected products.

Devices included in the recall include clipping devices used for placement in the gastro-intestinal (GI) tract for hemostasis, endoscopic marking, anchoring jejunal feeding tubes, or as a supplementary method for closure of GI tract luminal perforations; pelvic floor repair kits used for pelvic floor repair of pelvic organ prolapse; fiber optic laser energy delivery devices; and implantable mesh slings used for stress urinary incontinence.

Anyone with information regarding the stolen products or who has received suspicious or unsolicited offers for the recalled devices after the date of theft is encouraged to contact the FDA Office of Criminal Investigations at (800) 551-3989, or by visiting the OCI website at www.FDA.gov/OCI. Any serious side effects with this or any other medical device should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch.