[Recalled] PBD-203-0707 BILIARY STENT, model no. PBD-203-0707 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage. — Inspection confirmed a small percentage of sterile packages with inadequate pac… | FDA 2021-01-

Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

This Class II recall concerns device products distributed in Japan and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Aomori Olympus Co., Ltd.

• INJECTOR FORCEMAX 25G 2.5MM, model no. NM-400U-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract. — Class II
• KD-611L ELECTROSURGICAL KNIFE, model no. KD-611L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract. — Class II
• K-202 GUIDE SHEATH KIT 2.0MM, model no. K-202 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs. — Class II
• NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610U-0323 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract. — Class II
• SD-230U-20 ELECTROSURGICAL SNARE, model no. SD-230U-20 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract. — Class II
• B7-2LA BALLOON CATHETER 13MM DIA 3.2, model no. B7-2LA - Product Usage: Used with endoscopes for injection of contrast medium or other medical fluid into the biliary or pancreatic tract. — Class II

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.