FDA (Devices) recall action 90769
The FDA (Devices) publishes a recall like this one as 61 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 61 pages.
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Hobbs Medical recalled 10 units of its Helical Retrieval Basket due to mislabeled expiration dates that extend the product's shelf life, affecting devices distributed in the US and select countries between 2018 and 2020.
Hobbs Medical is recalling transbronchial aspiration needles with incorrect expiration dates on labels. The 18 affected units were distributed in the US, Canada, Austria, Belgium, Finland, and Norway from March 2018 to September 2020.
Hobbs Medical is recalling Helical Retrieval Baskets with incorrect expiration dates that extend shelf life. Devices distributed from March 2018 through September 2020 may be used beyond their safe operating period.
Hobbs Medical is recalling Biliary Pigtail Stent Kits due to incorrect expiration dates on device labels that extend shelf life, affecting 15 units distributed from March 2018 to September 2020.
Hobbs Medical recalls Freeman Pancreatic Flexi-Stent kits with incorrect expiration dates on the label, which extends the stated shelf life and could allow use of expired devices.
Hobbs Medical is recalling Hobbs Helical Retrieval Basket (Catalog Number 4830) due to an incorrect expiration date on the device label. Affected devices have lot numbers ending in 'R' and were distributed in the US from March 2018 to September 2020.
Hobbs Medical is recalling Biliary Pigtail Stent Kits with incorrect expiration dates on labels. The incorrect dates extend the product shelf life, potentially allowing devices to be used past their actual expiration.
Hobbs Medical is recalling 140 units of its Hobbs Scope Introducer due to incorrect label expiration dates that extend the shelf life. Affected devices were distributed in the US and internationally from March 2018 to September 2020.
Hobbs Medical recalls biliary stent kits with incorrect expiration dates that extend shelf life. The kits were distributed from 2018 to 2020 in the US and select countries.
Hobbs Medical is recalling its Polypectomy Snare for an incorrect expiration date on the label that extends shelf life. Affected devices were distributed in the US and other countries from March 2018 to September 2020.
Hobbs Medical is recalling Posi-Stop Injection Needles due to incorrect expiration dates on device labels that extend shelf life. Devices distributed between March 2018 and September 2020 could be used beyond their actual expiration.