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 Freeman Pancreatic Flexi-Stents due to incorrect expiration dates on device labels. The mislabeled dates extend shelf life, potentially allowing use of expired devices.
Hobbs Medical is recalling Helical Retrieval Baskets due to incorrect expiration dates on device labels. The mislabeling extends the shelf life, potentially allowing use of expired devices.
Hobbs Medical is recalling the Freeman Pancreatic Flexi-Stent Kit because the device label displays an incorrect expiration date that extends the shelf life. U.S. distribution of affected devices occurred between March 25, 2018 and September 28, 2020.
Hobbs Medical is recalling its Cytology Brush (catalog 4204) because device labels show incorrect expiration dates that extend the claimed shelf life. Affected devices were distributed in the US and several other countries from March 2018 to September 2020.
Hobbs Medical is recalling Retrieval Forceps with incorrect expiration dates on device labels. Affected devices distributed between March 2018 and September 2020 may be used past their actual expiration.
Hobbs Medical is recalling Freeman Pancreatic Flexi-Stent devices with incorrect expiration dates on labels. Affected units distributed in the US and internationally from 2018 to 2020 may have extended shelf lives beyond accuracy.
Hobbs Medical recalled Freeman Pancreatic Flexi-Stent devices due to incorrect expiration dates on labels that extend the shelf life, potentially allowing use beyond intended timeframe.
Hobbs Medical Flex-Ez Guide Wire devices were labeled with an incorrect expiration date that extends shelf life beyond the intended duration. Affected devices were distributed in the US and internationally from March 2018 to September 2020.
Hobbs Medical recalls Freeman Pancreatic Flexi-Stent Kit units with incorrect expiration dates on labels, extending apparent shelf life. Units distributed in the US and Canada, Austria, Belgium, Finland, and Norway from 2018–2020 are affected.
Hobbs Medical recalls Freeman Pancreatic Flexi-Stent Kits due to mislabeled expiration dates that may extend shelf life. Affected devices with lot numbers ending in R were distributed in the US and internationally from 2018-2020.
Hobbs Medical recalled Posi-Stop Injection Needles with incorrect expiration dates on labels, potentially allowing use of units past actual expiration. The recall affects 17 units distributed in the US and several countries.
Hobbs Medical is recalling Polypectomy Snare model 4565-OLY due to incorrect expiration dates on device labels that extend the product's shelf life. Affected devices were distributed between March 2018 and September 2020.
Hobbs Medical recalls Freeman Pancreatic Flexi-Stent Kits with incorrect expiration dates on labels that may extend shelf life beyond the actual expiration date.
Hobbs Medical is recalling Helical Retrieval Baskets (Catalog 4822) with incorrect expiration dates on device labels. The mislabeled dates extend the shelf life, risking use of expired devices that may not perform as intended.
Hobbs Medical, Inc. is recalling Hobbs Helical Retrieval Baskets with lot numbers ending in R due to incorrect expiration dates on device labels. Affected units were distributed worldwide from March 2018 to September 2020.
Hobbs Medical is recalling Freeman Pancreatic Flexi-Stent devices with incorrect expiration dates on their labels. The labeling error extends the shelf life beyond the intended timeframe.
Hobbs Medical Spray Catheter devices sold between March 2018 and September 2020 have incorrect expiration dates on their labels. The error may extend the device's shelf life beyond its actual expiration.
Hobbs Medical is recalling Freeman Pancreatic Flexi-Stents with incorrect expiration dates on device labels that extend shelf life. Devices were distributed in the US and internationally from March 2018 to September 2020.
Hobbs Medical is recalling Freeman Pancreatic Flexi-Stent devices due to incorrect expiration dates on the device labels. Affected units distributed in the US and internationally from March 2018 to September 2020 may have been used beyond their actual safe shelf life.
Hobbs Medical is recalling Freeman Pancreatic Flexi-Stent devices distributed between March 2018 and September 2020 due to incorrect expiration dates on product labels. The mislabeled devices display extended shelf-life information that does not reflect actual product safety.
Hobbs Medical is recalling Freeman Pancreatic Flexi-Stent devices with incorrect expiration dates on labels that extend perceived shelf life beyond actual device longevity.
Freeman Pancreatic Flexi-Stents with incorrect expiration dates on labels may be used beyond their validated shelf life. The recall affects devices distributed in the US and five other countries from March 2018 through September 2020.
Hobbs Medical is recalling Freeman Pancreatic Flexi-Stent devices due to incorrect expiration dates on product labels. The labeling error extends the stated shelf life, potentially allowing use of degraded devices.
Hobbs Medical is recalling certain Biliary Pigtail Stent Kits due to incorrect expiration dates on device labels that extend shelf life beyond actual validity. Affected devices distributed between March 2018 and September 2020 may be used beyond their true expiration date.
Hobbs Medical is recalling Freeman Pancreatic Flexi-Stent devices due to incorrect expiration dates on product labels. The incorrect dates extend the shelf life, potentially allowing use beyond the actual safe expiration.