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 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 Helical Retrieval Baskets with incorrect expiration dates on labels. The labeled shelf life extends beyond the actual safe duration for device use.
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 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 recalls Biliary Pigtail Stent Kits with labeling showing incorrect expiration dates that extend the shelf life. Affected kits were distributed to US and international customers from March 2018 to 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 Hobbs Posi-Stop Injection Needles due to incorrect expiration dates on device labels that extend the shelf life. Affected devices have lot numbers ending in 'R' distributed from 2018–2020.
Hobbs Medical, Inc. is recalling Biliary Pigtail Stent Kits with incorrect expiration dates displayed on device labels. Affected devices distributed from March 2018 through September 2020 may be used beyond their validated shelf life.
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 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 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 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 Biliary Pigtail Stent Kits distributed from March 2018 to September 2020 due to incorrect expiration date labels that extend the shelf life beyond the actual safe period.
Hobbs Medical Grasping Forceps (Catalog 5008) were distributed with incorrect expiration dates that extend shelf life beyond the device's actual safe use period. Affected units with lot numbers ending in 'R' were distributed from March 2018 to September 2020.
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 is recalling polypectomy snares with incorrect expiration dates on labels. Affected devices have lot numbers ending in R and were distributed from March 2018 to September 2020.
Hobbs Medical is recalling Spray Catheter devices due to incorrectly labeled expiration dates that extend shelf life beyond the actual safe-use period. The recall affects 275 units distributed between March 2018 and September 2020.
Hobbs Medical is recalling Freeman Pancreatic Flexi-Stent devices with incorrect expiration dates on labels that extend perceived shelf life beyond actual device longevity.
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 Cytology Brush Catalog Number 4206 due to incorrect expiration dates on product labels that extend the intended shelf life. Approximately 300 units were distributed nationwide and internationally between March 2018 and September 2020.
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, Inc. is recalling Grasping Forceps due to incorrect expiration dates on device labels. Affected devices may be used beyond their safe shelf life if the mislabeled expiration dates are not corrected.
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 Freeman Pancreatic Flexi-Stent Kits with incorrect expiration dates on labels, potentially allowing devices to be used beyond their actual safe shelf life. Affected units were distributed from March 2018 to September 2020.