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 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 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 recalls Freeman Pancreatic Flexi-Stent Kits due to labeling errors showing incorrect expiration dates that extend the shelf life of affected devices.
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 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 recalls Freeman Pancreatic Flexi-Stent devices with incorrect expiration dates that extend shelf life, affecting devices distributed in the US and five other countries from 2018 to 2020.
Hobbs Medical is recalling Polypectomy Snare devices (Catalog Number 4564) due to incorrect expiration dates on labels that extend the stated shelf life. The 35 affected units, distributed in the US and select countries, may be used beyond their actual safe shelf life.
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.
Hobbs Medical is recalling Polypectomy Snares (Catalog 7202) with incorrect expiration dates on labels, which could allow use of expired devices. Units were distributed in the US and several other countries from March 2018 to September 2020.
Hobbs Medical is recalling Biliary Pigtail Stent Kits for incorrect expiration dates on product labels that may extend shelf life. Affected kits were distributed nationwide and internationally between March 2018 and September 2020.
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 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, Inc. is recalling Posi-Stop Injection Needles with lot numbers ending in 'R' due to incorrect expiration dates on device labels. The mislabeling extends the apparent shelf life, potentially allowing use of expired sterile devices.
Freeman Pancreatic Flexi-Stent Kits are recalled due to device labels displaying incorrect expiration dates that extend shelf life. Affected units were distributed in the US and select countries from March 2018 to September 2020.
Hobbs Medical is recalling Biliary Pigtail Stent Kits due to incorrect expiration dates on device labels that extend shelf life beyond actual product expiration, potentially resulting in use of expired devices.
Hobbs Medical polypectomy snares have incorrect expiration dates on labels that extend the device shelf life beyond safe limits. Affected products distributed from March 2018 to September 2020 may be used past their intended expiration.
Hobbs Medical recalls Transbronchial Aspiration Needle (Catalog 4621) for incorrect expiration dates extending shelf life. Affected devices distributed in the US and internationally from March 2018 to 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, 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 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.
Hobbs Medical recalls the Freeman Pancreatic Flexi-Stent Kit due to incorrect expiration dates on product labels that extend shelf life. Affected devices were distributed to the US and international markets from March 2018 through September 2020.
Hobbs Medical recalls the Helical Retrieval Basket due to labels displaying incorrect expiration dates that extend the device's shelf life. Affected units distributed worldwide from March 2018 to September 2020 may be used beyond their validated lifespan.
Hobbs Medical is recalling Posi-Stop Injection Needles (lot numbers ending in R) due to incorrect expiration dates on labels that extend shelf life. Affected devices were distributed in the US from March 2018 to September 2020.
Hobbs Medical is recalling Hobbs Posi-Stop Injection Needles with certain lot numbers because device labels display an incorrect expiration date, extending the product's indicated shelf life.
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.