Category
FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.
Medical device recalls are the FDA's highest-volume stream. They cover implantable devices like pacemakers and joint replacements, hospital diagnostics and lab analyzers, surgical instruments, software-as-a-medical-device, and consumer-facing hardware like CPAP machines, blood-pressure cuffs, and glucose monitors. The volume comes from the wide range of products in scope and from the FDA's broad definition of 'corrective action' — software updates, IFU revisions, and labeling corrections all show up as recalls.
For Class I device recalls, the device's defect creates a reasonable risk of serious injury or death — these are the urgent ones. Class II covers issues that may cause temporary or medically reversible harm, often around accuracy or calibration. Class III is for products that don't comply with FDA rules but pose no real safety risk; in practice many software-update letters are Class III.
If you depend on a recalled device for ongoing care, don't disconnect or stop using it before talking to the prescribing clinician — interrupting therapy for a CPAP or a continuous glucose monitor can be more dangerous than the recall it's responding to. Almost every device recall offers a remedy that doesn't require you to surrender the device first.
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 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.
American Contract Systems is recalling COVID test kits incorrectly labeled for SARS-CoV-2 testing use. The 39,575 kits distributed in Pennsylvania should not be used with COVID devices.
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 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 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 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.
Medline Industries is recalling 1,760 Venclose procedure packs due to incorrect introducer/sheath component size. Affected kits contain 12cm components instead of the required 7cm.
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 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 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 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, 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.
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 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 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 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 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 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 Freeman Pancreatic Flexi-Stent devices with incorrect expiration dates on labels that extend perceived shelf life beyond actual device longevity.
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 with certain lot numbers because device labels display an incorrect expiration date, extending the product's indicated shelf life.
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 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 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.
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