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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 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 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.
Hu-Friedy K360 scalpel handles may separate from the grip during use, allowing the tip to fall into a patient's mouth and cause cuts or choking.
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 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 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 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.
Olympus recalls the VC-10 Vacuum Curettage System due to serious injury risk from incompatible collection canisters. The FDA warns users against using accessories not listed in the device's instructions.
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 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 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 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 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 recalls Freeman Pancreatic Flexi-Stent Kits with incorrect expiration dates on labels that may extend shelf life beyond the actual expiration date.
Johnson & Johnson Surgical Vision is recalling 53,624 units of Veritas Advanced Infusion Packs due to manufacturing defects causing broken or cracked irrigation luers that could compromise ophthalmic surgical procedures.
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 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.
Baxter Healthcare is recalling 334,932 Prismaflex M Set M150 devices due to a mistranslation in instructions that creates contradictory information about patient body weight restrictions.
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 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 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 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 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 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.
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