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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.
Synthes (USA) Products LLC is recalling 196 DePuy Synthes Hammertoe Continuous Compression Implants due to an incorrect drill guide size that will not properly prepare bone for the implant, creating potential for bone damage.
BD Vacutainer blood collection tubes are recalled due to isobutylene contamination that may cause false positive results in blood alcohol testing.
Medicina Uk Ltd is recalling 12,000 Oral Tip Syringes (Code: OT005) because the plunger component was manufactured with polyethylene instead of the approved polypropylene material. The syringes do not meet raw material specifications.
Medicina Uk Ltd is recalling Medicina Reusable Oral Syringe 2.5ml units because plunger components were manufactured with polyethylene instead of the specified polypropylene material.
Intersurgical Solus Standard size 3 laryngeal mask airways are marked with incorrect size 4 information, which may cause misuse or improper sizing of the airway device.
B. Braun is recalling CARESITE SMALLBORE EXT SET T-PORT 5 IN. devices due to potential bonded joint failure that could cause leakage or detachment during use. The malfunction may result in delayed therapy, bloodstream infection risk, and exposure to hazardous medications.
Medicina UK Ltd is recalling Reusable Oral Syringes because plungers were manufactured from unapproved polyethylene instead of the specified polypropylene material.
Medline recalls CENTURION SnagFree Chest Tube insertion trays because a silk suture component was sterilized twice instead of once, potentially compromising its integrity. The affected lot contains 18 kits distributed in California and Texas.
ARROW INTERNATIONAL Inc. is recalling an ARROW Pressure Injectable Arrowgard Blue Advance Midline Catheter Kit due to mislabeling. The package labels incorrectly specify a double-lumen 5.5 French catheter, but the kit contains a single-lumen 4.5 French catheter.
Siemens Healthcare Diagnostics recalls N Antiserum to Human IgG reagent for laboratory analyzers because it does not meet expected High-Dose Hook Effect performance specifications for IgG measurements in certain sample types.
Abbott is recalling MitraClip and TriClip Clip Delivery Systems due to clip locking malfunctions. Failed procedures may result in mitral regurgitation recurrence, device embolization, or tissue injury.
BALT USA is recalling Optima Coil System models OPTI0208CSS10 and OPTI0308CSS10 due to a labeling discrepancy where pouch labels do not match carton labels. These endovascular devices require verification before use.
Medicina Uk Ltd is recalling Medicina ENFit 5ml Reusable Enteral Syringes because the plunger component was manufactured with polyethylene instead of the specified polypropylene material.
Approximately 620,000 COVID-19 rapid test devices were distributed in the U.S. without FDA Emergency Use Authorization or approval. Consumers should not use these unauthorized test kits.
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 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 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 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.
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-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.
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 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.
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.
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 devices with incorrect expiration dates that extend shelf life, affecting devices distributed in the US and five other countries from 2018 to 2020.
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