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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.
American Contract Systems Inc recalls 41 URO Robotic Pack surgical kits distributed in Ohio because sterilization assurance requirements could not be confirmed. Non-sterile equipment may lead to delayed treatment.
Merge Healthcare's VERICIS Merge Cardio software (versions 9.0.6 and 9.0.8) may produce measurement inconsistencies under specific workflows. Derived measurements may not match primitive measurements in final patient reports.
American Contract Systems Inc is recalling 91 CRANI PACK cranial procedure kits because a critical component cannot be confirmed to meet sterility requirements, making them unsuitable for surgical use.
American Contract Systems Inc is recalling certain Vein Tray models because sterilization assurance requirements could not be confirmed. The affected units may lack functionality and could lead to delayed treatment.
American Contract Systems Inc is recalling 630 laparoscopy pack kits due to unconfirmed sterilization assurance. This could cause loss of functionality and treatment delays.
Merge Healthcare's VERICIS Merge Cardio cardiovascular information system may display inconsistent measurements under specific workflows involving ultrasound remeasurement or manual measurement editing. No illnesses have been reported.
American Contract Systems is recalling 1,836 Labor and Delivery PPS kits due to inability to confirm sterilization requirements were met. The affected units may lose functionality, potentially delaying patient treatment.
Medline is recalling 880 medical convenience kits containing plastic syringes with potential leaks and breakage. The syringes were identified as defective and may pose health risks to patients.
American Contract Systems unable to confirm sterilization of 956 General Angio Pack kits distributed nationwide. Unsterile devices may lose functionality and delay patient treatment.
American Contract Systems Inc is recalling C-Section PPS positioning systems due to inability to confirm sterilization assurance requirements were met. The failure could lead to loss of functionality and delayed treatment.
American Contract Systems is recalling C-Section surgical packs (252 kits) after being unable to confirm sterilization assurance. Lack of verified sterilization could delay or prolong surgical treatment.
American Contract Systems Inc recalled 690 laceration trays because the company cannot confirm sterilization assurance requirements were met. The recalled devices may lose functionality, potentially delaying or prolonging patient treatment.
American Contract Systems Inc is recalling 90 Open Heart Adult Side A surgical kits due to inability to confirm sterilization requirements were met. Unsterilized devices could lose functionality and delay patient treatment.
Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer (206 units) because an encoder wheel misalignment on the motor shaft can cause the instrument to stop and delay patient test results.
American Contract Systems Inc is recalling 237 laparoscopy surgical packs because sterilization assurance could not be confirmed. The packs may experience loss of functionality and require treatment delays.
Zimmer Orthopedics recalls shoulder prosthesis models due to excess material in the taper that prevents proper surgical assembly. Five complaints reported.
American Contract Systems Inc is recalling Delivery Pack medical devices (Models SGDV22D-01 and SGDV22E) because sterilization assurance requirements were not confirmed. Unsterilized devices may not function properly and could delay treatment.
Oridion Medical's CO2 sampling and airway adapter devices may be difficult to disconnect from endotracheal tubes, potentially causing treatment delays and serious respiratory complications in neonatal, infant, and pediatric patients.
American Contract Systems Inc is recalling 1,200 DR DIULUS Injection Pack kits because the manufacturer cannot confirm sterilization assurance requirements were met. This may result in loss of functionality and treatment delays.
B. Braun Medical is recalling Introcan Safety 3 IV catheters because the valve housing may detach, causing fluid leakage. Approximately 28,200 units are affected.
American Contract Systems Inc is recalling 534 kits of General Laparoscopic Pack-LF surgical instruments because sterilization assurance could not be confirmed. This could result in loss of functionality and treatment delays.
Microstream Neonatal-Infant Intubated CO2 Filter Lines may become difficult or impossible to disconnect from endotracheal tubes during clinical procedures, potentially delaying treatment and causing unintended extubation.
Medline is recalling 1,482 units of Proxima sterile surgical drapes due to potential breaches in pouch packaging that could compromise sterility. No illnesses have been reported.
Microstream CO2 sampling adapters may become difficult or impossible to disconnect from endotracheal tubes, potentially delaying critical procedures and causing respiratory complications.
Microstream CO2 sampling lines may be difficult to disconnect from endotracheal tubes, potentially delaying treatment or causing unintended tube removal.
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