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.
Philips Respironics is recalling Wisp and Wisp Youth nasal masks because they lack warnings about magnetic components that could interfere with implanted medical devices or cause eye injuries from metallic splinters.
IN MY BATHROOM LLC is recalling 485 units of the Seago SG-153 handheld UV-C germicidal wand nationwide due to excessive ultraviolet-C radiation. Consumers should stop using the device and contact the manufacturer for instructions.
Zimmer, Inc. is recalling certain G7 Acetabular System acetabular shells (52 MM and 60 MM) because the outer sterile package has corner walls thinner than specification, which could crack during transit and potentially lead to surgical complications or infection.
Wright Medical Technology recalls 32 units of Stryker EVOLVE Proline Stem due to labeling mismatch: outer packages are labeled with one stem size but contain a different size. Surgeons should verify device size before implantation.
B. Braun is recalling 94,000 Introcan Safety FEP 14G catheters due to potential leakage at the catheter hub. Affected units were distributed in the US and Canada.
Wright Medical is recalling EVOLVE Proline Stem devices due to labeling errors where the outer package does not match the device inside. Affected devices are size-mismatched, which could lead to incorrect surgical placement.
Hologic recalls 233 BioZorb LP Markers nationwide due to removable labels showing incorrect expiration dates. Implants labeled with January 2022 dates may be mistakenly used after their actual July 2024 expiration.
Synthes is recalling Hammertoe Continuous Compression Implant (CCI) Kits because the drill pin is incompatible with the included drill template, which may delay surgery or cause soft tissue damage and adverse tissue reactions.
Philips has recalled MR Patient Care Portal 5000 desktop units (Model 453564792561) due to intermittent audio failure. The device may fail to produce audio, and standard troubleshooting does not reliably resolve the issue.
FDA recalls TANDEM LIFE LivaNova LIFESPARC Controllers due to critical software failures that cause the device to freeze, crash, or stop displaying data. The controllers are used in cardiopulmonary bypass procedures.
Medline ClearPro closed suction catheters may have a connector that separates from the device during patient suctioning. The malfunction affects 65,320 units distributed nationwide and internationally.
Cook Incorporated is recalling Cope Mandril Wire Guide stainless steel guidewires because the packaging chevron seal may be completely breached, compromising device sterility. Affected lots total 2,748 units in the US and 302 internationally.
Cook Incorporated is recalling Roadrunner PC Wire Guide guidewires due to a complete breach of the sterile packaging seal. The breach may compromise device sterility, affecting 202 units in the US and 11 internationally.
Cook Incorporated recalls Roadrunner PC Wire Guide devices due to a potential packaging seal breach that may compromise sterility. The recall affects 115 units distributed domestically and internationally.
Cook Incorporated is recalling Bentson Wire Guide devices due to potential packaging defects that may compromise device sterility.
Cook Incorporated is recalling specific lots of Double Flexible Tipped Wire Guide Guidewire devices due to a complete breach of the packaging chevron seal, which may compromise sterility.
Tandem Diabetes Care is recalling approximately 8,399 t:slim X2 insulin pumps due to software malfunctions that may affect blood sugar control. A software update is available to resolve the issues.
A software update for BD Pyxis MedBank medication dispensing cabinets contains an incompatible file that prevents Matrix drawers from opening, potentially delaying medication access in healthcare facilities.
Barco NV recalls 169 NexxisOR system network adapters (models K9303078A and K9303097A) due to installation issues. The affected devices were distributed in Florida, Illinois, and New Jersey.
Cook Incorporated is recalling Roadrunner PC Hydrophilic Guidewires due to potential packaging seal breaches that may compromise device sterility. Affected devices were distributed in the United States and internationally.
CooperSurgical is recalling BT37 benchtop incubator humidifier and filter kits due to a potential sterile barrier breach. The defect may allow unsterilized devices to contaminate and degrade embryos during incubation.
Cook Incorporated is recalling Coons Interventional Wire Guide devices because the chevron seal on packaging may be completely breached, compromising sterility. 1,236 units were distributed.
Cook Incorporated is recalling Roadrunner PC Wire Guide devices due to a breach in packaging's chevron seal that may compromise sterility. Affected devices should not be used.
Malvern Panalytical is recalling 76 NanoSight LM10 laboratory instruments that do not comply with Class 1 laser safety requirements. The company is taking this action to prevent potential laser exposure risks.
Cook Incorporated recalls Roadrunner PC Wire Guide devices due to packaging seal breaches that may compromise sterility. Devices were distributed nationwide and internationally.
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