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.
AVID Medical is recalling Halyard BIOPSY PACK surgical kits due to loose metal flakes from sponge forceps and towel clamps. Metal flakes could enter a patient's surgical site, potentially causing local or foreign body reactions.
AVID Medical recalls Halyard Pacemaker Drape surgical instruments because metal flakes may detach from sponge forceps and towel clamps. Loose metal fragments could enter surgical sites undetected and cause local or foreign body reactions.
The SafeControl handset component of Sentida beds may revert to an active mode after power restoration, potentially causing unintended bed movement. Consumers should ensure beds are safely positioned before power interruptions.
The Metrix Company is recalling VYGON 250 mL IV fluid containers that have been found to leak during filling. Leaking containers cannot properly contain intravenous fluid.
AVID Medical is recalling Halyard CATH LAB PACK surgical kits because sponge forceps and towel clamp components may shed loose metal flakes that could enter a patient's surgical site, posing a risk of local or foreign body reactions.
Stryker is recalling 403,730 Neptune SafeAir Smoke Evacuation Pencil units because they may activate unexpectedly when plugged in, creating a risk of electrical burns to patients and physicians.
AVID Medical is recalling Halyard angiography pack surgical instruments due to loose metal flakes that could detach and enter a patient's surgical site, potentially causing foreign body reactions.
Bard Peripheral Vascular's Venclose RF ablation catheters may have swapped signal wires causing excessive heating. The defect can lead to temperatures exceeding therapeutic levels, increasing risk of thermal injury.
AVID Medical, Inc. is recalling the Halyard Interventional Tray medical kits because sponge forceps and towel clamps may shed small metal flakes. These loose flakes could enter a patient's surgical site undetected, causing local or foreign body reactions.
The FDA is recalling Imed EVA BAG IV bags after a limited number were found to leak during filling. The affected bags were distributed nationwide and in Canada.
The MEERA CL mobile operating table may experience error code 50037 that stops table movement during use, causing surgical procedure delays. Getinge recalled 342 units distributed worldwide.
IMAGEnet 6 ophthalmic software's Hood Report overlay can mislead clinicians about clinical correlations unsupported by evidence. Affects 3,144 units nationwide.
AVID Medical is recalling Halyard Lower Extremity Pack surgical kits because sponge forceps and towel clamps may shed loose metal flakes that could enter a patient's surgical site undetected, potentially causing local or foreign body reactions.
AVID Medical is recalling Halyard PACK MINOR surgical kits due to loose metal flakes that may detach from forceps and towel clamps. These flakes could potentially enter a patient's surgical site, causing local or foreign body reactions.
The MEERA CL operating table may experience error code 50037, causing the table to unexpectedly stop during operation. This error occurs sporadically when controlled via an IR-Hand Control and may delay surgical procedures.
AVID Medical recalls Halyard SAMMC ANGIOGRAPHY medical convenience kits due to loose metal flakes on sponge forceps and towel clamps. Metal flakes may enter surgical sites, potentially causing local reactions or foreign body complications.
AVID Medical is recalling Halyard ORTHO PACK kits because sponge forceps and towel clamps may shed loose metal flakes that could enter a patient's surgical site, causing local or foreign body reactions.
AVID Medical is recalling Halyard IR BIOPSY PACK due to loose metal flakes in forceps and towel clamps that could detach and enter the surgical site, potentially causing local or foreign body reactions.
AVID Medical recalls Halyard TAH-BUNDLE medical kits with sponge forceps and towel clamps. Loose metal flakes may detach and enter surgical sites, potentially causing local or foreign body reactions.
AVID Medical is recalling Halyard MINOR PACK medical kits because sponge forceps and towel clamps may shed loose metal fragments. These could enter surgical sites undetected, potentially causing local or foreign body reactions.
Halyard ENDOVASCULAR Model VMED008-02 surgical convenience kits are recalled due to potential loose metal flakes in sponge forceps and towel clamps. These flakes could enter a surgical site and cause local or foreign body reactions.
AVID Medical is recalling Halyard ORAL SURGERY HEAD medical convenience kits (Model SAMM029-15) due to potential loose metal flakes that could detach from forceps and clamps and enter the surgical site, posing risk of local or foreign body reactions.
Cook Incorporated is recalling Approach CTO Micro Wire Guide devices due to incorrect expiration dates on affected lot labels. The recall affects 2,005 units in the US and 1,145 units overseas.
AVID Medical recalls Halyard LAPAROTOMY GYN surgical packs due to loose metal flakes on sponge forceps and towel clamps. Metal fragments may enter the surgical site and cause local or foreign body reactions.
AVID Medical recalls Halyard ANGIO PACK surgical kits due to loose metal flakes that could detach and enter a patient's surgical site. The recall affects 284 units distributed nationwide.
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