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.
Select lots of HydroPICC 4Fr catheters are mislabeled with expiration dates that exceed their actual expiration. Affected units should not be used.
Medline Industries is recalling 60 units of its Breast Biopsy Kit nationwide because the outer wrapping is not sterile. Only the kit's contents maintain sterility.
Access Vascular, Inc is recalling HydroPICC 4Fr Single Lumen catheters (Model 80001001) due to incorrect expiration date labeling. The devices expire earlier than the labeled date.
MEDLINE INDUSTRIES is recalling CENTURION MEDICAL PRODUCTS Circumcision Tray kits (Lot 22HMH649) because the outer packaging is non-sterile, though the surgical contents inside remain sterile.
GE Nuclear Medicine 600/800 series imaging systems may have faulty detectors that could fall, causing serious injury. Mitigation measures may not be properly implemented on 34 units distributed worldwide.
GE is recalling 86 Nuclear Medicine 600/800 series systems worldwide due to a potential failure in a safety mitigation. If not correctly implemented, the detector can fall and cause life-threatening injury.
GE Medical Systems is recalling 380 GE Nuclear Medicine 600/800 series diagnostic imaging systems worldwide due to potential failure in detector mitigation that could allow the detector to fall, risking life-threatening injury.
GE Nuclear Medicine 600/800 series systems (748 units distributed worldwide) may have improperly implemented detector fall mitigations. If the mitigation fails, the detector can fall and cause life-threatening bodily injury.
GE Nuclear Medicine 600/800 series systems have a safety mitigation that may not be correctly implemented, allowing the detector to fall and cause life-threatening injury. 557 units are affected worldwide.
GE Nuclear Medicine BRIVO B615 imaging systems may have an ineffective safety mitigation, allowing the detector to fall and cause life-threatening injury. The FDA issued a Class I recall for seven units distributed worldwide.
The collar release pin on affected Smart Correction Dual Joint Express Struts may back out, preventing proper length adjustment and potentially delaying surgical correction.
Medline Industries is recalling sterile surgical trays used in plastic and reconstructive surgery because blades within the kits can puncture the outer foil packaging, potentially compromising sterility. Approximately 15,009 units were distributed nationwide and internationally.
Medline Industries is recalling sterile procedural trays because sterile blades may puncture the outer packaging foil, potentially compromising sterility. No injuries have been reported.
Medline Industries is recalling Sterile Procedural Trays (LS MS PACK) because the sterile blade inside can potentially puncture the outer packaging layer, compromising sterility.
Quest Medical recalls Precision Delivery Sets (models PD06F and PDT05CV2) due to tubing that may detach, potentially causing patient infection. Approximately 13,900 units were distributed nationwide.
Medline Industries is recalling sterile procedural trays because blades within the kits may puncture the outer foil packaging, potentially compromising sterility.
Medline Industries recalls sterile surgical procedural trays because blades inside could puncture the outer sterile packaging, potentially compromising kit sterility.
Medline Industries is recalling sterile procedural trays because sterile blades within the kits may puncture the outer foil sterile packaging, potentially compromising sterility.
Medline Industries is recalling approximately 27,563 units of sterile procedural trays used in surgery because sterile blades may puncture the outer foil packaging layer, potentially compromising sterility.
Olympus is recalling the SPiN Thoracic Navigation System (model SYS-4000) due to an incorrect DVI cable that produces grainy images during bronchoscopy procedures, requiring extended troubleshooting time.
MEDLINE INDUSTRIES is recalling six models of sterile surgical trays due to a potential for blades within the kits to puncture the sterile packaging. Affected trays were distributed worldwide.
Medline Industries is recalling TRACH PACK sterile procedure kits because sterile blades within the kits can puncture the outer foil packaging, potentially compromising product sterility.
Medline recalls sterile surgical trays (Universal Plastic and Knee Arthroscopy Pack) because sterile blades can puncture the outer foil packaging, potentially compromising sterility.
MEDLINE INDUSTRIES is recalling sterile surgical trays used in robotic and laparoscopic procedures because blades within the kits can puncture the outer foil packaging. The recall affects 1,212 cases (2,101 units) distributed worldwide.
Medline sterile procedural trays are recalled because sterile blades within the kits can puncture the outer foil packaging, potentially compromising sterility. 622 cases (1,619 units) have been distributed worldwide.
Looking for a different category? Browse all recalls.