Recalls
Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.
Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.
The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.
Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.
Minimum severity
First Source Inc is recalling the First Source Vision M portable X-ray cart because the bolt securing the positioning arm to the gas spring may come loose and fall onto a patient.
Certain Zyno Medical Z800 series infusion pumps contain faulty power supply modules that cannot charge the rechargeable battery. When unplugged from AC power, affected pumps may lack sufficient charge to operate.
Medline Industries is recalling 12,588 sterile surgical convenience kits due to weak seals on Pure Pouch components that may breach sterility. Products were distributed nationwide across 23 states.
Medline recalled 7,673 surgical convenience kits nationwide due to weak seals in the Pure Pouch component that may compromise sterility of surgical instruments. No injuries have been reported.
Philips is recalling Avalon ultrasound transducers used for monitoring fetal heart rate. The device may produce inaccurate measurements when monitoring multiple fetuses, potentially delaying detection of fetal distress.
Medline surgical convenience kits containing Pure Pouch components with weak seals may fail to maintain sterility, potentially compromising the safety of contained medical instruments. Affected kits were distributed nationwide across 23 states.
Medline sterile surgical kits are being recalled nationwide due to weak seals in the Pure Pouch component that may allow sterility breach. The recall affects 12,588 units distributed across 23 states.
Applied Medical Technology is recalling 74 units of the AMT Initial Placement Dilator Set (Model IP-DIL) due to incorrect guidewire labeling. The labeling error could result in improper guidewire selection during gastrostomy placement procedures.
Nalu Medical recalls 13 neurostimulation and peripheral nerve stimulation kits due to a manufacturing defect that may prevent the implantable pulse generator from functioning, stopping pain signal inhibition.
Medline is recalling 12,588 sterile surgical kits with Pure Pouch components that have weak seals, potentially compromising sterility and exposing patients and surgical teams to non-sterile instruments.
Angiodynamics is recalling IsoLoc Prostate Immobilization Balloons (ISO-100, Lot 5402) for mislabeling. Devices have 100cc fill volume but are labeled as ISO-60 (60cc).
BD Pyxis automated dispensing cabinets were shipped with socket-outlet power strips that lack IEC electrical certification, potentially exposing users to leakage currents and electric shock.
Siemens ARTIS icono angiography systems with certain detectors may deliver higher-than-intended radiation doses in rare cases. The issue occurs when incorrect copper prefiltration is applied during initial x-ray exposure after patient registration.
A software issue in BD Alaris System Manager version 12.5.1 may prevent the PC unit from connecting to the server, potentially affecting wireless data transmission. CareFusion 303, Inc. is recalling the affected software version nationwide.
Medline is recalling over 7,600 Open Heart surgical convenience kits nationwide due to weak seals on the Pure Pouch component. The seals may fail and compromise the sterility of the surgical instruments inside.
Siemens ARTIS icono angiography systems with specific detector configurations may deliver higher radiation doses than intended in rare cases. The issue occurs during the first X-ray exposure after patient registration.
Medline is recalling Neuro IR surgical convenience kits due to weak seals in the Pure Pouch component that may compromise sterility. The recall affects 12,588 kits distributed nationwide.
Stryker Corporation has recalled expired sterile cannula devices distributed nationwide. The devices were past their expiration date, potentially compromising sterility and device safety.
Stryker Sustainability Solutions is recalling 6 units of BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters because they do not meet FDA testing requirements. The devices were distributed to Japan.
Medline is recalling approximately 12,588 sterile surgical kits used for childbirth procedures because weak seals on Pure Pouch components may fail and compromise sterility.
SeaSpine Orthopedics recalls Fathom Pedicle-Based Retractor C/C Blades due to manufacturing defects that could cause bone fracture or damage during surgery. 21 units were distributed nationwide.
Beckman Coulter is recalling 116 DxI 9000 Immunoassay Analyzers due to a software defect that fails to properly validate calibrator barcodes, potentially resulting in incorrect calibration curves and erroneous patient test results.
The Life2000 Ventilator may fail to charge or experience intermittent charging behavior due to damage to the battery charger dongle. This FDA Class I recall affects approximately 2,510 units distributed nationwide.
Inspire Medical Systems recalls the Model 3028 Implantable Pulse Generator due to a manufacturing defect causing electrical leakage and system malfunction that requires revision surgery. The recall affects 24 devices distributed in the US and Germany.
Philips is recalling 307 SENSE XL TORSO COIL 3.0T units used in MR imaging systems worldwide due to potential for coils to overheat and cause patient burn injuries.