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.
Minimum severity
Orthofix recalled the PILLAR SA Ti spinal implant due to labeling errors stating 33mm width instead of the actual 37mm. The discrepancy affects three lots distributed in Colorado and California.
Siemens is recalling 20 Artis Pheno fluoroscopic X-ray systems due to limited movement after startup. The issue affects specific serial numbers across multiple US states.
Baxter Healthcare recalls Novum IQ infusion pumps due to software anomalies that may cause blank display screens or false motor movement alerts. 43,922 units affected.
Baxter Healthcare is recalling Novum IQ Syringe Pumps due to software defects that may cause blank Run screens or false motor movement errors. Approximately 22,703 units distributed in the US, Puerto Rico, and Canada are affected.
Boston Scientific is recalling the WATCHMAN FXD Curve Access System worldwide due to increased risk of air embolism during transseptal cardiac procedures, especially in patients under sedation. The risk occurs without adequate positive pressure-controlled ventilation.
mo-Vis BVBA is recalling All-round Joystick R-net Light wheelchair components with firmware version 2.3 or lower due to a defect that may cause unintended wheelchair movement upon power-up.
Medtronic is recalling 34,549 DLP Left Heart Vent Catheters (Model 12113) because the catheters may not retain their shape. The defect affects devices distributed worldwide and could compromise catheter function during cardiac surgery.
The IDM-MICRO-R electrical wheelchair component is recalled because a firmware timing fault may cause the wheelchair to move unexpectedly when powered on. Affected units have firmware versions 2.3 and lower.
Boston Scientific is recalling the WATCHMAN TruSeal Access System due to increased risk of air embolism when transseptal procedures are performed without positive pressure ventilation, particularly in sedated patients.
Boston Scientific is recalling the WATCHMAN TruSeal Access System components due to higher risk of air embolism when transseptal procedures are performed without positive pressure ventilation. All 340,185 non-expired units distributed worldwide are affected in this Class I recall.
Dexcom G7 and ONE+ CGM apps fail to alert when the transmitter fails. The app silently stops glucose monitoring without notifying the user, risking missed detection of dangerous blood glucose events and delayed treatment.
Dexcom G7 and ONE+ continuous glucose monitoring apps may fail to alert users of sensor failures, potentially delaying treatment of dangerous blood sugar events. Affected Android, iOS, and watchOS versions can silently stop reporting readings without notifying the user.
Medtronic is recalling 25,261 DLP Left Heart Vent Catheters (Model 12115) because they may not retain their shape. This Class I recall affects catheters distributed worldwide and in the US.
The Micro Joystick R-net wheelchair control component may cause unintended movement when powered on with the joystick out of neutral. Firmware versions 2.3 and lower have timing issues that skip the safety neutral check.
Boston Scientific is recalling WATCHMAN FXD Curve Access System units due to increased air embolism risk when procedures are performed without positive pressure-controlled ventilation. The recall affects approximately 340,185 units distributed worldwide.
mo-Vis is recalling the IDM-MULTI-R electrical wheelchair component due to a firmware timing issue that may cause unintended wheelchair movement when powered on. The defect could bypass the neutral check if the joystick is not centered.
Medtronic is recalling DLP Left Heart Vent Catheters (Model 12110) because they may not retain their shape during use. This defect could affect device function in cardiac surgical procedures.
Baxter Healthcare is issuing an urgent correction for the Novum IQ Syringe Pump due to software anomalies that may display a blank run screen or generate false motor movement errors. The correction affects 10,101 units distributed in the US, Puerto Rico, and Canada.
Boston Scientific's WATCHMAN TruSteer Access System is recalled due to increased air embolism risk when procedures use conscious or deep sedation without proper ventilation. Risk is highest in patients with low left atrial pressure.
Dexcom G7 and ONE+ app versions fail to alert users when the glucose sensor fails. Without alerting, they stop reporting glucose values, which can delay detection of dangerous blood sugar levels and treatment.
Boston Scientific is recalling all batches of the WATCHMAN TruSeal Access System worldwide due to increased risk of air embolism when procedures are performed without positive pressure-controlled ventilation.
Boston Scientific is recalling the WATCHMAN FXD Curve Access System (340,185 units) due to increased air embolism risk during transseptal heart procedures performed without positive pressure-controlled ventilation, particularly in sedated patients.
Dexcom's G7 and ONE+ CGM apps fail to alert users when the sensor fails. Instead of notifying the user, the app silently ends monitoring, potentially delaying treatment of dangerous blood sugar extremes.
The FDA is recalling 3 Multi Joystick R-net electrical wheelchair components due to a firmware defect that may cause unintended wheelchair movement when powered on. Firmware versions 2.3 and lower are affected.
Boston Scientific recalled the WATCHMAN TruSeal Access System for increased air embolism risk during transseptal procedures without positive pressure ventilation, especially in patients with low left atrial pressure or hypovolemia.