State
73,509 recalls have nationwide distribution and so reach Indiana. 9,590 additional recalls listed Indiana specifically in their distribution scope.
Of the 9,590 recalls naming Indiana we have scored against our rubric, 1,913 (20%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,529 (26%) are Severe.
Which agencies issued them
These figures cover only the 9,590 recalls whose distribution notice names Indiana specifically. The 73,509 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.
CardioQuip is recalling 1,478 Modular Cooler-Heater devices because the labeling does not include proper water-quality maintenance and device inspection guidance.
Johnson & Johnson is recalling TECNIS Eyhance intraocular lenses due to elevated endotoxin levels exceeding internal and FDA specification limits. Affected lenses were distributed nationwide in Illinois.
Specialized Bicycle Components is recalling Tarmac SL7 bicycles and framesets because the fork steerer tube can crack or break after harsh impact, posing fall and injury hazards. About 6,900 units sold nationwide from July 2020 through August 2021 are affected.
ZOLL is recalling its Quattro IVTM Disposable Pack and Start UP Kit due to potential leaks in the catheter or tubing. The recall affects 579 bundled kits distributed worldwide.
Flower Orthopedics is recalling 77 Flower E-Kit bone fixation kits because they are missing a required CDG 200 Cannulated Countersink component. The incomplete kits could compromise orthopedic surgical procedures.
Exactech is recalling 31,201 TRULIANT Knee System tibial inserts whose packaging lacks an oxygen barrier layer. The implants were distributed worldwide.
Certain 2020-2021 Porsche Taycan vehicles have hazard lights that may activate in non-emergency situations, potentially confusing drivers. Dealers will reprogram the lights at no cost.
Exactech is recalling ARTHROFOCUS Polyethylene Tibial Inserts due to packaging defects. Inserts lacked an oxygen barrier layer in their vacuum bag packaging, which could compromise device integrity.
ZOLL Circulation is recalling 3,425 units of the ICY Intravascular Heat Exchange Catheter Kit due to potential leaks in the catheter or start-up kit tubing. A labeling update has been issued.
ZOLL Circulation is recalling approximately 1,122 ICY Heparin infusion kits distributed worldwide due to potential leaks in the catheter or start-up kit tubing. No illnesses or injuries have been reported.
ZOLL Circulation is recalling COOL LINE intravascular heat exchange catheters due to potential leaks in the catheter or start-up kit tubing that could affect their function during medical procedures.
Nox T3s Recorder sleep monitoring devices are being recalled due to a firmware error that causes inaccurate detection of device position, which may affect diagnostic accuracy.
Welch Allyn Inc Mortara is recalling ELI 280 Resting Electrocardiographs due to device malfunction under specific operator workflows. The recall affects 14,630 units distributed nationwide and internationally.
Paltop Advanced Dental Solutions is recalling 337 Scan Abutment MU devices due to manufacturing tolerance deviations in orientation and sizing that may delay dental restoration procedures.
ZOLL is issuing a labeling update for the QUATTRO Intravascular Heat Exchange Catheter Kit (188 units) addressing potential leaks from the catheter or start-up kit tubing.
ZOLL Circulation is updating product labeling for Quattro IVTM disposable packs and start-up kits due to potential leaks from catheter or tubing components. Distribution includes US nationwide and international markets.
ZOLL Circulation is addressing potential leaks in Quattro IV Disposable Packs and Start-Up Kits through a labeling update affecting 334 bundles distributed worldwide.
FDA recalls 1,380 CardioQuip Modular Cooler-Heater 1000(i) devices worldwide due to labeling missing guidance on water-quality maintenance and device inspection procedures.
CardioQuip heater-cooler refrigeration modules used in operating rooms could develop bacterial contamination in water systems, potentially exposing patients to infection during surgery.
Innovative Orthopedic Technologies is recalling the ARCH Leg Positioning System due to manufacturing defects that prevent locking pins from properly engaging under load.
ZOLL Circulation is recalling the COOLINE Intravascular Heat Exchange Catheter Kit due to potential leaks from the catheter or start-up kit tubing. 2,833 units are affected globally.
Exactech is recalling knee implant system inserts that were packaged in vacuum bags lacking an oxygen barrier layer. This packaging defect may compromise product sterility and integrity.
ATTUNE Revision Tibial Augment (5mm) packaging may include incompatible screws, potentially delaying surgery. Distributed to 10 US states.
ZOLL has recalled its COOL LINE Intravascular Heat Exchange Catheter Kit due to potential leaks in catheter and tubing components, affecting approximately 6,395 units distributed worldwide.
Exactech recalls Vantage Total Ankle System components due to vacuum-sealed packaging lacking an oxygen barrier layer, which could allow oxidative degradation of polyethylene inserts over time.