State
73,092 recalls have nationwide distribution and so reach Indiana. 9,585 additional recalls listed Indiana specifically in their distribution scope.
Of the 9,585 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 2,148 (22%) are Severe.
Which agencies issued them
These figures cover only the 9,585 recalls whose distribution notice names Indiana specifically. The 73,092 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.
American Contract Systems, Inc. is recalling the Hand Pack AKHD97C medical convenience kit because an inoperable chart recorder caused humidity readings to fall outside specifications, preventing confirmation of sterilization assurance.
Ascend Laboratories recalled 117,493 bottles of Mycophenolic Acid tablets nationwide because the tablets failed to meet dissolution specifications. Patients taking this medication should consult their doctor.
Boston Scientific Corporation is recalling WallFlex Esophageal Stent Systems and Agile Esophageal Over-the-Wire Stent Systems due to potential delivery catheter tip detachment during insertion procedures.
Boston Scientific is recalling the Wallflex Esophageal Stent System and Agile Esophageal Over the Wire Stent System due to potential delivery catheter tip detachment during placement. Wallflex devices totaling 115 units are affected.
The BD Phoenix M50 instruments may misidentify Escherichia coli (E. coli) in clinical samples, potentially causing misdiagnosis and inappropriate treatment. About 4,295 affected units were distributed worldwide.
TMJ Solutions Inc is recalling the Stryker TMJ Unilateral Implant because patient-fitted prostheses contained incorrect components. Patients should contact their healthcare provider immediately.
The FDA is recalling LINK Universal Handles due to risk of material failure when first used. The surgical instrument may break during surgery, compromising patient safety.
Boston Scientific is recalling Wallflex and Agile esophageal stent systems due to potential detachment of the delivery catheter tip during stent placement. These devices are used to maintain patency in esophageal strictures caused by malignant tumors or esophageal fistulas.
American Contract Systems is recalling the PACEMAKER PACK (Lot 2405112) due to an inoperable chart recorder that prevented confirmation of sterilization requirements. Affected units were distributed in MO, MN, MA, OH, and NE.
Empower Pharmacy is recalling a pyridoxine (B6) injection solution because sterility assurance could not be confirmed. The recalled product is lot 609763 with a beyond-use date of 04/18/2025.
American Contract Systems recalls 360 units of Endovascular AAA Pack due to inability to confirm sterilization requirements were met. An inoperable chart recorder prevented verification that environmental conditions during sterilization met required specifications.
Siemens ACUSON Maple ultrasound systems may perform incorrect unit conversion in software, producing values 10 times smaller than actual. This could lead to misdiagnosis or inappropriate patient management.
Merit Medical Systems is recalling Custom Procedure Kits (REF: K12T-11077) with 7F sheath introducers that are incorrectly labeled as 7.5F, a labeling discrepancy affecting 24 units distributed nationwide.
CooperSurgical is recalling Origio Sperm Wash Medium because low sodium pyruvate levels could compromise gamete development.
Merit Medical Systems is recalling 1,892 Prelude Sheath Introducer devices due to a labeling error: devices labeled as 7.5F are actually sized as 7F. The dimensional mislabeling could result in incorrect device selection during medical procedures.
Philips SmartPath dStream MRI devices have loose screws in the RF carrier assembly that may interfere with the moving tabletop, potentially delaying diagnosis. Affected units should be inspected and repaired immediately.
Hologic is recalling Selenia Dimensions and 3Dimensions software due to a defect that may cause blurry images and potential misdiagnosis.
Boston Scientific is recalling WallFlex and Agile esophageal stent systems due to potential delivery catheter tip detachment. The recall affects 79 units distributed worldwide.
Ultrasonic cleaner solutions contaminated with pathogenic bacteria may cause serious infections if used in medical or dental procedures, and may leak or become bloated. Patients and healthcare workers handling the products are at risk.
Boston Scientific recalls WallFlex and Agile Esophageal Stent Systems due to potential delivery catheter tip detachment. The affected stents treat esophageal strictures and may cause procedural complications if detachment occurs.
Bard Peripheral Vascular is recalling BARD MAGNUM Disposable Core Tissue Biopsy Needles due to possible packaging damage from manufacturing that may compromise sterility.
American Contract Systems is recalling the Essentia MAJ Laparotomy Std Pack because an equipment failure prevented confirmation of sterilization requirements for this medical convenience kit.
Philips recalls certain Ingenia 1.5T MRI devices due to loose assembly screws that may block the patient tabletop, potentially delaying diagnosis and causing patient anxiety.
American Contract Systems is recalling 3 units of the COPM11B pacemaker medical kits due to inability to confirm sterilization requirements were met. An inoperable chart recorder caused humidity readings to exceed specifications during manufacturing.
Boston Scientific is recalling the Agile Esophageal Over-the-Wire Stent System due to potential for delivery catheter tip detachment. Seven affected units distributed worldwide are identified by lot numbers 32889020 and 33178844.