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.
Centinel Spine is recalling the Prodisc C SK cervical disc implant due to blue discoloration identified as foreign contamination on the inlay during assembly. The contamination was not fully evaluated in manufacturing validations.
Boston Scientific is recalling Wallflex Esophageal Stent Systems due to potential delivery catheter tip detachment that could affect proper stent deployment during medical procedures.
Cook Biotech is recalling 35 units of Biodesign Fistula Plug surgical implants that expire before their printed expiration dates, potentially compromising device function.
CooperSurgical is recalling Origio Sperm Wash Medium because low sodium pyruvate levels could compromise gamete development.
Glenmark Pharmaceuticals recalls Mupirocin Ointment nationwide due to subpotency, meaning some lots contain less active ingredient than specified. Affected customers should contact their pharmacy or prescriber.
Allergen is recalling specific lots of Refresh LACRI-LUBE eye ointment (763,426 tubes) due to potential breaches in the tube seal that may compromise sterility. Consumers should verify their product lot number against the recall list.
Karl Storz Hopkins Telescope 6 endoscopes (59 units, nationwide) are recalled because their reprocessing instructions lack FDA review and approval for safety and efficacy.
Philips is recalling 33 Ingenia 3.0T MRI scanners whose Integrated Radio Frequency Carrier assembly screws may come loose and block the horizontal tabletop, potentially causing diagnostic delays.
Karl Storz Hopkins Telescope 6 endoscopes are being recalled because the instructions for use contain reprocessing procedures not reviewed or approved by the FDA. Affected units should not be used until corrected instructions are provided.
Custodiol HTK Solution is subject to a Class II recall due to the potential for particles in the solution. The affected product consists of 48 cartons distributed in North Carolina.
Karl Storz is recalling 78 endoscopes because their instructions for use contain reprocessing modalities that have not been reviewed or approved by the FDA.
American Contract Systems is recalling Nasal Sinus Pack units due to manufacturing control failures that prevent confirmation of sterilization. Affected units were distributed to multiple states.
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.
Cook Biotech is recalling 8 units of Biodesign Recto-Vaginal Fistula Plug devices because they expire before the date printed on the label. The affected products may lose sterility if used after actual expiration.
American Contract Systems is recalling 60 Shoulder SESH18I medical convenience kits nationwide due to equipment failure that resulted in out-of-specification humidity readings, preventing sterilization assurance confirmation.
Boston Scientific's Wallflex and Agile esophageal stent systems are recalled due to the potential for delivery catheter tip detachment. The recall affects 146 units distributed worldwide.
Arrow International recalls over 14,000 arterial kits due to reports of open packaging seals. The recall affects multiple models distributed nationwide.
Cardinal Health is recalling Salem Sump Dual Lumen Stomach Tubes due to reports of anti-reflux valve breakage caused by improper use. Product labeling has been updated.
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.
Philips is recalling 63 units of the Ingenia Ambition X MRI scanner due to loose screws in the IRF carrier assembly that may block the imaging tabletop and potentially delay diagnosis.
Cook Biotech is recalling 3 units of Biodesign Fistula Plug surgical implants because they expire before the printed expiration date. The devices were distributed worldwide.
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.
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.
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.
CooperSurgical is recalling Origio Sperm Wash Medium due to low sodium pyruvate concentration that could compromise sperm cell development. This affects 980 units distributed worldwide, including throughout the US.