State

Indiana product recalls

73,363 recalls have nationwide distribution and so reach Indiana. 9,587 additional recalls listed Indiana specifically in their distribution scope.

What the numbers show

Total: 9,587
Critical: 1,913
Severe: 2,149
Most recent: 2026-09-30

Of the 9,587 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 2,149 (22%) are Severe.

Which agencies issued them

These figures cover only the 9,587 recalls whose distribution notice names Indiana specifically. The 73,363 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

18426–18450 of 82950

SevereFDA (Drugs)·D-0456-2023·2023-03-15
Drug Recall: Pharmedica Non-Sterile MSM Drops Due to Contamination
Pharmedica USA recalled Purely Soothing 15% MSM Drops nationwide due to non-sterility concerns. The voluntary Class I recall affects approximately 1,904 bottles distributed via e-commerce and trade shows.
Product
Purely Soothing 15% MSM Drops, packaged in a)15 ml, .5 fl oz bottle, UPC 7 31034 91382 9; and b) 30 ml, 1.014 fl oz bottle, UPC 7 31034 91379 9; Manufactured by: Pharmedica USA, Phoenix, AZ.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1146-2023·2023-03-15
Cardiosave Rescue Intra-Aortic Balloon Pumps recalled for connection failure
Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps due to a coiled cord cable connection failure that may cause unexpected device shutdown and loss of communication.
Product
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0433-2023·2023-03-15
Eye Drop Recall: Brimonidine Tartrate Due to Cracked Bottle Caps
Apotex Corp. is recalling Brimonidine Tartrate eye drops (67,056 bottles nationwide) because cracks in bottle caps may compromise sterility and expose patients to contamination.
Product
BRIMONIDINE TARTRATE — BRIMONIDINE TARTRATE (BRIMONIDINE TARTRATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1220-2023·2023-03-15
CardioMEMS Patient Electronics System Recalled for Excessive Radiofrequency Emissions
CardioMEMS heart-failure monitoring devices are recalled due to radiofrequency emissions that can interfere with other medical devices like pacemakers when operating nearby.
Product
CardioMEMS HF System Patient Electronics System (PES), Model number CM1100, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0416-2023·2023-03-15
Shirakiku Shichimi Togarashi Spice Recalled for Undeclared Sesame
Shirakiku Shichimi Togarashi spice (Lot 12262023) is recalled because it contains undeclared sesame due to potential product mix-up. The 2,617 packages were distributed nationwide and internationally.
Product
SPICE SHICHIMI TOGARASHI 300g UPC: 074410341213 Brand: Shirakiku Distributed by: Wismettac Asian Foods, Inc. Santa Fe Springs, CA 90670 Product of China
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1219-2023·2023-03-15
CardioMEMS Heart Monitoring System Emissions May Interfere With Pacemakers
FDA recalls CardioMEMS HF System patient monitor for radiofrequency signal emissions that can interfere with pacemakers, defibrillators, and other implanted medical devices. The emissions exceed radiofrequency limits.
Product
CardioMEMS HF System Patient Electronics System (PES), Model number CM1010, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0439-2023·2023-03-15
NaturalCare bioAllers Homeopathic Drops Recalled for Manufacturing Quality Defect
Nutraceutical Corporation is recalling NaturalCare bioAllers homeopathic liquid drops nationwide due to a raw material manufacturing quality issue. The recall affects lot 222076 with an expiration date of 03/27.
Product
NaturalCare bioAllers, Mold, Yeast and Dust, Homeopathic, Liquid Drops, 20% Alcohol, 1 FL OZ( 30mL), Mfd. for Nutraceutical Corp. NaturalCare Park City, UT, 84098 USA
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1235-2023·2023-03-15
Radiation Therapy System Software Issue May Cause Unexpected Dose
Sensus Healthcare recalls 23 units of the SRT-100 Vision superficial X-ray radiation therapy system due to a software dose timer malfunction that may result in unexpected radiation delivery to patients.
Product
Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2; Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-1214-2023·2023-03-15
Siemens epoc Host 2 blood gas analyzer recalled for pO2 measurement quality control issue
Siemens is recalling 22,156 units of the epoc Host 2 blood gas analyzer due to pO2 measurement quality control issues related to barometric pressure. The devices are distributed worldwide.
Product
epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, Canada 10736388 epoc Host 2, China 10736389 epoc Host 2, Japan 10736390 epoc Host 2, Refurbished 10736393 epoc Host 2, Canada, Refurbished 10736394 epoc Host 2, Japanese, Refurbished…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1209-2023·2023-03-15
COVID-19 Diagnostic Test Kits May Leak, Causing Invalid Results
DiaSorin Molecular's Simplexa COVID-19 Direct test kits may leak, potentially causing contamination and invalid test results. The FDA has issued a Class II recall affecting approximately 90,142 units distributed nationwide.
Product
Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1212-2023·2023-03-15
Blood Sample Collection Kits Shipped With Incorrect Identification Labels
LetsGetChecked Blood Sample Collection kits were distributed with incorrect shipping labels that assigned samples to wrong users. This could result in incorrect Hepatitis C Virus test results or rejected samples due to demographic mismatches.
Product
LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device specifically intended for the primary containment and preservation of blood samples.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0418-2023·2023-03-15
Given Imaging SmartBar Cereal Bar Recalled for Potential Tobacco Beetle Contamination
Given Imaging Ltd. is recalling SmartBar Cereal Bars because they may be contaminated with tobacco beetles. Consumers should not consume the affected product.
Product
Given Imaging SmartBar Cereal Bar; Net Weight 2.53 oz (72 g); Ingredients: glucose syrup, soy crisps, oats, pea protein, puffed wheat (wheat, sugar), concentrated pineapple juice, fructose, dried cranberries (cranberries, sugar, sunflower oil), dried apples, brown sugar, invert…
Category
Food
Distribution
38 states
HighFDA (Devices)·Z-1216-2023·2023-03-15
LATITUDE NXT Remote Patient Monitoring System Alerts Not Displaying
Boston Scientific's LATITUDE NXT system failed to display cardiac alerts for 1,531 patient records during 2022. Contact Boston Scientific to determine if your patients were affected.
Product
LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0438-2023·2023-03-15
NatraBio Cold and Sinus Nasal Spray Recalled for Manufacturing Deviation
Nutraceutical Corporation is recalling NatraBio Cold & Sinus Nasal Spray (0.8 FL Oz) lot 222016 due to manufacturing deviations and product discoloration. The product was distributed nationwide.
Product
NatraBio, Cold& Sinus Nasal Spray, Homeopathic Medicine, 0.8 FL Oz. ( 24ml), Mfd. for Healthway Corp. Comments or Questions NatraBio Shelburne Falls, MA 01370 USA, UPC 3 71400 55711 2
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1221-2023·2023-03-15
CardioMEMS Hospital Electronics System RF Emissions May Interfere With Implanted Devices
St. Jude Medical is recalling the CardioMEMS HF System (Model CM3000) due to excessive radiofrequency emissions that may interfere with pacemakers, defibrillators, and other implanted devices during use. The recall affects 1,905 units distributed worldwide.
Product
CardioMEMS HF System Hospital Electronics System (HES), Model number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1229-2023·2023-03-15
Cardiosave Hybrid Intra-Aortic Balloon Pump recalled for helium regulator failure
Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pump models due to helium regulator failures that may prevent proper device operation and replenishment.
Product
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-0800-33…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1210-2023·2023-03-15
Simplexa Flu A/B & RSV Diagnostic Kits Recalled for Leaking Components
DiaSorin is recalling 4,142 Simplexa Flu A/B & RSV Direct Gen II diagnostic kits due to leaking Direct amplification Discs that may cause contamination, cross-contamination, invalid test results, and system error codes.
Product
Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: MOL2656; with previous assay definition v5.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0415-2023·2023-03-15
Chili Pepper Powder Recalled for Undeclared Sesame Allergen
Shirakiku brand Chili Pepper Powder (ICHIMI TOGARASHI) is being recalled nationwide and internationally because it contains sesame that is not declared on the ingredient label. Consumers with sesame allergies should not consume this product.
Product
Chili Pepper Powder (ICHIMI TOGARASHI) 300g UPC: 074410341169 Brand: Shirakiku Distributed by: Wismettac Asian Foods, Inc. Santa Fe Springs, CA 90670 Product of China
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1218-2023·2023-03-15
CardioMEMS Heart Failure Monitor Recalled for Radiofrequency Emissions
St. Jude Medical is recalling certain CardioMEMS heart failure monitoring devices due to excessive radiofrequency emissions that could interfere with pacemakers, defibrillators, and other implanted medical devices when in close proximity.
Product
CardioMEMS HF System Patient Electronics System (PES), Model number CM1000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1232-2023·2023-03-15
Cardiosave Rescue Pump Recall for Defective O-Rings Causing Helium Leaks
Datascope is recalling 47 Cardiosave Rescue cardiac pump units due to damaged O-rings on the quick disconnect fitting causing helium leaks that interrupt therapy.
Product
Cardiosave Rescue. Model Number: 0998-00-0800-83.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0445-2023·2023-03-15
FDA Recalls Phenylephrine IV Solution for Manufacturing Practice Deviations
Denver Solutions recalls 8,136 units of Phenylephrine HCl IV solution nationwide due to manufacturing practice deviations. The FDA classified this Class II recall as affecting prescription injectable solutions distributed to hospitals and government facilities.
Product
Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-148-94
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1233-2023·2023-03-15
Monaco RTP System software may calculate radiation therapy doses inaccurately
Elekta's Monaco RTP radiation therapy treatment planning software may display inaccurate radiation doses when re-optimizing plans after adding anatomical contours. The defect affects 2,020 units distributed nationwide and internationally.
Product
Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1213-2023·2023-03-15
Baxter peritoneal dialysis cap incorrectly sealed, risks inadequate disinfection
Baxter MiniCap Disconnect Cap pouches may have faulty seals allowing air exposure, risking inadequate disinfection of the sterile connector used in peritoneal dialysis.
Product
Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable administration set for peritoneal dialysis
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1224-2023·2023-03-15
CardioMEMS PA Sensor models affected by radio-frequency range at high elevations
St. Jude Medical recalls CardioMEMS PA Sensors that may operate outside intended frequency range above 2,000 feet elevation, risking inaccurate readings in heart failure monitoring. Approximately 1,905 units affected.
Product
CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1225-2023·2023-03-15
CardioMEMS Heart Failure Sensor May Give Inaccurate Readings at High Elevations
St. Jude Medical is recalling 317 CardioMEMS PA Sensors due to operation outside their intended frequency range at elevations above 2,000 feet, which may cause inaccurate pressure readings or signal acquisition problems.
Product
CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians…
Category
Medical Device
Distribution
Distributed nationwide