The Recall Desk

State

Indiana product recalls

73,509 recalls have nationwide distribution and so reach Indiana. 9,589 additional recalls listed Indiana specifically in their distribution scope.

What the numbers show

Total
9,589
Critical
1,913
Severe
2,528
Most recent
2026-10-14

Of the 9,589 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 2,528 (26%) are Severe.

Which agencies issued them

These figures cover only the 9,589 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.

25651–25675 of 83098

  • SevereFDA (Devices)·Z-0007-2022·2021-10-20

    Abbott Alinity m SARS-CoV-2 Test Kit Recalled for Potential False Positives

    Abbott Molecular recalls its Alinity m SARS-CoV-2 Amp Kit (Non-US Assay), an in vitro diagnostic test, due to potential for false positive results. Approximately 11,408 units were distributed worldwide.

    Product
    Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0079-2022·2021-10-20

    Philips Defibrillators Recall: Customers Uninformed of Previous Recalls

    Customers of Philips HeartStart FRx defibrillators were not notified of previous recalls associated with various defibrillator models. This is a Class II medical device recall.

    Product
    Philips, HeartStart FRx + Defibrillator, Model # Model #s: 861304
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0110-2022·2021-10-20

    United Orthopedics USTAR II knee implant component recalled for specification failures

    Uoc Usa Inc recalls 3 United Orthopedics USTAR II knee components that fail to meet manufacturing specifications for concentricity and dynamic fatigue testing. These defects could affect implant performance.

    Product
    United Orthopedics USTAR II Knee System USTAR II Knee System Segment Part, RHS, 25 mm Length, Catalog # 2915-1025
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0087-2022·2021-10-20

    Automation System Interface Module Firmware May Misassociate Test Results to Samples

    Inpeco's automation interface module firmware may incorrectly associate laboratory test results with patient sample IDs, potentially causing incorrect patient results.

    Product
    FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V825000·2021-10-20

    2021-2022 Audi vehicles recalled for rear-view camera software failure

    Volkswagen Group is recalling certain 2021-2022 Audi vehicles due to a software error that may prevent the rear-view camera from displaying when reversing, potentially reducing driver visibility and increasing crash risk.

    Product
    AUDI — AUDI A3, Q8, Q3, A5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0112-2022·2021-10-20

    Flower Drill Bit Kit 2.4mm missing AO connect feature

    Flower Orthopedics Corporation is recalling 33 units of its 2.4mm Drill Bit Kit (Lot 2101321194) because the drill bits lack the AO connect feature, which may delay surgical procedures.

    Product
    Flower Drill Bit Kit 2.4 mm-intended to be used with solid 2.4mm screws and can be used with any plate as part of the Flower Small and Medium Implant Set and uses the small locking mechanism. Catalog Number: DBK 024
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0084-2022·2021-10-20

    MYLA Diagnostic System Software Versions Recalled for Risk of False Negatives

    BioMerieux MYLA diagnostic system software versions 4.7–4.8.2 may produce false negative results under certain conditions, potentially missing diagnoses. Affected units are being recalled worldwide.

    Product
    MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0011-2022·2021-10-20

    Green Field Farms Chocolate Milk Recall for Improper Pasteurization

    Green Field Farms Co-op is recalling chocolate milk products due to improper pasteurization. The affected products were distributed to Indiana, New Jersey, and Ohio.

    Product
    Green Field Farms Chocolate Milk 1/2 gallon glass jar, 6 units per case 53oz plastic bottle, 6 units per case 12oz plastic bottle, 8 units per case
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0106-2022·2021-10-20

    Ion Flexison Biopsy Needle recalled for potential sheath tip separation

    Intuitive Surgical recalled 1,625 Ion Flexison Biopsy Needles due to potential sheath tip separation from the shaft. Affected units are distributed across 29 US states and China; no injuries have been reported.

    Product
    Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-0083-2022·2021-10-20

    Cobas EGFR Mutation Test v2 may return false mutation detection results

    The cobas EGFR Mutation Test v2 may produce false positive results for exon 20 insertion mutations, potentially leading to inappropriate treatment. Healthcare providers should verify detected mutations using alternative methods.

    Product
    cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0116-2022·2021-10-20

    Elekta Medical Linear Accelerator Diode Component Destructive Failure Risk

    Elekta Medical Linear Accelerators may experience destructive diode failure with risk of ejected matter. Service personnel could be injured during component removal.

    Product
    Elekta Medical Linear Accelerator (EMLA), configured as follows: a. Elekta Precise Digital Accelerator; b. Elekta Harmony; c. Elekta Synergy; d. Elekta Infinity; e. Versa HD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0109-2022·2021-10-20

    Babylog VN500 Ventilator Firmware Defect May Cause Brief Ventilation Interruption

    A software defect in the Babylog VN500 Ventilator may cause it to restart, interrupting ventilation and losing PEEP for about 8 seconds. The issue affects 2,169 units distributed nationwide.

    Product
    Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight. Catalog Number: 8417400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0117-2022·2021-10-20

    Beckman Coulter Power Processor 3K Recalled for Missing Splash Guard

    Beckman Coulter is recalling Power Processor 3K laboratory equipment due to a missing splash guard that may expose users to hazardous materials. Approximately 271 units were distributed in the U.S. and internationally.

    Product
    Power Processor 3K, 3K High Speed Stockyards Module Nameplate: PP 3K Stockyard (Refrig) 9707 REF A88116
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0082-2022·2021-10-20

    Bio-Rad BioPlex 2200 ANA Screen Control lot incompatible with reagents

    Bio-Rad Laboratories has recalled certain lots of BioPlex 2200 ANA Screen Control Sets due to incompatibility with older lots of ANA Screen Reagent Packs and Calibrator Sets, which may affect test accuracy.

    Product
    BioPlex 2200 ANA Screen Control Set, REF: 663-1131 incompatible with ANA Screen Reagent Packs/ANA Kits, REF: 665-1150; and ANA Screen Calibrator Sets, REF: 663-1101
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0078-2022·2021-10-20

    Philips HeartStart Defibrillator Recall: Previous Recall Notifications Not Sent

    Philips HeartStart FR2+ Defibrillators (models M3860A and M3861A) were not accompanied by notifications about previous recalls. Affected customers should contact Philips for information about prior safety issues.

    Product
    Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0108-2022·2021-10-20

    Evita V500 Ventilator Software Defect May Cause Temporary Ventilation Loss

    Draeger's Evita V500 ventilator software version 2.51 and lower may restart unexpectedly, briefly stopping ventilation and breathing support. 6,797 units are affected nationwide.

    Product
    Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients. Catalog Number: 8416400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0081-2022·2021-10-20

    Philips HeartStart HS1 OnSite Defibrillator Recall: Notification of Previous Recalls

    Philips North America LLC is recalling 15 units of the HeartStart HS1 OnSite Defibrillator (Models M5066A and M5067A) due to failure to notify customers of previous recalls associated with these devices.

    Product
    Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-0113-2022·2021-10-20

    Flower Drill Bit Kit Missing AO Connect Feature, May Delay Procedures

    Flower Orthopedics Corporation is recalling Flower Drill Bit Kit 2.7mm (DBK 027) due to missing AO connect feature that may delay surgical procedures. Affected kits were distributed across multiple U.S. states.

    Product
    Flower Drill Bit Kit 2.7mm- The Drill Bit Kit, 2.7mm (DBK 027) is intended to be used with solid 2.7mm screws and can be used with any the Flower Small and Medium Implant Set Flower Ankle Plating Set , Flower Rear Foot/Calcaneus Plating Set or Flower Upper Extremity Plating…
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0080-2022·2021-10-20

    Philips HeartStart HS1 Home Defibrillator: Customers Not Notified of Previous Recalls

    Philips is recalling nine units of the HeartStart HS1 Home Defibrillator (Model M5068A) because customers were not notified of previous recalls associated with various defibrillator models.

    Product
    Philips, HeartStart HS1 Home Defibrillator, Model # Model number: M5068A
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-0114-2022·2021-10-20

    Flower Lag Screw Kit drill bits missing AO connect feature recalled

    Flower Orthopedics is recalling Flower Lag Screw Kit 2.7 mm because drill bits lack the AO connect feature, which may delay surgical procedures.

    Product
    Flower Lag Screw Kit 2.7 mm-intended to be used with 2.7mm lag screws and can be used with any plate that as part of the Flower Small and Medium Implant Set, Flower Ankle Plating Set , Flower Rear Foot/Calcaneus Plating Set , or Flower Upper Extremity Plating Set and uses the…
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Drugs)·D-0006-2022·2021-10-20

    Potassium Chloride Extended-Release Tablets Recalled for Failed Dissolution

    Strides Pharma Inc. is recalling Potassium Chloride Extended-Release Tablets, USP 10 mEq because the tablets fail to meet dissolution specifications, which may affect drug effectiveness.

    Product
    POTASSIUM CHLORIDE — POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0111-2022·2021-10-20

    Flower Drill Bit Kit missing AO connect feature may delay procedures

    Flower Orthopedics is recalling Flower Drill Bit Kit 2.0 mm kits because drill bits are missing the AO connect feature, which may result in procedural delays. Affected units were distributed across multiple states.

    Product
    Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and can be used with any plate that has been cleared as part of the Flower Small and Medium Implant Set and uses the small locking mechanism. mechanism. Catalog Number: DBK 020 2013002721
    Category
    Medical Device
    Distribution
    10 states
  • SevereNHTSA·21V822000·2021-10-19

    Newmar Motorhomes Power Steering Pump Defect Recall

    Newmar is recalling 2020-2022 Essex, King Aire, and London Aire motorhomes due to a power steering pump machining defect that can result in loss of steering assist and increased crash risk. Affected owners should contact Newmar for free inspection and replacement.

    Product
    NEWMAR — NEWMAR ESSEX, LONDON AIRE, KING AIRE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V823000·2021-10-19

    Sutphen Fire Trucks Recalled for Excessively Bright LED Lights

    Sutphen is recalling two fire trucks because their LED lights are too bright, potentially blinding other drivers and increasing crash risk.

    Product
    SUTPHEN — SUTPHEN FIRE TRUCK
    Category
    Vehicle
    Distribution
    Distributed nationwide