The Recall Desk

State

Indiana product recalls

72,820 recalls have nationwide distribution and so reach Indiana. 9,554 additional recalls listed Indiana specifically in their distribution scope.

What the numbers show

Total
9,554
Critical
1,903
Severe
2,135
Most recent
2026-09-02

Of the 9,554 recalls naming Indiana we have scored against our rubric, 1,903 (20%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,135 (22%) are Severe.

Which agencies issued them

These figures cover only the 9,554 recalls whose distribution notice names Indiana specifically. The 72,820 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

176–200 of 82374

  • HighFDA (Devices)·Z-2986-2026·2026-08-26

    ConvaTec Esteem Body Soft Convex Urostomy Pouches Recalled for Leakage

    ConvaTec is recalling Esteem Body Soft Convex Urostomy Pouches because they may leak from the cap during use.

    Product
    Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704, 423705, 423707, 423708, 423709, 423710, 423712, 423713, 423714, 423715, 423716, 423717, 423718, 423721, 423722, 423723, 423725, 423726, 423727.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2965-2026·2026-08-26

    Siemens Immulite 2000 Syphilis Screen Recall for Negative Bias

    Siemens Healthineers is recalling 24 units of the Immulite 2000 Syphilis Screen assay due to a potential negative patient bias that may report low reactive results as nonreactive.

    Product
    Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2952-2026·2026-08-26

    Intersurgical Recalls One-Piece Guedel Airway Devices Due to Occlusion Risk

    Intersurgical Inc is recalling 21,269 One-Piece Guedel Airway devices because they may be occluded or partially occluded. The devices were distributed in six US states.

    Product
    One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2983-2026·2026-08-26

    Fort Defiance Automated Field Steam Sterilizer Recalled for Electrical Grounding Defect

    Fort Defiance Industries is recalling Automated Field Steam Sterilizers because a water recovery system connector may lose ground continuity, creating an unreliable fault current return path.

    Product
    Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2962-2026·2026-08-26

    Boston Scientific Recalls Suture Cinch Endoscopic Tissue Approximation Devices

    Boston Scientific is recalling Suture Cinch Long endoscopic tissue approximation devices because they may fail to deploy the implant or cut the suture.

    Product
    Suture Cinch Long 1pk. Endoscopic tissue approximation device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2963-2026·2026-08-26

    Maquet Critical Care Recalls Y Sensor Modules for Electrical Safety Testing Omission

    Maquet Critical Care AB is recalling nine Y Sensor Modules for the SERVO-U/-N ventilator systems because they did not undergo required electrical safety and functional tests during production.

    Product
    GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; part of the SERVO-U/-N continuous ventilator system, for facility use. Maquet Critical Care AB, is a subsidiary of Getinge.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2966-2026·2026-08-26

    Siemens Immulite 2000 Syphilis Screen Recalled for Negative Bias

    Siemens Healthineers is recalling Immulite 2000 Syphilis Screen assays because a negative patient bias may cause low reactive results to be reported as nonreactive.

    Product
    Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2987-2026·2026-08-26

    restor3d Recalls Veritas Standard Glenoid Baseplates Due to Machining Defect

    restor3d Inc. is recalling 59 Veritas Standard Glenoid Baseplates because incorrect machining of peripheral screw holes may cause improper screw engagement.

    Product
    Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard Glenoid Baseplate Model/Catalog Number: 1500-1030; 1500-1035 Software Version: N/A - off-the-shelf hardware product Product Description: The restor3d Reverse Total Shoulder Arthroplasty System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2967-2026·2026-08-26

    Paragonix KidneyVault Portable Renal Perfusion System Recalled for Firmware Defect

    Paragonix Technologies is recalling 1,445 KidneyVault Portable Renal Perfusion Systems because a firmware defect may cause the device to lose configuration, resulting in a blank screen and loss of displayed preservation parameters.

    Product
    Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2969-2026·2026-08-26

    Gentherm Medical Recalls Innercool Coolblue Console Due to Overheating Risk

    Gentherm Medical is recalling 46 Innercool Coolblue Console units because overheating of the 115V CPU board may cause the device to shut down.

    Product
    Innercool Coolblue Console, Model STx; Thermal regulating system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2958-2026·2026-08-26

    Arrowhead DE LLC Recalls Arrow-LOK Implants Due to Sterility Assurance Concerns

    Arrowhead DE LLC is recalling 4,171 Arrow-LOK Implants because they did not undergo a required gamma radiation dose audit, which could reduce sterility assurance and lead to patient infection.

    Product
    Arrow-LOK Implant, REF: 21-253519, 21-253522, 21-253525, 21-253528, 21-253530, 21-253533, 21-253535, 21-253540, 21-253545, 21-253550, 21-353513, 21-353516, 27-253519, 27-253522, 27-253525, 27-253528, 27-253530, 27-253533, 27-253535. Implant indicated for fixat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·26E061000·2026-08-26

    Bell Recalls Pit Boss Helmets for Lack of Impact Protection

    Bell Sports is recalling specific Pit Boss helmets that may lack proper impact protection, increasing injury risk in crashes.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0765-2026·2026-08-26

    Shilpa Medicare Recalls Discolored PEMRYDI RTU Injection Vials

    Shilpa Medicare is recalling 9,489 vials of PEMRYDI RTU (pemetrexed disodium) due to reports of green to dark green discoloration in the solution.

    Product
    PEMRYDI RTU — PEMRYDI RTU (PEMETREXED DISODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-1234-2026·2026-08-26

    Prospector Popcorn Fudge Brownie Popcorn Recalled for Nutrient Labeling Errors

    Prospector Popcorn is recalling Fudge Brownie Gourmet Popcorn because the packaging incorrectly lists higher amounts of potassium and calcium than the product actually contains.

    Product
    Prospector Popcorn Fudge Brownie Gourmet Popcorn 1.5oz and 3.5oz
    Category
    Food
    Distribution
    45 states
  • ModerateFDA (Drugs)·D-0774-2026·2026-08-26

    Mylan Recalls Acamprosate Calcium Tablets Due to Dissolution Failure

    Mylan Pharmaceuticals is recalling Acamprosate Calcium tablets that failed to meet dissolution specifications.

    Product
    ACAMPROSATE CALCIUM — ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2971-2026·2026-08-26

    Paragon 28 Recalls Custom Foot Implant Due to Material Defect

    Paragon 28, Inc. is recalling a custom-made foot implant due to elevated oxygen levels that may reduce material ductility.

    Product
    Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2950-2026·2026-08-26

    EndoFLIP System Recall Due to Incorrect Catheter Expiration Flags

    FDA is recalling 327 EndoFLIP Systems because a software error incorrectly flags catheters as expired, making them unavailable for clinical procedures.

    Product
    EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1 10884521808096 05391530810166 DL ENDOFLIP 1 10884521786684 Endoscopic measuring system, including catheter components.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2957-2026·2026-08-26

    Kico Knee Innovation Recalls ARVIS Surgical Navigation System Due to Sensor Issue

    Kico Knee Innovation is recalling 78 ARVIS Surgical Navigation System Gen 2 units because an internal sensor issue may cause the eyepiece image to appear tilted.

    Product
    Brand Name: Kico Knee Innovation Product Name: ARVIS SURGICAL NAVIGATION SYSTEM GEN 2 Model/Catalog Number: IN-29200 Software Version: ARVIS Hip and Knee Gap Balance Software v3.3.2 (IN-28200) ARVIS Shoulder Software v2.0.3 (IN-23630) Product Description: The ARVIS system is
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2968-2026·2026-08-26

    Gentherm Medical Recalls Blanketrol II Thermal Regulating Systems

    Gentherm Medical is recalling 182 Blanketrol II Model 222S thermal regulating systems because overheating of the 115V CPU board may cause the device to shut down.

    Product
    Blanketrol II Model 222S; Thermal regulating system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2951-2026·2026-08-26

    Foundation Medicine Recalls Hamilton Microlab STAR Liquid Handler Software

    Foundation Medicine is recalling 32 Hamilton Microlab STAR Liquid Handler units due to a software issue causing spontaneous closures.

    Product
    Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·H-1235-2026·2026-08-26

    Prospector Popcorn Recalled for Inaccurate Nutrient Labeling

    Prospector Popcorn is recalling Belgian Chocolate Toffee Gourmet Popcorn due to inaccurate nutrient declarations for Iron and Vitamin D.

    Product
    Prospector Popcorn Belgian Chocolate Toffee Gourmet Popcorn 3.5oz
    Category
    Food
    Distribution
    45 states