The Recall Desk

State

Indiana product recalls

72,992 recalls have nationwide distribution and so reach Indiana. 9,556 additional recalls listed Indiana specifically in their distribution scope.

What the numbers show

Total
9,556
Critical
1,903
Severe
2,136
Most recent
2026-09-16

Of the 9,556 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 2,136 (22%) are Severe.

These figures cover only the 9,556 recalls whose distribution notice names Indiana specifically. The 72,992 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

8776–8800 of 82548

  • HighFDA (Devices)·Z-0686-2025·2024-12-25

    Philips Access Point Software Issue Risks Patient Data Loss

    Philips Smart-Hopping 2.0 Access Points may reset after 82 days, risking loss of patient data and network disconnections. No injuries have been reported.

    Product
    Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0690-2025·2024-12-25

    K-Systems T47 Warming Plate May Exceed Set Temperatures

    CooperSurgical recalls K-Systems T47 Warming Plates because temperature may exceed the desired set value, potentially affecting biological materials. The device alarms appropriately when this occurs.

    Product
    Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23055 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0703-2025·2024-12-25

    OEC 3D Mobile Fluoroscopic X-Ray System Tube Sealing Defect Recall

    GE OEC Medical Systems is recalling 84 OEC 3D mobile fluoroscopic X-ray systems due to manufacturing defects in X-ray tube sealing that can cause oil leaks and loss of imaging capability.

    Product
    OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopic C-Arm imaging system used to assist trained surgeons and other qualified physicians. The system is used to provide fluoroscopic Xray images and volumetric reconstructions durin
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Drugs)·D-0142-2025·2024-12-25

    FDA Recalls Health-Tec Benzocaine Topical Anesthetic Due to Manufacturing Defect

    Keystone Industries recalls Health-Tec Topical Anesthetic (Benzocaine 20%) lot BNZ-001646 due to manufacturing defects. Scratches found in the mixing vessel caused product rejection designation, but product was inadvertently shipped.

    Product
    HEALTH-TEC TOPICAL ANESTHETIC — HEALTH-TEC TOPICAL ANESTHETIC (BENZOCAINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0688-2025·2024-12-25

    K-Systems G85 Mini Incubator May Exceed Desired Temperature

    CooperSurgical recalls 37 K-Systems G85 Mini Incubators because the device warming surfaces may exceed the desired set temperature. The unit alarms when this occurs, but affected serial numbers require verification.

    Product
    Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Drugs)·D-0153-2025·2024-12-25

    OTC Ophthalmic Solution Recalled for Lack of Sterility Assurance

    REGENER-EYES ophthalmic solution is being recalled nationwide due to lack of sterility assurance. Consumers should stop using affected lots immediately.

    Product
    PROFESSIONAL Regener-Eyes, Ophthalmic Solution (glycerin 0.5%) , 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL; Manufactured by: Regenerative Processing Plant, LLC, 34176 US HWY 19N, FL, NDC 82305-003-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0689-2025·2024-12-25

    K-Systems T47 Warming Plate may exceed desired temperatures

    The K-Systems T47 Warming Plate has a temperature control defect where warming surfaces may exceed desired set temperatures. CooperSurgical is recalling 22 affected units distributed to fertility clinics.

    Product
    Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23054 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Drugs)·D-0151-2025·2024-12-25

    VCF Contraceptive Pre-filled Applicators Recalled for Out-of-Specification Active Ingredient

    Apothecus Pharmaceutical recalls 33,659 boxes of VCF nonoxynol-9 contraceptive gel nationwide due to out-of-specification active ingredient assay from manufacturing deviations. No illnesses reported.

    Product
    VCF CONTRACEPTIVE PRE-FILLED APPLICATORS — VCF CONTRACEPTIVE PRE-FILLED APPLICATORS (NONOXYNOL-9)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0706-2025·2024-12-25

    GE OEC 9800 X-Ray System Recalled for Insufficient Tube Sealing

    GE OEC 9800 fluoroscopic X-ray systems are recalled due to insufficient sealing of X-ray tubes, which can result in oil leaks and loss of imaging capability. 25 systems distributed in the U.S. and internationally are affected.

    Product
    OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscop
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Drugs)·D-0152-2025·2024-12-25

    Ophthalmic solution recalled for lack of sterility assurance

    Regener-Eyes ophthalmic solution is being recalled due to lack of sterility assurance. Approximately 170,812 bottles distributed nationwide are affected.

    Product
    LITE Regener-Eyes, Ophthalmic Solution (glycerin 0.4%), 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL; Manufactured by: Regenerative Processing Plant, LLC, 34176 US HWY 19N, FL, NDC 82305-006-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0704-2025·2024-12-25

    Fluoroscopic X-Ray System Recalled for Insufficient X-Ray Tube Sealing

    GE OEC Elite mobile fluoroscopic X-ray systems are recalled due to insufficient sealing of X-ray tubes, which can cause oil leaks and loss of imaging capability. Approximately 100 systems have been affected.

    Product
    OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Drugs)·D-0138-2025·2024-12-25

    Topical Anesthetic Gel Recalled for Manufacturing Equipment Defect

    Keystone Industries is recalling Benzocaine 20% topical anesthetic gel due to scratches in the manufacturing mixing vessel. Despite Quality Assurance rejection, the product was inadvertently shipped to customers.

    Product
    M&S Dental Supply Co LLC., Topical Anesthetic Gel, Benzocaine 20%, Net Wt. 1 oz. (30ml), Manufactured for: M&S Dental Supply Co LL, 105-30 101 Avenue, Ozone Park, NY 11416.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0285-2025·2024-12-25

    Impossible Spicy Ground Sausage Recalled for Potential Metal Contamination

    Impossible Foods is recalling Impossible Spicy Ground Sausage due to potential metal pieces in the product. The recall affects 32,536 cases distributed nationwide with use-by dates between June 28, 2025 and January 28, 2026.

    Product
    Impossible Spicy Ground Sausage Meat from plants 14oz chub, UPC 8 16697 02109 5; 8 retail chubs per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0144-2025·2024-12-25

    Pearson Quality Topical Anesthetic Gel Recalled Due to Manufacturing Defect

    Keystone Industries is recalling Pearson Quality Topical Anesthetic Gel (20% Benzocaine) due to manufacturing equipment defects that could allow product contamination. The affected lot was inadvertently shipped despite quality control rejection.

    Product
    Pearson Quality, Topical Anesthetic Gel, 20% Benzocaine, For Professional Use Only, Net Contents: 1 oz (30 g), Manufactured for Pearson Dental Supply Inc., Sylmar, CA 91342 USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0657-2025·2024-12-25

    Ambler Surgical Bipolar Pencil recalled for outer tube structural failure

    Kirwan Surgical Products is recalling the Ambler Surgical Bipolar Pencil 25 Gauge Straight (Model PD7226) because the outer stainless-steel tube may break or detach during use. 4,470 units worldwide are affected.

    Product
    Ambler Surgical Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: PD7226. The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the retinal area durin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0692-2025·2024-12-25

    K-Systems Incubator Device Recall: Temperature May Exceed Desired Setting

    CooperSurgical is recalling 34 K-Systems incubator devices used in assisted reproduction procedures. The warming surfaces may exceed the desired set temperature, though the device will alarm if this occurs.

    Product
    Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g.,
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Drugs)·D-0147-2025·2024-12-25

    Benzocaine Topical Gel Recalled Due to Manufacturing Quality Defect

    Keystone Industries recalls Ipana 20% Benzocaine Topical Gel due to a manufacturing quality issue. The bulk product was released from a mixing vessel with scratches despite Quality Unit rejection.

    Product
    Ipana, 20% Benzocaine Topical Gel, 28g, Maxill Inc., St Thomas ON Canada.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0154-2025·2024-12-25

    Olanzapine 2.5 mg Tablets Recalled for Failed Impurity Specifications

    Macleods Pharmaceuticals is recalling Olanzapine 2.5 mg tablets nationwide due to failed impurities and degradation specifications. The recall affects one production lot distributed across the United States.

    Product
    OLANZAPINE — OLANZAPINE (OLANZAPINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0141-2025·2024-12-25

    Patterson Dental Topical Anesthetic Recalled for Manufacturing Quality Defect

    Keystone Industries is recalling one lot of Patterson Dental Topical Anesthetic due to manufacturing quality deviations. The product was shipped despite being marked for rejection due to scratches in the mixing vessel.

    Product
    PATTERSON DENTAL TOPICAL ANESTHETIC — PATTERSON DENTAL TOPICAL ANESTHETIC (BENZOCAINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0150-2025·2024-12-25

    Dihydroergotamine Mesylate Injection recalled due to discoloration

    Provepharm Inc. is voluntarily recalling Dihydroergotamine Mesylate Injection nationwide due to discoloration in specific lots. Patients should contact their healthcare provider if they have used the affected product.

    Product
    DIHYDROERGOTAMINE MESYLATE — DIHYDROERGOTAMINE MESYLATE (DIHYDROERGOTAMINE MESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0137-2025·2024-12-25

    Benzocaine Topical Anesthetic Recalled for Manufacturing Equipment Defect

    Gelato Benzocaine 20% topical anesthetic (Lot BNZ-001646) is recalled due to scratches found in the mixing vessel during manufacturing. The defective product was inadvertently released despite quality control rejection, though no illnesses have been reported.

    Product
    GELATO TOPICAL ANESTHETIC — GELATO TOPICAL ANESTHETIC (BENZOCAINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0148-2025·2024-12-25

    FDA Recalls Benzo-Jel Topical Anesthetic Gel Due to Manufacturing Defect

    Henry Schein's Benzo-Jel Topical Anesthetic Gel is being recalled due to manufacturing quality deviations. Scratches were discovered on the mixing vessel after the product had been inadvertently released and distributed to customers.

    Product
    Henry Schein, Benzo-Jel, Topical Anesthetic Gel, 20% Benzocaine, 1 fl. oz. (29.6 mL), Distributed by Henry Schein, Melville, NY 11747, For Professional Use Only,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0143-2025·2024-12-25

    Topical anesthetic gel recall due to manufacturing quality control deviation

    Keystone Industries recalls Burkhart Topical Anesthetic Gel due to CGMP deviations discovered during quality inspection. The product was inadvertently released despite being flagged for rejection.

    Product
    Burkhart, Topical Anesthetic Gel, Benzocaine 20%, Gluten Free, 1 FL. OZ (30 ml), Manufactured for Burkhart Dental Supply, Tacoma, Washington 98409.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0691-2025·2024-12-25

    K-Systems R65 embryo incubator temperature may exceed setpoint

    CooperSurgical's K-Systems R65 Trolley reproductive incubators may experience temperature excursions above desired setpoints, though devices will alarm when this occurs. The FDA issued a Class II recall of 43 units across eight U.S. states.

    Product
    Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and em
    Category
    Medical Device
    Distribution
    14 states