State

Indiana product recalls

73,190 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 73,190 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

14451–14475 of 82777

HighFDA (Devices)·Z-0508-2024·2023-12-13
DJO EMPOWR Knee System Recall: Incorrect Device in Packaging
Encore Medical is recalling 37 DJO surgical EMPOWR Porous Knee System SIZE 8 devices distributed nationwide because incorrect product components were packaged with certain units.
Product
DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF 243-01-108 DJO surgical EMPOWR KNEE", PRESS FIT BP MINUS, 8L REF 353-03-108 For the treatment of patients who are candidates for knee arthroplasty per the Indication for…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0439-2024·2023-12-13
CardioQuip Modular Cooler-Heater Units Recalled for Heating Chamber Malfunction
CardioQuip Modular Cooler-Heater units are being recalled due to a potential heating-chamber malfunction that could cause melting and burning of internal components. 125 units distributed across 15 US states are affected.
Product
CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-0433-2024·2023-12-13
ProCuity Hospital Bed Model 3009 Lacks Required Electrical Safety Tests
Stryker Medical is recalling ProCuity hospital beds with missing electrical safety test documentation, creating risk of electrical shock or tissue burns.
Product
ProCuity bed series, model number 3009, item number: 3009PX-ZM-600.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0502-2024·2023-12-13
Cooper Surgical catheter recall due to component detachment risk
The Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr catheter may detach or leak due to defective bonding material used in assembly. The 73 affected units were distributed nationwide and internationally.
Product
Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of fallopian tubes. Model…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0437-2024·2023-12-13
DRX Revolution Mobile X-Ray System Electrical Component Failure Recall
Carestream Health is recalling the DRX Revolution Mobile X-Ray System due to unexpected failure of electrical components in the CPI generator. The recall affects approximately 3,961 units distributed worldwide.
Product
DRX Revolution Mobile X-Ray System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0493-2024·2023-12-13
Integra Cranial Access Kit packaging defect compromises device sterility
Integra LifeSciences is recalling 59 Integra Cranial Access Kits due to outer packaging that can split without external force, compromising device sterility. Affected units (Lot 6837706, exp. 1-Mar-25) should be discontinued immediately.
Product
Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7040
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0473-2024·2023-12-13
Intraocular Lens Implants Recalled for Specification Non-Compliance
Staar Surgical recalls six EVO+VISIAN intraocular lens implants due to potential specification non-compliance. The affected units were distributed across 38 US states.
Product
EVO+VISIAN Implantable Collamer Lens, REF:VTICM5_13.7. Phakic Toric Intraocular lens.
Category
Medical Device
Distribution
38 states
HighFDA (Devices)·Z-0490-2024·2023-12-13
Blood Ketone Test Strips Recalled for False Negative Results
Stanbio Laboratory is recalling STAT-Site M BHB Test Strips due to stability deterioration that causes false negative results. This defect may delay diagnosis and treatment of patients with conditions such as diabetic ketoacidosis.
Product
STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0427-2024·2023-12-13
ProCuity Hospital Beds: Missing electrical safety tests pose burn and shock risk
Stryker's ProCuity hospital beds (model 3009) lack electrical safety test values, creating a risk of tissue burns and electrical shock to patients. The beds were distributed nationwide and internationally.
Product
ProCuity bed series, model number 3009, item number: 3009PX-LE-400.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0503-2024·2023-12-13
Medical Catheter Set Recalled for Faulty Bonding Material
CooperSurgical is recalling H/S ELLIPTOSPHERE CATH 5 FR Sets (169 units) due to incorrect bonding material that may cause component detachment or leakage, potentially delaying diagnostic procedures.
Product
Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of fallopian tubes Model…
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·23V841000·2023-12-13
Multiple Porsche electric vehicles: 220V charging cable fire risk recall
Porsche is recalling multiple electric vehicle models due to fire risk from overheating 220V/240V charging cables. Owners should not use these cables and should instead use 110V charging or public stations.
Product
PORSCHE — PORSCHE PANAMERA 4S E-HYBRID, PANAMERA TURBO S E-HYBRID, TAYCAN 4 CROSS TURISMO, TAYCAN 4S
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0146-2024·2023-12-13
Baxter Healthcare Injectable Ondansetron Recalled for Failed pH Specifications
Baxter Healthcare Corporation is recalling approximately 6 million vials of Ondansetron Hydrochloride injection due to manufacturing defects where pH levels failed to meet specifications.
Product
ONDANSETRON HYDROCHLORIDE — ONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0467-2024·2023-12-13
Staar EVO +VISIAN Implantable Collamer Lens Recalled for Specification Compliance Issue
Staar Surgical is recalling EVO +VISIAN Implantable Collamer Lens devices due to a potential that the devices may not meet specifications. Patients should consult their eye care provider.
Product
EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
Category
Medical Device
Distribution
38 states
HighFDA (Devices)·Z-0430-2024·2023-12-13
ProCuity Hospital Patient Beds Recalled for Missing Electrical Safety Testing
Stryker is recalling ProCuity bed series model 3009 because they are missing electrical safety test values, presenting a risk of tissue burn or electrical shock to patients.
Product
ProCuity bed series, model number 3009, item number: 3009PX-LEX-450.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0142-2024·2023-12-13
Children's Acetaminophen Suspension Recalled for Failed Impurity Specifications
KinderFarms is recalling KinderMed KIDS' PAIN & FEVER Acetaminophen oral suspension nationwide due to failed impurity and degradation specifications that do not meet FDA standards.
Product
PAIN AND FEVER — PAIN AND FEVER (ACETAMINOPHEN)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0449-2024·2023-12-13
Monarch Platform Bronchoscope Software Issue Causes Flipped Display
Auris Health is recalling 110 units of the Monarch Platform bronchoscope due to a software defect that may flip the image display. This inverted view could impact visualization during airway procedures.
Product
Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w
Category
Medical Device
Distribution
34 states
HighFDA (Devices)·Z-0484-2024·2023-12-13
Atrium Firm PVC Thoracic Catheter Recalled for Sterilization Nonconformance
Atrium Medical Corporation is recalling 2,460 units of the Atrium Firm PVC Thoracic Catheter 36FR Straight due to sterilization nonconformance that caused premature product aging and inaccurate expiration dating. Facilities in 14 U.S. states are affected.
Product
Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-0472-2024·2023-12-13
Intraocular Lens Implants Recalled Due to Potential Specification Non-Compliance
Staar Surgical is recalling 11 EVO+VISIAN implantable collamer lenses distributed across 38 US states because they may not meet manufacturing specifications. No illnesses or injuries have been reported.
Product
EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_13.2. Phakic Toric Intraocular lens.
Category
Medical Device
Distribution
38 states
HighFDA (Devices)·Z-0450-2024·2023-12-13
Monarch Platform Bronchoscopy Device Recalled for Software Image Inversion
AURIS HEALTH INC is recalling approximately 110 units of the Monarch Platform bronchoscopy surgical device due to a software defect that can flip the displayed image during procedures. No injuries have been reported.
Product
Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w
Category
Medical Device
Distribution
34 states
HighFDA (Devices)·Z-0497-2024·2023-12-13
Integra Cranial Access Kit recalled over outer packaging defect
Integra LifeSciences recalled the Integra Cranial Access Kit (160 units) due to a defect in the outer packaging that can split and compromise device sterility, creating an infection risk for neurosurgical procedures.
Product
Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP06
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0428-2024·2023-12-13
ProCuity Patient Beds Recalled Missing Electrical Safety Test Values
Stryker is recalling ProCuity patient beds (model 3009) for missing required electrical safety test documentation, creating a risk of electrical shock or tissue burn.
Product
ProCuity bed series, model number 3009, item number: 3009PX-LE-450.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0434-2024·2023-12-13
ProCurity patient beds recalled for electrical safety testing defects
Stryker is recalling ProCurity bed series (model 3009) due to missing electrical safety test values that could pose risk of electrical shock or tissue burn. Affected units were distributed nationwide and internationally.
Product
ProCurity bed series, model number 3009, item number: 3009PX-ZMX-450.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0137-2024·2023-12-13
Bupropion Hydrochloride Extended-Release Tablets Recalled for Failed Dissolution
Sun Pharmaceutical is recalling Bupropion Hydrochloride Extended-Release Tablets 200 mg due to failed dissolution specifications. The recall affects 2,016 bottles with lot HAD0630A distributed nationwide.
Product
BUPROPION HYDROCHLORIDE — BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0506-2024·2023-12-13
TENS Devices Recalled for Missing Instruction Manual Warnings
Liberty Medical Solutions is recalling 473 Multi-Mode TENS stimulator units distributed in five states due to missing warnings and contraindications in instruction manuals.
Product
Multi-Mode Stimulator, Transcutaneous Electrical Nerve Stimulation
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0140-2024·2023-12-13
LET Gel Topical Anesthetic Recalled Due to Incorrect Product Formulation
Right Value Drug Stores is recalling LET Gel topical anesthetic syringes nationwide due to incorrect product formulation. Patients should not use affected syringes and should consult their healthcare provider.
Product
LET Gel (Lidocaine HCL/Epinephrine Bitartrate/Tetracaine HCL 4%/0.18%/0.5% Topical Gel), Single-use Topical Syringe, 3mL syringe, 10/pack, Rx only, Carie Boyd Pharmaceuticals, 8400 Esters Blvd, Ste# 190, Irving, TX 75063, NDC73271-1003-1
Category
Drug
Distribution
Distributed nationwide