State

Indiana product recalls

72,971 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.

Which agencies issued them

These figures cover only the 9,556 recalls whose distribution notice names Indiana specifically. The 72,971 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

6476–6500 of 82527

HighFDA (Devices)·Z-2018-2025·2025-07-02
CDI OneView System BPM Probe temperature sensor measurement inaccuracy
Terumo Cardiovascular Systems is recalling CDI OneView System BPM Probe units due to thermistor assembly errors that cause inaccurate temperature and blood gas measurements, potentially leading to inappropriate clinical decisions.
Product
CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1997-2025·2025-07-02
Bigfoot Unity Diabetes Management System Pen Caps Unresponsive Due to Firmware Error
Bigfoot Biomedical is recalling Bigfoot Unity Diabetes Management System Pen Caps due to a firmware issue that may cause insulin pens to become unresponsive. People with diabetes may lack information needed to make timely treatment decisions.
Product
Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmware 1.3.0 Release Configuration, Rev H SW-300689-02 Bigfoot Inject v1 Pen Cap RCAP Firmware 1.3.0 Release Configuration, Rev H The Bigfoot Unity Diabetes Management System that include the
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2034-2025·2025-07-02
Philips Spectral CT Computed Tomography X-ray System Software
Philips Spectral CT systems with affected software may experience unintended motion of the gantry or table that could lead to contact with operators or patients. Additional software issues may also affect CT performance.
Product
Spectral CT. Computed tomography X-ray system.
Category
Medical Device
Distribution
19 states
HighFDA (Devices)·Z-2003-2025·2025-07-02
BD Insyte Autoguard BC Pro IV Catheter Needle Retraction Defect
Becton Dickinson is recalling BD Insyte Autoguard BC Pro Winged Shielded IV Catheters (REF 382944) due to reports that the catheter needle may retract slowly or fail to retract completely.
Product
REF: 382944, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2002-2025·2025-07-02
BD Insyte Autoguard Shielded IV Catheter needle retraction defect
Becton Dickinson is recalling one lot of BD Insyte Autoguard Shielded IV Catheters (REF 381433, 20GA x 1.00 in) due to reports that the catheter needle may retract slowly or fail to retract completely.
Product
REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnly
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2000-2025·2025-07-02
BD Insyte Autoguard BC Winged IV Catheter Needle Retraction Issue
Becton Dickinson is recalling a specific lot of BD Insyte Autoguard BC Winged IV catheters (REF 382633, Lot 4222721) due to reports that the catheter needle may be slow to retract or fail to retract entirely.
Product
REF: 382633, BD Insyte Autoguard BC Winged, Shielded IV Catheter with Blood Control Technology, 20GA x 1.00 in (1.1x25 mm) 63 mL/min, STERILEEO, RxOnly
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2025-2025·2025-07-02
PRIMA 4MM Eccentrical Adaptor With Screw Medical Device Recall
Limacorporate S.p.A is recalling PRIMA 4MM Eccentrical Adaptor with Screw devices because the black laser marking used to identify positioning may be missing. The defect could affect proper device placement during use.
Product
PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2006-2025·2025-07-02
BD Insyte Autoguard Winged Shielded IV Catheter Needle Retraction Issue
Becton Dickinson is recalling BD Insyte Autoguard Winged Shielded IV Catheters (Lot# 4282308) because the catheter needle may be slow to retract or fail to retract entirely following use.
Product
REF: 381923 BD Insyte Autoguard Winged Shielded IV Catheter, 22 GA x 1.00 in (0.9 x 25 mm) 35 mL/min, STERILEEO, RxOnly
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2008-2025·2025-07-02
Altivate Reverse Torx Peripheral Screw labeling mismatch recall
Encore Medical is recalling Altivate Reverse Torx Peripheral Screws because package labeling indicates a different screw size than the product actually included. This mismatch could lead to incorrect surgical implantation.
Product
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Model/Catalog Number: 506-04-126 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthr
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-2010-2025·2025-07-02
Altivate Reverse Torx Peripheral Screws Package Labeling Mismatch
Encore Medical is recalling Altivate Reverse Torx Peripheral screws because the package labeling lists a different screw size than what is actually included in the package.
Product
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm Model/Catalog Number: 506-04-118 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthr
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-1999-2025·2025-07-02
BD Insyte Autoguard Shielded IV Catheter needle retraction failure recall
Becton Dickinson is recalling BD Insyte Autoguard Shielded IV Catheters (REF 381423, 22GA X 1.00 IN) due to the possibility that the catheter needle may be slow to retract or fail to retract entirely.
Product
REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/min, STERILEEO, RxONLY
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1996-2025·2025-07-02
DxI 9000 Access Immunoassay Analyzer calibration system error recall
Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer C11137 due to calibration issues where curves switch from passed to failed status due to system errors, potentially causing erroneous test results.
Product
DxI 9000 Access Immunoassay Analyzer C11137
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1995-2025·2025-07-02
Medline Umbilical Tray sterile packaging defect recall
Medline is recalling umbilical trays due to a possible packaging defect in the outer Tyvec pouch that protects the sterile product. The defect may compromise sterility.
Product
Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2012-2025·2025-07-02
Caphosol Artificial Saliva sachets recalled for out-of-specification stability
Recordati Rare Diseases is recalling Caphosol Artificial Saliva 32-dose sachets because stability test results for Solution B were out of specification during process validation.
Product
Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solution B Calcium)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2027-2025·2025-07-02
Atellica CH Diluent Contaminated with Sodium Hypochlorite
Siemens Healthcare Diagnostics is recalling Atellica CH Diluent (SMN 11099300, Lot 0000195412) due to contamination with sodium hypochlorite, which may affect laboratory test results.
Product
Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2009-2025·2025-07-02
Altivate Reverse Torx Peripheral Screw labeling mismatch recall
Encore Medical is recalling Altivate Reverse Torx Peripheral Screws because package labeling lists a different size than the actual product included inside.
Product
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm Model/Catalog Number: 506-04-122 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthr
Category
Medical Device
Distribution
18 states
ModerateFDA (Devices)·Z-2011-2025·2025-07-02
Altivate Reverse Torx Peripheral Screw package labeling mismatch
Encore Medical is recalling Altivate Reverse Torx Peripheral Screws because the package labeling lists a different size than the actual product included inside.
Product
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm Model/Catalog Number: 506-04-130 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthr
Category
Medical Device
Distribution
18 states
ModerateFDA (Drugs)·D-0483-2025·2025-07-02
Tirzepatide Injections Pre-filled Syringe Recalled for Sterility Assurance
Thrive Health Solutions is recalling Tirzepatide Injections 20mg/mL pre-filled syringes due to lack of assurance of sterility. Approximately 826 syringes distributed nationwide are affected.
Product
Tirzepatide Injections, 20mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2026-2025·2025-07-02
Jewel Precision Reusable Rigid Sterilization Container System Instructions Mismatch
Jewel Precision Reusable Rigid Sterilization Container System (Model JP-24-6) is being recalled because the Instructions for Use do not match the FDA-cleared indications for use or sterility shelf life.
Product
Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1998-2025·2025-07-02
LUCAS Chest Compression System demonstration units recalled
Jolife AB is recalling LUCAS 2, 3, and 3.1 chest compression system demonstration units that may have been provided to customers for clinical use instead of demonstration purposes only.
Product
LUCAS 2, 3 and 3.1 LUCAS chest compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0489-2025·2025-07-02
Dobutamine Injection Recall Due to Discoloration and Cracked Vials
Pfizer is recalling one lot of Dobutamine Injection (250 mg/20 mL) nationwide due to discoloration and discolored solution caused by cracked vials. Healthcare facilities should quarantine and return affected units.
Product
DOBUTAMINE — DOBUTAMINE (DOBUTAMINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·H-0090-2025·2025-07-02
Nootri Toto food product recalled due to insanitary conditions
East Africa Boutique, LLC is recalling Nootri Toto (1 kg packages) distributed to seven retailers in Indiana, Kentucky, Missouri, and Ohio due to products being held under insanitary conditions.
Product
Nootri Toto, Net Weight 1 kg, packaged in a cardboard box, packed 12 boxes per case
Category
Food
Distribution
4 states
ModerateFDA (Food)·H-0094-2025·2025-07-02
Probese Caps dietary supplement recalled for undeclared food dyes
Probese Caps, a dietary supplement with Iron sold in 90-count bottles, is being recalled because it contains undeclared Allura Red (Red No. 40) and Brillant Blue (Blue No. 1) in the gelatin capsules.
Product
Probese Caps, dietary supplement with Iron. 90-count bottles. Legere Pharmaceuticals 15344 N 83rd way, Scottsdale AZ 85260 (Product does not have a UPC)
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Food)·H-0091-2025·2025-07-02
Prothin Dietary Supplement Recall for Undeclared Food Dyes
Preventics, Inc. is recalling Prothin dietary supplement packets because they contain undeclared Allura Red (Red No. 40) and Brillant Blue (Blue No. 1) in the gelatin capsules, which may affect consumers with dye sensitivities or allergies.
Product
Prothin, dietary supplement. Seven Packets containing 2 tablets and 4 capsules. Legere Pharmaceuticals 15344 N 83rd way, Scottsdale AZ 85260 (Product does not have a UPC)
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Food)·H-0092-2025·2025-07-02
Super ProTHIN Plus Dietary Supplement Recalled for Undeclared Dyes
Preventics, Inc. dba Legere Pharmaceuticals is recalling Super ProTHIN Plus dietary supplement because gelatin capsules contain undeclared Allura Red (Red No. 40) and Brillant Blue (Blue No. 1) food colorings.
Product
Super ProTHIN Plus, dietary supplement. Seven Packets with 2 tablets & 4 Capsules and 1 packet with 14 Nutrilean capsules. Legere Pharmaceuticals 15344 N 83rd way, Scottsdale AZ 85260 (Product does not have a UPC)
Category
Food
Distribution
Distributed nationwide