State

Indiana product recalls

72,940 recalls have nationwide distribution and so reach Indiana. 9,555 additional recalls listed Indiana specifically in their distribution scope.

What the numbers show

Total: 9,555
Critical: 1,903
Severe: 2,136
Most recent: 2026-09-09

Of the 9,555 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 9,555 recalls whose distribution notice names Indiana specifically. The 72,940 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

3451–3475 of 82495

ModerateFDA (Devices)·Z-1295-2026·2026-02-11
Sphincterotome KD-V411M-3020 recalled over a skipped thermoforming step
Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V411M-3020, because devices which did not undergo thermoforming could deform and lose performance.
Product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3020 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1229-2026·2026-02-11
Prismaflex HF1000 set 107140 recalled over a dislodging deaeration chamber
Vantive US Healthcare is recalling 93,576 Prismaflex HF1000 Sets, product code 107140, because the deaeration chamber may dislodge from the Prismaflex Control Unit.
Product
PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1291-2026·2026-02-11
Sphincterotome KD-V411M-1530 recalled over a skipped thermoforming step
Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V411M-1530, because devices which did not undergo thermoforming could deform and lose performance.
Product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1530 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1241-2026·2026-02-11
CT software applications recalled because they lack FDA clearance
Siemens is removing three software applications from five NAEOTOM Alpha.Prime CT systems because the applications have not received FDA 510(k) clearance.
Product
NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0301-2026·2026-02-11
Bisoprolol and hydrochlorothiazide tablets recalled over a nitrosamine impurity
Unichem Pharmaceuticals USA is recalling a lot of Bisoprolol Fumarate and Hydrochlorothiazide tablets, 2.5 mg/6.25 mg, for not meeting the N-Nitroso Bisoprolol impurity specification limits.
Product
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE — BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1273-2026·2026-02-11
Single use 3-lumen sphincterotomes recalled over a skipped thermoforming step
Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V411M-0725, because devices which did not undergo thermoforming could deform and lose performance.
Product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0725; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1289-2026·2026-02-11
Sphincterotome KD-401Q-0730 recalled over a skipped thermoforming step
Olympus is recalling the Disposable Triple Lumen Sphincterotome, model KD-401Q-0730, because devices which did not undergo thermoforming could deform and lose performance.
Product
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0730 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1292-2026·2026-02-11
Sphincterotome KD-V411M-3030 recalled over a skipped thermoforming step
Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V411M-3030, because devices which did not undergo thermoforming could deform and lose performance.
Product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3030 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1282-2026·2026-02-11
Sphincterotome KD-VC412Q-0215 recalled over a skipped thermoforming step
Olympus is recalling the Single Use 3-Lumen Sphincterotome V (Distal Wire guided), model KD-VC412Q-0215, because devices which did not undergo thermoforming could deform and lose performance.
Product
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC412Q-0215; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1310-2026·2026-02-11
Hoist sling bars recalled after a lifting bar mounting bolt broke
ETAC A/S is recalling 64 units of Molift 2-point sling bars, accessories to mobile hoists after a customer reported the bolt for mounting the lifting bar breaking during assembly and load testing.
Product
Brand Name: Molift Product Name: Molift 2-point sling bars (Accessory to mobile hoists) Model/Catalog Numbers: (1) 1530101, (2) 1530102 Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional, impairment due t
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·H-0463-2026·2026-02-11
Organic garlic salt recalled over a no salt claim on the label
Organic Spices is recalling 524 cases of Spicely Organic garlic salt because the product contains salt and is mislabeled.
Product
spicely ORGANIC garlic salt NO ARTIFICIAL COLORING NO GLUTEN - NO MSG - NO SOY NO PRESERVATIVES - NO WHEAT NO SUGAR - NO SALT - NO IRRADIATION Net wt: 3.4oz (96g) Ingredients: Salt, *Garlic *Organic www.spicely.com Organic Spices Inc, Fremont CA 94538 UPC: 826998007643
Category
Food
Distribution
13 states
ModerateFDA (Devices)·Z-1283-2026·2026-02-11
Sphincterotome KD-VC433Q-0720 recalled over a skipped thermoforming step
Olympus is recalling the Single Use 3-Lumen Sphincterotome V (Distal Wire guided), model KD-VC433Q-0720, because devices which did not undergo thermoforming could deform and lose performance.
Product
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC433Q-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0342-2026·2026-02-11
Diclofenac topical gel recalled after failing viscosity specifications
Sun Pharmaceutical Industries is recalling a lot of Diclofenac Sodium Topical Gel, 3%, after an out of specification viscosity result slightly below the limit.
Product
DICLOFENAC SODIUM — DICLOFENAC SODIUM (DICLOFENAC SODIUM)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1274-2026·2026-02-11
Sphincterotome KD-V411M-0730 recalled over a skipped thermoforming step
Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V411M-0730, because devices which did not undergo thermoforming could deform and lose performance.
Product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1285-2026·2026-02-11
Sphincterotome KD-411Q-0720 recalled over a skipped thermoforming step
Olympus is recalling the Disposable Triple Lumen Sphincterotome, model KD-411Q-0720, because devices which did not undergo thermoforming could deform and lose performance.
Product
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0720 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1281-2026·2026-02-11
Sphincterotome KD-VC411Q-0330 recalled over a skipped thermoforming step
Olympus is recalling the Single Use 3-Lumen Sphincterotome V (Distal Wire guided), model KD-VC411Q-0330, because devices which did not undergo thermoforming could deform and lose performance.
Product
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0330; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1277-2026·2026-02-11
Sphincterotome KD-VC431Q-0730 recalled over a skipped thermoforming step
Olympus is recalling the Single Use 3-Lumen Sphincterotome V (Distal Wire guided), model KD-VC431Q-0730, because devices which did not undergo thermoforming could deform and lose performance.
Product
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1275-2026·2026-02-11
Sphincterotome KD-V431M-0720 recalled over a skipped thermoforming step
Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V431M-0720, because devices which did not undergo thermoforming could deform and lose performance.
Product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1276-2026·2026-02-11
Sphincterotome KD-V431M-0730 recalled over a skipped thermoforming step
Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V431M-0730, because devices which did not undergo thermoforming could deform and lose performance.
Product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·H-0464-2026·2026-02-11
Organic celery salt recalled over a no salt claim on the label
Organic Spices is recalling 391 cases of Spicely Organic celery salt because the product contains salt and is mislabeled.
Product
spicely ORGANIC celery salt NO ARTIFICIAL COLORING NO GLUTEN - NO MSG - NO SOY NO PRESERVATIVES - NO WHEAT NO SUGAR - NO SALT - NO IRRADIATION Net wt: 2.4oz (68g) Ingredients: Salt, *Celery Seeds *Organic www.spicely.com Organic Spices Inc, Fremont CA 94538 UPC: 826998007605
Category
Food
Distribution
13 states
ModerateFDA (Devices)·Z-1221-2026·2026-02-11
Hematology diluents recalled over elevated platelet background check counts
Beckman Coulter is recalling 76,098 units of COULTER DxH Diluent and DxH ECO Diluent because specific lots contribute to elevated platelet Daily Checks background counts.
Product
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells on all UniCel DxH Coulter Cellular Analysis Systems. For use as a rinsing agent on the
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1308-2026·2026-02-11
Molift Mover 205 hoists recalled after a mounting bolt broke
ETAC A/S is recalling 95 Molift Mover 205 mobile hoists after a customer reported the bolt for mounting the lifting bar breaking during assembly and load testing.
Product
Brand Name: Molift Product Name: Molift Mover 205 Model/Catalog Number: (1) M14000, (2) M1401, (3) M1402, (4) M14050, (5) M14150, (6) M1402-01, (7) M14050-00 (8) M14001;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1300-2026·2026-02-11
Bubble sensors recalled over connecting cables that can be damaged
Maquet Cardiopulmonary is recalling 3,050 Bubble Sensors because excessive bending of the connecting cable can damage the Venous Bubble Sensor or cause loose cable contact.
Product
Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1239-2026·2026-02-11
SOMATOM X.ceed software applications recalled over missing FDA clearance
Siemens is removing three software applications from two SOMATOM X.ceed CT systems because the applications have not received FDA 510(k) clearance.
Product
SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1271-2026·2026-02-11
Sphincterotome KD-V411M-0330 recalled over a skipped thermoforming step
Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V411M-0330, because devices which did not undergo thermoforming could deform and lose performance.
Product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0330; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Category
Medical Device
Distribution
Distributed nationwide