The Recall Desk

State

Indiana product recalls

72,919 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 72,919 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

2301–2325 of 82474

  • ModerateFDA (Devices)·Z-1833-2026·2026-04-29

    Medline Medical Device Kits With Rescinded FDA Clearances

    FDA has rescinded the 510(k) clearances for certain Medline medical device kits including control syringes, guidewires, and high-pressure tubing. Medline is recalling approximately 58,836 units distributed nationwide.

    Product
    Medline Kits: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB; 2) MANIFOLD KIT LOW PRESSURE OFF, Model Number: VASCSLPOFF1; 3) EP MANIFOLD KIT, Model Number: VASC1018A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1881-2026·2026-04-29

    Medline Convenience Kits with Polycarbonate Syringes Unapproved Design Changes

    Medline Industries is recalling select Convenience Kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA 510(k) clearance.

    Product
    Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BARIATRIC DYNJ905153M, DYNJ905153N GENERAL LAPAROSCOPY PACK DYNJ81602 LAPAROSCOPY DYNJ905157K, DYNJ905157L LAPAROTOMY PACK DYNJ46675G MAJOR LITHOTOMY PACK DYNJ81607 MAJ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0484-2026·2026-04-29

    Pantoprazole Sodium Tablets Recalled for Discoloration Issues

    Hetero Labs Limited is recalling Pantoprazole Sodium 40 mg delayed-release tablets due to discoloration—some tablets are darker than normal with lighter-colored spots. The firm received five complaints about the affected tablets.

    Product
    PANTOPRAZOLE SODIUM — PANTOPRAZOLE SODIUM (PANTOPRAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1901-2026·2026-04-29

    OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Lever Failure

    Olympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2113) because the Version 2 reprocessor connecting tube lock levers may fail prematurely. The defect could affect proper connection during endoscope reprocessing.

    Product
    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1850-2026·2026-04-29

    Medline Arthroscopy Pack regulatory clearance rescinded

    The FDA has rescinded regulatory clearances for certain Control Syringes, Guidewires, and High-Pressure Tubing included in Medline's Arthroscopy Pack (Model DYNJ82440). Affected units should not be used.

    Product
    Medline Kits: 1) ARTHROSCOPY PACK, Model Number: DYNJ82440
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1900-2026·2026-04-29

    OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Lever Failure

    Olympus Corporation of the Americas is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2112) because the Version 2 reprocessor connecting tube lock levers may fail prematurely.

    Product
    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1830-2026·2026-04-29

    Medline Namic Control Syringes recalled due to rescinded FDA clearance

    Medline Industries is recalling Medline Namic Control Syringes (Model DYNJSYR10CWRB) because the FDA has rescinded their 510(k) regulatory clearance. The recall affects 24,170 units distributed nationwide.

    Product
    Medline Namic Syringes: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1887-2026·2026-04-29

    Medline Convenience Kits with 10mL Syringes recalled for unapproved design changes

    Medline Industries is recalling Convenience Kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects approximately 270,311 units distributed nationwide and internationally.

    Product
    Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EXTREMITY PACK DYNJ34846C HAND PACK DYNJ83218A, DYNJ85396 LAMINECTOMY DYNJ905156R MAJOR EXTREMITY DYNJ905159L, DYNJ905159M MAJOR EXTREMITY PACK DYNJ69926A PODIATRY PACK D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1919-2026·2026-04-29

    IV Administration Sets Potential Backflow and Occlusion Risk

    B. Braun is correcting gravity and pump administration sets used with specific infusion pumps due to risk of medication backflow from secondary containers into primary containers and occlusion during priming.

    Product
    Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1902-2026·2026-04-29

    OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Lever Failure Risk

    Olympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2114) because the Version 2 reprocessor connecting tube lock levers may fail prematurely, potentially affecting equipment operation and patient safety during endoscope reprocessing.

    Product
    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1885-2026·2026-04-29

    Medline 10mL Polycarbonate Colored Syringes Kits Recalled for Unapproved Design Changes

    Medline Industries is recalling Convenience Kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects syringes distributed worldwide, including the US, Canada, Panama, and Barbados.

    Product
    Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes GU DAVINCI PACK - LF DYNJ909398A ROBOTIC PACK DYNJ908706D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1839-2026·2026-04-29

    Medline ENT and Vascular Kits with Rescinded Regulatory Clearances

    Medline Industries is recalling three ENT and vascular kits (513 units nationwide) because their regulatory clearances for certain components—Control Syringes, Guidewires, and/or High-Pressure Tubing—have been rescinded.

    Product
    Medline Kits: 1) ENT PACK, Model Number: DYNJ59030B; 2) ENT, Model Number: DYNJ908586C; 3) LH 3 PORT W/O WASTEBAG, Model Number: VASC1081C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1849-2026·2026-04-29

    Medline Medical Device Kits Recall for Loss of 510(k) Clearance

    Medline Industries is recalling certain surgical and medical kits because their 510(k) regulatory clearances for Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. About 2,609 units were distributed nationwide.

    Product
    Medline Kits: 1) BWNBORO CRANIOTOMY PACK-LF, Model Number: DYNJ32841F; 2) CRANIOTOMY PACK-LF, Model Number: DYNJ46069D 3) CAMPUS EXTREMITY PK, Model Number: DYNJ51935A 4) FOOT -XRAY BOWL MEDCUP SPECCUP, Model Number: DYNJ68902A 5) RADIOLOGY SPINE PACK, Model Number: DYNJ806
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1838-2026·2026-04-29

    Medline Heart Transplant Biopsy Kit regulatory clearance rescinded

    Medline Industries is recalling Heart Transplant Biopsy Kit (Model DYNJ37543A) after the FDA rescinded regulatory clearances for certain Control Syringes, Guidewires, and High-Pressure Tubing used in the kit.

    Product
    Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0493-2026·2026-04-29

    Omega-3-Acid Ethyl Esters capsules recalled for failed capsule specifications

    The Harvard Drug Group LLC is recalling Omega-3-Acid Ethyl Esters capsules (1 gram, 50-count cartons) due to failed capsule specifications discovered during routine stability testing.

    Product
    OMEGA-3-ACID ETHYL ESTERS — OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1880-2026·2026-04-29

    Medline Convenience Kits with Polycarbonate Syringes Recalled for Unapproved Design Changes

    Medline Industries is recalling Convenience Kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects approximately 270,311 units distributed in the US and internationally.

    Product
    Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes MINOR ENT SINUS PACK-LF DYNJ0101278F DYNJ0101278G DYNJ0101278I SINUS PACK DYNJ56262
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1895-2026·2026-04-29

    LeadCare Ultra Blood Lead Test Kit Recalled for False Positive Results

    Magellan Diagnostics is recalling the LeadCare Ultra Blood Lead Test Kit (Catalog Number 70-8098) because use with certain third-party micro-collection devices may produce unexpectedly elevated and false positive results, potentially causing delayed diagnosis and unnecessary additional testing.

    Product
    LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the following materials: " Sensors (8 containers of 24 each; 192 tests) " Treatment Reagent Tubes (8 containers of 24 each; 192 tests) " Calibration Button (1 @) " Lead Co
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1893-2026·2026-04-29

    LeadCare II Blood Lead Test Kit Recall for Inaccurate Results

    Magellan Diagnostics is recalling LeadCare II Blood Lead Test Kits because certain third-party micro-collection devices may produce falsely elevated lead results, potentially causing unnecessary testing and delayed results.

    Product
    (1)(2) LeadCare¿ II Blood Lead Test Kit, (3)LeadCare¿ II 5X Blood Lead Test Kit, (4)LeadCare¿ II 9X Blood Lead Test Kit ; Catalog Number(s): (1) 70-6762, (2) 70-6762RUO, (3) 70-8404 (Box containing 5 Test Kits), (4) 70-9000 (Box containing 9 test kits); The LeadCare II kit is p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1840-2026·2026-04-29

    Medline General Laparoscopy Kit regulatory clearance rescinded

    The FDA has rescinded the 510(k) regulatory clearances for certain Control Syringes, Guidewires, and High-Pressure Tubing components in Medline's General Laparoscopy Kit (Model CDS930027Y). Affected units should not be used.

    Product
    Medline Kits: 1) GENERAL LAPAROSCOPY, Model Number: CDS930027Y
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0486-2026·2026-04-29

    Furosemide tablets recalled for presence of N-nitroso impurity

    Leading Pharma, LLC is recalling Furosemide 80 mg tablets due to the presence of N-nitroso-Furosemide (NNF) above the recommended intake limit, caused by manufacturing deviations.

    Product
    FUROSEMIDE — FUROSEMIDE (FUROSEMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1897-2026·2026-04-29

    nanOss 3D Bone Graft Substitute Incorrectly Labeled with Five-Year Shelf Life

    XTANT Medical Holdings is recalling nanOss 3D Advanced Bone Graft Substitute products due to incorrect labeling showing a 5-year shelf life when the approved shelf life is four years.

    Product
    nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300-251008: nanOss 3D Advanced Bone Graft Substitute, 25x100x8mm, 20cc 90-300-25508: nanOss 3D Advanced Bone Graft Substitute, 25x50x8mm, 10cc 90-300-251004: nanOss 3D Advanced Bone Gr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1884-2026·2026-04-29

    Medline Convenience Kits with 10mL Syringes Recalled for Unapproved Design

    Medline Industries is recalling certain convenience kits containing 10mL polycarbonate colored syringes because of unapproved design changes made outside of FDA 510(k) clearance. The affected kits were distributed nationwide and to Canada, Panama, and Barbados.

    Product
    Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ANGIO KIT PACK DYNJ50783B ANGIO PHC DYNJ37485C C.I.C.N. ANGIO PACK DYNJ53064B FHT P NEURO PACK DYNJ39931D NEURO ARTERIOGRAM PACK-LF DYNJ0948060F NEURO KIT NAM0003
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0498-2026·2026-04-29

    Lactated Ringers Irrigation 3000 mL Bags Recall: Sterility Concern

    B. Braun Medical Inc. is recalling Lactated Ringers Irrigation 3000 mL bags due to lack of assurance of sterility and potential leakage from the diaphragm port after foil removal.

    Product
    LACTATED RINGERS IRRIGATION — LACTATED RINGERS IRRIGATION (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE AND CALCIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1889-2026·2026-04-29

    Medline Convenience Kits with Polycarbonate Syringes Recalled

    Medline Industries is recalling Medline Convenience Kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance.

    Product
    Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E P DRAPE PACK-LF DYNJ0373061J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1917-2026·2026-04-29

    Arrowgard Blue MAC Central Venous Access Kit recalled for defective adhesive

    Arrow International is recalling the Arrowgard Blue MAC Two-Lumen Central Venous Access Kit due to incorrect manufacturing of the liquid adhesive by a supplier. The recall affects 95 units distributed in nine U.S. states.

    Product
    Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-21142-DMC UDI code: (01)10801902218930(17)270630(11)251211(10)33F25M0671 The MAC Multi-Lumen Central Venous Access Device with Arrowg+ard Blue technology permits short-term
    Category
    Medical Device
    Distribution
    Distributed nationwide