The Recall Desk

State

Indiana product recalls

20,189 recalls have nationwide distribution and so reach Indiana. 0 additional recalls listed Indiana specifically in their distribution scope.

About recalls in Indiana

Most US product recalls have nationwide distribution — the manufacturer ships into every state and the recall sweeps the same way. We include those in this listing because they affect Indiana consumers even though the source notice doesn’t name the state. State-specific recalls are usually for products with regional distribution (a regional dairy, a local store brand) or where the agency was able to narrow the affected shipments to specific destinations.

If you’re checking whether a recall affects your purchase, the recall detail page lists the exact production lot codes, UPCs, and best-by dates. Match those against your package — distribution scope is a starting filter, not the final answer.

8451–8475 of 20189

  • HighFDA (Devices)·Z-2279-2024·2024-07-17

    TOTAL KNEE Procedure Tray Recalled for Ethylene Oxide Sterilization Residuals

    American Contract Systems is recalling TOTAL KNEE procedure trays (Catalog BFTK01Z, lot 983241) due to ethylene oxide and ethylene chlorohydrin residuals exceeding regulatory limits for permanent-use medical devices.

    Product
    TOTAL KNEE - 247546 Procedure tray Catalog Number: BFTK01Z
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2302-2024·2024-07-17

    Medical knee procedure kit recalled for excessive sterilization chemical residue

    American Contract Systems Inc is recalling TOTAL KNEE-Procedure Kits due to excessive ethylene oxide and ethylene chlorohydrin residues on the cast padding component. The recall affects 85 units distributed nationwide.

    Product
    TOTAL KNEE-Procedure Kit Catalog Number: SMTK21C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0587-2024·2024-07-17

    Dianeal Low Calcium Dialysis Solution Recall: Sterility Risk from Connector Leaks

    Baxter Healthcare recalls 6,874 bags of Dianeal Low Calcium peritoneal dialysis solution due to potential leaks in the connector assembly that could compromise product sterility.

    Product
    DIANEAL LOW CALCIUM WITH DEXTROSE — DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2294-2024·2024-07-17

    Knee Procedure Kit Recalled for Elevated Chemical Residuals

    American Contract Systems Inc is recalling 26 TOTAL KNEE Procedure Kits due to excess ethylene oxide and ethylene chlorohydrin residues on the cast padding component that exceed safe exposure limits.

    Product
    TOTAL KNEE -Procedure Kit Catalog Number: QPTK95B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2304-2024·2024-07-17

    Arthroscopy Procedure Kit Recalled Due to Ethylene Oxide Residue

    American Contract Systems Inc is recalling 27 arthroscopy procedure kits because ethylene oxide and ethylene chlorohydrin residuals in the cast padding exceeded safe exposure limits for permanent implants.

    Product
    ARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22V
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2345-2024·2024-07-17

    Hemodialysis Blood Pump Rotor Spare Part Recalled for Loose Sheaves

    Fresenius Medical Care is recalling hemodialysis blood pump rotor spare parts due to reports of loose or dislodged guide sheaves. The affected model is distributed nationwide in the U.S. and Canada.

    Product
    RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2324-2024·2024-07-17

    ZOLL Powerheart G5 AED shipping film may prevent shock delivery

    ZOLL Powerheart G5 AED devices are shipped with a protective film on the front panel. If not removed before use, the film may prevent the shock button from being pressed, delaying or preventing defibrillation therapy.

    Product
    ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). Model/Catalog Number: G5S-00A G5S-0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2340-2024·2024-07-17

    Blood Pump Rotor for Hemodialysis System Recalled for Loose Components

    Fresenius Medical Care is recalling Blood Pump Rotor components used in hemodialysis systems after reports of loose or dislodged guide sheaves during use. The defect affects 372 units distributed nationwide and in Canada.

    Product
    190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2308-2024·2024-07-17

    Knee Procedure Kit Recalled Due to Ethylene Oxide Residual Contamination

    American Contract Systems Inc recalls 174 units of CUSTOM KNEE procedure kits due to ethylene oxide and ethylene chlorohydrin residuals exceeding safe exposure limits for permanent contact devices.

    Product
    CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AG
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0594-2024·2024-07-17

    Compounded Lidocaine-Epinephrine Injectable Recalled Nationwide for Subpotent Epinephrine

    Tailstorm Health Inc is recalling a compounded lidocaine-epinephrine injection nationwide due to subpotent epinephrine component. The recall affects 12,525 vials of lot number 2311003.

    Product
    Lidocaine HCL Injection, USP 2% 200mg/10mL (20mg/mL) and EPINEPHRINE HCl 1:200,000, 10 ml Single Dose Vial, Rx only, Compounded drug by Medivant Healthcare, 158 S Kyrene Rd, Chandler, AZ 85226, NDC 81483-0038-0, UPC 3 81483 00380 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2338-2024·2024-07-17

    Endoscopic Vessel Harvesting System Recalled for C-Ring Wire Straightening

    Maquet Cardiovascular recalled 2,463 VASOVIEW HEMOPRO 2 surgical systems due to C-Ring wire straightening and component misalignment affecting tool positioning. No injuries have been reported.

    Product
    The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2277-2024·2024-07-17

    Procedure Tray Recalled for Excess Ethylene Oxide Residue

    American Contract Systems is recalling a lower extremity procedure tray (48 units) due to ethylene oxide residuals that exceed FDA safety limits for permanent exposure medical devices.

    Product
    LOWER EXTREMITY - 247542- Procedure tray Catalog Number: BFLE56X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2286-2024·2024-07-17

    Procedure Tray Recalled Due to Excess Sterilization Residue

    American Contract Systems Inc is recalling HAND WRIST FOREARM-LF Procedure trays due to ethylene oxide sterilization residues exceeding safe limits for permanent exposure devices.

    Product
    HAND WRIST FOREARM-LF Procedure tray Catalog Number: CCHD17B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2342-2024·2024-07-17

    Blood Pump Rotor Spare Part Recalled for Loose Guide Sheaves

    Fresenius Medical Care recalls a blood pump rotor spare part used in dialysis systems in Canada due to reports of loose or dislodged guide sheaves after use. No injuries have been reported.

    Product
    191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2344-2024·2024-07-17

    Blood Pump Rotor Spare Part Recall Due to Loose Guide Sheaves

    Fresenius is recalling 17 Blood Pump Rotor spare parts nationwide due to loose or dislodged guide sheaves that develop after use. The affected rotor components are used in K@HOME dialysis machines.

    Product
    RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2327-2024·2024-07-17

    Presource surgical kits recalled for syringe design defect risk

    Cardinal Health is recalling 136,753 Presource surgical kits nationwide because included Shenli syringes contain design modifications that could cause inaccurate dosing and device leakage, risking patient harm.

    Product
    Presource kits and trays, labeled as: 1) ANGIOGRAPHY PACK, Catalog Number SAN13BS605; 2) ANGIOGRAPHY PACK, Catalog Number SAN13BS606; 3) ANGIOGRAPHY PACK, Catalog Number SAN13BS607; 4) ANGIOGRAPHY PACK, Catalog Number SAN13BS608; 5) ANGIOGRAPHY PACK, Catalog Number SAN13BS6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2346-2024·2024-07-17

    Hemodialysis System Blood Pump Rotor Recall Due to Loose Sheaves

    Fresenius is recalling blood pump rotors in home hemodialysis systems due to loose or dislodged guide sheaves reported during clinical use. The defect could affect proper pump operation during dialysis treatment.

    Product
    RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2311-2024·2024-07-17

    Hand Pack Procedure Kit recalled for excess ethylene oxide residuals

    American Contract Systems Inc is recalling the HAND PACK-Procedure Kit (catalog WEHD16C) due to ethylene oxide and ethylene chlorohydrin residuals exceeding safety limits.

    Product
    HAND PACK-Procedure Kit Catalog Number: WEHD16C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2305-2024·2024-07-17

    Hip Procedure Kit Recalled for Excessive Ethylene Oxide Sterilization Residuals

    American Contract Systems Inc is recalling 393 units of the TPK Anterior Hip Pack nationwide due to ethylene oxide and ethylene chlorohydrin residuals exceeding safe limits for permanent exposure medical devices.

    Product
    TPK ANTERIOR HIP PACK 176483-Procedure Kit Catalog Number: TPAH21E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2283-2024·2024-07-17

    Orthopedic knee procedure tray recalled for sterilization residue levels

    American Contract Systems Inc is recalling 84 units of the ARTHRO KNEE BEACHES PACK BHS procedure tray because residual sterilization chemicals exceeded permissible exposure limits. The affected units were distributed nationwide.

    Product
    ARTHRO KNEE BEACHES PACK BHS- Procedure tray Catalog Number: BPKB46B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2337-2024·2024-07-17

    Endoscopic Vessel Harvesting System Recalled for Altered Component Spacing

    Maquet Cardiovascular is recalling 600 units of the VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System due to reports of C-Ring wire straightening and altered spacing between components. No adverse events have been reported.

    Product
    The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2298-2024·2024-07-17

    Knee Arthroscopy Kit Recalled for Excessive Sterilant Chemical Residue

    American Contract Systems Inc is recalling 270 units of a knee arthroscopy surgical kit because sterilization chemical residues exceed safe limits for permanent device contact.

    Product
    KNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: SFAR60A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2309-2024·2024-07-17

    Orthopedic ORIF Hip Rod Procedure Kit Recalled for Sterilization Residuals

    American Contract Systems Inc is recalling its ORIF HIP IM RODDING FEMUR-Procedure Kit (28 units) because ethylene oxide and ethylene chlorohydrin residuals in the cast padding exceeded safe limits for permanent implants.

    Product
    ORIF HIP - IM RODDING FEMUR-Procedure Kit Catalog Number: UTHP44S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2282-2024·2024-07-17

    Procedure Tray Recalled for Excessive Ethylene Oxide Residuals

    American Contract Systems Inc is recalling 129 units of ARTHO KNEE BAPTIST SOUTH PACK Procedure trays (lot numbers 953241, 882241) due to ethylene oxide and ethylene chlorohydrin sterilization residuals exceeding safe limits for permanent-contact medical devices.

    Product
    ARTHO KNEE BAPTIST SOUTH PACK Procedure tray Catalog Number: BPKA49B
    Category
    Medical Device
    Distribution
    Distributed nationwide