The Recall Desk

State

Indiana product recalls

72,907 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.

These figures cover only the 9,555 recalls whose distribution notice names Indiana specifically. The 72,907 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

1226–1250 of 82462

  • HighFDA (Devices)·Z-2468-2026·2026-06-24

    ConMed AirSeal 8mm 100mm optical obturator ports may trigger overpressure alerts

    ConMed AirSeal 8 mm Access Ports with Low Profile Bladeless Optical Tip Obturators, 100 mm length, are being recalled because of the potential for overpressure alerts.

    Product
    ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS8-100LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2461-2026·2026-06-24

    Stryker Triathlon size 3 baseplate packaging contained a size 4 implant

    Triathlon Universal Baseplate Size 3 packaging is being recalled after Stryker identified that it contained a Size 4 baseplate, and vice versa. Seven units are affected.

    Product
    TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2495-2026·2026-06-24

    Medline urethroplasty kits contain catheters failing performance specifications

    Medline urology urethroplasty procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 91 units are affected.

    Product
    MEDLINE Medical Procedure Kits labeled as: 1) KIT UROLOGY URETHROPLASTY, Medline Kit Number/SKU DYKMBNDL117C; 2) URETHROPLASTY, Medline Kit Number/SKU DYNJ908978; 3) URETHROPLASTY, Medline Kit Number/SKU DYNJ908978F.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2480-2026·2026-06-24

    Medline 15 Fr urethral catheterization trays fail performance specifications

    Medline Urethral Catheterization Trays with red rubber latex catheter, 15 Fr, are being recalled because samples did not meet performance specifications. 8,327,756 units are affected.

    Product
    MEDLINE Urethral Catheterization Tray, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYNC1816, 15 Fr; 2. DYND10350, 15 Fr.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2482-2026·2026-06-24

    Medline red rubber urethral catheterization trays fail performance specifications

    Medline Urethral Catheterization Trays with red rubber latex catheter, 15 Fr, are being recalled across all lots because samples did not meet performance specifications. 235,658 units affected.

    Product
    MEDLINE Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline Product Number/SKU (REF) DYND18350
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2474-2026·2026-06-24

    ConMed AirSeal 12mm palm grip 100mm ports may trigger overpressure alerts

    ConMed AirSeal 12 mm Access Ports with Palm Grip Bladeless Optical Tip Obturators, 100 mm length, are being recalled because of the potential for overpressure alerts.

    Product
    ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS12-100LPI. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2496-2026·2026-06-24

    Medline cardiovascular draping and basin kits contain substandard catheters

    Medline CV Draping/Basin procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 1,432 units are affected.

    Product
    MEDLINE Medical Procedure Kits labeled as: 1) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483A; 2) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483B; 3) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483C; 4) CV DRAPING/BASIN 2PART PACK, Medline Kit Number/SKU DY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2473-2026·2026-06-24

    ConMed AirSeal 12mm bladeless optical obturators may trigger overpressure alerts

    ConMed AirSeal 12 mm Access Ports with Low Profile Bladeless Optical Tip Obturators are being recalled because of the potential for overpressure alerts. 71,151 packs affected.

    Product
    ConMed AirSeal 12mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. Catalog Number: iAS12-120LPI. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2469-2026·2026-06-24

    ConMed AirSeal 5mm 75mm optical obturator ports may trigger overpressure alerts

    ConMed AirSeal 5 mm Access Ports with Low Profile Bladeless Optical Tip Obturators, 75 mm length, are being recalled because of the potential for overpressure alerts.

    Product
    ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 75mm Length. Catalog Number: iAS5-75LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2488-2026·2026-06-24

    Medline cardiovascular and peripheral vascular packs contain substandard catheters

    Medline CV and peripheral vascular procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 1,248 units affected.

    Product
    MEDLINE Medical Procedure Kits labeled as: 1) BNT CV PACK, Medline Kit Number/SKU DYNJ912271; 2) CV PACK PART 1, Medline Kit Number/SKU DYNJ31204D; 3) KIT PERIPHERAL VASCULAR MMC, Medline Kit Number/SKU DYNJ905368D; 4) KIT PERIVASCULAR MMC, Medline Kit Number/SKU DYNJ905
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2481-2026·2026-06-24

    Medline pre-connected urethral catheterization trays fail performance specifications

    Medline Pre-connected Urethral Catheterization Trays with red rubber latex catheter, 15 Fr, are being recalled across all lots. The action covers 4,304,669 units.

    Product
    MEDLINE Pre-connected Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline Product Number/SKU (REF) DYND10407
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2500-2026·2026-06-24

    Medline carotid neuro and VP shunt packs contain substandard catheters

    Medline Carotid Neuro Packs and VP Shunt CDS kits are being recalled because representative samples did not meet applicable catheter performance specifications. 342 units affected.

    Product
    MEDLINE Medical Procedure Kits labeled as: 1) CAROTID NEURO PACK, Medline Kit Number/SKU DYNJ44926G; 2) VP SHUNT CDS, Medline Kit Number/SKU CDS983800J; 3) VP SHUNT CDS, Medline Kit Number/SKU CDS983800K.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2477-2026·2026-06-24

    Giraffe OmniBed replaceable units share the canopy fastener disengagement defect

    Giraffe OmniBed Field Replaceable Units are being recalled because fasteners securing the canopy soffit can disengage and fall into the patient compartment. 265 units affected.

    Product
    Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2475-2026·2026-06-24

    Giraffe OmniBed incubator canopy fasteners can fall into patient compartment

    Giraffe OmniBed incubator-warmers, all models, are being recalled because fasteners securing the canopy soffit can disengage and fall into the patient compartment. 19,587 units affected.

    Product
    Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2485-2026·2026-06-24

    Medline combined laparoscopy kits contain catheters failing performance specifications

    Medline Laparoscopy Combined - No Ndl procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 72 units affected.

    Product
    MEDLINE Medical Procedure Kits labeled as: LAPAROSCOPY COMBINED - NO NDL, Medline Kit Number/SKU DYNJ37378A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2501-2026·2026-06-24

    Medline labour delivery and vaginal kits contain substandard catheters

    Medline labour and delivery and vaginal procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 24,388 units affected.

    Product
    MEDLINE Medical Procedure Kits labeled as: 1) BR L&D PACK, Medline Kit Number/SKU DYNJ47625B; 2) GYN VAGINAL, Medline Kit Number/SKU DYNJ912219; 3) KIT MAJ VAG SET UP, Medline Kit Number/SKU DYNJ907033B; 4) MINOR VAG PACK, Medline Kit Number/SKU DYNJ68663B; 5) OB DELIV
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2476-2026·2026-06-24

    Giraffe OmniBed Carestation canopy fasteners can fall into patient compartment

    Giraffe OmniBed Carestations are being recalled because fasteners securing the canopy soffit can disengage and fall into the patient compartment. 23,430 units affected.

    Product
    Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an infant incubator and an infant warmer, Model Numbers 2082844-001-XXX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2483-2026·2026-06-24

    Medline 14 Fr coude latex catheters fail performance specifications

    Medline Intermittent Latex Coude Catheters pre-connected to a collection bag, 14 Fr, are being recalled across all lots because samples did not meet performance specifications. 8,260 units affected.

    Product
    MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 14 Fr, 1000mL, Medline Product Number/SKU (REF) URO4RR14C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2499-2026·2026-06-24

    Medline nursing kits contain catheters failing applicable performance specifications

    Medline Nursing Kits, SKU EDUC1044, are being recalled because representative samples did not meet applicable catheter performance specifications. 730 units are affected.

    Product
    MEDLINE Medical Procedure Kits labeled as: NURSING KIT, Medline Kit Number/SKU EDUC1044
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2464-2026·2026-06-24

    ConMed AirSeal 5mm smooth access ports may trigger overpressure alerts

    ConMed AirSeal 5 mm Smooth Access Ports and Obturators with Blunt Tip are being recalled because of the potential for overpressure alerts. 497 packs, or 2,982 units, are affected.

    Product
    ConMed AirSeal 5 mm Smooth Access Port and Obturator with Blunt Tip, 150mm Length. Catalog Number: iASB5-150. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2497-2026·2026-06-24

    Medline bioburden test and cystectomy kits contain substandard catheters

    Medline procedure kits including the Bioburden Test Kit and Kit Uro Robot Cystectomy are being recalled because sample catheters did not meet performance specifications. 123,030 units affected.

    Product
    MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT, Kit Uro Robot Cystectomy, etc. (see the recall documents for a full list of products)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2478-2026·2026-06-24

    Mito Red Light Super Mobile batteries may catch fire

    The Mito Red Light Super Mobile near-infrared therapy device is being recalled because its lithium-ion battery may malfunction, causing it to catch fire or burst into flames.

    Product
    Mito Red Light, Super Mobile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2466-2026·2026-06-24

    ConMed AirSeal 12mm blunt tip 100mm ports may trigger overpressure alerts

    ConMed AirSeal 12 mm Access Ports and Obturators with Blunt Tip, 100 mm length, are being recalled because of the potential for overpressure alerts. 1,261 packs affected.

    Product
    ConMed AirSeal 12mm Access Port and Obturator with Blunt Tip, 100mm Length. Catalog Number: iASB12-100. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2462-2026·2026-06-24

    Stryker Triathlon size 4 baseplate packaging contained a size 3 implant

    Triathlon Universal Baseplate Size 4 packaging is being recalled after Stryker identified that it contained a Size 3 baseplate, and vice versa. Seven units are affected.

    Product
    TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400.
    Category
    Medical Device
    Distribution
    Distributed nationwide