The Recall Desk

State

Tennessee product recalls

72,913 recalls have nationwide distribution and so reach Tennessee. 7,819 additional recalls listed Tennessee specifically in their distribution scope.

What the numbers show

Total
7,819
Critical
1,317
Severe
1,653
Most recent
2026-09-09

Of the 7,819 recalls naming Tennessee we have scored against our rubric, 1,317 (17%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,653 (21%) are Severe.

These figures cover only the 7,819 recalls whose distribution notice names Tennessee specifically. The 72,913 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

1226–1250 of 80732

  • HighFDA (Devices)·Z-2503-2026·2026-06-24

    Medline gynaecology laparoscopy packs contain catheters failing performance specifications

    Medline gynaecology procedure kits including basic GYN, D&C hysteroscopy and GYN laparoscopy packs are being recalled over catheter specification failures. 44,656 units affected.

    Product
    MEDLINE Medical Procedure Kits labeled as BASIC GYN, CW LAP GYN, D&C HYSTEROSCOPY, CW LAP GYN, DEACONESS PELVIC LAP PACK, FLOYD LAP GYN, GYN LAP PACK, GYN LAPAROSCOPY, GYN MINOR PACK, etc. (see the recall documents for a full list of affected products)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2502-2026·2026-06-24

    Medline pelvic laparoscopy packs contain catheters failing performance specifications

    Medline Pelvic Lap Packs are being recalled because representative samples did not meet applicable catheter performance specifications. 20 units are affected.

    Product
    MEDLINE Medical Procedure Kits labeled as: PELVIC LAP PACK, Medline Kit Number/ SKU DYNJ53820B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2519-2026·2026-06-24

    HeartMate 3 system controllers recalled over backup battery failures

    HeartMate 3 System Controllers, model 106531US, are being recalled due to 11 volt backup battery failures. 694 units are affected.

    Product
    Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A Product Description: The HeartMate 3" System Controller acts as the central power and communication hub for the HeartMate 3 LVAS. It passes power from the P
    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-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-2489-2026·2026-06-24

    Medline vasectomy reversal kits contain catheters failing performance specifications

    Medline Bilateral Micro Vasectomy Reversal kits are being recalled because representative samples did not meet applicable catheter performance specifications. 588 units affected.

    Product
    MEDLINE Medical Procedure Kits labeled as: BILAT MICRO VASECTOMY REVERSAL, Medline Kit Number/SKU DYNJ68302
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2472-2026·2026-06-24

    ConMed AirSeal 12mm palm grip 150mm ports may trigger overpressure alerts

    ConMed AirSeal 12 mm Access Ports with Palm Grip Bladeless Optical Tip Obturators, 150 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, 150mm Length. Catalog Number: iAS12-150LPI. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
    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-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-2471-2026·2026-06-24

    ConMed AirSeal 5mm 100mm optical obturator ports may trigger overpressure alerts

    ConMed AirSeal 5 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 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS5-100LP. 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-2479-2026·2026-06-24

    Medline red rubber urethral catheters fail applicable performance specifications

    Medline Urethral Catheters in red rubber latex, spanning French sizes 08 to 22, are being recalled because samples did not meet performance specifications. 2,237,471 units affected.

    Product
    MEDLINE Urethral Catheter, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYND13508 - 08 Fr; 2. DYND13510 - 10 Fr; 3. DYND13512 - 12 Fr; 4. DYND13514 - 14 Fr; 5. DYND13515 - 15 Fr; 6. DYND13516 - 16 Fr; 7. DYND13518 - 18 Fr; 8. DYND13520 - 20 Fr;
    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-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-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-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-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-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-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-2487-2026·2026-06-24

    Medline open heart and cardiac kits contain catheters failing specifications

    Medline open heart and cardiac procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 168,968 units are affected.

    Product
    MEDLINE Medical Procedure Kits labeled as CH OPEN HEART, ADULT CARDIAC KIT, AHT CVOR CABG, APH EMERGENCY OPEN HEART PACK, Etc. (see recall documents for a full list of products)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2494-2026·2026-06-24

    Medline tonsil packs contain catheters failing performance specifications

    Medline Tonsil Pack Cath procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 384 units are affected.

    Product
    MEDLINE Medical Procedure Kits labeled as: TONSIL PACK CATH, Medline Kit Number/SKU DYNJ65199A
    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-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