The Recall Desk

State

Tennessee product recalls

72,907 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.

Which agencies issued them

These figures cover only the 7,819 recalls whose distribution notice names Tennessee specifically. The 72,907 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

551–575 of 80726

  • HighFDA (Devices)·Z-2799-2026·2026-08-05

    Medical Convenience Kits Recalled Over Endotoxin Variability in Neurological Sponges

    Windstone Medical Packaging is recalling 465 AMS medical convenience kits in connection with a Medicom recall of Ritmed Neurological Sponges due to potential endotoxin level variability.

    Product
    AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Part Number AMS10411B; 2) ENT Pack, Part Number AMS10411C; 3) Rhinoplasty Pack, Part Number AMS11963A; 4) Spine Pack, Part Number AMS12636C; 5) Lumbar Lami Pack, Part Number AMS12731; 6)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2652-2026·2026-08-05

    Philips Ingenuity CT Scanners Recalled Due to Bolus Tracking Trigger Issue

    Philips is recalling 182 Ingenuity CT systems in the US because the clinical scan may not trigger automatically after Bolus Tracking, potentially causing patient rescan and extra radiation.

    Product
    Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity CT Upgrades Ingenuity CT China Ingenuity Core 128 Elite Brazil
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2827-2026·2026-08-05

    Stryker Hoffmann II Connecting Rod Micro Recalled Due to Potential Cracking

    Stryker is recalling Hoffmann II Connecting Rod Micro 3 x 30mm (catalog 50796030) because the rods may crack after cleaning and sterilization. FDA has classified this as Class II.

    Product
    Stryker Hoffmann II Connecting Rod Micro 3 x 30mm. Catalog Number: 50796030.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2830-2026·2026-08-05

    Stryker Hoffmann II Carbon Connecting Rods Recalled Over Potential Cracking

    Stryker GmbH is recalling Hoffmann II Carbon Connecting Rods (catalog 50796060) because they may crack after cleaning and sterilization. The recall covers all lots and about 9,658 units distributed worldwide.

    Product
    Stryker Hoffmann II Connecting Rod Micro 3 x 60mm. Catalog Number: 50796060.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2804-2026·2026-08-05

    Midline Catheter Recalled Over Risk of Leaking or Cracking at Hub

    Argon Medical Devices is recalling its L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm (REF 384620) because the hub may leak or crack, potentially causing therapy interruption, blood loss, or bloodstream infection.

    Product
    L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm, REF: 384620
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-2824-2026·2026-08-05

    GEM Premier 5000 Blood Analyzer Recalled Over Bar Code Reader Patient ID Risk

    Instrumentation Laboratory is recalling the GEM Premier 5000 blood analyzer system because bar code reader wands may assign patient results to the wrong patient ID. The FDA has classified this as a Class II recall.

    Product
    Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2833-2026·2026-08-05

    Stryker Hoffmann II Connecting Rod Micro May Crack After Cleaning and Sterilization

    Stryker GmbH is recalling Stryker Hoffmann II Connecting Rod Micro 3 x 150mm due to the potential for the rods to crack following cleaning and sterilization processes.

    Product
    Stryker Hoffmann II Connecting Rod Micro 3 x 150mm. Catalog Number: 50796150.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-1190-2026·2026-08-05

    Mellish Island Super Skin Dietary Supplement Recalled Over Undeclared Fish Collagen

    Mellish Island Corp. is recalling 1,600 bottles of Super Skin dietary supplement because the label does not declare that its marine collagen comes from fish, a potential allergen.

    Product
    Mellish Island Super Skin; Dietary Supplement; 60 Capsules, 2 per day; Distributed by Mellish Island Corp. UPC: 8 58792 00332 3
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2825-2026·2026-08-05

    GEM Premier 5000 Blood Analyzer Recalled Over Bar Code Reader Patient ID Risk

    Instrumentation Laboratory is recalling the GEM Premier 5000 portable blood analyzer system because bar code reader wands may assign patient results to the wrong patient ID. The recall affects 21 units distributed nationwide.

    Product
    Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Portable blood analyzer system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0734-2026·2026-08-05

    Mycophenolate Mofetil Injection Recalled Due to Precipitate in Vials

    Mylan Pharmaceuticals is recalling one lot of Mycophenolate Mofetil for Injection, 500 mg/vial, because precipitate was found in the vials. The recall covers 5,688 vials distributed nationwide.

    Product
    MYCOPHENOLATE MOFETIL — MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOFETIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2821-2026·2026-08-05

    Bar Code Reader Wands for GEM Premier Blood Analyzers Recalled Due to Misidentification Risk

    Instrumentation Laboratory is recalling Bar Code Reader (BCR) wands used with GEM Premier 5000 and 7000 systems because they may assign patient results to the wrong patient ID.

    Product
    GEM Premier 5000 with IQM2 Model/Catalog Number: 00024019255 and GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Portable blood analyzer system. Affected Accessory: Bar Code Reader (BCR) Wand Part No. 00024015859
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2802-2026·2026-08-05

    Medical convenience kits recalled due to potential endotoxin level variability

    Windstone Medical Packaging, Inc. is recalling specific lots of AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits because of potential unexpected variability in endotoxin levels.

    Product
    AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Laminectomy Pack, Pack Number AMS13574A; 2) ACDF/Fusion Pack, Pack Number AMS14710B; 3) Spine Pack, Pack Number AMS14991A; 4) Spine Pack, Pack Number AMS14991B; 5) Spinal Pack, Pack Number AMS16278;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2795-2026·2026-08-05

    Permobil M3 Corpus Power Wheelchair Recalled Over Firmware Stability Issue

    Permobil is recalling M3 Corpus Power Wheelchairs with firmware version 1.26.2 because the firmware lacks a speed restriction when the seat lift exceeds 50 mm, which may cause falls or tip-overs.

    Product
    Permobil M3 Corpus Power Wheelchair with Heavy Duty Shock REF:120031, Model version 3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2822-2026·2026-08-05

    Bar Code Reader Wands for GEM Premier Blood Analyzers Recalled Due to Misidentification Risk

    Instrumentation Laboratory is recalling Bar Code Reader (BCR) wands used with GEM Premier 5000 and 7000 systems because they may assign patient results to the wrong patient ID.

    Product
    Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Intelligent Quality Management 3 (iQM3) is used as the quality control (QC) and assessment system for the GEM Premier 7000. portable blood analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2823-2026·2026-08-05

    Portable Blood Analyzer System Recalled Due to Barcode Reader Misidentification Risk

    Instrumentation Laboratory is recalling GEM Premier 5000 portable blood analyzer systems because BCR wands may assign patient results to an incorrect patient ID. FDA classifies this as Class II.

    Product
    Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2820-2026·2026-08-05

    OsteoBallast and Ballast bone graft extenders recalled due to insufficient material volume

    IsoTis OrthoBiologics, Inc. is recalling OsteoBallast and Ballast bone graft extenders because they may contain less demineralized bone matrix than intended.

    Product
    OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2805-2026·2026-08-05

    Permobil Recalls M5 Corpus Power Wheelchairs Due to Firmware Drive Inhibit Issue

    Permobil Inc. is recalling 715 M5 Corpus Power Wheelchairs (REF 120032) because firmware versions 1.27 through 1.57 lack drive inhibit logic, which may allow driving under restricted conditions and cause instability.

    Product
    M5 Corpus Power Wheelchair REF,120032
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0730-2026·2026-08-05

    Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution Recalled Due to Defective Container

    Micro Labs USA Inc. is recalling one lot of Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution nationwide because the container may have broken cap spikes and undeliverable drops.

    Product
    DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION — DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2810-2026·2026-08-05

    Arterial Cannula Recalled Due to Risk of Pinhole Leaks During Bypass

    Medtronic is recalling 3,621 EOPA 3D Arterial Cannula DIL TIP 22FR units because pinhole leaks may occur during cardiopulmonary bypass, risking hypovolemia, vessel injury, hypotension, ischemia, and organ dysfunction.

    Product
    EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78222
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2651-2026·2026-08-05

    Philips IQon Spectral CT Recalled Due to Automatic Scan Trigger Failure

    Philips is recalling IQon Spectral CT systems because the clinical scan may not start automatically after Bolus Tracking, requiring manual triggering and potentially causing extra radiation exposure.

    Product
    IQon Spectral CT IQon Spectral CT Upgrades
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2826-2026·2026-08-05

    Blood Analyzer Bar Code Reader May Assign Patient Results to Incorrect Patient ID

    Instrumentation Laboratory is recalling certain GEM Premier 5000 blood analyzer systems because the bar code reader wand may assign patient results to the wrong patient ID.

    Product
    Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Portable blood analyzer system
    Category
    Medical Device
    Distribution
    Distributed nationwide