The Recall Desk

State

Tennessee product recalls

73,741 recalls have nationwide distribution and so reach Tennessee. 7,859 additional recalls listed Tennessee specifically in their distribution scope.

What the numbers show

Total
7,859
Critical
1,324
Severe
1,973
Most recent
2026-10-28

Of the 7,859 recalls naming Tennessee we have scored against our rubric, 1,324 (17%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,973 (25%) are Severe.

Which agencies issued them

These figures cover only the 7,859 recalls whose distribution notice names Tennessee specifically. The 73,741 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

34276–34300 of 81600

  • HighFDA (Devices)·Z-0531-2020·2019-12-04

    Zimmer Biomet Recalls Guide Wires Due to Bacterial Endotoxin and Debris

    Zimmer Biomet is recalling 2.0mm Ball Nose Guide Wires because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.

    Product
    2.0MM BALL NOSE GUIDE WIRE, Item Nos. 281017006 - Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0530-2020·2019-12-04

    Zimmer Biomet Recalls Ball Nose Guide Wires Due to Cleaning Issues

    Zimmer Biomet is recalling Ball Nose Guide Wires because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.

    Product
    BALL NOSE GUIDE WIRE 80CM, 100CM. Item Nos. 281001080 281001100 Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0580-2020·2019-12-04

    Boston Scientific Recalls Rebel Monorail Coronary Stent Systems

    Boston Scientific is recalling 14,145 Rebel Monorail PtCr Coronary Stent Systems because they may be missing a hydrophilic coating step.

    Product
    Rebel Monorail PtCr Coronary Stent System, REF / Catalog No. H7493927324300, Rebel MR OUS 3.0mm x 24mm. The Rebel Monorail (MR) Stent System is a balloon expandable Platinum Chromium (PtCr) Alloy stent pre-mounted on a Monorail Catheter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0583-2020·2019-12-04

    GN Hearing Recalls Behind-the-Ear Hearing Aids Due to Software Bug

    GN Hearing is recalling 590 behind-the-Ear hearing aids because a software bug in a repair tool altered sound amplification specifications, potentially increasing gain.

    Product
    Behind-the-Ear hearing aids, Model Numbers: Q962-DRW, T561-DRW, T562-DRW, T762-DRW, T777-DW, AMZ964-DRW, ET588-DWH, ET598-DW, ET788-DWH, ET798-DW, ET988-DWH, ET998-DW, FT861-DRW, FT862-DRW, RE561-DRWC, RE762-DRW, RE961-DRWC, RE962-DRW, PZ862-DRW, LT561-DRW, LT561-DRWZ…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0524-2020·2019-12-04

    Zimmer Biomet Recalls HHR Tess Cleats Due to Bacterial Endotoxin

    Zimmer Biomet is recalling Comprehensive HHR Tess Cleats because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.

    Product
    Comprehensive HHR Tess Cleat, Item Nos. 110260 110261 110262 110263 Product Usage: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0516-2020·2019-12-04

    Beckman Coulter Recalls UniCel DxH Slidemaker Stainer Devices Due to Bent Probe Risk

    Beckman Coulter is recalling UniCel DxH Slidemaker Stainer devices because a bent dispense probe may cause cell carryover, leading to erroneous lab results and potential inappropriate patient treatment.

    Product
    UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II) - Product Usage: The intended use is as follows: The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0575-2020·2019-12-04

    Abbott Recalls Alinity c Carbon Dioxide Reagent Kits Due to CO2 Absorption

    Abbott is recalling Alinity c Carbon Dioxide Reagent Kits because atmospheric carbon dioxide can be absorbed into the reagent, potentially causing incorrect test results.

    Product
    Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward Island Canada
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·19V864000·2019-12-04

    Ford Recalls 2017-2019 Super Duty Trucks for Tailgate Latch Defect

    Ford is recalling 2017-2019 Super Duty trucks because water intrusion may cause the tailgate to open unexpectedly, creating a road hazard.

    Product
    FORD — FORD F-350 SD, F-250 SD, F-450 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0525-2020·2019-12-04

    Zimmer Biomet Recalls Comprehensive RS Cleat CAP Due to Contamination

    Zimmer Biomet is recalling Comprehensive RS Cleat CAP devices because elevated levels of bacterial endotoxin and residual debris remain on the products due to a cleaning issue.

    Product
    Comprehensive RS Cleat CAP, Item No. 110300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0527-2020·2019-12-04

    Zimmer Biomet Recalls Copeland HA Resurfacing Heads Due to Cleaning Issues

    Zimmer Biomet is recalling Copeland HA Resurfacing Heads because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.

    Product
    Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0529-2020·2019-12-04

    Zimmer Biomet Recalls Guide Wires Due to Bacterial Endotoxin and Debris

    Zimmer Biomet is recalling specific Aim/Art Guide Wires because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.

    Product
    GUIDE WIRE 2.2MM X 28IN, Aim/Art Guide wire, Item No. 809222028 - Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0577-2020·2019-12-04

    Boston Scientific Recalls Emerge Monorail PTCA Catheters Due to Coating Defect

    Boston Scientific is recalling Emerge Monorail PTCA Dilatation Catheters because they may lack a required hydrophilic coating. The recall covers 14,145 devices distributed nationwide and in Canada.

    Product
    Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493919308200 EMERGE MR, OUS 2.00mm X 8mm; 2. REF/Catalog No. H7493918912200, EMERGE MR US 2.00MM X 12MM; 3. REF/Catalog No.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0518-2020·2019-12-04

    Becton Dickinson Recalls Site~Rite 8 Ultrasound Systems Due to Battery Indicator Defect

    Becton Dickinson is recalling 2,215 Site~Rite 8 Ultrasound Systems because the battery indicator may falsely show charge, causing abrupt shutdowns without warning.

    Product
    Site~Rite 8 Ultrasound Systems-intended for diagnostic ultrasound imaging of the human body. Site~Rite 8 Ultrasound System, Catalog No.9770500 Refurbished, Site~Rite¿ 8 System, Catalog No.9770500R Site~Rite 8 Ultrasound System, Catalog No.9770501 Refurbished Site~Rite¿ 8…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0532-2020·2019-12-04

    Zimmer Biomet Recalls Total Elbow Replacement Devices Due to Cleaning Issues

    Zimmer Biomet is recalling specific total elbow replacement devices because elevated levels of bacterial endotoxin and residual debris remain on them due to a cleaning issue.

    Product
    LT DISC ULNA - HA/PC; RT DISC ULNA - HA/PC; LT DISC HMRL- HA/PC; RT DISC HMRL- HA/PC; DISC XS ULNA POR; DISC SEG ULNA POR; and Custom devices Item Nos. 114754 114755 114744 114745 114704 114705 114756 114757 114714 114715 114746 114747 114706 114707…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0534-2020·2019-12-04

    Nextremity Solutions Recalls Stratum Foot Plating System Screws Due to Incorrect Specifications

    Nextremity Solutions is recalling 49 units of Stratum Foot Plating System screws because they may contain the incorrect screw type and length.

    Product
    Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile. Catalog Number: STRM-NL-3550ST - Product Usage: The Stratum Foot Plating System is a plate and screws construct indicated for fixation of fractures, osteotomies, nonunions, malunions and fusions of small bones and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0513-2020·2019-12-04

    Medline Recalls EVENCARE G3 Blood Glucose Test Strips Due to Seal Defects

    Medline Industries is recalling EVENCARE G3 Blood Glucose Test Strips because incomplete seals may cause the strips to expire prematurely.

    Product
    EVENCARE G3 Blood Glucose Test Strips, 1 test strip per foil pouch, 50 foil pouches per box, 12 boxes per case.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0551-2020·2019-12-04

    Boston Scientific Recalls Advanix Pancreatic Stents Due to Shelf Life Labeling Error

    Boston Scientific is recalling 54 units of Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month duration.

    Product
    Advanix Pancreatic Stent, Straight Leading Barb, 10F x 6cm UPN: M00536640
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0545-2020·2019-12-04

    Abbott Alinity ci Level Sensor Bulk Solution Recalled for Reliability Issues

    Abbott is recalling Alinity ci Level Sensor Bulk Solution kits due to potential cracks caused by environmental stress, which may affect reliability.

    Product
    Accessory kit, Alinity c containing Alinity ci Level Sensor, Bulk Solution
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0585-2020·2019-12-04

    Vygon Recalls 4Fr CT Midline Catheter Trays Due to Sizing Error

    Vygon MFG, Inc. is recalling 75 units of 4Fr x 20cm Single Lumen CT Midline Basic Trays because a 3Fr catheter may have been packaged instead of the correct 4Fr size.

    Product
    4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0560-2020·2019-12-04

    Boston Scientific Pancreatic Stent Recalled for Incorrect Shelf Life Labeling

    Boston Scientific is recalling 35 units of Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month shelf life.

    Product
    Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 18cm UPN: M00536730
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0553-2020·2019-12-04

    Boston Scientific Recalls Pancreatic Stents Due to Incorrect Shelf Life Labeling

    Boston Scientific is recalling 97 Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month duration.

    Product
    Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 8cm UPN: M00536660
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0550-2020·2019-12-04

    Boston Scientific Pancreatic Stent Recall Due to Incorrect Shelf Life Labeling

    Boston Scientific is recalling Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month period.

    Product
    Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 5cm UPN: M00536630
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0559-2020·2019-12-04

    Boston Scientific Recalls Pancreatic Stents Due to Incorrect Shelf Life Labeling

    Boston Scientific is recalling 179 Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month shelf life.

    Product
    Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 15cm UPN: M005337206
    Category
    Medical Device
    Distribution
    Distributed nationwide