State

Tennessee product recalls

73,809 recalls have nationwide distribution and so reach Tennessee. 7,860 additional recalls listed Tennessee specifically in their distribution scope.

What the numbers show

Total: 7,860
Critical: 1,324
Severe: 1,974
Most recent: 2026-11-04

Of the 7,860 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 1,974 (25%) are Severe.

Which agencies issued them

These figures cover only the 7,860 recalls whose distribution notice names Tennessee specifically. The 73,809 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

40851–40875 of 81669

HighFDA (Devices)·Z-3260-2018·2018-10-03
Boston Scientific LATITUDE Programming System Recalled for Stimulation Risk
Boston Scientific is recalling 74 LATITUDE Programming Systems due to a potential for unintended cross-chamber stimulation in pacing devices.
Product
Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3215-2018·2018-10-03
Philips INTEGRIS CV Ceiling Monitor Suspension Recall for Detachment Risk
Philips is recalling INTEGRIS CV systems because the ceiling monitor suspension may detach, causing the monitor to fall and potentially injure patients, users, or bystanders.
Product
INTEGRIS CV, System Code 722030 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3247-2018·2018-10-03
Shockwave S4 IVL Catheters Recalled for Inflation Pressure Failure
Shockwave Medical is recalling 612 Shockwave S4 IVL Catheters because they may fail to maintain required inflation pressure during treatment.
Product
The Shockwave S4 IVL Catheters are intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Shockwave S4, Peripheral…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-3276-2018·2018-10-03
Bausch + Lomb Stellaris Elite Vit Cutter Recall for Back Cap Separation
Bausch + Lomb is recalling Stellaris Elite Vit Cutters because the back cap can separate from the cutter body.
Product
Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Combined Mid-Field Elite Pack, REF SE5525MV (containing the Stellaris Elite 25 GA Vit Cutter, Model BL5628), packaged in sterile trays, 6 trays/shipper.
Category
Medical Device
Distribution
26 states
HighFDA (Devices)·Z-3263-2018·2018-10-03
Biomet Recalls HipLOC Hip Fracture Fixation System Plates
Biomet UK Ltd. is recalling 44 units of the HipLOC Hip Fracture Fixation System due to an undersized bore that may prevent the lag screw from fitting.
Product
HipLOC Hip Fracture Fixation System-Hiploc System 135¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-135-004 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3273-2018·2018-10-03
Bausch + Lomb Stellaris Elite Vit Cutter Recall Due to Cap Separation
Bausch & Lomb is recalling Stellaris Elite 25 GA Vit Cutters because the back cap may separate from the cutter body.
Product
Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Wide-Field Elite Pack, REF SE5425WV (containing the Stellaris Elite 25 GA Vit Cutter, Model BL5628), packaged in sterile trays, 6 trays/shipper.
Category
Medical Device
Distribution
26 states
HighFDA (Devices)·Z-3227-2018·2018-10-03
Philips Allura Xper F010 Ceiling Monitor Suspension Recall
Philips is recalling Allura Xper F010 systems because the ceiling monitor suspension may detach, causing the monitor to fall and potentially injure patients or users.
Product
Allura Xper F010, System Code 722003 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3259-2018·2018-10-03
Boston Scientific Recalls VISIONIST X4 CRT-P Pacemakers Due to Battery Depletion
Boston Scientific is recalling VISIONIST X4 CRT-P pacemakers because hydrogen-induced accelerated battery depletion may require early replacement.
Product
VISIONIST X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)
Category
Medical Device
Distribution
48 states
HighFDA (Devices)·Z-3228-2018·2018-10-03
Philips AlluraXperFOlO/lO Ceiling Monitor Suspension Recall
Philips is recalling 5,115 AlluraXperFOlO/lO systems because the ceiling monitor suspension may detach, causing the monitor to fall and potentially injure patients or users.
Product
AlluraXperFOlO/lO, System Code 722005 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3269-2018·2018-10-03
Bausch + Lomb Stellaris Elite Vit Cutter Recall for Cap Separation
Bausch & Lomb is recalling Stellaris Elite Vit Cutters because the back cap may separate from the cutter body during use.
Product
Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Mid-Field Elite Pack, REF SE5423MV (containing the Stellaris Elite 23 GA Vit Cutter, Model BL5627), packaged in sterile trays, 6 trays/shipper.
Category
Medical Device
Distribution
26 states
HighFDA (Devices)·Z-3233-2018·2018-10-03
Philips Allura Xper F010 DR Table Recall for Monitor Detachment Risk
Philips is recalling 5,115 Allura Xper F010 DR Tables because the ceiling monitor suspension may detach, posing a risk of injury from falling equipment.
Product
Allura Xper F010 DR Table, System Code 722014 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3225-2018·2018-10-03
Philips Allura Xper FD1O C Ceiling Monitor Recall for Detachment Risk
Philips is recalling 5,115 Allura Xper FD1O C systems because the ceiling monitor suspension may detach, causing the monitor to fall and potentially injure patients, users, or bystanders.
Product
Allura Xper FD1O C, System Code 722001 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3238-2018·2018-10-03
Philips Medical Monitor Ceiling Suspension Recall for Detachment Risk
Philips is recalling 5,115 medical monitor ceiling suspensions because the monitor may detach from the actuator, posing a risk of injury to patients and users.
Product
Cesar-DMCP-Visub(HM2000/3000), System Code 72239 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3266-2018·2018-10-03
Bausch + Lomb Stellaris Elite Vit Cutter Recall Due to Cap Separation
Bausch & Lomb is recalling Stellaris Elite Vit Cutters because the back cap may separate from the cutter body.
Product
Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Mid-Field Elite Pack, REF SE5420M (containing the Stellaris Elite 20 GA Vit Cutter, Model BL5626), packaged in sterile trays, 6 trays/shipper.
Category
Medical Device
Distribution
26 states
HighFDA (Devices)·Z-3258-2018·2018-10-03
Boston Scientific Recalls VALITUDE X4 CRT-P Pacemakers Due to Battery Depletion
Boston Scientific is recalling VALITUDE X4 CRT-P pacemakers because hydrogen-induced accelerated battery depletion may require early replacement.
Product
VALITUDE X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)
Category
Medical Device
Distribution
48 states
HighFDA (Devices)·Z-3232-2018·2018-10-03
Philips Allura Xper F020 DR Table Recall for Monitor Suspension Defect
Philips is recalling 5,115 Allura Xper F020 DR Tables because the ceiling monitor suspension may detach, posing a risk of injury from falling equipment.
Product
Allura Xper F020 DR Table, System Code 722023 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3241-2018·2018-10-03
Durex Real Feel Polyisoprene Condoms Recalled for Burst Pressure Failure
Reckitt Benckiser is recalling Durex Real Feel Polyisoprene Condoms because they failed to meet the required burst pressure specification.
Product
Durex Real Feel Polyisoprene Condoms, 10 count and 24 count, SKU Numbers 02340-89456-14 and 02340-89457-00 Product Usage: The Durex Synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3236-2018·2018-10-03
Philips Allura Xper F020 Biplane DR Table Recall for Monitor Suspension Defect
Philips is recalling 5,115 Allura Xper F020 Biplane DR Tables because the monitor ceiling suspension may detach, causing the monitor to fall and potentially injure patients, users, or bystanders.
Product
Allura Xper F020 Biplane DR Table, System Code 722020 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3223-2018·2018-10-03
Philips Allura Xper FD2O Biplane Recall for Monitor Suspension Defect
Philips is recalling 5,115 Allura Xper FD2O Biplane systems because the monitor ceiling suspension may detach, causing the monitor to fall and risk injury.
Product
Allura Xper FD2O Biplane, System Code 722013 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3217-2018·2018-10-03
Philips INTEGRIS Allura 15-12 Biplane Monitor Suspension Recall
Philips is recalling INTEGRIS Allura 15-12 biplane systems because the monitor ceiling suspension may detach, causing the monitor to fall and potentially injure patients, users, or bystanders.
Product
INTEGRIS Allura 15-12 (biplane), System Code 722044 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3239-2018·2018-10-03
Philips Medical Monitor Ceiling Suspension Recall Due to Detachment Risk
Philips is recalling 5,115 medical monitor ceiling suspensions because the monitor may detach and fall, posing an injury risk to patients and users.
Product
Cesar Powerpack-Visub(V3000), System Code 72243 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3254-2018·2018-10-03
Intuitive Surgical Recalls da Vinci Redundant Medical Grade Power Supply Units
Intuitive Surgical is recalling specific da Vinci Surgical System power supply units that were manufactured incorrectly and may fail during use.
Product
da Vinci Si/X/Xi Surgical System Redundant Medical Grade Power Supply (RMGPS) Units The da Vinci System consists of a Surgeon Console, a Patient Cart, and a Vision Cart and is used with an endoscope, da Vinci EndoWrist instruments, and accessories to perform minimally…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3271-2018·2018-10-03
Bausch + Lomb Stellaris Elite Vit Cutter Recall for Cap Separation
Bausch & Lomb is recalling Stellaris Elite vit cutters because the back cap may separate from the body. The defect poses a risk of harm during use.
Product
Bausch + Lomb Stellaris Elite 25 GA Vit Cutter, Model BL5628, 7500 cpm, packaged in sterile pouches, 6/shipper.
Category
Medical Device
Distribution
26 states
HighFDA (Devices)·Z-3214-2018·2018-10-03
Philips INTEGRIS Allura 9 Biplane Recall for Monitor Suspension Defect
Philips is recalling INTEGRIS Allura 9 biplane systems because the monitor ceiling suspension may detach, causing the monitor to fall and potentially injure patients, users, or bystanders.
Product
INTEGRIS Allura 9 (biplane), System Code 722021 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3240-2018·2018-10-03
Stryker Recalls Hoffmann LRF Hexapod Software Due to Calculation Error
Stryker GmbH is recalling 233 units of Hoffmann LRF Hexapod Software because it may compute erroneously accelerated correction plans under specific settings.
Product
Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: HLRF 1.0-2/002, HLRF 1.1-2/002
Category
Medical Device
Distribution
Distributed nationwide