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.

37051–37075 of 81600

HighFDA (Devices)·Z-1712-2019·2019-06-12
Flowonix Prometra Clinician Programmer Software Recall for Unexpected Pump Shutdowns
Flowonix Medical Inc is recalling Prometra Clinician Programmer software due to a defect that can cause intrathecal pumps to shut down unexpectedly.
Product
Prometra Clinician Programmer (Touchscreen) Software version 2.00.29, Cat. No. 12828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1695-2019·2019-06-12
Philips IntelliVue MX40 Patient Monitor Recalled for Battery Notification Defects
Philips is recalling IntelliVue MX40 Patient Monitors because they may fail to provide visual or audible alerts when the battery is low.
Product
IntelliVue MX40 Patient Monitor, Product number 857146, Service Numbers All: 453564711531 and 453564711541 - Product Usage: Used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX40 is…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1702-2019·2019-06-12
AngioDynamics Solero Microwave Tissue Ablation System Recall for Delayed Procedure Risk
AngioDynamics is recalling Solero Microwave Tissue Ablation System applicators to reduce the risk of patient harm from delayed procedures via manual and software updates.
Product
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Applicator 14cm PG Catalog Number: 700106001 UPN:H7877001060010; (2)Solero Applicator 14cm PG US Catalog Number:700106001US UPN: H787700106001US0 Product Usage: The Solero Microwave Tissue…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1693-2019·2019-06-12
Philips IntelliVue MX40 Patient Monitor Recalled for Battery Issues
Philips is recalling IntelliVue MX40 Patient Monitors because they may consume excess power and fail to provide visual or audible low-battery alerts.
Product
IntelliVue MX40 Patient Monitor, Product number 865351, Service Numbers All other countries: 453564451791, 453564451811, 453564467721, 453564467741, 453564467761, 453564467781, 453564467801, 453564467821, 453564467841, 453564467861, 453564262531, and 453564262551 - Product…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1714-2019·2019-06-12
Flowonix Prometra Programmable Pump Recalled for Unexpected Shutdowns
Flowonix Medical Inc. is recalling 809 Prometra Programmable Pumps because a software defect can cause the pump to shut down unexpectedly.
Product
Prometra Programmable Pump, Cat. No. 11827 For intrathecal infusion.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1727-2019·2019-06-12
Stryker High Flow Tube Set Recalled for Leaking and Detachment
Stryker is recalling High Flow Tube Sets with Real-Time Pressure Sensing because they consistently leak and detach from the cassette.
Product
Stryker High Flow Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-680, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1708-2019·2019-06-12
Stryker AXS Infinity LS Plus Long Sheath Recalled for Brittle Behavior
Stryker Neurovascular is recalling AXS Infinity LS Plus Long Sheaths because a design issue can cause the device to become brittle and fracture.
Product
Stryker Neurovascular, AXS Infinity LS Plus Long Sheath, Rx Only, Sterile EO, USA Customer Service 855-91 NEURO (916-3876): a) REF: INC-11196-70, 70cm, b) REF: INC-11196-80, 80cm, c) REF: INC-11196-90, 90cm Product Usage: Indications for Use: The AXS Infinity LS Plus…
Category
Medical Device
Distribution
Distributed nationwide
HighCPSC·19137·2019-06-12
Mares Recalls XR Buoyancy Compensation Vests Due to Drowning Hazard
Mares is recalling XR buoyancy compensation vests because the deflation button can unscrew, causing loss of buoyancy and a drowning hazard. No injuries have been reported.
Product
Mares XR buoyancy compensation vests
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1694-2019·2019-06-12
Philips IntelliVue MX40 Patient Monitor Recalled for Battery Notification Issues
Philips is recalling IntelliVue MX40 Patient Monitors because they may fail to provide visual or audible low-battery alerts, potentially disrupting patient monitoring.
Product
IntelliVue MX40 Patient Monitor, Product number 865352, Service Numbers All: 453564262571, 453564262591, 453564615311, 453564615331, 453564615351, and 453564615371 Product Usage: Used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1728-2019·2019-06-12
Stryker Heated Tube Set Recall for Leaking and Detachment Issues
Stryker is recalling 19,083 boxes of Heated Tube Sets with Real-Time Pressure Sensing because they consistently leak and detach from the cassette.
Product
Stryker Heated Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-690, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1700-2019·2019-06-12
AngioDynamics Solero Microwave Tissue Ablation System Recall for Delayed Procedures
AngioDynamics is recalling 314 Solero Microwave Tissue Ablation System generators to update manuals and software, reducing the risk of patient harm from procedure delays.
Product
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator PG (1) Catalog Number:12740000 UPN: H78712740000 (2) Solero Generator US PG Catalog Number: 12740000US UPN: H78712740000US0 (3) Solero Generator Service Loaner PG Catalog No: 12740000L…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1704-2019·2019-06-12
AngioDynamics Solero Microwave Tissue Ablation System Recall for Procedure Delay Risk
AngioDynamics is recalling 1,846 Solero Microwave Tissue Ablation System applicators to reduce the risk of patient harm from procedure delays.
Product
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 29cm PG Catalog Number:700106003 UPN: H7877001060030 (2)Solero Applicator 29cm PG US Catalog Number:700106003US UPN:H787700106003US0 Product Usage: The Solero Microwave Tissue…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1719-2019·2019-06-12
Centurion Medical Recalls Sterile Nail Clippers Due to Compromised Seals
Centurion Medical Products Corporation is recalling sterile nail clippers because the sterile barrier pouch seals are compromised, potentially affecting sterility.
Product
Sterile Nail Clipper Concave Edge (67710)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1713-2019·2019-06-12
Flowonix Prometra Programmer Software Recall for Unexpected Pump Shutdowns
Flowonix Medical Inc is recalling 40 units of Prometra Programmer software due to a defect that causes intrathecal pumps to shut down unexpectedly.
Product
Prometra Programmer (Grand Prime) Software version 2.00.29, Cat. No. 13828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1703-2019·2019-06-12
AngioDynamics Solero Microwave Tissue Ablation System Recall for Delayed Procedures
AngioDynamics is recalling 7,348 Solero Microwave Tissue Ablation applicators to update manuals and software, reducing the risk of patient harm from procedure delays.
Product
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 19cm PG Catalog Number: 700106002 UPN: H7877001060020 (2)Solero Applicator 19cm PG US Catalog Number:700106002US UPN: H787700106002US0 Product Usage: The Solero Microwave Tissue…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1742-2019·2019-06-12
Bio-Rad Recalls MRSASelect In Vitro Diagnostic Plates Due to Abnormal Coloration
Bio-Rad Laboratories is recalling 5,212 units of MRSASelect in vitro diagnostic plates due to abnormal agar coloration and non-characteristic colony growth.
Product
MRSASelect, IVD, REF 63747, containing 20 plates per package. The MRSASelect is indicated for use in conjunction with other laboratory tests and clinical data available to aid in the identification and diagnosis of MRSA from patients with skin and soft-tissue infections.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1718-2019·2019-06-12
I.T.S. GmbH Recalls Titanium Rim Plates Due to Incorrect Laser Marking
I.T.S. GmbH is recalling 65 titanium rim plates because they have the wrong article number laser marked on them. The devices were distributed in the US and several international countries.
Product
Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The implant temporarily stabilizes bone segments until bony consolidation has taken place. After this, the implant has no more use and can be removed.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1721-2019·2019-06-12
Kerr/Pentron Recalls Glutaraldehyde Solution Due to Labeling Discrepancy
Kerr/Pentron is recalling Regimen 28 Day Glutaraldehyde Solution because the bottle label states a 45-minute immersion time, while the product instructions specify 90 minutes.
Product
Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution
Category
Medical Device
Distribution
21 states
ModerateFDA (Devices)·Z-1733-2019·2019-06-12
Smith Medical JELCO Hypodermic Needle Recall for Incorrect Specifications
Smiths Medical ASD Inc. is recalling JELCO Hypodermic Needles with incorrect length and gauge. The recall covers 109,000 units distributed nationwide.
Product
Smith Medical JELCO Hypodermic Needle-Pro EDGE Safety Device Safety Device Rx Only Sterile Product Usage: Is a disposable, single use device intended for injection or aspiration of fluids using a Luer lock or Luer slip syringe. The needle protection device covers the needle…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1707-2019·2019-06-12
NxStage PureFlow B Solution Recalled for Incorrect Product Number Labeling
NxStage Medical is recalling specific lots of PureFlow B Solution because they were mislabeled with the incorrect product number.
Product
NxStage PureFlow B Solution, REF RFP-401, M535RPF4010 NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1709-2019·2019-06-12
Abbott Recalls Alinity c Cuvette Segments Due to Seating Defect
Abbott is recalling Alinity c Cuvette Segments because individual cuvettes may seat lower than designed, potentially preventing the sample probe from making efficient contact with the cuvette bottom.
Product
Alinity c Cuvette Segments, List Number 04S47-01 Product Usage: The Alinity c Cuvettes are used on the Alinity c system processing module. The Alinity c processing module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1706-2019·2019-06-12
NxStage PureFlow B Solution Recalled for Incorrect Product Number Labeling
NxStage Medical is recalling 1,998 units of PureFlow B Solution because certain lots were mislabeled with the incorrect product number.
Product
NxStage PureFlow B Solution, REF RFP-400, M535RFP4000 Product NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1730-2019·2019-06-12
Microbiologics Recalls Cepheid Xpert MRSA Control Panels Due to Incorrect Shelf Life
Microbiologics Inc is recalling 249 units of Cepheid Xpert MRSA/MRSA NxG and Xpert SA Nasal Complete Control Panels because they have an incorrect shelf life.
Product
Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195) UDI: 70845357041226 Product Usage: On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direct US consignees requesting them to complete a MEDICAL DEVICE CORRECTION FORM…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1731-2019·2019-06-12
Microbiologics Recalls Cepheid Xpert SA Nasal Control Panels for Shelf Life Error
Microbiologics is recalling 235 units of Cepheid Xpert SA Nasal Complete Control Panels due to incorrect shelf life labeling.
Product
Cepheid Xpert SA Nasal Complete Control Panel (Catalog #8196) UDI: 70845357041233 Product Usage: On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direct US consignees requesting them to complete a MEDICAL DEVICE CORRECTION FORM…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1732-2019·2019-06-12
Smiths Medical Recalls Portex Tracheostomy Tubes with Incorrect Inner Cannula Size
Smiths Medical ASD Inc. is recalling 7,840 Portex Blue Line Ultra Tracheostomy Tubes because they were packaged with an incorrect size inner cannula.
Product
Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in part, Product Usage: The Portex Blue Line Ultra¿ Tracheostomy Tubes are indicated for airway maintenance of tracheostomized patients.
Category
Medical Device
Distribution
Distributed nationwide