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.

35376–35400 of 81600

HighFDA (Devices)·Z-2767-2019·2019-10-09
WOM Aquilex Fluid Control System Bag Deflector Recalled for Pump Deficit Error
WOM World of Medicine AG is recalling Aquilex Fluid Control System bag deflectors because the pump's displayed deficit may differ from the actual deficit, posing a potential risk to patients.
Product
Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2758-2019·2019-10-09
Howmedica Recalls Triathlon Femoral Distal Augments Due to Device Overhang
Howmedica Osteonics Corp. is recalling 171 units of Triathlon Femoral Distal Augments due to a device overhang issue that protrudes beyond the mating femoral component.
Product
TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 RIGHT Catalog # 5541-A-202 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0063-2020·2019-10-09
KRS Global Biotechnology Recalls Hydroxocobalamin Vials Due to Sterility Concerns
KRS Global Biotechnology is recalling 345 vials of Hydroxocobalamin 30 mg/30 mL for IM use due to a lack of assurance of sterility.
Product
Hydroxocobalamin 30 mg/30 mL (1 mg/mL) 30 mL Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678334
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0008-2020·2019-10-09
Baxter ExactaMix IV Bags Recalled for Potential Leaking
The Metrix Company is recalling Baxter ExactaMix IV bags due to a potential for leaking. The recall covers 332,640 units distributed nationwide.
Product
ExactaMix, Model: H938905, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 250 ml/ 1250 ml, Baxter - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0006-2020·2019-10-09
Metrix Secure EVA IV Bags Recalled for Potential Leaking
The Metrix Company is recalling 54,720 Secure EVA dual chamber IV bags due to a potential for leaking. The affected units were distributed in the US and Canada.
Product
SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 4000mL, REF 66641 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0007-2020·2019-10-09
FDA Recalls ExactaMix IV Bags Due to Potential Leaking
The FDA is recalling 175,392 ExactaMix IV bags due to a potential for leaking. The bags are used for intravenous admixture programs.
Product
ExactaMix, Model: H938901, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 500 ml/ 2500 ml, Baxter - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0003-2020·2019-10-09
Metrix Secure EVA IV Bags Recalled for Potential Leaking
The Metrix Company is recalling 1,512 Secure EVA dual chamber IV bags due to a potential for leaking. The affected bags were distributed nationwide in the US.
Product
SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 4000mL, (legless) REF 66640 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0002-2020·2019-10-09
Metrix Secure EVA Dual Chamber Container Recall for Leaking
The Metrix Company is recalling 4,284 Secure EVA dual chamber containers due to a potential for leaking. The affected bags are used for intravenous admixtures.
Product
SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 3000mL, (legless) REF 66630 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0053-2020·2019-10-09
KRS Global Biotechnology Recalls Glutathione Vials Due to Sterility Concerns
KRS Global Biotechnology is recalling 402 vials of Glutathione 30 mL due to a lack of assurance of sterility. The product was distributed nationwide.
Product
Glutathione 30 mL Vial-For IM Use-Hypertonic solution, 6,000 mg/30 mL (200 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC3321674186
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0005-2020·2019-10-09
Metrix Secure EVA Dual Chamber IV Bags Recalled for Leaking
The Metrix Company is recalling 234,720 Secure EVA dual chamber IV bags due to a potential for leaking. The affected units were distributed nationwide in the US.
Product
SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 3000mL, REF 66631 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0062-2020·2019-10-09
KRS Global Biotechnology Recalls Hydroxocobalamin Vials Due to Sterility Concerns
KRS Global Biotechnology is recalling 345 vials of Hydroxocobalamin 10 mg/20 mL due to a lack of assurance of sterility. The recall covers all lots remaining within expiry and is distributed nationwide.
Product
Hydroxocobalamin 10 mg/20 mL (0.5 mg/mL) 20 mL fill in a 30 mL Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678337
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0100-2020·2019-10-09
Sermorelin and GHRP-2 Lyophilized Vials Recalled Due to Sterility Concerns
KRS Global Biotechnology is recalling 120 vials of Sermorelin and GHRP-2 because the company cannot assure the products are sterile.
Product
Sermorelin, 3 mg / GHRP-2, 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674092
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0018-2020·2019-10-09
Implant Direct Sybron Recalls Mislabeled Dental Implant Vials
Implant Direct Sybron Manufacturing is recalling 22 vials of dental implants due to incorrect part numbers on the vial caps.
Product
ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0119-2020·2019-10-09
Alkermes Recalls Vivitrol Kits Due to Needle Labeling Error
Alkermes is recalling 16,231 Vivitrol kits because 1-inch needles were incorrectly placed in sleeves labeled for 1.5-inch needles. The drug vials are not affected.
Product
VIVITROL — VIVITROL (NALTREXONE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2766-2019·2019-10-09
Roche Accu-Chek Performa II Meters Recalled for Damaged Capacitor
Roche Diabetes Care is recalling Accu-Chek Performa II meters because a damaged capacitor may cause short battery life or prevent the device from turning on.
Product
Accu-Chek Performa II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. The…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0001-2020·2019-10-09
Metrix Secure EVA Dual Chamber IV Bags Recalled for Leaking Risk
The Metrix Company is recalling 1,596 Secure EVA dual chamber IV bags due to a potential for leaking. The affected bags were distributed nationwide.
Product
SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 1500mL, (legless) REF 66615 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2762-2019·2019-10-09
Zimmer Sidus Stem-Free Shoulder Humeral Head Recall for Incorrect Labeling
Zimmer GmbH is recalling 19 Sidus Stem-Free Shoulder Humeral Head implants due to incorrect size labeling on the packaging.
Product
Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthopedic implant - Product Usage: The Sidus Stem-Free Shoulder is designed for long-term implantation into the human shoulder joint as a total shoulder arthroplasty in combination with Zimmer or Biomet s…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2763-2019·2019-10-09
Beckman Coulter Access Cortisol Reagent Recalled for Cross-Contamination
Beckman Coulter is recalling Access Cortisol Reagent due to cross-contamination that may cause falsely decreased patient results.
Product
The Access Cortisol Reagent. REF (Catalog Number) 33600, Lot 831755. A paramagnetic particle, chemiluminscent immunoassay. Product Usage: The assay is a paramagnetic particle, chemiluminescent immunoassay for the quanitative determination of cortisol levels in human serum…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2765-2019·2019-10-09
Roche Recalls Accu-Chek Aviva II Meters Due to Damaged Capacitor
Roche Diabetes Care is recalling 26,600 Accu-Chek Aviva II meters because a damaged capacitor may cause short battery life or prevent the device from turning on.
Product
Accu-Chek Aviva II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. The…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0066-2020·2019-10-09
Labetalol HCl syringes are recalled due to lack of sterility assurance
The FDA is recalling 6,405 units of Labetalol HCl single-dose syringes because there was insufficient assurance of sterility during production. No illnesses or injuries have been reported.
Product
Labetalol HCl 5 mg/mL 20 mg/4 mL (5 mg/mL) 4 mL Fill in a 6 mL Single Dose Syringe, Rx only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676419
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0029-2020·2019-10-09
CooperSurgical Embryology Heated Plate Recall Due to Touchpad Malfunction
CooperSurgical is recalling 60 Embryology Heated Plates within the RI Witness system because the touchpad may not work properly after cleaning.
Product
Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, & 6-70-807-B - Product Usage: RI Witness uses Radio Frequency Identification (RFID) to detect and monitor all activity in the IVF laboratory. The system helps mitigate the risk of human error…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2764-2019·2019-10-09
ELITech Viva-ProE Systems Recalled for Software Malfunction
ELITech Group B.V. is recalling 89 Viva-ProE Systems because a software malfunction causes the devices to become inoperable.
Product
Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: The ELITech Clinical Systems Selectra ProM is an automated clinical chemistry system intended for use in clinical laboratories. It is intended to be used for a variety of assay methods that have been…
Category
Medical Device
Distribution
Distributed nationwide
SevereNHTSA·19V716000·2019-10-08
2019 Mercedes-Benz and Freightliner Sprinter Door Component Recall
Daimler Vans USA is recalling 2019 Mercedes-Benz and Freightliner Sprinter vans because an incorrectly installed door component may make doors harder to open after a severe frontal crash.
Product
MERCEDES-BENZ — MERCEDES-BENZ, FREIGHTLINER SPRINTER 2500, SPRINTER 4500, SPRINTER 3500, SPRINTER 1500
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·19V715000·2019-10-08
Mercedes-Benz Recalls Metris Vans Due to Exposed Battery Fire Risk
Daimler Vans USA is recalling 2016-2019 Mercedes-Benz Metris vehicles because the backup battery compartment may lack a cover, creating a fire hazard if conductive material contacts the terminals.
Product
MERCEDES-BENZ — MERCEDES-BENZ METRIS
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·20703·2019-10-08
Kawasaki Recalls Lawn Mower Engines Due to Burn and Fire Hazards
Kawasaki is recalling about 950 lawn mower engines because a fuel injector leak can cause burns or fires. No injuries have been reported.
Product
Lawn mower engines
Category
Consumer Product
Distribution
Distributed nationwide