January 2020 recalls

534 recalls were announced in January 2020.

What the numbers show

Critical: 40
Severe: 228
High: 165
Moderate: 85
Low: 16

Of the 534 recalls this month scored against our rubric, 7% are Critical, 43% are Severe.

Which agencies issued them

501–534 of 534

HighFDA (Devices)·Z-0725-2020·2020-01-01
GE Healthcare ApexPro Telemetry System Recalled for Cybersecurity Vulnerabilities
GE Healthcare is recalling 11,347 ApexPro Telemetry Systems worldwide due to cybersecurity vulnerabilities in specific server versions connected to hospital networks.
Product
ApexPro Telemetry System - Product Usage: The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area.…
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-0461-2020·2020-01-01
Northern Fisheries Recalls Frozen Yellowfin Tuna Steaks Due to Histamine Levels
Northern Fisheries Ltd. is recalling 1,052 cases of frozen yellowfin tuna steaks in Florida, Georgia, New York, Illinois, and Rhode Island due to potential scombrotoxin fish poisoning.
Product
Frozen Yellowfin Tuna Steak, 4 oz. and 6 oz., Keep Frozen, Imported/Distributed: Mical Seafood Inc., 10400 Griffin Rd, Suite #209, Cooper City, Florida 33328
Category
Food
Distribution
5 states
HighFDA (Devices)·Z-0721-2020·2020-01-01
Mazor Robotics Recalls Snapshot Tracker Kits Due to Manufacturing Defects
Mazor Robotics is recalling 93 Snapshot Tracker Kits because they were not manufactured to specifications, potentially causing navigational inaccuracies and patient injury.
Product
Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868
Category
Medical Device
Distribution
26 states
HighFDA (Food)·F-0439-2020·2020-01-01
White Castle Sliders Recalled for Possible Listeria Contamination
White Castle is recalling 894,078 cartons of Original Slider Hamburgers due to possible Listeria monocytogenes contamination. The product was distributed to 52 centers in 24 states.
Product
White Castle Sliders - The Original Slider Hamburgers
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-0726-2020·2020-01-01
GE Healthcare Recalls CIC Pro Central Stations Due to Cybersecurity Vulnerabilities
GE Healthcare is recalling 41,848 CIC Pro Clinical Information Center Central Stations worldwide due to cybersecurity vulnerabilities in connected telemetry systems.
Product
CIC Pro Clinical Information Center Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data in a centralized location within a hospital or clinical environment. CIC Pro Clinical Information Center central station…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0724-2020·2020-01-01
Bard Max-Core Biopsy Instrument Recalled for Firing Failures
Bard Peripheral Vascular Inc is recalling 727,034 units of the Bard Max-Core Disposable Core Biopsy Instrument due to complaints of failure to fire and failure to obtain samples.
Product
BARD MAX-CORE Disposable Core Biopsy Instrument - Product Usage: The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0440-2020·2020-01-01
White Castle Jalapeno Cheese Sliders Recalled for Listeria Risk
White Castle is recalling Jalapeno Cheese Sliders due to possible Listeria monocytogenes contamination. The product was distributed to 52 centers in 24 states.
Product
White Castle Sliders - Jalapeno Cheese Sliders - Jalapeno Cheeseburgers, UPC 8298801106 (6pk Jalapeno Cheeseburger)
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-0727-2020·2020-01-01
GE Healthcare CARESCAPE Central Station Recalled for Cybersecurity Vulnerabilities
GE Healthcare is recalling CARESCAPE Central Station units due to cybersecurity vulnerabilities in specific network-connected versions.
Product
CARESCAPE Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data within a hospital or clinical environment. The CARESCAPE Central Station is intended to collect information from a network and display this data.…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0736-2020·2020-01-01
RayStation Radiation Therapy Software Recalled for Beam Editing Bug
RaySearch Laboratories is recalling RayStation software versions 4.0 through 9.0 because a bug may reset beam settings, requiring dose recalculation.
Product
RayStation stand-alone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0 - Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0733-2020·2020-01-01
Medtronic Lamicel Cervical Dilators Recalled for Sterilization Defect
Medtronic Xomed is recalling Lamicel 20PK 3MM INTL Cervical Dilators because the sterilization dose did not meet the required Sterility Assurance Level.
Product
Lamicel 20PK 3MM INTL Cervical dilator
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0735-2020·2020-01-01
Medtronic Lamicel Sponges Recalled for Sterilization Dose Deficiency
Medtronic Xomed is recalling Lamicel 10PK 10MM INTL sponges because the routine sterilization dose does not meet the required Sterility Assurance Level.
Product
Lamicel 10PK 10MM INTL
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0719-2020·2020-01-01
3M Recalls Durapore Advanced Surgical Tape Due to Bond Failure Risk
3M is recalling Durapore Advanced Surgical Tape because long-term exposure to high moisture may cause bond failure and fiber fraying, posing a risk of accidental ingestion or aspiration.
Product
3M Durapore Advanced, Surgical Tape, Model Numbers: 1590-0, 1590-1, 1590-2, 1590-3, 1591-0, 1591-1, 1591-2, 1591-3, 1590S-1, 1590S-2, 1590B-118, 1590B-136
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0459-2020·2020-01-01
Northern Fisheries Recalls Frozen Yellowfin Tuna Loins Due to Histamine Levels
Northern Fisheries Ltd. is recalling 200 cases of frozen yellowfin tuna loins because they may contain increased levels of histamine, posing a risk of scombrotoxin fish poisoning.
Product
Frozen Yellowfin Tuna Loins, 5-8 lbs, Keep Frozen, Imported/Distributed: Mical Seafood Inc., 10400 Griffin Rd, Suite #209, Cooper City, Florida 33328
Category
Food
Distribution
5 states
ModerateFDA (Devices)·Z-0728-2020·2020-01-01
Cardinal Health Recalls S.M.A.R.T. Stents for Incorrect MRI Labeling
Cardinal Health is correcting labeling on S.M.A.R.T. Nitinol Stent Systems that incorrectly stated they were 'MRI Safe' instead of 'MRI Conditional'.
Product
S.M.A.R.T. Nitinol Stent System and the S.M.A.R.T. Control Nitinol Stent System. The SMART stent system includes a self-expanding stent made of Nitinol (nickel-titanium alloy) material and a 6 French (2.0 mm) or 7 French (2.3 mm) sheathed delivery system. The stent is laser…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0743-2020·2020-01-01
Axis-Shield Homocysteine Reagent Recalled for Potential Performance Issues
Axis-Shield Diagnostics is recalling 740 units of Liquid Stable 2-Part Homocysteine Reagent due to potential performance issues detected during routine testing.
Product
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR100 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0442-2020·2020-01-01
Ferris Coffee and Nut Company Recalls Cinnamon Roasted Almonds for Labeling Error
Ferris Coffee and Nut Company is recalling R.H. Macys & Co. Cinnamon Roasted Almonds due to an incorrect product label on the back panel.
Product
R.H. Macys & Co. Cinnamon Roasted Almonds, in 10oz metal tin, UPC 788709600317
Category
Food
Distribution
15 states
ModerateFDA (Devices)·Z-0737-2020·2020-01-01
Diagnostica Stago Recalls STA Unicalibrator Due to Positive Bias
Diagnostica Stago is recalling 5,498 units of STA Unicalibrator because a positive bias was confirmed when compared to International Standards.
Product
STA UNICALIBRATOR (ref. 00675)
Category
Medical Device
Distribution
42 states
ModerateFDA (Devices)·Z-0741-2020·2020-01-01
PTS Test Strips Recalled for Under-Recovery Against Reference Method
Polymer Technology Systems is recalling specific CHOL+HDL+GLU test strips because they show under-recovery when tested against a reference method.
Product
PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers
Category
Medical Device
Distribution
16 states
ModerateFDA (Devices)·Z-0740-2020·2020-01-01
Ortho Clinical Diagnostics Recalls Urine Electrolyte Diluent Due to Instability
Ortho Clinical Diagnostics is recalling Urine Electrolyte Diluent because the product may become unstable when stored in a 2mL cup for 7 days.
Product
Urine Electrolyte Diluent, Product Code: 1112352 - Product Usage: used to dilute urine specimens for analysis of sodium (Na+) and potassium (K+) on VITROS 250/350/5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0729-2020·2020-01-01
Cordis Precise Nitinol Stent System Labeling Correction for MRI Information
Cardinal Health is correcting labeling on Cordis Precise Nitinol Stent Systems because the instructions incorrectly stated the device was MRI Safe instead of MRI Conditional.
Product
Cordis Precise Nitinol Stent System. The Cordis PRECISE Nitinol Stent System devices are designed to deliver a flexible, self-expanding endoluminal stent to the carotid vasculature via over-the-wire (OTW) 5.5F or 6F sheathed delivery systems. The stent is cut from a solid…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0628-2020·2020-01-01
Spectrum Laboratory Products Recalls Subpotent Estriol Micronized USP
Spectrum Laboratory Products is recalling specific lots of Estriol Micronized USP because assay results did not meet specifications.
Product
Estriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triol; Oestriol] Micronized, USP, CAS 50-27-1, packaged in a) 1 G glass bottles, b) 5 G glass bottles, c) 25 G glass bottles, d) 100 G glass bottles, e) 500 G glass bottles, and f) 1 KG plastic bottles, Rx Only, Spectrum…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0730-2020·2020-01-01
Cardinal Health Recalls S.M.A.R.T. Stents for Incorrect MRI Labeling
Cardinal Health is correcting labeling on S.M.A.R.T. stents that incorrectly stated they were MRI Safe. The correct classification is MRI Conditional.
Product
Cordis S.M.A.R.T. CONTROL /S.M.A.R.T. Vascular Stent System. The S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stent Systems consist of a self-expanding stent made of Nitinol (nickel-titanium alloy) material that is pre-mounted on an over-the-wire delivery system. The stents…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0723-2020·2020-01-01
Lifelines Neuro Recalls ElectroTek Temporal Sensor Cables for Labeling Errors
Lifelines Neuro is recalling 12 ElectroTek Temporal Sensor Cables due to potential incorrect placement labels that could lead to improper electrode placement during EEG studies.
Product
ElectroTek Temporal Sensor Cable Gold - Long Length, Single Length - Product Usage: The electroencephalographic system ElectroTek is intended to acquire, display, and store the electrical activity of a patient s brain obtained by placing electrodes on the patient s scalp. The…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0722-2020·2020-01-01
Lifelines Neuro Recalls ElectroTek EEG Sensor Cables Due to Labeling Error
Lifelines Neuro is recalling eight ElectroTek EEG temporal sensor cables because incorrect placement labels could lead to improper electrode positioning during brain activity studies.
Product
ElectroTek Temporal Sensor Cable Gold - Long Length, Graduated - Product Usage: The electroencephalographic system ElectroTek is intended to acquire, display, and store the electrical activity of a patient s brain obtained by placing electrodes on the patient s scalp. The…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0720-2020·2020-01-01
Abbott Recalls Mislabeled Radiofrequency Cannulas Due to Manufacturing Error
Abbott Medical is recalling 470 radiofrequency cannulas that were incorrectly labeled with a 5mm active tip length instead of 10mm.
Product
CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S - Product Usage: Disposable Radiofrequency Cannulae are provided in either straight, curved, or curved blunt geometries with a stylet inserted in the cannula. Cannulae are insulated except for…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0739-2020·2020-01-01
Ortho Clinical Diagnostics Recalls VITROS 7% BSA Diluent Due to Instability
Ortho Clinical Diagnostics is recalling VITROS 7% BSA diluent because it may become unstable when stored in a 2mL cup for seven days.
Product
7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Product Usage: is used to dilute samples when assay values exceed the reportable (dynamic) range using the VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0738-2020·2020-01-01
Diagnostica Stago Recalls STA System Control N + P Due to Positive Bias
Diagnostica Stago is recalling 5,437 units of STA System Control N + P because a positive bias was confirmed on specific calibrator levels.
Product
STA SYSTEM CONROL N + P (ref. 00678)
Category
Medical Device
Distribution
42 states
ModerateFDA (Devices)·Z-0742-2020·2020-01-01
Axis-Shield Homocysteine Reagent Recalled for Potential Performance Issues
Axis-Shield Diagnostics is recalling 740 units of Liquid Stable 2-Part Homocysteine Reagent due to potential under-recovery of sample results.
Product
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHBC100 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0626-2020·2020-01-01
Pharmedium Recalls Subpotent Repinephrine Bitartrate Injection Bags Nationwide
Pharmedium Services LLC is voluntarily recalling 864 bags of repinephrine bitartrate injection because the drug was subpotent. The recall covers nationwide distribution in the U.S.
Product
NORepinephrine Bitartrate 8 mg added to 500 mL 5% Dextrose Injection USP (16 mcg per mL) Total Volume 508.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0745-2020·2020-01-01
Tosoh AIA-PACK B12 Pretreatment Set Recalled for Barcode Reading Errors
Tosoh Smd Inc is recalling AIA-PACK B12 Pretreatment Sets due to barcode scanning issues that may delay diagnostic results.
Product
AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of calibrators/controls. Part Number: 020706
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0732-2020·2020-01-01
AAP Implantate Drill CS 4.0 Recalled for Incorrect Instructions
AAP Implantate Ag is recalling 7 units of INTEGRA Drill CS 4.0 in Texas due to incorrect instructions for use.
Product
INTEGRA, Drill CS 4.0, quick coupling single use, REF 430425
Category
Medical Device
Distribution
1 state
LowFDA (Drugs)·D-0627-2020·2020-01-01
Pharmedium Recalls Subpotent Repinephrine Bitartrate Injection Bags
Pharmedium Services LLC is recalling 5,808 bags of Repinephrine Bitartrate Injection due to subpotent drug levels. The FDA classified this as a Class III recall.
Product
NORepinephrine Bitartrate 4 mg added to 250 mL 5% Dextrose Injection USP (16 mcg per mL) Total Volume 254.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0731-2020·2020-01-01
INTEGRA Drill CS 4.5 Recalled for Incorrect Instructions for Use
AAP Implantate Ag is recalling two units of INTEGRA Drill CS 4.5 in Texas due to incorrect instructions for use.
Product
INTEGRA, Drill CS 4.5, quick coupling single use, REF 430453
Category
Medical Device
Distribution
1 state
LowFDA (Drugs)·D-0625-2020·2020-01-01
Pharmedium Recalls Subpotent Repinephrine Bitartrate Injection Bags
Pharmedium Services LLC is voluntarily recalling 5,820 bags of subpotent repinephrine bitartrate injection. The FDA classified this as a Class III recall.
Product
NORepinephrine Bitartrate 8 mg added to 250 mL 5% Dextrose Injection USP (32 mcg per mL) Total Volume 258.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478.
Category
Drug
Distribution
Distributed nationwide

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