The Recall Desk

Archive

November 2020 recalls

382 recalls were announced in November 2020.

What the numbers show

Critical
11
Severe
85
High
183
Moderate
78
Low
25

Of the 382 recalls this month scored against our rubric, 3% are Critical, 22% are Severe.

201–300 of 382

  • HighFDA (Devices)·Z-0314-2021·2020-11-11

    GE Healthcare Recalls 9100c NXT Systems Due to Flow Sensor Defects

    GE Healthcare is recalling 37 9100c NXT systems because flow sensors may have damaged tubes with small punctures or cuts.

    Product
    9100c NXT system - Product Usage: Device is licensed and distributed outside of the US only.
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-0366-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Concerns

    Zimmer Biomet is recalling specific ZCA All Poly Acetabular Cups because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 49 mm Number: 00-8065-646-32
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0312-2021·2020-11-11

    GE Datex-Ohmeda Avance CS2 Anesthesia System Recalled for Damaged Flow Sensors

    GE Healthcare is recalling 88 Avance CS2 Anesthesia Systems because flow sensors may have damaged tubes with small punctures or cuts.

    Product
    GE Datex-Ohmeda Avance CS2 Anesthesia System - Product Usage: intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation.
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-0422-2021·2020-11-11

    3M Red Dot Monitoring Electrode Recall Due to Corrosion Risk

    3M is recalling Red Dot Monitoring Electrodes because corrosion could cause performance failures in the ECG monitoring product.

    Product
    3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 50 electrodes per pouch; 20 pouches per shipper box (1000 electrodes total).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0331-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 49 mm Item Number: 00-8065-546-28
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0379-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 57 mm Number: 00-8065-654-22
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0396-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 59 mm Number: 00-8065-956-32
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0339-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Hip Prosthesis Cups Due to Sterilant Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 53 mm Item Number: 00-8065-550-28
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0340-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 53 mm Item Number: 00-8065-550-32
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0356-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Hip Prosthesis Components Due to Sterilant Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 61 mm Number: 00-8065-558-32
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0341-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Hip Cups Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 acetabular hip cup components because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 55 mm Item Number: 00-8065-552-22
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0367-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Hip Cups Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 acetabular hip cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 51 mm Number: 00-8065-648-22
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0368-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Concerns

    Zimmer Biomet is recalling specific acetabular cup hip prosthesis components because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 51 mm Number: 00-8065-648-26
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0361-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Cup Hip Prosthesis Components

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 47 mm Number: 00-8065-644-26
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0362-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 47 mm Number: 00-8065-644-28
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0369-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Hip Prosthesis Components Due to Sterilant Concerns

    Zimmer Biomet is recalling specific acetabular cup hip prosthesis components because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 51 mm Number: 00-8065-648-28
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0354-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 61 mm Number: 00-8065-558-26
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0398-2021·2020-11-11

    Gordian Surgical Recalls TroClose 1200 Devices Due to High Endotoxin Levels

    Gordian Surgical is recalling 300 TroClose 1200 devices because endotoxin test results exceeded acceptable levels. The devices are used in endoscopic and laparoscopic surgeries.

    Product
    TroClose 1200 - Product Usage: intended for use in a variety of gynecologic, general and urologic endoscopic procedures, to create and maintain a port of entry and to facilitate the delivery of absorbable sutures and anchors through soft tissues of the body during endoscopic / la
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0313-2021·2020-11-11

    GE Datex-Ohmeda Aisys CS2 Anesthesia System Recalled for Damaged Flow Sensors

    GE Healthcare is recalling 101 Aisys CS2 Anesthesia Systems because flow sensors may have damaged tubes, posing a risk to patients.

    Product
    GE Datex-Ohmeda Aisys CS2 Anesthesia System - Product Usage: is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric adult). The device is intended for volume or pressure control ventilation.
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-0355-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cup hip prosthesis components because the hydrogen peroxide sterilant used was not evaluated for biocompatibility.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 61 mm Number: 00-8065-558-28
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0325-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 hip prosthesis components because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 45mm Item Number: 00-8065-542-26 Hip prosthesis component
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0365-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 49 mm Number: 00-8065-646-28
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0397-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 61 mm Number: 00-8065-958-32
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0420-2021·2020-11-11

    3M Recalls Novaplus Monitoring Electrodes Due to Corrosion Risk

    3M is recalling Novaplus Monitoring Electrodes because corrosion could cause performance failures. The recall affects 156,600 units distributed worldwide.

    Product
    Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 3 electrodes per card; 1 card per pouch; 200 pouches per shipper box (600 electrodes total).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0353-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cup hip prosthesis components because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 61 mm Number: 00-8065-558-22
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0391-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 49 mm Number: 00-8065-946-32
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0380-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Cup Hip Prosthesis Components

    Zimmer Biomet is recalling 412 acetabular cup hip prosthesis components because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 57 mm Number: 00-8065-654-26
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0394-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 hip prosthesis components because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 55 mm Number: 00-8065-952-32
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0358-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 45 mm Number: 00-8065-642-22
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0383-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 59 mm Number: 00-8065-656-22
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0423-2021·2020-11-11

    3M Red Dot Monitoring Electrode Recall Due to Corrosion Risk

    3M is recalling Red Dot Monitoring Electrodes because corrosion could cause performance failures in the ECG monitoring product.

    Product
    3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 50 electrodes per pouch; 20 pouches per shipper box (1000 electrodes total).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0381-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 57 mm Number: 00-8065-654-28
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0336-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 51 mm Item Number: 00-8065-548-32
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0359-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Hip Cups Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 acetabular hip cup components because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 45 mm Number: 00-8065-642-26
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0389-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 61 mm Number: 00-8065-658-28
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0351-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Acetabular Cups Due to Sterilant Concerns

    Zimmer Biomet is recalling 412 hip prosthesis acetabular cups because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 59 mm Number: 00-8065-556-28
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0323-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 hip prosthesis components because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 43mm Item Number: 00-8065-540-22 Hip prosthesis component
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0347-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 57 mm Number: 00-8065-554-28
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0400-2021·2020-11-11

    Siemens ARTIS Icono X-Ray System Recalled for Software Misalignment

    Siemens is recalling ARTIS Icono X-ray systems due to a software defect that may cause inaccurate image overlays, potentially leading to patient danger.

    Product
    ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0384-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 59 mm Number: 00-8065-656-26
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0386-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 59 mm Number: 00-8065-656-32
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0352-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 59 mm Number: 00-8065-556-32
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0324-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling specific ZCA All Poly Acetabular Cup hip prosthesis components because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 45mm Item Number: 00-8065-542-22 Hip prosthesis component
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0310-2021·2020-11-11

    Genicon Li-Gator Laparoscopic Clip Applier Recalled for Malfunction

    Genicon, Inc. is recalling 8,872 Li-Gator Single Use Laparoscopic Clip Appliers due to device malfunction causing the applier to jam and clip loading failures.

    Product
    A Li-Gator Single Use Laparoscopic Clip Applier, 10 mm X 29 cm - Product Usage: intended for use on tubular structures or vessel wherever a metal litigating clip is intended
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0342-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Hip Cups Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 55 mm Item Number: 00-8065-552-26
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0348-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 57 mm Number: 00-8065-554-32
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0378-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Hip Cups Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 acetabular hip cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 55 mm Number: 00-8065-652-32
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0374-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Hip Prosthesis Cups Due to Sterilant Concerns

    Zimmer Biomet is recalling 412 acetabular hip prosthesis cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 53 mm Number: 00-8065-650-32
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0328-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 47 mm Item Number: 00-8065-544-28
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0387-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Hip Prosthesis Cups Due to Sterilant Concerns

    Zimmer Biomet is recalling 412 acetabular hip prosthesis cups because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 61 mm Number: 00-8065-658-22
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0327-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Hip Prosthesis Cups Due to Sterilant Concerns

    Zimmer Biomet is recalling 412 acetabular hip prosthesis cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 47 mm Item Number: 00-8065-544-26
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0363-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Hip Cup Components Due to Sterilant Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 49 mm Number: 00-8065-646-22
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0370-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling specific ZCA All Poly Acetabular Cup hip prosthesis components because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 51 mm Number: 00-8065-648-32
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0337-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Hip Cups Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 acetabular hip cup components because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 53 mm Item Number: 00-8065-550-22
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0424-2021·2020-11-11

    Cardinal Health Recalls MONOJECT Hypodermic Needles Due to Detachment Risk

    Cardinal Health is recalling MONOJECT Standard Hypodermic Needles because the needle may detach from the cartridge, posing a risk of needle stick injury.

    Product
    Covidien MONOJECT Standard Hypodermic Needle, Polypropylene Hub 22 G x 3/4". Intended use to facilitate activities such as: withdrawal of medication from a container, aspiration of fluid from a patient, injection of medication into a patient, and transfer fluids Item Code: 888
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0357-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling specific acetabular cup hip prosthesis components because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 43 mm Number: 00-8065-640-22
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0364-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 49 mm Number: 00-8065-646-26
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0388-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Cup Hip Prosthesis Components

    Zimmer Biomet is recalling 412 acetabular cup hip prosthesis components because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 61 mm Number: 00-8065-658-26
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0395-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 57 mm Number: 00-8065-954-32
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0392-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cup hip prosthesis components because the hydrogen peroxide sterilant used was not evaluated for biocompatibility.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 51mm Number: 00-8065-948-32
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0332-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32mm, Neutral, O.D. Cup with Spacers, 49 mm Item Number: 00-8065-546-32
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0350-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Hip Cups Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 acetabular hip cups because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 59 mm Number: 00-8065-556-26
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0376-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Cup Hip Prosthesis Components

    Zimmer Biomet is recalling 412 acetabular cup hip prosthesis components because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 55 mm Number: 00-8065-652-26
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0329-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cup hip prosthesis components because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 49 mm Item Number: 00-8065-546-22
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0393-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 53 mm Number: 00-8065-950-32
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0349-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 59 mm Number: 00-8065-556-22
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0334-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Hip Cups Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 acetabular hip cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 51 mm Item Number: 00-8065-548-26
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0419-2021·2020-11-11

    3M Recalls Novaplus Monitoring Electrodes Due to Corrosion Risk

    3M is recalling Novaplus Monitoring Electrodes because corrosion could cause performance failures. The recall affects 1,572,000 units distributed worldwide.

    Product
    Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 5 electrodes per card; 1 card per pouch; 200 pouches per shipper box (1000 electrodes total).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·026-2020·2020-11-11

    Stuffed Foods LLC Recalls Frozen Mac and Cheese Bites for Undeclared Soy

    Stuffed Foods LLC is recalling approximately 1,818 pounds of frozen Mac & Cheese Bites because the product contains soy, an undeclared allergen, and may be misbranded as Buffalo Style Chicken Poppers.

    Product
    Stuffed Foods LLC — Stuffed Foods LLC Recalls Frozen Snack Products Due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0371-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Hip Cups Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 acetabular hip cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 53 mm Number: 00-8065-650-22
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0360-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Cup Hip Prosthesis Due to Sterilant Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 47 mm Number: 00-8065-644-22
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0385-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Acetabular Cups Due to Sterilant Concerns

    Zimmer Biomet is recalling 412 hip prosthesis acetabular cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 59 mm Number: 00-8065-656-28
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0382-2021·2020-11-11

    Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns

    Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 57 mm Number: 00-8065-654-32
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0390-2021·2020-11-11

    Zimmer Biomet Recalls Acetabular Cup Hip Prosthesis Components

    Zimmer Biomet is recalling 412 acetabular cup hip prosthesis components because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.

    Product
    ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 61 mm Number: 00-8065-658-32
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0421-2021·2020-11-11

    3M Red Dot Monitoring Electrode Recall Due to Corrosion Risk

    3M is recalling Red Dot Monitoring Electrodes because corrosion could cause performance failures in the ECG monitoring product.

    Product
    3M Red Dot Monitoring Electrode with 4mm Adapter - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 10 electrodes per card; 4 cards per pouch; 20 pouches per shipper box (800 electrodes total).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0055-2021·2020-11-11

    Medichem Recalls Chlorhexidine Gluconate 20% Due to Discoloration

    Medichem S.A. is voluntarily recalling 60,000 kg of Chlorhexidine Gluconate 20% in Alabama, New Jersey, and Texas due to discoloration.

    Product
    Chlorhexidine Gluconate 20% 0012 Medichem, S.A. NDC 53296-0012-0
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0321-2021·2020-11-11

    Primus Ultra2 Resolution Variants System Recalled for Lack of FDA Clearance

    Primus Corporation is recalling 97 Ultra2 Resolution Variants Systems because the devices did not receive FDA pre-market approval or clearance.

    Product
    Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation
    Category
    Medical Device
    Distribution
    20 states
  • ModerateFDA (Devices)·Z-0418-2021·2020-11-11

    Angiodynamics 5F Micro-Introducer Kits Recalled for Incorrect Device Packaging

    Angiodynamics, Inc. is recalling 32 kits of 5F Standard Micro-Introducer Kits because they may contain a 4F Sheath/Dilator component instead of the correct device.

    Product
    Angiodynamics 5F Standard Micro-Introducer Kit - indicated for percutaneous introduction of a guidewire or catheter into the vascular system, Catalog Number: 06597035 UPN: H787065970355
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0074-2021·2020-11-11

    Lidl Organic Butter Microwave Popcorn Recalled for Foreign Material

    Lidl US is recalling Organic Butter Microwave Popcorn because a raw ingredient supplier identified foreign material.

    Product
    Lidl Organic Butter Microwave Popcorn, 3 x 3.3oz, 10 boxes per case and 3 popcorn bags per box .
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0402-2021·2020-11-11

    Microbiologics Recalls Klebsiella Pneumoniae Strain Due to Incorrect VIM-1 Status

    Microbiologics Inc is recalling 46 units of a Klebsiella pneumoniae strain because it is VIM-1 negative instead of the expected VIM-1 positive status.

    Product
    Catalog 02145P, Klebsiella pneumoniae derived from NCTC 13439 - Product Usage: intended to be used as controls to verify the performance of assays, reagents or media that are intended to be used in microbial testing for the detection and identification of a cultured microorganism
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0322-2021·2020-11-11

    RTI Surgical Recalls Streamline OCT Navigated Instruments Due to Missing Drill Guide

    RTI Surgical is recalling 76 units of Streamline OCT Navigated Instruments because the system does not include a drill guide. The devices were distributed to one distributor in Michigan.

    Product
    Streamline OCT Navigated Instruments, Catalog numbers 26-DRILL-MDN 26-FTAP-30-MDN 26-FTAP-35-MDN 26-FTAP-40-MDN 26-FTAP-40-MDN 26-FTAP-45-MDN 26-S-FINDER-MDN Components of a surgical navigation device.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0319-2021·2020-11-11

    Boston Scientific Recalls LATITUDE Programming Systems Due to Software Defect

    Boston Scientific is recalling eight Model 3300 LATITUDE Programming Systems because a software defect may cause EGM trace channels to display as a flat line during specific tests.

    Product
    Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support Application
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0320-2021·2020-11-11

    RTI Surgical Recalls Streamline MIS Navigation System Taps

    RTI Surgical is recalling 143 units of Streamline MIS Navigation System Taps because they are not compatible with the Streamline MIS tap sleeve.

    Product
    Streamline MIS Navigation System Taps, Catalog numbers 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN 04-CANNTAP-55-MDN 04-CANNTAP-65-MDN 04-CANNTAP-75-MDN 04-CANNTAP-85-MDN 04-CTAP-TT-65-MDN 04-S-FINDER-MDN 05-SCREWINS-CL-MDN 05-SIMPDRIVER-MDN
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0311-2021·2020-11-11

    GE Healthcare Recalls Aestiva/5 MRI Anesthesia Systems Due to Flow Sensor Defect

    GE Healthcare is recalling two Aestiva/5 MRI Anesthesia Systems because flow sensors may have damaged tubes with small punctures or cuts.

    Product
    Aestiva/5 MRI Anesthesia System - Product Usage: The Aestiva/5 MRI Anesthesia System provides the functional feature set offered by the conventional Aestiva/5 to the clinician with the added ability to be used in the MR environment. Among those standard Aestiva/5 features is the
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0318-2021·2020-11-11

    OriGen Biomedical Recalls Expired 3/8 FloPump Medical Devices

    OriGen Biomedical is recalling six units of 3/8-inch FloPump devices distributed in Texas because the products were expired.

    Product
    3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0413-2021·2020-11-11

    Synthes SynMesh Cage System Recalled for Incorrect Statutory Labeling

    Synthes (USA) Products LLC is recalling 6 units of the SynMesh Cage System because the statutory label incorrectly identifies the device as a general medical device.

    Product
    END RING 22MM X 28MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495-396 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration th
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0403-2021·2020-11-11

    DePuy Synthes SYNMESH CAGE System Recalled for Incorrect Labeling

    Synthes (USA) Products LLC is recalling 10 units of DePuy Synthes SYNMESH CAGE System devices distributed in Japan due to incorrect statutory labeling.

    Product
    DePuy Synthes SYNMESH 10MM DIA 18MM HEIGHT (TI) Product Number: 495.344 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-0066-2021·2020-11-11

    Jubilant Recalls Subpotent Olanzapine Orally Disintegrating Tablets Nationwide

    Jubilant Cadista Pharmaceuticals is voluntarily recalling 23,616 blister packs of Olanzapine Orally Disintegrating Tablets, 5 mg, because the product was found to be subpotent.

    Product
    Olanzapine Orally Disintegrating Tablets, 5 mg, 30 count (3x10 unit dose) blister pack, Rx only, Manufactured by: Jubilant Generics, Ltd., Roorkee, India, Marketed by: Jubilant Cardista Pharmaceuticals, Inc., Salisbury, MD NDC 59746-0306-32
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0411-2021·2020-11-11

    Synthes SynMesh Cage System Recalled for Incorrect Statutory Labeling

    Synthes (USA) Products LLC is recalling 9 units of the SynMesh Cage System because the statutory label incorrectly identifies the device as a 'general medical device' rather than a 'specially controlled medical device.'

    Product
    END RING 17MM X 22MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495.392 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration th
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0410-2021·2020-11-11

    Synthes SynMesh Cage System Recalled for Incorrect Statutory Labeling

    Synthes (USA) Products LLC is recalling 23 units of the SynMesh Cage System because the statutory label incorrectly identifies the device as a 'general medical device' rather than a 'specially controlled medical device.'

    Product
    END RING 15MM DIA/0 DEG (TI) Product Number: 495.386 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0408-2021·2020-11-11

    Synthes SynMesh Cages Recalled for Incorrect Statutory Labeling

    Synthes (USA) Products LLC is recalling 16 SynMesh Cages distributed in Japan because the statutory label incorrectly identified them as general medical devices.

    Product
    END RING 10MM DIA/0 DEG (TI) Product Number: 495.384 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0404-2021·2020-11-11

    Synthes SYNMesh Vertebral Body Replacement Devices Recalled for Labeling Error

    Synthes (USA) Products LLC is recalling 12 units of SYNMesh vertebral body replacement devices because the statutory label incorrectly identifies them as 'general medical devices' instead of 'specially controlled medical devices.'

    Product
    SYNMESH 12MM DIA 88MM HEIGHT (TI) Product Number: 495.357 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0407-2021·2020-11-11

    Synthes SYNMesh Vertebral Body Replacement Recalled for Labeling Error

    Synthes (USA) Products LLC is recalling 5 units of SYNMesh vertebral body replacement devices because the statutory label incorrectly identifies them as general medical devices.

    Product
    SYNMESH¿ 22MM X 28MM 88MM HEIGHT (TI) Product Number: 495.379 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best sui
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0414-2021·2020-11-11

    Synthes SynMesh Cage System Recalled for Incorrect Labeling

    Synthes (USA) Products LLC is recalling 4 units of the SynMesh Cage System because the statutory label incorrectly identifies the device as a 'general medical device' instead of a 'specially controlled medical device.'

    Product
    END RING 22MM X 28MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495-398 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration th
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0405-2021·2020-11-11

    Synthes SYN MESH Vertebral Body Replacement Recalled for Labeling Error

    Synthes (USA) Products LLC is recalling 17 units of SYN MESH vertebral body replacement devices because the statutory label incorrectly identifies them as 'general medical devices' instead of 'specially controlled medical devices.'

    Product
    SYNMESH 15MM DIA 88MM HEIGHT (TI) Product Number: 495.366 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited
    Category
    Medical Device
    Distribution
    0 states

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