Medical device recalls
39180 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2020-02-12FDA-DeviceCardinal HealthClass IIAAMI 3 ROYALSILK SCRBNURGOWN BNS XL, Gown. Item Code 90380NC
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- 2020-02-12FDA-DeviceCardinal HealthClass IIAAMI 3 ROYALSILK SCRBNURGOWN BNS L, Gown. Item Code 90280NC
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- 2020-02-12FDA-DeviceCardinal HealthClass IIAAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- 2020-02-12FDA-DeviceCardinal HealthClass IIAAMI 3 NONREIN SCRBNURGOWN BNS XL, Gown. Item Code 90370NB
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- 2020-02-12FDA-DeviceCardinal HealthClass IIAAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- 2020-02-12FDA-DeviceCardinal HealthClass IIAAMI 3 FABREINF SCRUB SURG GWN L NS, Gown. Item Code 90970NA
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- 2020-02-12FDA-DeviceCardinal HealthClass IIAAMI 3 FABREINF SURG GOWN L NS, Item Code 9511NB
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- 2020-02-12FDA-DeviceCardinal HealthClass IIAAMI 3 NON-REINF SURG GOWN 2XL BNS, Item Code 9575NB
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- 2020-02-12FDA-DeviceCardinal HealthClass IIAAMI 3 FABRIC REINFORCEDGown 2XL NS, Item Code 9571NA
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- 2020-02-12FDA-DeviceClinical Diagnostic Solutions, Inc.Class IIMedonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011
A mix-up of autosampler tube positions with a possibility of misidentification of sample results and a risk of operator injury from an exposed aspiration needle.
- 2020-02-12FDA-DeviceZimmer Biomet, Inc.Class IICoonrad/Morrey Total Elbow Humeral Assembly, Extra Small, 4-inch Length. Model No. 32-8105-027-04. UDI (01)00889024274006 (17)241031(10)64481139 The device is a Humeral component; elbow joint metal/polymer constrained cemented prosthesis.
The lot contained two outer pins instead of one outer and one inner pin.
- 2020-02-12FDA-DeviceRoche Diabetes Care, Inc.Class IIACCU-CHEK AVIVA ASPAC STRIP 50CT- intended for Blood Glucose Monitoring System Catalog Number: 06453970020
Inability to dose the test strips, may result in a temporary inability to get a result that could lead to a delay in treatment and/or therapy decisions
- 2020-02-12FDA-DeviceRoche Diabetes Care, Inc.Class IIAccu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitoring System Catalog Number: 06908217001
Inability to dose the test strips, may result in a temporary inability to get a result that could lead to a delay in treatment and/or therapy decisions
- 2020-02-12FDA-DeviceRoche Diabetes Care, Inc.Class IIAccu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monitoring System Catalog Number: 06908349001
Inability to dose the test strips, may result in a temporary inability to get a result that could lead to a delay in treatment and/or therapy decisions
- 2020-02-12FDA-DeviceW. L. Gore & Associates Inc.Class IIGORE¿ EXCLUDER¿ Iliac Branch Endoprosthesis (IBE)
Firm has received reports of leading end catheter component separations.
- 2020-02-12FDA-DeviceW. L. Gore & Associates Inc.Class IIGORE¿ EXCLUDER¿ AAA Endoprosthesis
Firm has received reports of leading end catheter component separations.
- 2020-02-12FDA-DeviceCardinal Health 200, LLCClass IIGenius 2 Tympanic Thermometer Private Label Item Code: 3069
The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range (¿ 0.2¿C for Genius 2 and ¿ 0.3¿C for Genius 3 thermometers). The measurement readings drift upwards over time, which means that the thermometers could exceed the upper stated accuracy tolerance of +0.2¿C for Genius 2 or +0.3¿C for Genius 3.
- 2020-02-12FDA-DeviceCardinal Health 200, LLCClass IIGenius 2 Tympanic Thermometer OEM Tympanic Item Code: 303063
The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range (¿ 0.2¿C for Genius 2 and ¿ 0.3¿C for Genius 3 thermometers). The measurement readings drift upwards over time, which means that the thermometers could exceed the upper stated accuracy tolerance of +0.2¿C for Genius 2 or +0.3¿C for Genius 3.
- 2020-02-12FDA-DeviceCardinal Health 200, LLCClass IIGenius 2 Tympanic Thermometer OEM Tympanic Item Code:303062
The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range (¿ 0.2¿C for Genius 2 and ¿ 0.3¿C for Genius 3 thermometers). The measurement readings drift upwards over time, which means that the thermometers could exceed the upper stated accuracy tolerance of +0.2¿C for Genius 2 or +0.3¿C for Genius 3.
- 2020-02-12FDA-DeviceCardinal Health 200, LLCClass IIGenius 3 Tympanic Thermometer- electric thermometer Item Code: 303013
The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range (¿ 0.2¿C for Genius 2 and ¿ 0.3¿C for Genius 3 thermometers). The measurement readings drift upwards over time, which means that the thermometers could exceed the upper stated accuracy tolerance of +0.2¿C for Genius 2 or +0.3¿C for Genius 3.
- 2020-02-12FDA-DeviceCardinal Health 200, LLCClass IIGenius 2 Tympanic Thermometer (discontinued) Item Code: 303000
The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range (¿ 0.2¿C for Genius 2 and ¿ 0.3¿C for Genius 3 thermometers). The measurement readings drift upwards over time, which means that the thermometers could exceed the upper stated accuracy tolerance of +0.2¿C for Genius 2 or +0.3¿C for Genius 3.
- 2020-02-12FDA-DeviceEthicon, Inc.Class IICoated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture.
Some sutures in the lot may exhibit a small section of braid fraying, which can lead to reduced tensile strength at that point.
- 2020-02-12FDA-DeviceZimmer Biomet, Inc.Class IIJamshidi Bone Marrow Aspiration Needle Item Number: 00-1103-007-00
Potential for the expiration date on the outer label that was applied by Zimmer Biomet to exceed the expiration date on the inner label
- 2020-02-12FDA-DeviceCare Essentials Pty., Ltd.Class IICocoon Convective Warming System, Product Code: CWS5000 (110V).
Potential for thermal damage near the power cord connector and Power Entry Module (PEM) due to improper connection of the power cord connector and PEM pins on the Cocoon Convective Warming System.
- 2020-02-12FDA-DeviceCare Essentials Pty., Ltd.Class IICocoon Convective Warming System, Product Code: CWS4000 (110V).
Potential for thermal damage near the power cord connector and Power Entry Module (PEM) due to improper connection of the power cord connector and PEM pins on the Cocoon Convective Warming System.
- 2020-02-12FDA-DevicePacific Medical Group Inc.Class IIPacific Medical Philips M1356A Ultrasound Transducer with belt/wire knob, FFPH5250
Fetal transducers distributed in advance of receiving 510(k) and international clearances.
- 2020-02-12FDA-DevicePacific Medical Group Inc.Class IIPacific Medical Philips M1355A Toco Transducer with belt wire/knob, FFPH3250
Fetal transducers distributed in advance of receiving 510(k) and international clearances.
- 2020-02-12FDA-DevicePacific Medical Group Inc.Class IIPacific Medical GE Corometrics Nautilus Ultrasound Transducer w/wing 5700LAX, FFCM5260
Fetal transducers distributed in advance of receiving 510(k) and international clearances.
- 2020-02-12FDA-DevicePacific Medical Group Inc.Class IIPacific Medical GE Corometrics Nautilus Ultrasound, 5700 (Old Style), FFCM5660
Fetal transducers distributed in advance of receiving 510(k) and international clearances.
- 2020-02-12FDA-DevicePacific Medical Group Inc.Class IIPacific Medical GE Corometrics Nautilus Ultrasound Transducer w/knob, 5700HAX, FFCM5205
Fetal transducers distributed in advance of receiving 510(k) and international clearances.
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