Probe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover Item ID: E5322N
Exact Medical Manufacturing
Class I - Dangerous
No 510k for the product to be used in a natural or surgical opening to the body
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
Probe Cover, 6" x 96", PE, w 3 elastic bands- Ultrasonic Transducer Cover Item ID: E6443N
Exact Medical Manufacturing
Class I - Dangerous
No 510k for the product to be used in a natural or surgical opening to the body
Due to issue with product sterility. Sterilization service provider had falsified records.
ACCU-CHEK SMARTVIEW 100 TEST STRIPS Item Number: 4742862
Cardinal Health
Class I - Dangerous
Due to shipping delays the devices were exposed to temperature excursions of 31.9ÂŋF, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Probe Cover, PE, Gel and Elastic bands, 6"x96"-Ultrasonic Transducer Cover Item ID: 1006664
Exact Medical Manufacturing
Class I - Dangerous
No 510k for the product to be used in a natural or surgical opening to the body
Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover Bulk Non-sterile Item ID: A-AU-0776NA
Exact Medical Manufacturing
Class I - Dangerous
No 510k for the product to be used in a natural or surgical opening to the body
reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
Pear Therapeutics
Class I - Dangerous
Due to a software issue, patients with a urine drug screen (UDS) received access to a contingency management wheel spin for potential rewards regardless of the UDS results. Positive UDS results should not have resulted in access to a wheel spin.
Class I - Dangerous
The device components experienced a manufacturing process error that resulted in surface damage from product handling.
Class I - Dangerous
Due to shipping delays the devices were exposed to temperature excursions of 31.9ÂŋF, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
novaplus, General Purpose Kit, Cat. No. 56603
Medical Action Industries, Inc. 306
Class I - Dangerous
There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits
Class I - Dangerous
Due to shipping delays the devices were exposed to temperature excursions of 31.9ÂŋF, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
DEXCOM G6 SENSOR 3 PACK Item Number: 5447552
Cardinal Health
Class I - Dangerous
Due to shipping delays the devices were exposed to temperature excursions of 31.9ÂŋF, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
Pear Therapeutics
Class I - Dangerous
Due to a software issue, patients with a urine drug screen (UDS) received access to a contingency management wheel spin for potential rewards regardless of the UDS results. Positive UDS results should not have resulted in access to a wheel spin.
Probe Cover, Lite poly, 6"x48", w two bands- Ultrasonic Transducer Cover Item ID: A-AU-1002N
Exact Medical Manufacturing
Class I - Dangerous
No 510k for the product to be used in a natural or surgical opening to the body
ONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT Item Number: 2990174
Cardinal Health
Class I - Dangerous
Due to shipping delays the devices were exposed to temperature excursions of 31.9ÂŋF, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
VAPORIZER VICKS 1.5GAL Item Number: 2354942
Cardinal Health
Class I - Dangerous
Due to shipping delays the devices were exposed to temperature excursions of 31.9ÂŋF, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
inLight Medical LED Pads used with Polychromatic light technology system
Inlightened Partners
Class I - Dangerous
LED pads with cord connectors that have v-shaped notches may not have been assembled properly. This issue could lead to a power interruption, causing the controller and power supply to shut down.
Transducer Cover 18x147cm, Kit, VIP Film w/ Bands & EMM Gel- Ultrasonic Transducer Cover Item ID: E6360
Exact Medical Manufacturing
Class I - Dangerous
No 510k for the product to be used in a natural or surgical opening to the body
Hays Innovation Ultrasound Probe Cover Kit - Ultrasonic Transducer Cover Item ID: HS2000HL
Exact Medical Manufacturing
Class I - Dangerous
No 510k for the product to be used in a natural or surgical opening to the body
Probe Cover 6"x48"- Ultrasonic Transducer Cover Item ID: SH29
Exact Medical Manufacturing
Class I - Dangerous
No 510k for the product to be used in a natural or surgical opening to the body