Probe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover Item ID: E5322N
Exact Medical Manufacturing
🏥 Medical Devices Class I - Dangerous
No 510k for the product to be used in a natural or surgical opening to the body
All Recalls
95,018 total recalls in our database
Probe Cover, 6" x 96", PE, w 3 elastic bands- Ultrasonic Transducer Cover Item ID: E6443N
Exact Medical Manufacturing
🏥 Medical Devices 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
🏥 Medical Devices Class I - Dangerous
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, 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
🏥 Medical Devices 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
🏥 Medical Devices 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
🏥 Medical Devices 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.
🏥 Medical Devices Class I - Dangerous
The device components experienced a manufacturing process error that resulted in surface damage from product handling.
🏥 Medical Devices Class I - Dangerous
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, 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
🏥 Medical Devices 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
🏥 Medical Devices Class I - Dangerous
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, 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
🏥 Medical Devices Class I - Dangerous
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, 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
🏥 Medical Devices 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
🏥 Medical Devices 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
🏥 Medical Devices Class I - Dangerous
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, 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
🏥 Medical Devices Class I - Dangerous
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, 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
🏥 Medical Devices 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
🏥 Medical Devices 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
🏥 Medical Devices 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
🏥 Medical Devices Class I - Dangerous
No 510k for the product to be used in a natural or surgical opening to the body