Hays Ultrasound kit Item ID: H1000SE
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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Other Medical Devices
🏥 Medical Devices • 15,203 recalls
6" x 48" Elastic Poly Probe Cover, T Tip,Tele Fold, 2 bands Item ID: A-AU-0852NA
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, PE, Elastic Bands, 15x244cm-6"x96" -Ultrasonic Transducer Cover Item ID: 1006576
Exact Medical Manufacturing
Class I - Dangerous
No 510k for the product to be used in a natural or surgical opening to the body
OPTICHAMBER DIAMOND SPACER WITH LARGE MASK Item Number: 4742326
Cardinal Health
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 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
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
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
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
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 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
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
VAPORIZER VICKS 1.5GAL Item Number: 2354942
Cardinal Health
Class I - Dangerous
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿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
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
Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028, 722029, 722035, 722038, and 722058.
Philips Medical Systems Nederlands
Class I - Dangerous
Certain low-voltage DC power supplies (DCPS) used in these products may be subject to an increased probability of failure. Failure of a DCPS may result in the sudden loss of imaging functionality or mechanical movement, depending on what subsystems the DCPS is powering.
Class I - Dangerous
Product contamination-a trace amount of dried bodily fluids may expose patients, health care providers to contaminates
FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144
BioFire Diagnostics
Class I - Dangerous
Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process.
Medical Action INDUSTRIES INC., Minor Procedure Tray, REF 61214
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