Respire Pink+ Hard/Soft Oral Sleep Apnea Device
Respire Medical
Class I - Dangerous
Potential for device breakage during use
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
ARROWgard Blue PLUS¿ Multi-Lumen CVC Kit with Blue FlexTip¿ Catheter; Product Code: MSO-45703-AHS
Arrow International
Class I - Dangerous
Product sterility may be compromised due to unsealed packaging.
Class I - Dangerous
Product sterility may be compromised due to unsealed packaging.
0.2 Micron Flat Epidural Filter; Product Code: EF-05500
Arrow International
Class I - Dangerous
Product sterility may be compromised due to unsealed packaging.
Potential keypad failure on VOLISTA StandOP Surgical Lights.
The MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may have been loaded with an incorrect electronic component. Failure to charge could potentially cause therapy to be interrupted or delayed.
Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.
nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical technicians.
NordicNeuroLab AS
Class I - Dangerous
An error was discovered in the interpretation of certain DICOM header tags that may lead to incorrect orientation labeling, and thus and indirect left-right, up-down or anterior-posterior flipping of images.
Arrow-Johans" ECG Adapter for Right Atrial Electrocadiography (RAECG); Product Code: EG-04900
Arrow International
Class I - Dangerous
Product sterility may be compromised due to unsealed packaging.
Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PHMC
Arrow International
Class I - Dangerous
Product sterility may be compromised due to unsealed packaging.
Maximal Barrier Drape; Product Codes: ASK-00376-SU
Arrow International
Class I - Dangerous
Product sterility may be compromised due to unsealed packaging.
Class I - Dangerous
Product sterility may be compromised due to unsealed packaging.
Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.
Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery.
Genesee BioMedical
Class I - Dangerous
Failure in a retractor blade due to corrosion. In the area of the blade where the bearing/button meets the blade body, corrosion can form, weakening the welded joint and may cause the bearing/button to break.
Double-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42802-VC and ASK-47702-VC
Arrow International
Class I - Dangerous
Product sterility may be compromised due to unsealed packaging.
Echogenic Needle; Product codes: PN-00215-E and PN-00217-E
Arrow International
Class I - Dangerous
Product sterility may be compromised due to unsealed packaging.
Spring Wire Guide Introducer Needle; Product Codes: AN-04320 and AN-04418
Arrow International
Class I - Dangerous
Product sterility may be compromised due to unsealed packaging.
VPS TipTracker Stylet Accessory; Product codes: RHY-177-TTSAP
Arrow International
Class I - Dangerous
Product sterility may be compromised due to unsealed packaging.
ARROWg+ard Blue(R) Central Venous Catheterization Kit; Product Code: ASK-24306-WHC1 and ASK-24306-WHC2
Arrow International
Class I - Dangerous
Product sterility may be compromised due to unsealed packaging.
Class I - Dangerous
Product sterility may be compromised due to unsealed packaging.