Class I - Dangerous
Product sterility may be compromised due to unsealed packaging.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Continuous Nerve Block Needle; Product Codes: AB-00090, AB-00150, AB-17040-N, AB-17080-N, AB-17110-N, AB-17140-N, AB-18080-N, AB-18110-N
Arrow International
Class I - Dangerous
Product sterility may be compromised due to unsealed packaging.
Respire Pink+ Hard Oral Sleep Apnea Device
Respire Medical
Class I - Dangerous
Potential for device breakage during use
Joerns Healthcare has identified a potential issue with some of the P.R.O. Matt and ProCair Mattresses. For the identified serial number range of P.R.O. Matt and ProCair Mattresses incorrect connectors (part #s 206-0401 & 206-0405) were provided by a Joerns supplier without the required internal shutoff valves, these shutoff valves prevent air from escaping from the mattress air cells.
Class I - Dangerous
Product sterility may be compromised due to unsealed packaging.
ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-42703-SJH
Arrow International
Class I - Dangerous
Product sterility may be compromised due to unsealed packaging.
SnapLock" Catheter/Syringe Adapter; Product Code: AS-05500
Arrow International
Class I - Dangerous
Product sterility may be compromised due to unsealed packaging.
Class I - Dangerous
The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle Counters.
Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. This condition may result in a discontinuous or open LINX device.
10 cc Luer-Slip Loss of Resistance Syringe; Product Code: LR-05501
Arrow International
Class I - Dangerous
Product sterility may be compromised due to unsealed packaging.
Class I - Dangerous
Joerns Healthcare has identified a potential issue with some of the P.R.O. Matt and ProCair Mattresses. For the identified serial number range of P.R.O. Matt and ProCair Mattresses incorrect connectors (part #s 206-0401 & 206-0405) were provided by a Joerns supplier without the required internal shutoff valves, these shutoff valves prevent air from escaping from the mattress air cells.
Class I - Dangerous
Product sterility may be compromised due to unsealed packaging.
Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-04018-OH1
Arrow International
Class I - Dangerous
Product sterility may be compromised due to unsealed packaging.
Class I - Dangerous
The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle Counters.
Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.
Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Code: ASK-45802-PHMW
Arrow International
Class I - Dangerous
Product sterility may be compromised due to unsealed packaging.
The devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.
Carina Ventilator, ventilator. Catalog no. 5704110. Long-term ventilator for treatment in hospitals by a qualified medical personnel.
Draeger Medical
Class I - Dangerous
The valve assembly material may become corroded due to insufficient cleaning by a supplier. There is a risk of the breathing gas becoming contaminated in the affected devices.
AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112
WRP Asia Pacific Sdn Bhd
Class I - Dangerous
Some left-handed gloves contain powder. Powdered surgical gloves are a banned medical device in the U.S. Powder on natural rubber latex gloves can aerosolize latex allergens, resulting in sensitization to latex and allergic reactions. Additional risks of powdered gloves include severe airway inflammation, conjunctivitis, dyspnea, as well as granuloma and adhesion formation when exposed to internal tissue.
Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. This condition may result in a discontinuous or open LINX device.