Class I - Dangerous
Due to a potential open seal in the sterile barrier packaging.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires
Galt Medical
Class I - Dangerous
Due to a potential open seal in the sterile barrier packaging.
CODMAN Disposable Perforator, 14mm. Cranial perforator.
Integra LifeSciences Corp. (NeuroSciences)
Class I - Dangerous
Inadequate weld that can potentially cause the product to disassemble.
Due to a potential open seal in the sterile barrier packaging.
Class I - Dangerous
In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S.
Class I - Dangerous
Incorrect labeling in which the front red pouch label did not match the actual size of the medical device. The label on the front of the scope incorrectly states 5.0/2.2 while the back label, shipping box and product inside correctly states 5.6/2.8.
Class I - Dangerous
Due to a potential open seal in the sterile barrier packaging .
GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002
GE Medical Systems China Co.
Class I - Dangerous
GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000
GE Medical Systems China Co.
Class I - Dangerous
GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
Potential crack in the female connector located on the Heat Exchanger/patient line set, which will lead to a fluid leak through the crack during priming of the Rapid Infuser.
myQA iON; Article Number: MQ10-000;
IBA Dosimetry GmbH
Class I - Dangerous
Wrong analysis results can occur if the user creates two structures with the same name, except for one differing by a special character.
The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
Class I - Dangerous
It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian).
GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002
GE Medical Systems China Co.
Class I - Dangerous
GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
Class I - Dangerous
Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of an IceSeed CX needle to the Cryoablation System, the user will be prompted to perform the Needle Integrity and Functionality Test (NIT) per standard protocols. The affected needles perform as intended unless they are disconnected and reconnected to any channel after testing. In this case, the Cryoablation System will prompt re-execution of the NIT.
The reason for the recall is incorrect sample barcode identification and processing errors that result in the reporting of erroneous and delayed results.
Medline procedure kits, labeled as: T AND A PACK -LF, REF DYNJ85792
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
Medline procedure kits, labeled as: 1) STERILE PREP KIT, REF DYNDA1359A; 2) STRL EK SINGLE PACK, REF DYNDA1360B; 3) SHEATH REMOVAL TRAY, REF DYNDC1311C; 4) SENSITIVE SKIN WEEKLY VAD, REF DYNDC3185; 5) NURSING SKILLS, REF EDUC05015A; 6) NURSING SUPPLY BAG, REF EDUC1024A.
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
Medline Sterile 0.9% Normal Saline, USP, 100mL, REF RDI30296
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.