All Recalls

95,114 total recalls in our database

Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.

Baxter Healthcare

🏥 Medical Devices Class I - Dangerous

There is a potential leak between the venous patient connector and patient's hemodialysis access.

Apr 14, 2021 Infusion Pumps View Details →

NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿s3 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77352

Nobel Biocare Procera

🏥 Medical Devices Class I - Dangerous

Not manufactured to specification

Mar 29, 2021 Implants & Prosthetics Nationwide View Details →

GS777 Wall Transformer Model: 77710 Intended Use: The GS777 Wall Transformer is intended for use in ambulatory and acute care settings.

Welch Allyn

🏥 Medical Devices Class I - Dangerous

Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and possible electrical shock

Apr 22, 2021 Other Medical Devices Nationwide View Details →

NPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s6 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77387

Nobel Biocare Procera

🏥 Medical Devices Class I - Dangerous

Not manufactured to specification

Mar 29, 2021 Implants & Prosthetics Nationwide View Details →

VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngeal (NP) and anterior nasal swab specimens collected in CDCs formulation of VTM.

Ortho-Clinical Diagnostics

🏥 Medical Devices Class I - Dangerous

Ortho investigated and confirmed the potential for unexpected failed calibration, and condition codes associated with the calibration, when using VITROS SARS-CoV-2 Ag Reagent Pack along with VITROS Immunodiagnostic Products SARS-CoV-2 Ag Calibrator, Lot 20.

May 3, 2021 Infusion Pumps Nationwide View Details →

BiPAP V30 Auto, US market: Continuous ventilator, non-life-supporting. Material Number: 1111178

Philips Respironics

🏥 Medical Devices Class I - Dangerous

Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not normally present creating a potential biosafety or toxicological hazard and 2. Sudden failure of the device causing a Ventilator Inoperative condition with the potential for asphyxia if not immediately identified and addressed by the care provider.

Apr 6, 2021 Patient Monitors Nationwide View Details →

ProBP 3400 Digital Blood Pressure Device ((handheld, desk mount, wall mount models) Model: 34XFHT-B Intended: ProBP 3400 automatically measures systolic and diastolic pressure (excluding neonates) and pulse rate, as well as calculates Mean Arterial Pressure (MAP).

Welch Allyn

🏥 Medical Devices Class I - Dangerous

Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and possible electrical shock

Apr 22, 2021 Patient Monitors Nationwide View Details →

NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s2 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics Material Number: 77339

Nobel Biocare Procera

🏥 Medical Devices Class I - Dangerous

Not manufactured to specification

Mar 29, 2021 Implants & Prosthetics Nationwide View Details →

Umbrosa umbrellas equipped with the Umbrosa Evolution Arm/Holder

Umbrosa NV, of Belgium

🏠 Consumer Products Class II - Moderate

The umbrella arm can break at the elbow while in use, posing an injury hazard.

May 27, 2021 Clothing & Accessories Nationwide View Details →

Williams Advanced Materials & Chemicals Recalls Three Chemical Products Due to Failure to Meet Child-Resistant Packaging Requirement and Violation of FHSA Labeling Requirement (Recall Alert)

Williams Advanced Materials & Chemicals Inc., of Clairton, Pa.

🏠 Consumer Products Class II - Moderate

The products Sodium Hydroxide, Heptane, or Naphtha must be in child resistant packaging, as required by the Poison Prevention Packaging Act (PPPA). The packaging of the products is not child resistant. The sodium hydroxide poses a risk of chemical burns and irritation to the skin and eyes. The heptane and naphtha pose a risk of eye, nose and throat irritation, headache, lightheadedness, dizziness, lack of coordination and loss of consciousness. In addition, the label on the products violates the Federal Hazardous Substance Act (FHSA) by omitting mandatory information on the packaging.

May 27, 2021 Other Consumer Products Nationwide View Details →