The STATCLAVE G4 is a dynamic air removal (prevacuum) tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. It is suitable for the sterilization of dental and medical instruments that are validated to be sterilized by steam. The STATCLAVE G4 has not been designed to sterilize liquid loads, bio medical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and / or damage to the autoclave.
All Recalls
95,018 total recalls in our database
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as STERILE SET FOR IMPLANT-LF, Model Number: OST011F.
MEDLINE INDUSTRIES, LP - Northfield
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
OEC 9800 Systems with 9-inch Image Intensifier
GE OEC Medical Systems
Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier falling, which could lead to injuries such as fractures, hematoma, contusion, bruise, pain.
Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148
Philips North America
Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted and the system will shut down
Certain lots of the products have a Naphthalene odor.
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DBD-FLAP HARVEST PACK, Model Number: DYNJ58575C
MEDLINE INDUSTRIES, LP - Northfield
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only
Johnson & Johnson Surgical Vision
Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.
OEC Elite Systems with 9-inch Image Intensifier
GE OEC Medical Systems
Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier falling, which could lead to injuries such as fractures, hematoma, contusion, bruise, pain.
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. LIVER 2018, Model Number: DYNJ905655A;
MEDLINE INDUSTRIES, LP - Northfield
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Incisive CT Plus-Computed Tomography X-Ray System Model: 728149
Philips North America
Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted and the system will shut down
Honda Model EU7000is Portable Generators
American Honda Motor Co. Inc., of Torrance, California
The fuel filler cap can improperly seal, resulting in fuel and/or fuel vapor leaking, posing a fire hazard.
Avena Mini Table Lamps
Unknown Manufacturer
A loose electrical cord connection in the lamps can pose a fire hazard.
Amana Packaged Terminal Air Conditioners/Heat Pumps (PTACs) equipped with "DigiAir" modules
Daikin Comfort Technologies Manufacturing L.P. (DCT), of Houston, Texas
The DigiAir module compressor can overheat, posing burn and fire hazards.
Maggie's Farm 14 oz Bed Bug & Flea Killer
Maggie's Farm Ltd., of Kansas City, Missouri
The pressurized aerosol bed bug and flea killer cans can rupture and expel shrapnel, posing injury and laceration hazards to consumers. In addition, leakage of contents can pose a risk of skin and eye irritation upon contact.
Philips Avent Digital Video Baby Monitors
Philips Consumer Lifestyle B.V., of The Netherlands
The rechargeable lithium-ion batteries in the Parent Unit monitors can overheat during charging, posing a risk of burns and property damage.