8MM,CADIERE FORCEPS,IS4000 ¿ REF 470049
Intuitive Surgical
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
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Other Medical Devices
🏥 Medical Devices • 15,203 recalls
8MM,TENACULUM FORCEPS,IS4000¿ REF 470207
Intuitive Surgical
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30. Single Use Mechanical Lithotriptor V used with Olympus endoscope for crushing calculi inside the bile duct.
Olympus Corporation of the Americas
Class I - Dangerous
Potential for distal tip tearing of the Mechanical Lithotriptor V.
8MM,MEGA SUTURECUT ND,IS4000¿ REF 470309
Intuitive Surgical
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
ECONO STERILE medical procedure kits labeled as: ECONO STERILE CEMENT SPATULA #24 STRL CS/25, Model Number 96-2245M, mixing utensil, dental
Sklar Instruments
Class I - Dangerous
Reports of various packaging issues that may result in a breach of the sterile barrier.
ECONO STERILE medical procedure kits labeled as: ECONO STERILE IUD EXTRACTOR DBL HK 10.5"CS25, Model Number 96-4146A
Sklar Instruments
Class I - Dangerous
Reports of various packaging issues that may result in a breach of the sterile barrier.
Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE
Karl Storz Endoscopy
Class I - Dangerous
Due to failure of manual cleaning validation, biopsy and grasping forceps like sterility assurance.
8MM,LONG BIPOLAR GRASPER,IS4000 REF 471400
Intuitive Surgical
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
GE Healthcare Varicam Millennium VG Discovery VH, Model/Catalog Numbers: 1) ASM000085; 2) ASM001092; 3) SYS000001; System, Tomography, Computed, Emission
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Class I - Dangerous
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 471205
Intuitive Surgical
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002A
Baxter Healthcare
Class I - Dangerous
There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO
GE Medical Systems
Class I - Dangerous
Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV
GE Medical Systems
Class I - Dangerous
Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
GE Healthcare Optima XR220amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-12; 2) 5555000-5; 3) 5555000-6; 4) A0659PB; 5) to be provided
GE Medical Systems
Class I - Dangerous
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track.
GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-3; 2) 5555000-4: 3) A0659MB
GE Medical Systems
Class I - Dangerous
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track.
Class I - Dangerous
The devices were inadvertently shipped after their expiration date.
There is a potential safety risk caused by physical disassociation of the back section from the bed frame of Skytron model series 3600, 6500, 6600 and 6700 operating room beds when used with the EnVisio Navigation System.
Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25
Nipro Renal Soultions USA
Class I - Dangerous
The outer case is mislabeled as 3.0 K, 2.0 Ca instead of 2.0 K, 3.0 Ca.
VACUETTE SAFELINK, REF: 450210
Greiner Bio-One GmbH
Class I - Dangerous
The VACUETTE SAFELINK Holder with male luer lock may leak blood due to the protective rubber sleeve bunching up and not retracting when using the device.
Class I - Dangerous
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track.