Class I - Dangerous
There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, located where the Cannula and Body components are welded together.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.
The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.
stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation
Wright Medical Technology
Class I - Dangerous
Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts.
ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and interventional procedures. Material Number: 10848600
Siemens Medical Solutions USA
Class I - Dangerous
Examination room monitor connected with the hybrid cable may have a display issue and no image function is available
Class I - Dangerous
A portion of the two products were incorrectly marked (etched) and packaged resulting in a product mismatch. The labels and laser etchings were switched on the two products.
FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051
Richard Wolf GmbH
Class I - Dangerous
Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in addition, the proximal forceps shaft is bent, the forceps can no longer be opened or restrictions begin even with a slight bending of the endoscope.
Class I - Dangerous
The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity M300 to fail to meet Frequency and Impulse Response requirements. In this condition, ECG waveforms with unusually narrow and/or high frequency QRS may be displayed or printed with QRS amplitudes intermittently lower than actual.
FLEX. GRASP. FORCEPS 6.6FR WL 550MM, Product Number 8736.685
Richard Wolf GmbH
Class I - Dangerous
Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in addition, the proximal forceps shaft is bent, the forceps can no longer be opened or restrictions begin even with a slight bending of the endoscope.
The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.
Class I - Dangerous
Mislabeled: Product is marked with GTIN # 04046955299592 however; the correct GTIN # is 04046955299607.
Class I - Dangerous
JULIET Lateral Lumbar Ti-Life Plate, a component of the JULIET Ti Lateral Lumbar Cage, may disassemble during the preparation stage before implantation, or during surgery when removing the implant holder, which could cause surgical delay.
Class I - Dangerous
The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.
Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment, Software versions VG2.1.3 and lower
Draeger Medical Systems
Class I - Dangerous
The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity M300 to fail to meet Frequency and Impulse Response requirements. In this condition, ECG waveforms with unusually narrow and/or high frequency QRS may be displayed or printed with QRS amplitudes intermittently lower than actual.
FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams
FUJIFILM Healthcare Americas
Class I - Dangerous
Arm which holds the tube head in place is susceptible to breaking, if the device breaks it could potentially cause serious harm or injury to the patient and/or user.
Sterile surgical convenience kit: regard Item Number: 800718003, GY00923C - WPH Major Vaginal Pack.
ROi CPS
Class I - Dangerous
The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.
GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b) 5311-01240-012; for peripheral nerve repair
Baxter Healthcare
Class I - Dangerous
The product is brittle and potentially crumbling upon handling or when being removed from its package.
Class I - Dangerous
There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, located where the Cannula and Body components are welded together.
Class I - Dangerous
There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, located where the Cannula and Body components are welded together.
FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 8735.685
Richard Wolf GmbH
Class I - Dangerous
Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in addition, the proximal forceps shaft is bent, the forceps can no longer be opened or restrictions begin even with a slight bending of the endoscope.