Class I - Dangerous
The epoxy on Apex manufactured epoxy-coated instruments can pop off.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Class I - Dangerous
As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.
Class I - Dangerous
As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.
Class I - Dangerous
As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.
Class I - Dangerous
The glass syringe used with Pressure Control Syringes may potentially break during use.
ORTHOFIX Catalogue Number: ref: 99-91600UE, UE XCALIBER METADIAPHYSEAL COMPLETE KIT, RX ONLY, UDI: (01)18032937169696
Orthofix Srl
Class I - Dangerous
As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.
Class I - Dangerous
Software issue identified in the software versions syngo CT VB20 running on the SOMATOM CT Scanner: scan aborts and system crashes
Class I - Dangerous
As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.
Class I - Dangerous
As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.
Universal Sexual Health Testing Kit
Privapath Diagnostics
Class I - Dangerous
A supplier informed PrivaPath Diagnostics that there is a potential for damaged tubes which could result in blood exposure or erroneous results due to an inappropriate blood-to-additive ratio.
Class I - Dangerous
The spring on the PEG-Extender can rust due to the type of steel used to manufacture it.
Visual-ICE utilizing the IceSeed 1.5 and IceRod 1.5 PLUS cryoablation needles could have issues with the needle clogging and/or inadequate freezing performance.
Class I - Dangerous
The epoxy on Apex manufactured epoxy-coated instruments can pop off.
RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066.
Randox Laboratories, Limited
Class I - Dangerous
Non-Esterified Fatty Acids (NEFA) FA115 batch 485343 is not meeting the performance claims and should not be used in any further testing.
Class I - Dangerous
The epoxy on Apex manufactured epoxy-coated instruments can pop off.
Class I - Dangerous
Table tilts without operator involvement as a result of liquid spilling into tilt console triggering a short circuit.
ORTHOFIX Catalogue Number: ref: 99-93601, GALAXY WRIST STERILE KIT, UDI: (01)18054242511656
Orthofix Srl
Class I - Dangerous
As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.
Class I - Dangerous
As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.
EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)
Monarch Medical Technologies
Class I - Dangerous
Product was distributed prior to approval or clearance from FDA.
Class I - Dangerous
As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.