Class I - Dangerous
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Container fill and transfer sets, 250 mL and 500 mL, . .
The Metrix Company
Class I - Dangerous
An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specifications.
Class I - Dangerous
US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.
A defective rotor yoke on Allegra X-5 allows improper rotor seating on the hub resulting in possible rotor failure if the buckets are loaded in an imbalanced configuration.
Dual Chamber Container fill and transfer sets, 250 mL / 1250 mL or 500 mL / 2500 mL
The Metrix Company
Class I - Dangerous
An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specifications.
Endotine Transbleph 3.5 (CFD-080-0167)
MicroAire Surgical Instruments
Class I - Dangerous
MicroAire has initiated a limited recall (29 Units)on the Endotine Transbleph 3.5 (CFD-080-0167), Lot # 285373, due to minor mislabeling ( the front label is correct, but the side label lists an incorrect part number, i.e. CFD-080-0177).
Class I - Dangerous
US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.
A software defect was discovered that causes images to be out of context with clinical information.
Product mix-up. The Avenir M¿ller Stem 6 lateral uncemented might be placed in the packaging of the Avenir M¿ller Stem 4 standard uncemented and vice versa. Potential for delay in surgery, and/or potential for use of incorrect implant which may in turn lead dismetry in patient and possibly the need for revision.
Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.
Ortho Clinical Diagnostics (OCD) confirmed a potential for biased calcium (Ca) results to be generated when using VITROS Ca Slides, GEN29, and the VITROS 250/350/950/5,1 FS, 4600 Chemistry System or the VITROS 5600 Integrated System. An increase in negatively biased calcium results complaints prompted the investigation that identified this product issue.
Anspach G1 High Speed Electric Handpiece Air Cooled (eG1A) Use for cutting and shaping bone including bones of the cranium and spine.
The Anspach Effort
Class I - Dangerous
The graphics at the attachment interface indicating locked and unlocked position are reversed.
Class I - Dangerous
WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution.
WalkMed Infusion
Class I - Dangerous
WalkMed Infusion, LLC Announces a Voluntary Field Action of the Triton Infusion Pump (model 300000) and Triton FP Infusion Pump (model 400000) Due to Unapproved Changes to the Software and Specifications of the Triton Infusion Pump (model 300000) and Unapproved Changes to the Intended Use of the Triton FP Infusion Pump (model 400000).
Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler devices due to the distributor no longer selling the Interchlor sanitizer (Product Code 205) referenced in its heater-cooler cleaning instructions.
Class I - Dangerous
Reagent lots # 15243MA and 15243MB shows a reduced stability once opened that does not meet the Instructions For Use claim of seven (7) days. A maximum bias of -37% was observed.
Class I - Dangerous
A variation in flute depth on the routers was observed. The variation in flute depth may cause the routers to be more susceptible to breakages. Risk to Health: Injury to critical soft tissue requiring surgical intervention may occur.
Class I - Dangerous
WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
Class I - Dangerous
WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution.
WalkMed Infusion
Class I - Dangerous
WalkMed Infusion, LLC Announces a Voluntary Field Action of the Triton Infusion Pump (model 300000) and Triton FP Infusion Pump (model 400000) Due to Unapproved Changes to the Software and Specifications of the Triton Infusion Pump (model 300000) and Unapproved Changes to the Intended Use of the Triton FP Infusion Pump (model 400000).