Class I - Dangerous
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Affixus Hip Fracture Nail Left 125 13 mm x 260 mm, Item Number 814413260 Product Usage: Intended for the fixation of fractures
Zimmer Biomet
Class I - Dangerous
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Class I - Dangerous
These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
Atellica IM CKMB Calibrator, Cat No. 10995532 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
Siemens Healthcare Diagnostics
Class I - Dangerous
A potential bias was identified with certain kits compared to the internal standards.
Class I - Dangerous
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and higher.
GE Healthcare
Class I - Dangerous
Remote comparison studies displayed may be associated with the wrong patient, without a caution icon present.
Class I - Dangerous
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Class I - Dangerous
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Affixus Hip Fracture Nail Left 130 11 mm x 360 mm, Item Number 814611360 Product Usage: Intended for the fixation of fractures
Zimmer Biomet
Class I - Dangerous
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Affixus Hip Fracture Nail Left 125 9 mm x 440 mm, Item Number 814409440 Product Usage: Intended for the fixation of fractures
Zimmer Biomet
Class I - Dangerous
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Affixus Hip Fracture Nail Left 125 11 mm x 360 mm, Item Number 814411360 Product Usage: Intended for the fixation of fractures
Zimmer Biomet
Class I - Dangerous
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Atellica IM 1600 Analyzer (SMN 11066000). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
Siemens Healthcare Diagnostics
Class I - Dangerous
Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks¿ and Ancillary Packs when more than one (1) lot of specific Reagent kits are loaded on the analyzer at the same time. 2. Sample barcodes may be incorrectly read 3. The Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer may not run CEA dilutions at 50x and 100x. The Analyzer may post a Sample Integrity Error when 50x or 100x dilutions are ordered for Carcinoembryonic Antigen (CEA). Dilution factors lower than 50x and neat samples are not affected by this behavior. 4. The Atellica CH 930 Analyzer may continue to display the default reporting units after the reporting units have been changed. 5. The Atellica CH 930 Analyzer may not display results for sample if certain assays are configured to auto-dilute results above or below the assay measuring interval.
Affixus Hip Fracture Nail Right 125 9 mm x 320 mm, Item Number 814309320 Product Usage: Intended for the fixation of fractures
Zimmer Biomet
Class I - Dangerous
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
McKesson Insulin Syringe 0.3mL 31GX5/16 Item Numbers: 102-SN310C31516P Product Usage: Indication of Use: Injection of U-100 insulin only.
Cypress Medical Products
Class I - Dangerous
Small hole at the end of the syringe is impeding suction of liquid.
Multirall(TM) 200Liko Strap Gripper P/N 3136250 overhead lift for patient transfer situations.
Liko AB
Class I - Dangerous
The products manufactured on 5/5/17 may be assembled incorrectly. If the incorrectly assembled products is used for patient transport, this could allow the patient to fall, resulting in potential injury to the patient.
Atellica Sample Handler Additional (SMN 11069004). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
Siemens Healthcare Diagnostics
Class I - Dangerous
Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks¿ and Ancillary Packs when more than one (1) lot of specific Reagent kits are loaded on the analyzer at the same time. 2. Sample barcodes may be incorrectly read 3. The Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer may not run CEA dilutions at 50x and 100x. The Analyzer may post a Sample Integrity Error when 50x or 100x dilutions are ordered for Carcinoembryonic Antigen (CEA). Dilution factors lower than 50x and neat samples are not affected by this behavior. 4. The Atellica CH 930 Analyzer may continue to display the default reporting units after the reporting units have been changed. 5. The Atellica CH 930 Analyzer may not display results for sample if certain assays are configured to auto-dilute results above or below the assay measuring interval.
Affixus Hip Fracture Nail Right 125 9 mm x 360 mm, Item Number 814309360 Product Usage: Intended for the fixation of fractures
Zimmer Biomet
Class I - Dangerous
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
Terumo Cardiovascular Systems
Class I - Dangerous
The service manual was not updated at the time of the release of software version 1.30.
SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009
Baxter Healthcare
Class I - Dangerous
If an operator attempts to manually program a Basic Infusion for a drug that is not included in the Drug Library using the Basic-Dose Mode, the operator will receive a false hard limit exceeded error, preventing him or her from programming the infusion.
ADVIA Centaur CKMB Calibrator, Cat No. 09318028 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.
Siemens Healthcare Diagnostics
Class I - Dangerous
A potential bias was identified with certain kits compared to the internal standards.