6376 M-1 Cot Fastener, catalog no. 6376000000
Stryker Medical Division of Stryker
Class I - Dangerous
The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect information.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Beijing Syntech Laser Nice Station Light Based Platform surgical lasers
Beijing Syntech Laser Co.
Class I - Dangerous
The noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007".
DeRoyal(R) SURGI MATE(R) Electrosurgical Pencil, Button Switch, with 15 ft (4.6 m) Cord and Holster, REF 88-001502 Product Usage: general surgical
DeRoyal Industries
Class I - Dangerous
Non-sterile product was packaged inside a case that was labeled as sterile.
SOMATOM Sensation 10 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Siemens Medical Solutions USA
Class I - Dangerous
to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
SOMATOM Sensation 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Siemens Medical Solutions USA
Class I - Dangerous
to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
Class I - Dangerous
The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
BD MAX DNA MMK Lab Use, catalog no. 442828
Becton Dickinson &
Class I - Dangerous
The package insert incorrectly lists the volume of the primer and probe diluent to use for the reconstitution of the master mix tube. Adding the incorrect amount of diluent could have an effect on the assay.
The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
Beijing Syntech Laser Trixel C02 Laser surgical lasers
Beijing Syntech Laser Co.
Class I - Dangerous
The noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007".
BD Vacutainer¿ Ultra TouchTM Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x ¿ x 12. Catalog no 367364
Becton Dickinson & Company
Class I - Dangerous
Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6.
T4 Zipper Toga (S/M); Catalog Number: 0400-810-000 Sterile personal protection garment
Stryker Instruments Div. of Stryker
Class I - Dangerous
Separation of material layers may occur, causing a potential risk of exposure to contaminants.
Class I - Dangerous
Products labeled for distribution outside the United States may have been distributed to customers in the United States.
Class I - Dangerous
A potential commingle that could result in the product in the package not matching the product on the outer label.
M/DN Intramedullary Fixation Humeral Guide Wire Bullet Tip 2.4 mm Diameter, 70 cm Length; Item Number: 00-2255-026-00
Zimmer Biomet
Class I - Dangerous
Potential failure of sterile packaging seal.
T4 Zipper Toga, X-Large; Catalog number: 0400-850-000 Sterile personal protection garment
Stryker Instruments Div. of Stryker
Class I - Dangerous
Separation of material layers may occur, causing a potential risk of exposure to contaminants.
The secondary packaging is labeled with an incorrect expiration date.
Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee system devices are intended for use in revision total knee arthroplasty to alleviate pain and restore function
Howmedica Osteonics
Class I - Dangerous
Firm became aware that the specific product/lot combinations referenced above may contain the incorrect size implant from what is labeled on the box.
Widefield OCT software feature for the Spectralis HRA+OCT and variants
Heidelberg Engineering
Class I - Dangerous
FDA notified Heidelberg Engineering that a 510(k) clearance is needed for the SPECTRALIS Widefield OCT feature, and, on November 27, 2017, Heidelberg Engineering submitted a new 510(k) for this feature. FDA has asked Heidelberg Engineering to instruct customers not to use the Widefield OCT software feature on the SPECTRALIS device until 510(k) clearance has been obtained for this software feature.
Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum.
Diagnostic Hybrids
Class I - Dangerous
There may be a loss of separation between Calibrators A and B which may impact the assay calibration at the lower end of the assay.
T5 Zipper Toga with Peel-Away Face Shield, (XL/T); Catalog number: 0400-850-100 Sterile personal protection garment
Stryker Instruments Div. of Stryker
Class I - Dangerous
Separation of material layers may occur, causing a potential risk of exposure to contaminants.