Class I - Dangerous
Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Class I - Dangerous
Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.
Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F
Toshiba American Medical Systems
Class I - Dangerous
It was found that during a procedure the Peak Skin Dose (PSD) value displayed by the Dose Tracking System (DTS) was larger than the DTS expected value. This issue occurs when the power for the Angio Workstation is turned on after the power for the Infinix system is turned on.
nail not properly engaging with the targeting jig due to certain undersized specification
Class I - Dangerous
Reported incidents of a patient step detaching from the table. A fall from a patient step detaching while in use could result in an injury to a patient or operator.
Cardinal, Digital Bariatric Scale 1) model 6876, Cap 600 and 2) model 6868 Cap 1000
Cardinal Scale Mfg
Class I - Dangerous
One complaint of a seat on a scale failing unexpectedly which can cause an injury.
Zimmer Biomet is conducting a voluntary recall for a single lot of the Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System after it was determined that two pieces from the lot were moved to finished goods and shipped despite having an open Non-Conformance Report (NCR). The NCR indicated that one piece from the lot had scratches and the other non-confirming threads.
AIA-PACK TgAb CONTROL SET
Tosoh Bioscience
Class I - Dangerous
The label contains two different methodologies. Quality Control values for non-FDA approved methodology (CL) are on the label in addition to the FDA approved methodology values (AIA). Two sets of instructions were included on the label.
Elecsys PreciControl Varia 3
Roche Diagnostics
Class I - Dangerous
e-barcode and value sheet for PreciControl Varia contains a typographical error for the target values for the Elecsys PTH (parathyroid hormone) and Elecsys PTH STAT immunoassays
Class I - Dangerous
Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.
Class I - Dangerous
Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.
Class I - Dangerous
Durability characteristics of reusable instruments were not established
Arrow(R) VPS(R) Access Kit for use with 4 and 5 Fr. Peripherally Inserted Central Venous Catheters
Arrow International
Class I - Dangerous
Arrow International is notifying each customer who received the affected that product that the kits do not contain important information regarding the 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing.
Class I - Dangerous
Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set stability claim is not being met.
SHBG IMMULITE 2000/IMMULITE 2000 XPi For the in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers-For the quantitative measurement of SHBG in serum, as aid in the differential diagnosis of hirsutism.
Siemens Healthcare Diagnostics
Class I - Dangerous
Certain lots of Sex Hormone Binding Globulin (SHBG) do not meet the thirty (30) day open vial adjustor stability claim when reconstituted and stored at 2-8ÂŋC, as published in the Instructions for Use (IFU). Adjustors stored at 2-8C after 14 days may show a bias in patient samples and quality control falling outside of published ranges. Lookback not recommended.
Abbott Vascular is initiating a recall of the Absorb Bioresorbable Vascular Scaffold (BVS) System due to studies showing elevated rates of major adverse events, specifically, myocardial infraction and scaffold thrombosis when compared to patients treated with the Xience metallic drug eluting stent.
Draco Enzymatic Deep-Cleaning Pad with Enzymatic Detergent Catalogue Number: HY0305Z
Madison Polymeric Engineering
Class I - Dangerous
Product is contaminated with Cladosporium cladosporioides/herbarum/phaenocomae.
Class I - Dangerous
Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.
Class I - Dangerous
Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.
Class I - Dangerous
Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.