Medical DeviceMay 24, 2017
BioMerieux SA ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a recall — FDA Z-2095-2017
False susceptible results
Class IIFDA: TerminatedBioMerieux SA
Latest records
Latest recalls — page 1633
The newest recall records with useful source details are listed here.
Medical DeviceMay 24, 2017
Beckman Coulter Cholesterol Reagent(CHOL 2 x 300), Catalog No. 467825 Intended for recall — FDA Z-2081-2017
Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results.
Class IIFDA: TerminatedBeckman Coulter Inc.
Medical DeviceMay 24, 2017
Bausch & Lomb Surgical SoftPort Easy-Load Lens Delivery System Model: EZ-28V Is used for the recall — FDA Z-2098-2017
Complaints concerning kinked haptics that were occurring during lens delivery.
Class IIFDA: TerminatedBausch & Lomb Surgical, Inc.
Medical DeviceMay 24, 2017
VORTRAN Automatic Resuscitator, VARPlus with Extension Kit recall — FDA Z-2092-2017
Vortran received a customer complaint that the spin-nut-DSS connector was assembled in the reverse direction on the oxygen tubing; making the connector unable to be screwed on due to the…
Class IIFDA: TerminatedVortran Medical Technology 1, Inc.
Medical DeviceMay 24, 2017
Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010 recall — FDA Z-1925-2017
LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concentrations in some blood samples. The issue is observed when blood samples are collected in…
Class IFDA: TerminatedMagellan Diagnostics, Inc.
Medical DeviceMay 24, 2017
Respironics California Philips V60 Ventilators, Material No. 850008, 1053613, 1053614 recall — FDA Z-2061-2017
Over time, low-frequency vibrations can cause the pins within the female connectors on the Motor Controller to Data Acquisition Board ribbon cable to become partially displaced causing…
Class IFDA: TerminatedRespironics California Inc.
Medical DeviceMay 24, 2017
Aesculap Implant Systems GP321R; ELAN 4 2-RING DIAMOND BURR COARSE D2.3; GP322R; ELAN 4 recall — FDA Z-2088-2017
Diamond particulates may break off the burr and fall into the surgical site. If the particles are not detected and are not removed from the surgical site a foreign body reaction may occur.…
Class IIFDA: TerminatedAesculap Implant Systems LLC
Medical DeviceMay 24, 2017
Siemens Healthcare Diagnostics ADVIA Centaur Systems Insulin ReadyPack recall — FDA Z-2086-2017
Current lots of ADVIA Centaur/XP/XPT/CP Insulin (IRI) assay recover approximately 40% higher than the World Health Organization (WHO) 1st IRP 66/304 standardization based on slope values.…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceMay 24, 2017
Ziehm Imaging solo FD Mobile Fluoroscopic C-arm recall — FDA Z-1893-2017
During Ziehm Imaging GmbH FDA inspection, the label for the Collimator and X-ray Control panel was missing the manufacturer date as part of the identification for certified component
Class IIFDA: TerminatedZiehm Imaging Inc.
Medical DeviceMay 24, 2017
Beckman Coulter HDL Cholesterol Reagent (HDL 2 x 200), Catalog No recall — FDA Z-2082-2017
Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results.
Class IIFDA: TerminatedBeckman Coulter Inc.
Medical DeviceMay 24, 2017
MEDLINE INDUSTRIES 14 mm Distraction Pin, Exagg Qty: 1 per pack recall — FDA Z-2106-2017
Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possible that the seal on the sterile packaging has been compromised resulting in a loss of…
Class IIFDA: TerminatedMEDLINE INDUSTRIES Inc.
Medical DeviceMay 24, 2017
Beckman Coulter Salicylate Reagent (SALY 2 x 45), Catalog No. 378194 recall — FDA Z-2084-2017
Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results.
Class IIFDA: TerminatedBeckman Coulter Inc.
Medical DeviceMay 24, 2017
Zimmer Gmbh Normed General Instruments 503004541: Werber Countersink Cannulated for micro recall — FDA Z-2111-2017
the devices used a different raw material to produce two countersink products which has higher hardness and higher carbon content resulting in device damage.
Class IIFDA: TerminatedZimmer Gmbh
Medical DeviceMay 24, 2017
Aesculap Implant Systems GE426R; HI-LINE XS DIAMOND BURR X-CRS.I D4.5MM; GE426SU; HI-LINE XS recall — FDA Z-2089-2017
Diamond particulates may break off the burr and fall into the surgical site. If the particles are not detected and are not removed from the surgical site a foreign body reaction may occur.…
Class IIFDA: TerminatedAesculap Implant Systems LLC
Medical DeviceMay 24, 2017
Beckman Coulter Access BR Monitor, Part No. 387620 recall — FDA Z-2074-2017
Following biases observed in the results of the French National Quality Controls, Beckman Coulter has been informed that a study completed by the French Competent Authority Agence nationale…
Class IIFDA: TerminatedBeckman Coulter Inc.
Medical DeviceMay 24, 2017
Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010 recall — FDA Z-1926-2017
LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concentrations in some blood samples. The issue is observed when blood samples are collected in…
Class IFDA: TerminatedMagellan Diagnostics, Inc.
Medical DeviceMay 24, 2017
Abbott Vascular NC Trek RX Coronary Dilatation Catheter, Part No. 1012448-06, 1012448-08 recall — FDA Z-2037-2017
Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon.
Class IFDA: TerminatedAbbott Vascular
Medical DeviceMay 24, 2017
Teleflex Medical WECK Visistat 35R Disposable Skin Stapler, Ref 528135, Rx Only, Sterile EO recall — FDA Z-2108-2017
Some boxes are labeled as containing Visistat Wide devices, when they in fact they contained Visistat Regular device.
Class IIFDA: CompletedTeleflex Medical
Medical DeviceMay 24, 2017
Beckman Coulter Enzymatic Creatinine Reagent (CR-E 2 x 200), Catalog No recall — FDA Z-2080-2017
Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results.
Class IIFDA: TerminatedBeckman Coulter Inc.
FoodMay 24, 2017
RALEY'S MUESLI ALMOND CRUNCH MUESLI CEREAL recall — FDA F-2155-2017
Internal label review found that coconut was not listed in the allergen declaration
Class IIFDA: TerminatedRaley's
FoodMay 24, 2017
ASK Foods Wegmans Wegmans Family Pack Potato Salad, Net Wt recall — FDA F-2240-2017
Wegman's Potato Salad, Net Wt. 48 oz is being recalled for undeclared egg as the containers were labeled with a nutritional and ingredient statement from a different product.
Class IFDA: TerminatedASK Foods Inc.
FoodMay 24, 2017
Kemps One Pint, UPC 41483-04127 recall — FDA F-2227-2017
Kemps is recalling select pints of Sweet Me Creamery Ice Cream and YO2 Frozen Yogurt because they may contain pieces of plastic.
Class IIFDA: TerminatedKemps, LLC
FoodMay 24, 2017
Kemps One Pint, UPC 41483-04143 recall — FDA F-2231-2017
Kemps is recalling select pints of Sweet Me Creamery Ice Cream and YO2 Frozen Yogurt because they may contain pieces of plastic.
Class IIFDA: TerminatedKemps, LLC
FoodMay 24, 2017
Kemps One Pint, UPC 41483-04124 recall — FDA F-2225-2017
Kemps is recalling select pints of Sweet Me Creamery Ice Cream and YO2 Frozen Yogurt because they may contain pieces of plastic.
Class IIFDA: TerminatedKemps, LLC
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