Medical DeviceJun 16, 2021
INNOVA MEDICAL GROUP COVID-19 Self-Test Kit *** INNOVA *** 7T recall — FDA Z-1537-2021
Due to distributing test kits to customers who were not part of a clinical investigation.
Class IFDA: OngoingINNOVA MEDICAL GROUP, Inc.
24,725medical device recall records
2,223FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.757 records
Database records
Records — page 501
24,725 detailed records are currently available in this category.
Medical DeviceJun 16, 2021
Alphatec Spine Atec Insignia Anterior Cervical Plate System, REF 136-0358 Insignia, ACP recall — FDA Z-1820-2021
There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
Class IIFDA: TerminatedAlphatec Spine, Inc.
Medical DeviceJun 16, 2021
DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented recall — FDA Z-1845-2021
Fifty (50) individual units from Lot D20111130 were distributed with the incorrect part number and size etched on the product.
Class IIFDA: TerminatedDePuy Orthopaedics, Inc.
Medical DeviceJun 16, 2021
Alphatec Spine Atec Insignia Anterior Cervical Plate System, REF 136-0242 Insignia, ACP recall — FDA Z-1812-2021
There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
Class IIFDA: TerminatedAlphatec Spine, Inc.
Medical DeviceJun 16, 2021
Alphatec Spine Atec Insignia Anterior Cervical Plate System, REF 136-0482 Insignia, ACP recall — FDA Z-1827-2021
There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
Class IIFDA: TerminatedAlphatec Spine, Inc.
Medical DeviceJun 16, 2021
Alphatec Spine Atec Insignia Anterior Cervical Plate System, REF 136-0356 Insignia, ACP recall — FDA Z-1819-2021
There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
Class IIFDA: TerminatedAlphatec Spine, Inc.
Medical DeviceJun 16, 2021
Alphatec Spine Atec Insignia Anterior Cervical Plate System, REF 136-0478 Insignia, ACP recall — FDA Z-1826-2021
There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
Class IIFDA: TerminatedAlphatec Spine, Inc.
Medical DeviceJun 16, 2021
Alphatec Spine Atec Insignia Anterior Cervical Plate System, REF 136-0238 Insignia, ACP recall — FDA Z-1810-2021
There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
Class IIFDA: TerminatedAlphatec Spine, Inc.
Medical DeviceJun 16, 2021
Alphatec Spine Atec Insignia Anterior Cervical Plate System, REF 136-0468 Insignia, ACP recall — FDA Z-1824-2021
There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
Class IIFDA: TerminatedAlphatec Spine, Inc.
Medical DeviceJun 16, 2021
DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06 recall — FDA Z-1832-2021
DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which was subsequently recalled due to mislabeling; the product is 0.5% Bupivacaine
Class IFDA: TerminatedDeRoyal Industries Inc.
Medical DeviceJun 16, 2021
NICO Myriad-LX Illumination Pack: REF: NN-1000 Mvriad-LX Illumination Pack. 11ga REF recall — FDA Z-1839-2021
(1) Updated IFU for the LX Illumination Packs: Warning - Avoid contact between the distal opening of the delivery sleeve and tissue/debris within the surgical.field to prevent complete…
Class IIFDA: TerminatedNico Corp.
Medical DeviceJun 9, 2021
Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code recall — FDA Z-1689-2021
Compromised sterile barriers due to the Tyvek Lid not properly adhering to the Tray and has the the potential to cause an infection
Class IIFDA: OngoingVygon U.S.A.
Medical DeviceJun 9, 2021
Zimmer Natural Nail -ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 125 CCD Left recall — FDA Z-1792-2021
Zimmer Natural Nail (ZNN) System-CMN Femoral Nail potential commingle between CCD angle 130 degree and 125 degree
Class IIFDA: TerminatedZimmer GmbH
Medical DeviceJun 9, 2021
CLINICAL LASERTHERMIA SYSTEMS AB Tranberg MR Stylet, 1.8mm/15G, 230mm, REF: 4013-06, Rx recall — FDA Z-1781-2021
single use devices labeled as sterile may not have been adequately sterilized
Class IIFDA: TerminatedCLINICAL LASERTHERMIA SYSTEMS AB
Medical DeviceJun 9, 2021
Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf recall — FDA Z-1773-2021
A software defect was identified where the Image Styles defined by presentation states from CHRS are not displayed in CHEV.
Class IIFDA: OngoingCHANGE HEALTHCARE CANADA COMPANY
Medical DeviceJun 9, 2021
Flower Orthopedics T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits recall — FDA Z-1698-2021
Cannulated Screwdrivers may break at the driver tip along the shaft, near the handle extending surgery time and additional x-ray to identify the fragments from the breakages
Class IIFDA: TerminatedFlower Orthopedics Corporation
Medical DeviceJun 9, 2021
Draeger Medical Critical Care Ventilator, Catalog Number(s): 8422200: Babylog VN600 recall — FDA Z-1692-2021
Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog VN600 and Babylog VN800: 1. Restart of ventilation unit. 2. Incorrect FiO2 high…
Class IIFDA: TerminatedDraeger Medical, Inc.
Medical DeviceJun 9, 2021
CLINICAL LASERTHERMIA SYSTEMS AB Tranberg MR Cannula, REF: 4013-05, Rx Only, Sterile EO recall — FDA Z-1780-2021
single use devices labeled as sterile may not have been adequately sterilized
Class IIFDA: TerminatedCLINICAL LASERTHERMIA SYSTEMS AB
Medical DeviceJun 9, 2021
CLINICAL LASERTHERMIA SYSTEMS AB Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm recall — FDA Z-1782-2021
single use devices labeled as sterile may not have been adequately sterilized
Class IIFDA: TerminatedCLINICAL LASERTHERMIA SYSTEMS AB
Medical DeviceJun 9, 2021
Zimmer Natural Nail- ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 130 CCD Left recall — FDA Z-1793-2021
Zimmer Natural Nail (ZNN) System-CMN Femoral Nail potential commingle between CCD angle 130 degree and 125 degree
Class IIFDA: TerminatedZimmer GmbH
Medical DeviceJun 9, 2021
Draeger Medical Critical Care Ventilator, Catalog Number(s): 8422300: Evita V600 - Product recall — FDA Z-1690-2021
Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog VN600 and Babylog VN800: 1. Restart of ventilation unit. 2. Incorrect FiO2 high…
Class IIFDA: TerminatedDraeger Medical, Inc.
Medical DeviceJun 9, 2021
LEPU MEDICAL TECHNOLOGY (BEIJING) CO Leccurate SARS-CoV-2, Antibody Rapid Test Kit recall — FDA Z-1619-2021
Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) is not authorized, cleared, or approved for marketing and/or distribution in the U.S.
Class IFDA: CompletedLEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD
Medical DeviceJun 9, 2021
Terumo Cardiovascular Systems The Sarns TCM II (system) is a source of recall — FDA Z-1791-2021
Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns and expectations. As a result, an updated cleaning protocol will not be developed by Terumo…
Class IIFDA: TerminatedTerumo Cardiovascular Systems Corporation
Medical DeviceJun 9, 2021
K2M Cascadia AN Interbody Convex 10x28x14mm recall — FDA Z-1697-2021
Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm
Class IIFDA: TerminatedK2M, Inc.
How to use this medical device recall index
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
What the database can and cannot tell you
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.