Medical DeviceMar 16, 2022
Medtronic Xomed NIM TRIVANTAGE EMG Endotracheal Tube recall — FDA Z-0743-2022
There is potential for multiple issues due to a manufacturing nonconformity.
Class IIFDA: OngoingMedtronic Xomed, Inc.
24,239medical device recall records
2,205FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.751 records
Database records
Records — page 447
24,239 detailed records are currently available in this category.
Medical DeviceMar 16, 2022
Nextremity Solutions Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small recall — FDA Z-0740-2022
During insertion of the middle phalanx implant into bone, the driver may deform the implant locking mechanism and result in inadequate mating force between the middle and proximal phalanx…
Class IIFDA: TerminatedNextremity Solutions
Medical DeviceMar 16, 2022
LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114 recall — FDA Z-0716-2022
COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approved for marketing and/or distribution in the U.S.
Class IFDA: OngoingLusys Laboratories, Inc.
Medical DeviceMar 16, 2022
Maquet Cardiovascular HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm recall — FDA Z-0729-2022
Outer labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Bifurcated Vascular Graft, D: 16 x 8 mm; L: 40 cm) does not correspond to the (inner) sterile packaging labelling (HEMASHIELD…
Class IIFDA: TerminatedMaquet Cardiovascular, LLC
Medical DeviceMar 16, 2022
Lusys Laboratories COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM recall — FDA Z-0718-2022
COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approved for marketing and/or distribution in the U.S.
Class IFDA: OngoingLusys Laboratories, Inc.
Medical DeviceMar 9, 2022
BioPro Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037 recall — FDA Z-0688-2022
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the…
Class IIFDA: TerminatedBioPro, Inc.
Medical DeviceMar 9, 2022
Microbiologics KWIK-STIK, Quality control kit for culture media, sold as: KWIK-STIK recall — FDA Z-0714-2022
This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specific lot was found susceptible to Gentamicin Synergy during in-house testing.
Class IIFDA: TerminatedMicrobiologics Inc.
Medical DeviceMar 9, 2022
BioPro Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814 recall — FDA Z-0683-2022
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the…
Class IIFDA: TerminatedBioPro, Inc.
Medical DeviceMar 9, 2022
Microbiologics QC Sets and Panels: Helix Elite recall — FDA Z-0697-2022
Real-time shelf life testing failed at 24 months
Class IIFDA: TerminatedMicrobiologics Inc.
Medical DeviceMar 9, 2022
K2M Everest MI XT Inner Dilator, Catalog Number 5101-90167 recall — FDA Z-0705-2022
Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and…
Class IIFDA: OngoingK2M, Inc.
Medical DeviceMar 9, 2022
Respironics California Philips Respironics V60 Plus Ventilator Part Number 1138747 recall — FDA Z-0663-2022
A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a bracket may become loose and potentially damage the capacitors, which could cause the…
Class IFDA: OngoingRespironics California, LLC
Medical DeviceMar 9, 2022
Acorn 130 Stairlift, Brooks 130 Stairlift, Acorn 180 Stairlift, and Acorn Outdoor Stairlift recall — FDA Z-0681-2022
The design of the seats did not consistently have the adequate strength required to support the customers weight with continued use.
Class IIFDA: OngoingAcorn Stairlifts, Inc.
Medical DeviceMar 9, 2022
Microbiologics QC Sets and Panels: KWIK-STIK Cepheid Smart GBS QC Set (Live Culture) recall — FDA Z-0704-2022
The Lactobacillus acidophilus negative control (item 0243 single KWIK-STIK) contained in the 8164 Cepheid Xpert GBS QC Set and 8165 Cepheid Smart GBS QC Set was found to test positive for…
Class IIFDA: TerminatedMicrobiologics Inc.
Medical DeviceMar 9, 2022
BioPro Titanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG, Part ID 16816 recall — FDA Z-0685-2022
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the…
Class IIFDA: TerminatedBioPro, Inc.
Medical DeviceMar 9, 2022
Wright Medical Technology The DARCO Locking Bone Plate System is designed with rhombus recall — FDA Z-0679-2022
Product was labelled with the incorrect manufacturing and distribution dates.
Class IIFDA: TerminatedWright Medical Technology, Inc.
Medical DeviceMar 9, 2022
BioPro Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 17197 recall — FDA Z-0690-2022
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the…
Class IIFDA: TerminatedBioPro, Inc.
Medical DeviceMar 9, 2022
Intuitive Surgical da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11 recall — FDA Z-0702-2022
Conductive Cannula Reducer metal tip may get dislodged from the plastic shaft. If unnoticed, additional surgery may be required to remove the metal tip. If the procedure proceeds without…
Class IIFDA: OngoingIntuitive Surgical, Inc.
Medical DeviceMar 9, 2022
Respironics California Philips Respironics V60 Ventilator Part Number 1053617 recall — FDA Z-0662-2022
A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a bracket may become loose and potentially damage the capacitors, which could cause the…
Class IFDA: OngoingRespironics California, LLC
Medical DeviceMar 9, 2022
Abbott Molecular Alinity m Integrated Reaction Units (IRU) recall — FDA Z-0710-2022
There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot.
Class IIFDA: TerminatedAbbott Molecular, Inc.
Medical DeviceMar 9, 2022
Shimadzu Medical Systems Digital Angiography System Bransist safire Generator Model recall — FDA Z-0654-2022
Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray radiation dose rate in…
Class IIFDA: OngoingShimadzu Medical Systems
Medical DeviceMar 9, 2022
Microbiologics Helix Elite" Molecular Standards: Inactivated Standard recall — FDA Z-0700-2022
Real-time shelf life testing failed at 24 months
Class IIFDA: TerminatedMicrobiologics Inc.
Medical DeviceMar 9, 2022
Lacrimedics Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE recall — FDA Z-0709-2022
The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility.
Class IIFDA: OngoingLacrimedics Inc.
Medical DeviceMar 9, 2022
Hobbs Medical Bronchial Microbiology Brush, Catalog Number 4310 and 4320 recall — FDA Z-0711-2022
The labeling for the Microbiology Brush identifies the device as a Bronchial Microbiology Brush. The device is only cleared for gastrointestinal use and is not cleared for bronchial use.
Class IIFDA: OngoingHobbs Medical, Inc.
Medical DeviceMar 9, 2022
BioPro Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813 recall — FDA Z-0682-2022
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the…
Class IIFDA: TerminatedBioPro, 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.