Medical DeviceApr 1, 2020
Cook Pericardiocentesis Set, Irrigation Catheter, Reference Part Number recall — FDA Z-1565-2020
The printed expiration dates are incorrect.
Class IIFDA: TerminatedCook Inc.
25,676medical device recall records
2,265FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.759 records
Database records
Records — page 628
25,676 detailed records are currently available in this category.
Medical DeviceApr 1, 2020
Hill-Rom NaviCare Patient Safety Software Versions 3.5.400-3.9.300 recall — FDA Z-1554-2020
There is a software issue which may result in failure to monitor or control patient's bed exit mechanism.
Class IIFDA: TerminatedHill-Rom Inc.
Medical DeviceApr 1, 2020
Carroll-Baccari MVAP MEDICAL SUPPLIES INC, Mavidon CardioPrep Single, 24 use cups, Re order recall — FDA Z-1550-2020
Samples of 114gm tubes of Lemon Prep, collected during a Food and Drug Administration inspection on October 15, 2019 were tested and found to be contaminated with Burkholderia cepacia.…
Class IIFDA: TerminatedCarroll-Baccari, Inc.
Medical DeviceApr 1, 2020
Medtronic MiniMed Paradigm Insulin pump, model number MMT-523 recall — FDA Z-1591-2020
The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An…
Class IIFDA: OngoingMedtronic MiniMed
Medical DeviceApr 1, 2020
Micro Therapeutics Inc., Dba Ev3 Neurovascular ev3 Pipeline Flex Embolization Device with recall — FDA Z-1528-2020
Embolization device delivery system may fracture at the distal section during device implantation. A weakened bond may result in unintended separation, where the distal portion of the…
Class IFDA: TerminatedMicro Therapeutics Inc., Dba Ev3 Neurovascular
Medical DeviceApr 1, 2020
Signature Orthopaedics Europe Encina HA Femoral Stem, Size 11 Coxa Vara Collared, REF recall — FDA Z-1568-2020
The firm has identified that packaging containing components of the hip replacement range are mislabeled. This could result in the product intended to be used for a procedure not included…
Class IIFDA: OngoingSignature Orthopaedics Europe Ltd
Medical DeviceApr 1, 2020
Bard Peripheral Vascular 1. Groshong 9.5 Dual-Lumen CV Catheter, Ref: 7726950, UDI recall — FDA Z-1574-2020
Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr…
Class IIFDA: TerminatedBard Peripheral Vascular Inc.
Medical DeviceApr 1, 2020
LivaNova USA VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 recall — FDA Z-1563-2020
False positive warning may occur after: 1) VNS Generator interrogated at 0mA normal output current, 2) Generator programmed to non-0mA output current, 3) In-session re-interrogation…
Class IIFDA: OngoingLivaNova USA Inc.
Medical DeviceApr 1, 2020
Siemens Healthcare Diagnostics Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for recall — FDA Z-1536-2020
Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceMar 25, 2020
Philips Integris Allura 9, system codes 722018 722021 recall — FDA Z-1488-2020
A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.
Class IIFDA: TerminatedPhilips North America, LLC
Medical DeviceMar 25, 2020
Philips Cardio Vascular-Allura Centron, system code 722400 recall — FDA Z-1494-2020
A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.
Class IIFDA: TerminatedPhilips North America, LLC
Medical DeviceMar 25, 2020
CRHF Medtronic CareLink 2090 Programmer recall — FDA Z-1524-2020
Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: improper access control and the cleartext transmission of sensitive information.
Class IIFDA: OngoingMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medical DeviceMar 25, 2020
Avid Medical Custom procedure trays containing medical components needed to facilitate recall — FDA Z-1517-2020
The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no…
Class IIFDA: TerminatedAvid Medical, Inc.
Medical DeviceMar 25, 2020
Siemens Healthcare Diagnostics IMMULITE 2000 Systems E2 Estradiol Catalog #: US: L2KE22(D) recall — FDA Z-1514-2020
Due to high discordant Estradiol results which.potentially affects all patient populations, A falsely elevated estradiol level could lead a clinician to misinterpret a patient as…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceMar 25, 2020
AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system recall — FDA Z-1502-2020
Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures.
Class IIFDA: TerminatedAgfa N.V.
Medical DeviceMar 25, 2020
XTANT MEDICAL OsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc in a syringe recall — FDA Z-1526-2020
The firm received one customer complaint concerning three OsteoSelect Demineralized Bone Matrix (DBM) devices which contained 5.0cc of putty, instead of 10.00cc of putty as labeled.
Class IIFDA: TerminatedXTANT MEDICAL Inc.
Medical DeviceMar 25, 2020
Siemens Medical Solutions USA Artis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling recall — FDA Z-1496-2020
A software issue could potentially cause the stand and table movements to be blocked.
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceMar 25, 2020
LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to recall — FDA Z-1498-2020
The firm is providing validated cleaning and disinfection instructions in their revised operating instructions to reduce the risk of NTM contamination.
Class IIFDA: TerminatedLivaNova USA Inc.
Medical DeviceMar 25, 2020
Avid Medical Custom procedure trays containing medical components needed to facilitate recall — FDA Z-1521-2020
The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no…
Class IIFDA: TerminatedAvid Medical, Inc.
Medical DeviceMar 25, 2020
Philips UroDiagnost Eleva, system code 708033 recall — FDA Z-1492-2020
A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.
Class IIFDA: TerminatedPhilips North America, LLC
Medical DeviceMar 25, 2020
Avid Medical Custom procedure trays containing medical components needed to facilitate recall — FDA Z-1523-2020
The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no…
Class IIFDA: TerminatedAvid Medical, Inc.
Medical DeviceMar 25, 2020
Aesculap Implant Systems Columbus R/PS TIB.PLATEAU Cemented, various sizes, Knee implant recall — FDA Z-1478-2020
Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.
Class IIFDA: TerminatedAesculap Implant Systems LLC
Medical DeviceMar 25, 2020
TeDan Surgical Innovations D-0014 3COR 14MM DISTRACTION SCREWS, 5/BOX, STERILE - Product recall — FDA Z-1504-2020
The items identified for recall are labeled as sterile. However, the manufacturer has found that product packaging for the lots listed above may be damaged, potentially exposing the product…
Class IIFDA: TerminatedTeDan Surgical Innovations LLC
Medical DeviceMar 25, 2020
Avid Medical Custom procedure trays containing medical components needed to facilitate recall — FDA Z-1518-2020
The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no…
Class IIFDA: TerminatedAvid Medical, 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.