Medical DeviceApr 5, 2023
Entopsis PCRopsis Reagent Buccal, IVD, REF 282001 recall — FDA Z-1296-2023
Presence of misleading label statements on the product label.
Class IIFDA: OngoingEntopsis, Inc.
23,781medical device recall records
2,201FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.751 records
Database records
Records — page 372
23,781 detailed records are currently available in this category.
Medical DeviceApr 5, 2023
COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D recall — FDA Z-1318-2023
Due to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inflation system.
Class IIFDA: OngoingCovidien
Medical DeviceApr 5, 2023
Limacorporate S.p.A SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210 recall — FDA Z-1317-2023
Shoulder glenoid fossa prosthesis was manufactured without tantalum markers so in the absence of the markers, on already implanted devices, a correct radiographic assessment of the hybrid…
Class IIFDA: OngoingLimacorporate S.p.A
Medical DeviceApr 5, 2023
Instrumentation Laboratory ACL ELITE PRO Refurbished)-Analyzer designed specifically for recall — FDA Z-1307-2023
Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments
Class IIFDA: OngoingInstrumentation Laboratory
Medical DeviceApr 5, 2023
Atrium Pneumostat Chest Drain Valve, Part Number 16100 recall — FDA Z-1302-2023
The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry Seal Chest Drains do not provide sufficient precaution against draining the device for…
Class IIFDA: OngoingAtrium Medical Corporation
Medical DeviceMar 29, 2023
DePuy Orthopaedics Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM recall — FDA Z-1263-2023
The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices…
Class IIFDA: OngoingDePuy Orthopaedics, Inc.
Medical DeviceMar 29, 2023
Biomet G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number recall — FDA Z-1284-2023
The outer package labeling and product etch are a 40 mm Size D liner, however, the implant is a 38 mm Size C liner.
Class IIFDA: OngoingBiomet, Inc.
Medical DeviceMar 29, 2023
DePuy Orthopaedics Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM recall — FDA Z-1266-2023
The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices…
Class IIFDA: OngoingDePuy Orthopaedics, Inc.
Medical DeviceMar 29, 2023
DePuy Orthopaedics Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM recall — FDA Z-1264-2023
The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices…
Class IIFDA: OngoingDePuy Orthopaedics, Inc.
Medical DeviceMar 29, 2023
Datascope Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbers recall — FDA Z-1277-2023
There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an…
Class IIFDA: OngoingDatascope Corp.
Medical DeviceMar 29, 2023
RAYSEARCH LABORATORIES AB Raystation treatment planning system for radiation therapy, Model recall — FDA Z-1281-2023
It is possible to set a non-zero collimator angle in the Virtual Simulation module. The angle will be correct in the user interface but if the plan is DICOM exported by using the VSIM…
Class IIFDA: OngoingRAYSEARCH LABORATORIES AB
Medical DeviceMar 29, 2023
Datascope Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31 recall — FDA Z-1276-2023
There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an…
Class IIFDA: OngoingDatascope Corp.
Medical DeviceMar 29, 2023
DePuy Orthopaedics Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM recall — FDA Z-1265-2023
The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices…
Class IIFDA: OngoingDePuy Orthopaedics, Inc.
Medical DeviceMar 29, 2023
DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B recall — FDA Z-1283-2023
The reason for the voluntary recall is due to shrinkage of the canister lid. This shrinkage causes the lid not to contact the outer shell to create a seal and thus, it does not create and…
Class IIFDA: OngoingDeRoyal Industries Inc.
Medical DeviceMar 29, 2023
Withings Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist recall — FDA Z-1280-2023
A software bug eliminated the initial ECG activation and review of the ECG under a physician. However, the device is only cleared for use under the care of a physician.
Class IIFDA: OngoingWithings
Medical DeviceMar 29, 2023
CooperVision Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90 recall — FDA Z-1282-2023
The lenses manufactured in the affected lot were made with a misaligned axis resulting in lenses with the incorrect power.
Class IIFDA: OngoingCooperVision, Inc.
Medical DeviceMar 29, 2023
Datascope Cardiosave Intra-Aortic Balloon Pump (IABP) Safety Disk, Model Number 0202-00-0140 recall — FDA Z-1278-2023
There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an…
Class IIFDA: OngoingDatascope Corp.
Medical DeviceMar 29, 2023
Datascope Cardiosave Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM) recall — FDA Z-1279-2023
There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an…
Class IIFDA: OngoingDatascope Corp.
Medical DeviceMar 29, 2023
Vapotherm Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code recall — FDA Z-1272-2023
There have been reports of excessive condensation associated with certain lots of the Low Flow Disposable Patient Circuits (DPCs) used with Precision Flow System which may lead to excessive…
Class IIFDA: OngoingVapotherm
Medical DeviceMar 29, 2023
DePuy Orthopaedics Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part recall — FDA Z-1267-2023
The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices…
Class IIFDA: OngoingDePuy Orthopaedics, Inc.
Medical DeviceMar 29, 2023
CareFusion 303 BD Pyxis Anesthesia ES System (PAS ES), REF: 327 recall — FDA Z-1207-2023
Automated dispensing cabinet drawer firmware may have inadvertently been downgraded to an earlier version of drawer firmware during new device installations or device replacement upgrades,…
Class IIFDA: OngoingCareFusion 303, Inc.
Medical DeviceMar 22, 2023
Becton Dickinson & Company BD Ultra-Fine Insulin Syringe 0.5mL, 8mm, 31G-Insulin Syringes recall — FDA Z-1240-2023
Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection.
Class IIFDA: OngoingBecton Dickinson & Company
Medical DeviceMar 22, 2023
Becton Dickinson & Company BD Insulin Syringes with the BD Micro-Fine IV Needle 0.5ml recall — FDA Z-1242-2023
Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection.
Class IIFDA: OngoingBecton Dickinson & Company
Medical DeviceMar 22, 2023
Intuitive Surgical Patient Side Cart, REF: 380620, with instrument arms, used as part of the recall — FDA Z-1262-2023
Preventative maintenance data was used to identify instrument Arms, part of surgical systems, that allow surgeons to perform surgical tasks, that may be at risk of insertion ballscrew…
Class IIFDA: OngoingIntuitive Surgical, 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.