Medical DeviceApr 20, 2022
Abbott Vascular 20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01) recall — FDA Z-0921-2022
Due to an increase in complaint trend for leaks and intermittent/loose connections.
Class IIFDA: OngoingAbbott Vascular
24,239medical device recall records
2,205FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.751 records
Database records
Records — page 440
24,239 detailed records are currently available in this category.
Medical DeviceApr 20, 2022
Nextremity Solutions Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit SKU recall — FDA Z-0912-2022
Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
Class IIFDA: TerminatedNextremity Solutions
Medical DeviceApr 20, 2022
Integra Universal Flexible Arm part number REF 1362275 recall — FDA Z-0906-2022
Excess force used to tighten the Universal Flexible Arm can cause the internal cable to break at the tip, resulting in an unusable condition.
Class IIFDA: OngoingIntegra LifeSciences Corp.
Medical DeviceApr 20, 2022
Graphic Controls Acquisition CLARAVUE Pre-wired Electrode - IP SET 12 RT ADULT-US Model recall — FDA Z-0938-2022
Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the…
Class IIFDA: TerminatedGraphic Controls Acquisition Corporation
Medical DeviceApr 20, 2022
Stanbio Laboratory Separation Technology Creamatocrit Plus recall — FDA Z-0905-2022
The device was being marketed as an IVD without a 510(k). Therefore, performance characteristics of these breast milk analyzers have not been adequately validated. An erroneous result could…
Class IIFDA: TerminatedStanbio Laboratory, LP
Medical DeviceApr 20, 2022
Volcano IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101 recall — FDA Z-0901-2022
Multi-Modality Touch Screen Modules (MM-TSM), which are bedside/secondary control units, used as part of Mobile IVUS systems, are missing the following labeling information: Unique Device…
Class IIIFDA: OngoingVolcano Corp
Medical DeviceApr 20, 2022
Volcano MM-TSM recall — FDA Z-0917-2022
Multi-Modality Touch Screen Modules (MM-TSM), used with integrated IVUS systems, may crack, or become damaged, which may affect their usability. They could become non-functional. Therefore,…
Class IIIFDA: OngoingVolcano Corp
Medical DeviceApr 20, 2022
Merit Medical Systems AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001 recall — FDA Z-0904-2022
A design change made to a hemostasis valve to improve manufacturability caused an internal gap between the rotator and the Y-body, where the guidewire can get caught, resulting in…
Class IIFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceApr 20, 2022
Nextremity Solutions Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU recall — FDA Z-0910-2022
Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
Class IIFDA: TerminatedNextremity Solutions
Medical DeviceApr 20, 2022
Nextremity Solutions Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut recall — FDA Z-0911-2022
Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
Class IIFDA: TerminatedNextremity Solutions
Medical DeviceApr 20, 2022
Graphic Controls Acquisition CLARAVUE Pre-wired Electrode - IP SET 5V RT ADULT Model recall — FDA Z-0940-2022
Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the…
Class IIFDA: TerminatedGraphic Controls Acquisition Corporation
Medical DeviceApr 20, 2022
Graphic Controls Acquisition CLARAVUE Pre-wired Electrode - IP SET M5 RT ADULT-US Model recall — FDA Z-0937-2022
Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the…
Class IIFDA: TerminatedGraphic Controls Acquisition Corporation
Medical DeviceApr 20, 2022
Graphic Controls Acquisition CLARAVUE Pre-wired Electrode - IP SET 6V RT ADULT-US Model recall — FDA Z-0939-2022
Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the…
Class IIFDA: TerminatedGraphic Controls Acquisition Corporation
Medical DeviceApr 20, 2022
Merit Medical Systems Access-9 Large Bore Hemostasis Valves, Catalog Code: 580775001 recall — FDA Z-0903-2022
A design change made to a hemostasis valve to improve manufacturability caused an internal gap between the rotator and the Y-body, where the guidewire can get caught, resulting in…
Class IIFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceApr 20, 2022
Graphic Controls Acquisition CLARAVUE Pre-wired Electrode IP-SET N3 - PEDIATRIC-US Model recall — FDA Z-0935-2022
Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the…
Class IIFDA: TerminatedGraphic Controls Acquisition Corporation
Medical DeviceApr 20, 2022
Abbott Vascular 20/30 Priority Pack Accessory Kit/.096 RHV - REF 1000186 WPL2122270-01 recall — FDA Z-0922-2022
Due to an increase in complaint trend for leaks and intermittent/loose connections.
Class IIFDA: OngoingAbbott Vascular
Medical DeviceApr 20, 2022
Varian Medical Systems Imaging Laboratory GmbH ARIA Radiation Therapy Management (RTM) recall — FDA Z-0942-2022
Software issue for treatment plan and image management application may result in mismatch values which could result in treatment in the wrong location
Class IIFDA: CompletedVarian Medical Systems Imaging Laboratory GmbH
Medical DeviceApr 20, 2022
Abbott Vascular 20/30 Priority Pack w/COPILOT - REF 1003327 WPL2122272-01 (2019-03-01) recall — FDA Z-0923-2022
Due to an increase in complaint trend for leaks and intermittent/loose connections.
Class IIFDA: OngoingAbbott Vascular
Medical DeviceApr 20, 2022
MEDLINE INDUSTRIES, LP - Northfield Hydroxybutyrate LiquiColor Tests - includes 3 bottles recall — FDA Z-0932-2022
Product was improperly store which may cause a delay in results.
Class IIFDA: TerminatedMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceApr 13, 2022
Maquet Cardiovascular Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001 recall — FDA Z-0887-2022
Potential for corrosion on the pins of the Ultima Activator II Reusable Drive Mechanism. Harms may include allergic reaction, metal toxicity, and other delayed responses.
Class IIFDA: OngoingMaquet Cardiovascular, LLC
Medical DeviceApr 13, 2022
Volcano SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version recall — FDA Z-0885-2022
If FFR measurement(s) are made prior to an iFR/FFR co-registration/pullback in the same procedural session, this could result in incorrect iFR/FFR Co-Registration results to be displayed,…
Class IIFDA: OngoingVolcano Corporation
Medical DeviceApr 13, 2022
GE Healthcare Signa 1.5T TwinSpeed Magnetic Resonance Imaging System recall — FDA Z-0857-2022
There is potential for the images to be flipped left to right.
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceApr 13, 2022
Shimadzu Medical Systems MODEL: X-RAY TV SYSSTEM SONIALVISION safire17 recall — FDA Z-0869-2022
It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting criteria in…
Class IIFDA: OngoingShimadzu Medical Systems
Medical DeviceApr 13, 2022
DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic recall — FDA Z-0879-2022
A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.
Class IIFDA: TerminatedDeRoyal Industries 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.