Medical DeviceAug 18, 2021
Edwards PediaSat Oximetry Catheter Kit, REF: XT3515SP, Exterior Diameter 5.5F (1.83 mm) recall — FDA Z-2279-2021
There is a potential for internal leaks within catheters.
Class IIFDA: TerminatedEdwards Lifesciences, LLC
24,239medical device recall records
2,205FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.751 records
Database records
Records — page 485
24,239 detailed records are currently available in this category.
Medical DeviceAug 18, 2021
Stryker Medical Division of Stryker GoBed II MedSurg Bed, Model Number FL28, Part #FL28EX recall — FDA Z-2223-2021
Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the…
Class IIFDA: OngoingStryker Medical Division of Stryker Corporation
Medical DeviceAug 18, 2021
Carl Zeiss Meditec Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX recall — FDA Z-2227-2021
Due to failure to acquire pre-market clearance for its high resolution tomographic/biomicroscope imaging device (Model 6000) prior to commercializing the device.
Class IIFDA: OngoingCarl Zeiss Meditec, Inc.
Medical DeviceAug 18, 2021
Stryker Medical Division of Stryker IsoGel Air - support surface assists in the prevention recall — FDA Z-2213-2021
Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the…
Class IIFDA: OngoingStryker Medical Division of Stryker Corporation
Medical DeviceAug 18, 2021
Merit Medical Systems Prelude SNAP Splittable Sheath Introducer, REF: PLS-1007, size 7F recall — FDA Z-2239-2021
There is a potential that 7F sheaths are packaged as 10F sheaths.
Class IIFDA: TerminatedMerit Medical Systems, Inc.
Medical DeviceAug 18, 2021
Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X recall — FDA Z-2235-2021
The balloon protective sheath may potentially be contaminated with a foreign material left over from the manufacturing process. The contaminant may transfer over from the sheath to the…
Class IIFDA: TerminatedCordis Corporation
Medical DeviceAug 18, 2021
Bard Peripheral Vascular TIN3018 Illinois Bone Marrow Aspiration/Intraosseous Infusion recall — FDA Z-2249-2021
Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.
Class IIFDA: OngoingBard Peripheral Vascular Inc.
Medical DeviceAug 18, 2021
Advance Dx 100 Blood Collection Card Quantity 25 REF CMT01 Advance Dx 100 Blood Collection recall — FDA Z-2237-2021
Due to high glucose test results when using the blood collection cards.
Class IIFDA: TerminatedAdvance Dx, Inc.
Medical DeviceAug 18, 2021
BioFire Diagnostics FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label recall — FDA Z-2245-2021
Due to product complaints received for false negative results (dropouts) with blood culture identification panel potential caused by a pouch manufacturing error.
Class IIFDA: TerminatedBioFire Diagnostics, LLC
Medical DeviceAug 18, 2021
Edwards PediaSat Oximetry Catheter Set, REF: XT358KTP, Exterior Diameter 5.5F, Usable Length recall — FDA Z-2282-2021
There is a potential for internal leaks within catheters.
Class IIFDA: TerminatedEdwards Lifesciences, LLC
Medical DeviceAug 18, 2021
Biomet Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 60 MM Item Number recall — FDA Z-2261-2021
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Class IIFDA: TerminatedBiomet, Inc.
Medical DeviceAug 18, 2021
HeartWare HVAD Implant Kit, REF MCS1705PU recall — FDA Z-2195-2021
Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events…
Class IFDA: OngoingHeartware, Inc.
Medical DeviceAug 18, 2021
Stryker Medical Division of Stryker Surgistool-intended to support a healthcare professional recall — FDA Z-2206-2021
Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the…
Class IIFDA: OngoingStryker Medical Division of Stryker Corporation
Medical DeviceAug 18, 2021
Beckman Coulter Access SARS-CoV-2 Antigen Calibrators, Catalog, REF: C68669, Contents: 1x2.5 recall — FDA Z-2256-2021
SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .
Class IIFDA: TerminatedBeckman Coulter Inc.
Medical DeviceAug 18, 2021
Biomet Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 70 MM Item Number recall — FDA Z-2268-2021
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Class IIFDA: TerminatedBiomet, Inc.
Medical DeviceAug 18, 2021
Integra LifeSciences CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to recall — FDA Z-2224-2021
Packaging-pouches with wrinkles across the Tyvek side may compromise the integrity of the pouch's sterile barrier
Class IIFDA: TerminatedIntegra LifeSciences Corp.
Medical DeviceAug 18, 2021
Stryker Medical Division of Stryker Electric MedSurg Bed FL23 - AC-powered adjustable recall — FDA Z-2222-2021
Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the…
Class IIFDA: OngoingStryker Medical Division of Stryker Corporation
Medical DeviceAug 18, 2021
Stryker Medical Division of Stryker TruRize Clinical Chair - support structure that places recall — FDA Z-2217-2021
Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the…
Class IIFDA: OngoingStryker Medical Division of Stryker Corporation
Medical DeviceAug 18, 2021
Stryker Medical Division of Stryker Isolibrium Support Surface - support surface assists in recall — FDA Z-2215-2021
Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the…
Class IIFDA: OngoingStryker Medical Division of Stryker Corporation
Medical DeviceAug 18, 2021
Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to recall — FDA Z-2240-2021
Potential for a manufacturing assembly error-may result in a non-functional audio indicator of device activation or a non-functional device, may cause unintended thermal burn, hemorrhage,…
Class IIFDA: TerminatedCovidien LLC
Medical DeviceAug 18, 2021
QURA S.R.L Spectrum Medical Quantum Standard heat exchanger recall — FDA Z-2277-2021
Product labeled as sterile may not have been adequately sterilized. In addition, these devices were imported to the US distributor, but the devices are not 510(k) cleared in the US.
Class IIFDA: TerminatedQURA S.R.L.
Medical DeviceAug 18, 2021
Stryker Medical Division of Stryker Prime TC-transport chair intended for medical purposes recall — FDA Z-2209-2021
Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the…
Class IIFDA: OngoingStryker Medical Division of Stryker Corporation
Medical DeviceAug 18, 2021
Edwards PediaSat Oximetry Catheter Kit, REF: XT358SJ, Usable Length 8 cm, Number of Lumens recall — FDA Z-2280-2021
There is a potential for internal leaks within catheters.
Class IIFDA: TerminatedEdwards Lifesciences, LLC
Medical DeviceAug 11, 2021
ROi CPS Regard NEWBORN KIT, LD00201K, Item Number: 830016011 recall — FDA Z-2168-2021
Instructions for use updated to include the following cautionary statement for the heel warmer, "Activate away from the user's face and away from the infant and others."
Class IIFDA: TerminatedROi CPS LLC
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.