Medical DeviceAug 18, 2021
Edwards PediaSat Oximetry Catheter Set, REF: XT358SP, Exterior Diameter 5.5F (1.83 mm) recall — FDA Z-2281-2021
There is a potential for internal leaks within catheters.
Class IIFDA: TerminatedEdwards Lifesciences, LLC
Monthly breakdown
2021 recalls by month
Select a month to review the recall records reported during that period.
December 2021194 records · 4 categoriesNovember 2021210 records · 4 categoriesOctober 2021342 records · 4 categoriesSeptember 2021300 records · 4 categoriesAugust 2021279 records · 4 categoriesJuly 2021251 records · 4 categoriesJune 2021361 records · 4 categoriesMay 2021226 records · 4 categoriesApril 2021279 records · 4 categoriesMarch 2021241 records · 4 categoriesFebruary 2021320 records · 4 categoriesJanuary 2021226 records · 4 categories
2021 recalls — page 50
Records are ordered by the best available source date.
Medical DeviceAug 18, 2021
Biomet Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 60 MM Item recall — FDA Z-2263-2021
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
Baxter Healthcare Dose IQ Safety Software used with Spectrum IQ Infusion Pump recall — FDA Z-2165-2021
Software issue: The defect creates a mismatch between linked drug identifiers (IDs) in the Dose IQ user interface (UI) and the binary drug library (BDL) loaded onto the Spectrum IQ pump.
Class IFDA: TerminatedBaxter Healthcare Corporation
Medical DeviceAug 18, 2021
Biomet Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 70 MM Item recall — FDA Z-2270-2021
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
Stryker Medical Division of Stryker S3 MedSurg Bed - intended to support and transport recall — FDA Z-2214-2021
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 EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL recall — FDA Z-2258-2021
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
Dutch Ophthalmic USA The device is a 25-gauge infusion line that is part of 25-gauge recall — FDA Z-2252-2021
Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line
Class IIFDA: OngoingDutch Ophthalmic USA, Inc.
Medical DeviceAug 18, 2021
Edwards PediaSat Oximetry Catheter Set, REF: XT3515SJ, Exterior Diameter 5.5F, Usable Length recall — FDA Z-2283-2021
There is a potential for internal leaks within catheters.
Class IIFDA: TerminatedEdwards Lifesciences, LLC
Medical DeviceAug 18, 2021
HeartWare HVAD Pump Accessories, REF MCS1753AK recall — FDA Z-2197-2021
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
Beckman Coulter ACCESS SARS-CoV-2 ANTIGEN QC, REF: C68670, CONTENTS: 3 X 6.0 mL QC1, 3 x 6.0 recall — FDA Z-2257-2021
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 A, 70 MM Item Number recall — FDA Z-2267-2021
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
Stryker Medical Division of Stryker InTouch 2131-intended to support a human patient in an recall — FDA Z-2210-2021
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
Biomet Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 60 MM Item recall — FDA Z-2265-2021
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
Simpleware ScanIP medical software recall — FDA Z-2254-2021
A issue (bug) has been identified with the interface and image software which could result in anatomical orientation tags/labels being displayed incorrectly. This could result in operator…
Class IIFDA: TerminatedSimpleware Product Group, SYNOPSYS NORTHERN EUROPE
Medical DeviceAug 18, 2021
Biomet Arcos Modular Revision Hip System Standard Cone Prox Body, Size C, 80 MM Item Number recall — FDA Z-2274-2021
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
Stryker Medical Division of Stryker Michael Graves with Stryker Highback Chair-intended for recall — FDA Z-2219-2021
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
HeartWare HVAD Outflow Graft, REF MCS1725OG recall — FDA Z-2196-2021
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 S3 MedSurg Bed - intended to support and transport recall — FDA Z-2216-2021
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
HeartWare HVAD Pump Implant Kit, REF 1153 recall — FDA Z-2191-2021
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
Simpleware ScanIP software recall — FDA Z-2253-2021
A issue (bug) has been identified with the interface and image software which could result in anatomical orientation tags/labels being displayed incorrectly. This could result in operator…
Class IIFDA: TerminatedSimpleware Product Group, SYNOPSYS NORTHERN EUROPE
Medical DeviceAug 18, 2021
Bard Peripheral Vascular TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with recall — FDA Z-2247-2021
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
Stryker Medical Division of Stryker Prime Big Wheel Stretcher-used as a short-term recall — FDA Z-2208-2021
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
Shent USA Grasper/Retriever, Alligator Jaw 2.4 mm x 5 mm x 230 cm recall — FDA Z-2229-2021
Mislabeled: Devices labeled as catalog #7208 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 230 cm) may actually be catalog #7226 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 8 mm…
Class IIFDA: CompletedShent USA, Inc.
Medical DeviceAug 18, 2021
Biomet Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM Item Number recall — FDA Z-2259-2021
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.
About the 2021 recall archive
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.