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FDA Recalls
›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 781–800 of 1,000 recalls

Class IITerminated

Edwards PediaSat Oximetry Catheter Kit, REF: XT358SJ, Usable Length 8 cm, Number of Lumens 3, Exterior Diameter 5.5F, Rx Only, Sterile EO, UDI: (01)00690103197495 *NOT DISTRIBUTED WITHIN THE US

Edwards Lifesciences, LLC

There is a potential for internal leaks within catheters.

July 9, 2021 · DeviceView details →

Class IITerminated

The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem, Gelweave Straight, Gelweave Trifurcate, Gelweave Ant-Flo, and Gelweave Valsalva vascular grafts: (1) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 14 x 8mm, Bifurcate 45cm, REF 631408, sterile. (2) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 16 x 8mm, Bifurcate 45cm, REF 631608, sterile. (3) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 18 x 9mm, Bifurcate 45 cm, REF 631809, sterile. (4) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 20 x 10mm, Bifurcate 45cm, REF 632010, sterile. (5) Vascutex Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 22 x 11mm, Bifurcate 45cm, REF 632211, sterile

Vascutek, Ltd.

The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.

July 8, 2021 · DeviceView details →

Class IITerminated

Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of assisting a disabled person while providing supportive elements for assisted transportation and seating for a child or small adult not to exceed 75 pounds.

Sunrise Medical (US) LLC

The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury.

July 8, 2021 · DeviceView details →

Class IITerminated

The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t

Vascutek, Ltd.

The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.

July 8, 2021 · DeviceView details →

Class IITerminated

Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of assisting a disabled person while providing supportive elements for assisted transportation and seating for a child or small adult not to exceed 75 pounds.

Sunrise Medical (US) LLC

The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury.

July 8, 2021 · DeviceView details →

Class IITerminated

Advance Dx 100 Blood Collection Card Quantity 25 REF CMT01 Advance Dx 100 Blood Collection Card and Foil Bags Quantity 500 Cards and Foil Bags REF CMT01/F02 IFU: Advance Dx 100 SSE(Serum Separating Extraction) Technology BLOOD COLLECTION INSTRUCTIONS

Advance Dx, Inc.

Due to high glucose test results when using the blood collection cards.

July 6, 2021 · DeviceView details →

Class IITerminated

CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1, SW release 3.0.2

Zeltiq Aesthetics, Inc

An incorrect error messaging system that could potentially lead to: 1) Reporting a thermal event error causing a user to re-treating the affected anatomic area within 24 hours, 2) Not reporting a thermal event or any other error codes causing a user to continue treating without being aware that a thermal event has occurred.

July 5, 2021 · DeviceView details →

Class IITerminated

The Hero Model 100 (H-100) is a system consisting of a smart pill dispenser and a medication management app.

Hero Health

Due to dispenser prompting for a missed dose that had already been dispensed

July 2, 2021 · DeviceView details →

Class IITerminated

Torque Limiting Adaptor, AO Connect, 4 N-m, part #027-203, reusable, a component of the Bodycad Fine Osteotomy Implant and Disposable Instrumentation Tray, part #025-004.

Laboratoires Bodycad, Inc.

There is a risk of breakage of the torque limiting adaptor if used counterclockwise and it must not be used with a power tool due to no test data validating this use.

July 2, 2021 · DeviceView details →

Class IITerminated

Medline Arthroscopy Kit, convenience kit, REF DYNJ904304B, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).

Medline Industries Inc

The kits may contain an expired component.

July 1, 2021 · DeviceView details →

Class IITerminated

ACCESS SARS-CoV-2 ANTIGEN QC, REF: C68670, CONTENTS: 3 X 6.0 mL QC1, 3 x 6.0 mL QC2, 1 QC VALUE CARD, IVD, Rx Only, UDI: (01)15099590742737;

Beckman Coulter Inc.

SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .

July 1, 2021 · DeviceView details →

Class IITerminated

ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTION SOLN, IVD, Rx Only, UDI: (01)15099590743017

Beckman Coulter Inc.

SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .

July 1, 2021 · DeviceView details →

Class IITerminated

ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080

DePuy Orthopaedics, Inc.

Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement

July 1, 2021 · DeviceView details →

Class IITerminated

Medline Knee Arthroscopy Kit, convenience kit, REF DYNJ902838C, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).

Medline Industries Inc

The kits may contain an expired component.

July 1, 2021 · DeviceView details →

Class IITerminated

ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713;

Beckman Coulter Inc.

SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .

July 1, 2021 · DeviceView details →

Class IITerminated

Potassium Hydroxide 10% (KOH 10%), Cat. No. 300145 Potassium Hydroxide 10% (KOH 10%) is intended for use in the demonstration of yeast and fungal elements in wet clinical preparations. Potassium Hydroxide digests the proteinaceous material in the specimen, leaving the fungal cell wall intact for direct microscopic observation.

Gibson Bioscience

A lot of KOH 10% was made with Hydrogen Peroxide 3% instead of KOH 10%.

July 1, 2021 · DeviceView details →

Class IITerminated

Medline Total Knee, convenience kit, REF DYNJ907129B, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).

Medline Industries Inc

The kits may contain an expired component.

July 1, 2021 · DeviceView details →

Class IITerminated

Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700

Howmedica Osteonics Corp.

The internal profile of the Triathlon Prim (Baseplate) is potentially oversized; there may be a witness mark (taper) at the bottom of the internal profile of the baseplate, which prevents the insert from locking on the baseplate.

July 1, 2021 · DeviceView details →

Class IITerminated

Medline Shoulder CDS convenience kits, REF DYNJ902837D and REF DYNJ902837F, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).

Medline Industries Inc

The kits may contain an expired component.

July 1, 2021 · DeviceView details →

Class IITerminated

Access SARS-CoV-2 Antigen Calibrators, Catalog, REF: C68669, Contents: 1x2.5 mL C0, 1x2.5mL C1, 1x CAL CARD, UDI: (01)15099590742720;

Beckman Coulter Inc.

SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .

July 1, 2021 · DeviceView details →

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