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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 3721–3740 of 39,430 recalls

Class IIOngoing

stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder Arthroplasty

Tornier S.A.S.

Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.

March 5, 2025 · DeviceView details →

Class IIOngoing

MEDLINE ReNewal ENT Coblator II PROcise mAx,W/ Integrated Cable Suction & Saline (Blue), Item Number REF EICA88980R

MEDLINE INDUSTRIES, LP - Northfield

Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.

March 5, 2025 · Device

View details →

Class IIOngoing

stryker Blueprint Mixed Reality Glenoid Box Lid, Catalog Number MRUE205, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty

Tornier S.A.S.

Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.

March 5, 2025 · DeviceView details →

Class IIOngoing

Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software Version: N/A Product Description: Influenza A And Influenza B Multiplex Nucleic Acid Assay; Real Time Nucleic Acid Component: No

Abbott Diagnostics Scarborough, Inc.

the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

March 4, 2025 · DeviceView details →

Class IIOngoing

InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA

Medtronic MiniMed, Inc.

Insulin pens may have been incorrectly assembled therefore users could experience the following: either the insulin cartridge will not fit into the cartridge holder; or the cartridge holder may be difficult to remove from the insulin pen. If the issue is present, and if the user does not have backup insulin they may experience temporary hyperglycemia.

March 4, 2025 · DeviceView details →

Class IIOngoing

Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus panel nucleic acid assay system Component: No

Abbott Diagnostics Scarborough, Inc.

the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

March 4, 2025 · DeviceView details →

Class IIOngoing

Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only

Cordis US Corp

product mix-up; Vascular stent labeled as one size but contains a different size.

March 4, 2025 · DeviceView details →

Class IIOngoing

Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software Version: N/A Product Description: Influenza A And Influenza B Multiplex Nucleic Acid Assay; Real Time Nucleic Acid Component: No

Abbott Diagnostics Scarborough, Inc.

The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

March 4, 2025 · DeviceView details →

Class IIOngoing

Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version: N/A Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets Component: No

Abbott Diagnostics Scarborough, Inc.

the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

March 4, 2025 · DeviceView details →

Class IIOngoing

Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) neurostimulators

Medtronic Neuromodulation

There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used.

March 4, 2025 · DeviceView details →

Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform Model/Catalog Number: Model 200 (Catalog Number: 8700-001070-1) Software Version: Version 2.0.1 Product Description: The AutoPulse Resuscitation System Model 200 is an automated, portable, battery powered device that compresses the chest of an adult human as an adjunct to manual CPR. Component: N/A

ZOLL Circulation, Inc.

AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compressions due to code FC1060.

March 4, 2025 · DeviceView details →

Class IIOngoing

Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus panel nucleic acid assay system Component: No

Abbott Diagnostics Scarborough, Inc.

The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

March 4, 2025 · DeviceView details →

Class IIOngoing

Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version: N/A Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets Component: No

Abbott Diagnostics Scarborough, Inc.

The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

March 4, 2025 · DeviceView details →

Class IIOngoing

Cordis, REF: C09060ML, Smart Control Vascular Stent System ILIAC, 9mm X 60mm 6F, SterileEO, Rx Only

Cordis US Corp

product mix-up; Vascular stent labeled as one size but contains a different size.

March 4, 2025 · DeviceView details →

Class IIOngoing

Medline Convenience kits used for various procedures: 1) NAIL PACK, Model Number: SUT15830A;

MEDLINE INDUSTRIES, LP - Northfield

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

March 3, 2025 · DeviceView details →

Class IIOngoing

Medline Convenience kits used for various procedures: 1) ED CRASH C-SECTION TRAY, Model Number: MNS13635A; 2) C-SECTION PCH-LF, Model Number: DYNJ81281; 3) C-SECTION PACK-LF, Model Number: OBK387M; 4) C-SECTION PCH-LF, Model Number: DYNJ81281; 5) NHS - C-SECTION SCG, Model Number: DYNJ40573A; 6) C-SECTION CDS, Model Number: CDS983998C; 7) C-SECTION ADD ON PACK, Model Number: DYNJ64300A; 8) EMERGENCY BIRTH PACK, Model Number: DYNJ55205; 9) C-SECTION PACK, Model Number: DYNJ56550; 10) C-SECTION ADD ON PACK, Model Number: DYNJ83507; 11) C-SECTION CLOSURE PACK, Model Number: DYNJ83248; 12) C-SECTION PCH-LF, Model Number: DYNJ81281

MEDLINE INDUSTRIES, LP - Northfield

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

March 3, 2025 · DeviceView details →

Class IIOngoing

Refer to RES

MEDLINE INDUSTRIES, LP - Northfield

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

March 3, 2025 · DeviceView details →

Class IIOngoing

Medline Convenience kits used for various procedures: 1) CW PERI GYN, Model Number: DYNJ80807B

MEDLINE INDUSTRIES, LP - Northfield

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

March 3, 2025 · DeviceView details →

Class IIOngoing

Medline Convenience kits used for various procedures: 1) T&A ENDO PACK, Model Number: DYNJ59620A; 2) TRAY ADD A CATH FOL UM MF 10ML, Model Number: DYND150200S

MEDLINE INDUSTRIES, LP - Northfield

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

March 3, 2025 · DeviceView details →

Class IIOngoing

Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number: DYNJ84116A

MEDLINE INDUSTRIES, LP - Northfield

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

March 3, 2025 · DeviceView details →

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