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  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

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

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 441–460 of 1,000 recalls

Class IITerminated

Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk

Stradis Medical, LLC dba Stradis Healthcare

This recall has been initiated to address bulk packed, non-sterile Intravascular Administration Sets that were erroneously distributed to fill orders for the sterile version of the same Intravascular Administration Set.

October 28, 2021 · DeviceView details →
Class IITerminated

EVLP Convenience Pack/Kit

Medline Industries Inc

NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.

October 27, 2021 · DeviceView details →
Class IITerminated

Venous Access Pack-LF Convenience Kit

Medline Industries Inc

NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.

October 27, 2021 · DeviceView details →
Class IITerminated

Major Vascular CDS Convenience Kit

Medline Industries Inc

NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.

October 27, 2021 · DeviceView details →
Class IITerminated

Bedside PICC CDS Convenience Kit

Medline Industries Inc

NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.

October 27, 2021 · DeviceView details →
Class IITerminated

Neuro Convenience Kit

Medline Industries Inc

NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.

October 27, 2021 · DeviceView details →
Class IITerminated

MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441

Aesculap Implant Systems LLC

Set screwdriver fails during surgery by deforming at the tip during engagement and manipulation of the implant.

October 25, 2021 · DeviceView details →
Class IITerminated

ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954

MEDLINE INDUSTRIES, LP - Northfield

Product was shipped from a Medline warehouse to a customer at room temperature instead of refrigerated (ice). If affected product is used, the results from this impacted Calcium reagent will not be provided due to probable Quality Control failure. A delay in diagnosis may be experienced with repeat testing resulting in patient (customer) inconvenience, pain, and cost of the repeat blood draw and testing. All HII1220001954 product shipped/stored at a Medline branch between July 2021 and August 2021 in the identified lots were incorrectly stored and shipped. Six (6) boxes have been shipped to end users at room temperature instead of refrigerated (ice). Five (5) boxes are on hold at a Medline warehouse.

October 22, 2021 · DeviceView details →
Class IITerminated

Artis Q.zen ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848354

Siemens Medical Solutions USA, Inc

If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure

October 20, 2021 · DeviceView details →
Class IITerminated

Artis Q floor with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848280

Siemens Medical Solutions USA, Inc

If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure

October 20, 2021 · DeviceView details →
Class IITerminated

Artis Q biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848282

Siemens Medical Solutions USA, Inc

If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure

October 20, 2021 · DeviceView details →
Class IITerminated

Artis zee floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094135

Siemens Medical Solutions USA, Inc

If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure

October 20, 2021 · DeviceView details →
Class IITerminated

Artis zee ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number:10094137

Siemens Medical Solutions USA, Inc

If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure

October 20, 2021 · DeviceView details →
Class IITerminated

Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number 100002824 Subcomponent of: SARS-CoV-2 Go-Strips, 3000555; SARS-CoV-2 Go-Plates, 3000562; SARS-Cov-2 Bulk Vials, 3000564

Biomeme, Inc.

The current IFU specifies a shelf-life of one week after resuspension of the RPC Buffer when stored at room temperature. Ongoing stability studies have indicated the need to shorten the life of the RPC Buffer once resuspended from the current instruction of one week to two days when stored at room temperature (15degC-30degC).

October 20, 2021 · DeviceView details →
Class IITerminated

Artis Q.zen biplane with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number:10848355

Siemens Medical Solutions USA, Inc

If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure

October 20, 2021 · DeviceView details →
Class IITerminated

Artis zee biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094141

Siemens Medical Solutions USA, Inc

If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure

October 20, 2021 · DeviceView details →
Class IITerminated

Aspiration Syringe Kit, REF: MVSK60

MICROVENTION INC.

Syringe Kits labeled for distribution OUS were inadvertently shipped to US customers.

October 20, 2021 · DeviceView details →
Class IITerminated

Artis Q ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848281

Siemens Medical Solutions USA, Inc

If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure

October 20, 2021 · DeviceView details →
Class IITerminated

Artis Q.zen floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848353

Siemens Medical Solutions USA, Inc

If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure

October 20, 2021 · DeviceView details →
Class IITerminated

Artis zee multi-purpose with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094139

Siemens Medical Solutions USA, Inc

If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure

October 20, 2021 · DeviceView details →
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