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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 41–60 of 1,000 recalls

Class IITerminated

EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base

MicroPort Orthopedics Inc.

One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Base, was opened during surgery and contained ETPKN7SL lot 1916715, size 7 Evolution MP Tibial Base, in the packaging.

October 28, 2022 · DeviceView details →
Class IITerminated

NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surgical navigation platform used to perform a reverse shoulder arthroplasty on the glenoid

Medacta Usa Inc

A warning has been added to the Surgical Technique for NextAR Shoulder, advising verification of suitable patient conditions prior to placement of the NextAR Shoulder Target Holder: WARNING Target fixation requires adequate coracoid bone stability. Osteoporosis, weakness of the coracoid process, or other deficiencies, could lead to adverse events including bone fracture. Verify that the coracoid bone and relevant patient conditions are suitable before proceeding.

October 27, 2022 · DeviceView details →
Class IITerminated

CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782

Cytocell Ltd.

An error with the chromomap on version 1 of the package insert which is incorrect. The nucleotide locations specified in the insert are correct but the map has been created using the wrong coordinates.

October 27, 2022 · DeviceView details →
Class IITerminated

CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy. This device is an analyte specific reagent probe covering the 14q32.2 locus proximal to the BCL11B gene on chromosome 14. Ref: MPD39781

Cytocell Ltd.

Device is mislabeled. The package insert for this ASR device contains a chromomap - an image showing the position the FISH probe maps to on the specific chromosome. For this device the chromomap in version 1 of the package insert is incorrect and doesn't not match the probe design or specification contained on the package insert

October 27, 2022 · DeviceView details →
Class IITerminated

GREER M. FAENI, 0.25 mL 20 MG/ML, Item: K6, Analyte Specific Reagent, HYPERSENSITIVITY PNEUMONITIS test system, gel diffusion kit for demonstrating precipitating antibodies.

Greer Laboratories, Inc.

The product was recalled because stability evaluation of the lots indicated a decrease in reactivity that could lead to a potential false-negative result interpretation. The issue was identified by the firm after failing to meet lot requirements for potency. The lot release error was discovered on October 08, 2021, after a failed potency test was determined during 6-month stability evaluation of retention material for the lots. The subsequent manufacturing investigation, which included a review of the lot release potency documentation, found that the initial lot release potency test for the lot was misinterpreted.

October 25, 2022 · DeviceView details →
Class IITerminated

GREER DIA - KIT ANTIGEN M. FAENI, 2.0mL 20 MG/ML, Analyte Specific Reagent, Item: K62, HYPERSENSITIVITY PNEUMONITIS test system, gel diffusion kit for demonstrating precipitating antibodies.

Greer Laboratories, Inc.

The product was recalled because stability evaluation of the lots indicated a decrease in reactivity that could lead to a potential false-negative result interpretation. The issue was identified by the firm after failing to meet lot requirements for potency. The lot release error was discovered on October 08, 2021, after a failed potency test was determined during 6-month stability evaluation of retention material for the lots. The subsequent manufacturing investigation, which included a review of the lot release potency documentation, found that the initial lot release potency test for the lot was misinterpreted.

October 25, 2022 · DeviceView details →
Class IITerminated

TrackX Insight Base Modular Instrument Tracker, 5L, REF #604-3TX, Sterile; and TrackX Insight Base Modular Instrument Tracker, 6.5L, Model #605-3TX, Sterile.

Trackx Technology Inc

The device is breaking and falling off the Nuvasive T-Handle with Hudson Adapter on certain Nuvasive XLIF instruments during surgery when malleted.

October 24, 2022 · DeviceView details →
Class IITerminated

eSuction Small Cavity, Model ET2005

Endo-Therapeutics, Inc.

Improper device regulatory classification

October 24, 2022 · DeviceView details →
Class IITerminated

regard DAVINCI PACK, GS00137W, Item Number 880132023; gastric surgery convenience kit

ROi CPS LLC

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

October 20, 2022 · DeviceView details →
Class IITerminated

regard BASIC NEURO, NU00259R, Item Number 800021018; neuro surgery convenience kit

ROi CPS LLC

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

October 20, 2022 · DeviceView details →
Class IITerminated

regard RETINAL PACK, EY00935C, Item Number 800730003; EYE surgery convenience kit

ROi CPS LLC

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

October 20, 2022 · DeviceView details →
Class IITerminated

regard NEURO PACK, NU00278L, Item Number 800040012; nuero surgery convenience kit

ROi CPS LLC

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

October 20, 2022 · DeviceView details →
Class IITerminated

regard BASIC NEURO, NU00259S, Item Number 800021019; neuro surgery convenience kit

ROi CPS LLC

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

October 20, 2022 · DeviceView details →
Class IITerminated

regard SPINE PACK, NU00260H, Item Number 800022008; ortho surgery convenience kit

ROi CPS LLC

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

October 20, 2022 · DeviceView details →
Class IITerminated

regard HIP ARTHROSCOPY, OR01092B, Item Number 880462002; ortho surgery convenience kit

ROi CPS LLC

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

October 20, 2022 · DeviceView details →
Class IITerminated

¿regard CV¿PART¿¿1¿BUNDLE¿- MERCY¿ST¿ANTHONY , CV01005H, Item Number 830099008; cardiac surgery convenience kit

ROi CPS LLC

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

October 20, 2022 · DeviceView details →
Class IITerminated

regard CERVICAL PACK, NU00303H, Item Number 800058008; neuro surgery convenience kit

ROi CPS LLC

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

October 20, 2022 · DeviceView details →
Class IITerminated

regard SHOULDER PACK, GS00125V, Item Number 880120022; ortho surgery convenience kit

ROi CPS LLC

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

October 20, 2022 · DeviceView details →
Class IITerminated

regard SHOULDER W BCH CHAIR, OR00356F, Item Number 800203006; ortho surgery convenience kit

ROi CPS LLC

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

October 20, 2022 · DeviceView details →
Class IITerminated

regard TOTAL HIP ARTHROPLASTY A&B, OR00032W, Item Number 880028023; ortho surgery convenience kit

ROi CPS LLC

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

October 20, 2022 · DeviceView details →
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