Civic Data
FDA RecallsAbout

FDA Recalls

  • Food recalls
  • Drug recalls
  • Device recalls

Browse

  • All recalls

About

  • About us
  • Guides
  • Data sources
  • Privacy policy

Data

  • OpenFDA API

© 2026Civic Data · Data sourced from OpenFDA, updated weekly · Not affiliated with the U.S. Food and Drug Administration · Always verify against official FDA sources before acting

  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 61–80 of 1,000 recalls

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 · Device
View details →
Class ITerminated

Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) ASK-42703-PCCH2, c) ASK-42703-PUPM1, d) ASK-45703-NS, e) ASK-45703-PAU, f) ASK-45703-PCAM1, g) ASK-45703-PCCH2, h) ASK-45703-PN; catheter introducer

ARROW INTERNATIONAL Inc.

There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the Arrow MAC Two-Lumen Central Venous Access Kit and the Arrow Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit.

October 27, 2022 · DeviceView details →
Class ITerminated

Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter introducer

ARROW INTERNATIONAL Inc.

There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the Arrow MAC Two-Lumen Central Venous Access Kit and the Arrow Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit.

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

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 ITerminated

Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST

Remel Inc

An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.

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 ITerminated

Thermo SCIENTIFIC, Sensititre GN7F, Gram Negative IVD AST

Remel Inc

An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.

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 →
← PreviousPage 4 of 50Next →