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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

Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 18 MM, 55 MM Long Item Number: 113618

Biomet, Inc.

The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor.

January 7, 2022 · DeviceView details →
Class IITerminated

Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 11 MM, 83 MM Long Item Number: 113631

Biomet, Inc.

The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor.

January 7, 2022 · DeviceView details →
Class IITerminated

Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 14 MM, 55 MM Long Item Number: 113614

Biomet, Inc.

The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor.

January 7, 2022 · DeviceView details →
Class IITerminated

ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154909003

DePuy Orthopaedics, Inc.

May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur.

January 5, 2022 · DeviceView details →
Class IITerminated

ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154706001

DePuy Orthopaedics, Inc.

May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur.

January 5, 2022 · DeviceView details →
Class IITerminated

eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version 4.5.1, eCareManager version 4.5.2, eCareManager version 4.6.0- a software tool intended for use by trained medical staff providing supplemental remote support to bedside care teams in the management and care of in-hospital patients. Model Number: 865325

Philips North America Llc

eCareManager (eCM) Sentry Score software not approved for use

January 3, 2022 · DeviceView details →
Class IITerminated

CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal Antigen in serum and CSF, REF CR2003, IVD, UDI: (01)00816387020919

Immuno-Mycologics, Inc

The firm found immunoassay products used to detect cryptococcal antigen in serum and cerebrospinal fluid to have reduced specificity (90% now versus 99% before). As a result, a small number of samples with positive test results may be false positives, which may cause some patients to initiate unnecessary anti-fungal therapy. Samples with negative test results are NOT affected.

January 3, 2022 · DeviceView details →
Class IITerminated

Exeter V40 Cemented Hip (150mm) Stem, Part Number 0580-1-440

Howmedica Osteonics Corp.

There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem.

December 30, 2021 · DeviceView details →
Class IITerminated

Exeter V40 Cemented Hip (125mm) Stem, Part Number 0580-1-044

Howmedica Osteonics Corp.

There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem.

December 30, 2021 · DeviceView details →
Class IITerminated

X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.

XTANT Medical

The proximal opening of the inserts exhibit an out of specification condition which would prevent the crossbar plates from appropriately engaging with the insert.

December 29, 2021 · DeviceView details →
Class IITerminated

MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032

Stryker Leibinger GmbH & Co. KG

Inside the packaging of one reported item a non-conforming product was found. Contrary to the design, the barrier layer was manufactured on the inferior side of the implant versus the superior side.

December 29, 2021 · DeviceView details →
Class ITerminated

Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02

CELLTRION USA INC

The affected lot was placed under quarantine in September 2021 due to complaints of alleged false positives, but 243 kits were erroneously released to customers in December 2021.

December 28, 2021 · DeviceView details →
Class IITerminated

MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL

Avanos Medical, Inc.

The External Retention Bolster contained in the kit may be a larger diameter than the tube.

December 22, 2021 · DeviceView details →
Class IITerminated

MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL

Avanos Medical, Inc.

The External Retention Bolster contained in the kit may be a larger diameter than the tube.

December 22, 2021 · DeviceView details →
Class IITerminated

8mm FlexDex Needle Driver, Product Code FD-335 ND

FlexDex Inc.

The firm is reinforcing the IFU instructions: "Do not use if the package is damaged." If upon inspection of the packaging, any damage is observed, including pinholes or tears in the pouch, the product should not be used.

December 22, 2021 · DeviceView details →
Class IITerminated

C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293

DRG International, Inc.

ODs of the standards too low(< 0.6 ODmax) may cause invalid runs, delayed patient results are possible

December 21, 2021 · DeviceView details →
Class ITerminated

bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator, 301.100.130. The bellavista 1000/1000e ventilator is intended to provide positive pressure ventilatory support to adult and pediatric patients, and optionally, infant and neonatal patients.

Vyaire Medical

Potential cessation in ventilation can occur under specific conditions.

December 20, 2021 · DeviceView details →
Class IITerminated

API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the identification of yeasts. It uses miniaturized tests as well as a specially adapted database. After manual inoculation of the strip, reading can be performed either automatically or manually and the identification is obtained using an identification software.

Biomerieux Inc

Risk of misidentification or delayed results with the absence of identification due to thermoforming defect.

December 20, 2021 · DeviceView details →
Class IIITerminated

Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 System configuration. A cardiopulmonary bypass speed control device.

LivaNova Deutschland GmbH

One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.

December 17, 2021 · DeviceView details →
Class IITerminated

NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R

Nobel Biocare Usa Llc

Due to 16 complaints related to drivers not engaging in implants. According to the firm's investigations, the incorrect offset gauge was potentially used during production of the implants. As a result, this could potentially lead to aborted or a delay in surgical procedure.

December 17, 2021 · DeviceView details →
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