All recall categories

Medical device recalls

Device recalls are the largest single group in this archive, because the FDA logs corrections and removals as well as outright withdrawals. Many are handled entirely between the manufacturer and a hospital and need nothing from a patient. Each notice states who has to act.

13,634 stored notices, reported between Jun 20, 2012 and Sep 9, 2026. Newest first.

Medical devices

Reported May 8, 2024

Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Abbott Medical

FDA (openFDA device enforcement)

Medical devices

Reported May 8, 2024

OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the method of freezing point depression to…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Advanced Instruments, LLC

FDA (openFDA device enforcement)

Medical devices

Reported May 8, 2024

ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part # 01-06-4;…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Advanced Research Medical, LLC

FDA (openFDA device enforcement)

Medical devices

Reported May 8, 2024

Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Alere San Diego, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported May 8, 2024

Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only,

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Allergan Sales, LLC

FDA (openFDA device enforcement)

Medical devices

Reported May 8, 2024

Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 7Fr., REF SU130-401D

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Cardinal Health 200, LLC

4 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported May 8, 2024

Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile, non-mutagenic surgical suture composed of…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Covidien, LP

FDA (openFDA device enforcement)

Medical devices

Reported May 8, 2024

Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Covidien

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported May 8, 2024

INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Innomed, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported May 8, 2024

IPS e.max ZirCAD CER/in. Prime BL1 C17/3- A zirconium oxide block for the fabrication of fixed, full-contour…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Ivoclar Vivadent Ag

5 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported May 8, 2024

Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber 21 Gauge REF OPOHF21L The…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Johnson & Johnson Surgical Vision, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported May 8, 2024

Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Medtronic Neuromodulation

FDA (openFDA device enforcement)

Medical devices

Reported May 8, 2024

Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy System and its accessories are intended…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Noah Medical

FDA (openFDA device enforcement)

Medical devices

Reported May 8, 2024

POWERSEAL 5 mm, 23 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Olympus Corporation of the Americas

2 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported May 8, 2024

The Oncology Essentials Package of the Spectral CT imaging system.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Philips North America LLC

FDA (openFDA device enforcement)

Medical devices

Reported May 8, 2024

RayStation 7.0.0.19. Radiation Therapy Treatment Planning System.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Raysearch Laboratories Ab

11 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported May 8, 2024

Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers: a. SM-20HF-Batt; b.…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Sedecal Sa

FDA (openFDA device enforcement)

Medical devices

Reported May 8, 2024

The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Stryker Neurovascular

FDA (openFDA device enforcement)

Medical devices

Reported May 8, 2024

Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

High riskUsing this product could cause serious injury, illness or death — stop using it now.

Thoratec Corp.

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported May 8, 2024

ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4 Holes, 80 MM, Sterile-…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Zimmer, Inc.

20 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported May 1, 2024

3M Durapore Surgical Tape, Catalog Number 1538-118

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

3M Company - Health Care Business

FDA (openFDA device enforcement)

Medical devices

Reported May 1, 2024

Alinity m System, Part Number: 08N53-002

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Abbott Molecular, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported May 1, 2024

Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang Hydrodissection Cannulas. These Custom…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Alcon Research, LLC

FDA (openFDA device enforcement)

Medical devices

Reported May 1, 2024

Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Baxter Healthcare Corporation

FDA (openFDA device enforcement)

Free recall alerts

Get alerted about new Medical device recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Related categories

RecallNow is not a government agency. Every notice above was published by the FDA, USDA FSIS or CPSC and links back to its source. Browse the whole archive.