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.
Reported Jul 12, 2023
OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.NeuroLogica Corporation
FDA (openFDA device enforcement)
Reported Jul 12, 2023
Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for Use
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Respironics, Inc.
FDA (openFDA device enforcement)
Reported Jul 12, 2023
KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Pro-Dex Inc.
FDA (openFDA device enforcement)
Reported Jul 12, 2023
Quidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Troponin I), 97022HS (CK-MB and Troponin I), 97000HSEU,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Quidel Cardiovascular Inc.
FDA (openFDA device enforcement)
Reported Jul 12, 2023
Aptio Automation Storage and Retrieval Module (SRM)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Jul 12, 2023
BETTA LINK SR KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in the repair of the natural…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.T.a.g. Medical Products Corporation, Ltd.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 12, 2023
SurgiMend; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 1.0 5x6 cm, 1.0 6x12 cm, 1.0 10x10 cm, 1.0…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.TEI Biosciences, Inc.
16 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 12, 2023
Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT retractor
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teleflex LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 12, 2023
LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lateral Left, 5mm- Intended for primary and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Waldemar Link GmbH & Co. KG (Mfg Site)
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 12, 2023
Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wright Medical Technology, Inc.
FDA (openFDA device enforcement)
Reported Jul 12, 2023
NexGen Precoat Stemmed Tibial Plate Size 5
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
FDA (openFDA device enforcement)
Reported Jul 5, 2023
RelieVR REF: RVX-2002, Rx Only. Virtual reality behavioral therapy device for pain relief.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Appliedvr
FDA (openFDA device enforcement)
Reported Jul 5, 2023
Perifix¿ / Epidural anesthesia kit (10 count carton)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 5, 2023
Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Centrella Bed
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 5, 2023
Access Hybritech p2PSA reagent, REF B03704 and REF A49752.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
FDA (openFDA device enforcement)
Reported Jul 5, 2023
Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien, LLC
FDA (openFDA device enforcement)
Reported Jul 5, 2023
Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DRE Medical Group Inc.
FDA (openFDA device enforcement)
Reported Jul 5, 2023
Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ellex Medical Pty Ltd.
FDA (openFDA device enforcement)
Reported Jul 5, 2023
Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 5, 2023
Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hologic, Inc.
FDA (openFDA device enforcement)
Reported Jul 5, 2023
LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2MML, REF 8730-82NE; LEGACY SMARTBASE NARROW…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Implant Direct Sybron Manufacturing LLC
FDA (openFDA device enforcement)
Reported Jul 5, 2023
REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Limacorporate S.p.A
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 5, 2023
Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Luminex Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 5, 2023
Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
FDA (openFDA device enforcement)
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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.