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 Nov 6, 2024
Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nihon Kohden America Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 6, 2024
Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)
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)
Reported Nov 6, 2024
Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Percussionaire Corporation
FDA (openFDA device enforcement)
Reported Nov 6, 2024
LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o 99577-000076 o…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Physio-Control, Inc.
FDA (openFDA device enforcement)
Reported Nov 6, 2024
Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Princeton Biomeditech Corp.
FDA (openFDA device enforcement)
Reported Nov 6, 2024
KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 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 Nov 6, 2024
remel BactiDrop Acridine Orange, REF 21502, 50 per package.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Remel, Inc.
FDA (openFDA device enforcement)
Reported Nov 6, 2024
smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSTHESIS, KNEE,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew Inc.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 6, 2024
CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Smiths Medical ASD Inc.
FDA (openFDA device enforcement)
Reported Nov 6, 2024
Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that includes reflective…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Trackx Technology Inc.
FDA (openFDA device enforcement)
Reported Nov 6, 2024
Brand Name: Vial2Bag Advanced¿ Product Name: Vial2Bag Advanced¿ 20mm Admixture Device Model/Catalog Number: 6070030…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.West Pharmaceutical Services AZ, Inc.
FDA (openFDA device enforcement)
Reported Nov 6, 2024
1) Flex Extenders, 5.2" x 15mm OD x 15mm ID REF S6411P 2) Flex Extender, 5.2" x 15mm OD x 22/15mm ID REF 7 5132 The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Westmed, Inc.
FDA (openFDA device enforcement)
Reported Oct 30, 2024
AD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (A style) Depth Electrode
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ad-Tech Medical Instrument Corporation
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 30, 2024
bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B-K Medical A/S
FDA (openFDA device enforcement)
Reported Oct 30, 2024
Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
9 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 30, 2024
Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Blue Ortho
FDA (openFDA device enforcement)
Reported Oct 30, 2024
Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, Version 2.0.101, 2.0.110,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
FDA (openFDA device enforcement)
Reported Oct 30, 2024
Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations. These anesthesia gas machines are intended…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Datex-Ohmeda, Inc.
10 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 30, 2024
Diasol Acid Concentrate REF G100325-10Dex 100
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Diasol, Inc.
FDA (openFDA device enforcement)
Reported Oct 30, 2024
Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 2 6 X 15 mL-IVD intended as a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mckesson Medical-Surgical Inc. Corporate Office
FDA (openFDA device enforcement)
Reported Oct 30, 2024
(1) Centurion Sterile CirClamp, Reorder #200CR; (2) Centurion CirClamp with 1.1cm Bell and Insert, Reorder #210CR,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
33 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 30, 2024
SynchroMed II Infusion Pump. Product Number: 8637-20
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 30, 2024
Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
3 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 30, 2024
STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Physio-Control, Inc.
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.