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.
13,791 stored notices, reported between Jun 20, 2012 and Oct 28, 2026. Newest first.
Reported Nov 13, 2024
Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minimally invasive surgery allowing access…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
FDA (openFDA device enforcement)
Reported Nov 6, 2024
Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c) REF…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Molecular, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 6, 2024
AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Accriva Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Nov 6, 2024
Ambu¿ VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number 412371000), 39 Fr…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ambu Inc.
FDA (openFDA device enforcement)
Reported Nov 6, 2024
a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P7900B000001, P7900B100010, P7900B100024,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
FDA (openFDA device enforcement)
Reported Nov 6, 2024
Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
FDA (openFDA device enforcement)
Reported Nov 6, 2024
Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LP
FDA (openFDA device enforcement)
Reported Nov 6, 2024
GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and infant warmer. Model Numbers: 1)…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Datex--Ohmeda, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 6, 2024
17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.DRG International, Inc.
FDA (openFDA device enforcement)
Reported Nov 6, 2024
ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ImaCor Inc.
FDA (openFDA device enforcement)
Reported Nov 6, 2024
MICR PATIE RND Model/Catalog Number: 801396. CODMAN Surgical Patties and CODMAN Surgical Strips are manufactured of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
22 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 6, 2024
AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s pharynx through the mouth to provide…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.King Systems Corp. dba Ambu, Inc.
7 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 6, 2024
VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500
High riskUsing this product could cause serious injury, illness or death — stop using it now.Maquet Cardiovascular, LLC
FDA (openFDA device enforcement)
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)
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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.