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 Mar 30, 2022
TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Cytocell Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 30, 2022
DigniCap Delta Scalp Cooling System, Product Number: 900-1001, Labeling: The DigniCap Scalp Cooling System User Manual…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Dignitana, Inc.
FDA (openFDA device enforcement)
Reported Mar 30, 2022
Medical Device products purchased from Family Dollar retail stores located in Alabama, Arkansas, Louisiana,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Dollar Tree Distribution, Inc.
FDA (openFDA device enforcement)
Reported Mar 30, 2022
Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 30, 2022
Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Outset Medical, Inc.
FDA (openFDA device enforcement)
Reported Mar 30, 2022
Azurion systems with software release R2.0.x
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Healthcare
FDA (openFDA device enforcement)
Reported Mar 30, 2022
Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The device is intended to be used in…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Philips Respironics, Inc.
FDA (openFDA device enforcement)
Reported Mar 23, 2022
Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories, Inc.
FDA (openFDA device enforcement)
Reported Mar 23, 2022
Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray, 22 g x 1.5" Spinal Needle with Manometer
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bard Peripheral Vascular Inc.
10 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 23, 2022
BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bio-Rad Laboratories, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 23, 2022
Dreamtome RX Cannulating Sphincterotome-DREAMTOME 44-20MM/260CM Material Number: M00584040
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
30 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 23, 2022
20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.CellEra LLC
4 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 23, 2022
GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700 (Desktop, REF…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
FDA (openFDA device enforcement)
Reported Mar 23, 2022
(1)Traverse Rail Carrier E-System, wide 31017XX component to Liko overhead lift, (2)Traverse Rail Carrier 31025XX…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hill-Rom, Inc.
FDA (openFDA device enforcement)
Reported Mar 23, 2022
Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents: FCR-X…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hologic, Inc.
FDA (openFDA device enforcement)
Reported Mar 23, 2022
Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.LivaNova Deutschland GmbH
FDA (openFDA device enforcement)
Reported Mar 23, 2022
LINQ II Insertable Cardiac Monitor
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
FDA (openFDA device enforcement)
Reported Mar 23, 2022
Mycoplasma genitalium Control Panel (Inactivated Pellet)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Microbiologics Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 23, 2022
SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sam Medical Products
FDA (openFDA device enforcement)
Reported Mar 23, 2022
STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the…
High riskUsing this product could cause serious injury, illness or death — stop using it now.SD Biosensor, Inc.
FDA (openFDA device enforcement)
Reported Mar 23, 2022
Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model: 11335791, Rx, CE Ultrasound imaging…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
FDA (openFDA device enforcement)
Reported Mar 23, 2022
Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 5201120008, non-sterile, a component of the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wright Medical Technology, Inc.
FDA (openFDA device enforcement)
Reported Mar 16, 2022
PuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006
Moderate riskThis product could cause temporary or reversible health problems — stop using it.3-D Matrix, Inc.
FDA (openFDA device enforcement)
Reported Mar 16, 2022
Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dispensing Pin W/Valve. A valve for aspiration…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B. Braun Medical, 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.