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 Sep 21, 2022
FABCO ORS DENTAL ROLLS, 1-1/2" STERILE, COTTON 3/8" Diameter x 1-1/2" (9.5mm x 38.1mm), packaged 5 /Pouch, 50…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carwild Corporation
FDA (openFDA device enforcement)
Reported Sep 21, 2022
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)RFPC-35-180 ORDER NUMBER (GPN) G07937. For vascular…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Incorporated
12 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 21, 2022
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. 0 DEG ACUMATCH CONSTRAINED LINER SZ E…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
9 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 21, 2022
SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C
Moderate riskThis product could cause temporary or reversible health problems — stop using it.FUJIFILM Healthcare Americas Corporation
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 21, 2022
MicroClave Clear Neutral Connector. A bidirectional connector used as an accessory to an intravascular catheter placed…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 21, 2022
Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Isopure Corp.
FDA (openFDA device enforcement)
Reported Sep 21, 2022
Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mako Surgical Corporation
FDA (openFDA device enforcement)
Reported Sep 21, 2022
INOmax DSIR -(delivery system) delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mallinckrodt, LLC.
FDA (openFDA device enforcement)
Reported Sep 21, 2022
Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b.…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Microbiologics Inc.
FDA (openFDA device enforcement)
Reported Sep 21, 2022
Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems (Cleveland) Inc.
FDA (openFDA device enforcement)
Reported Sep 21, 2022
PTS Panels CHOL+GLU Test Strips (REF 1765)
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Sep 21, 2022
QIAcube Connect MDx, Model No. 9003070
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Qiagen Sciences LLC
FDA (openFDA device enforcement)
Reported Sep 21, 2022
Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Steris Corporation Hopkins Facility
FDA (openFDA device enforcement)
Reported Sep 21, 2022
Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Technomed Europe
FDA (openFDA device enforcement)
Reported Sep 21, 2022
ZAP-X Radiosurgery System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zap Surgical Systems
FDA (openFDA device enforcement)
Reported Sep 14, 2022
Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x 1.3 mL CTRL +, For In…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Molecular, Inc.
FDA (openFDA device enforcement)
Reported Sep 14, 2022
Various Angiography packs/trays
Moderate riskThis product could cause temporary or reversible health problems — stop using it.American Contract Systems, Inc.
16 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 14, 2022
Optima Coil System Model OPTI0520CSF10. For endovascular embolization.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Balt USA, LLC
FDA (openFDA device enforcement)
Reported Sep 14, 2022
CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biosense Webster, Inc.
FDA (openFDA device enforcement)
Reported Sep 14, 2022
MEGA 8Fr 50cc Intra-Aortic Balloon Catheter
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Datascope Corporation
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 14, 2022
Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock BAG SPIKE w/ ADDITIVE PORT, DRY…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 14, 2022
Medline CHEST TUBE REORDER NO: DYNJ36762A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medline Industries Inc.
FDA (openFDA device enforcement)
Reported Sep 14, 2022
The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merchsource LLC
FDA (openFDA device enforcement)
Reported Sep 14, 2022
VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
1 more product in this recall
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.