FDA Medical Device Recalls
Latest medical device recalls, corrections, and removals from FDA. Stay informed about safety issues affecting medical devices.
ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403;…
In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the V…
View FDA Recall →Stryker Hoffmann II Connecting Rod Micro 3 x 90mm. Catalog Number: 50796090.
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
View FDA Recall →Photera 600 3-D, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at …
View FDA Recall →MEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF, Medline kit SKU CDSOPT590T…
The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled…
View FDA Recall →Optima XR200amx, Mobile Digital-Ready Radiographic System
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the…
View FDA Recall →Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and d…
ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate solve…
View FDA Recall →Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endosco…
Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal fo…
View FDA Recall →KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,
A product error defect may cause incorrect bracket placement.
View FDA Recall →MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896
A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops delivering ins…
View FDA Recall →Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 p…
Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect pati…
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