PlainRecalls

Medical Devices Recalls

Medical device recalls including implants, diagnostic equipment, and surgical tools

27,372 recalls · Page 124 of 548

FDA Devices Moderate Mar 1, 2023

Cardinal Health Presource Packs IV START TRAY I-Intended for IV access device CATALOG #: 01-5799A

Cardinal Health 200, LLC

FDA Devices Moderate Mar 1, 2023

Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10762472

Siemens Medical Solutions USA, Inc

FDA Devices Critical Mar 1, 2023

NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L)

Draeger Medical, Inc.

FDA Devices Moderate Mar 1, 2023

Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3 SDM-05000-2DC SDM-00001-M3D SDM-05000…

Hologic, Inc.

FDA Devices Moderate Mar 1, 2023

Cardinal Health Presource Packs IV START KIT-Intended for IV Access CATALOG #: 01A4553E

Cardinal Health 200, LLC

FDA Devices Moderate Mar 1, 2023

Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens…

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Mar 1, 2023

ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- In vitro diagnostic immunoassay for the qualitative detection of antibodies to the e an…

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Mar 1, 2023

Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Si…

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Mar 1, 2023

Uroskop Omnia Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762473

Siemens Medical Solutions USA, Inc

FDA Devices Critical Mar 1, 2023

NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577 (Size M), and MP01578 (Size L)

Draeger Medical, Inc.

FDA Devices Moderate Mar 1, 2023

(1) Medline Sterile Hand Pack, Item DYNJ63380A, 3 kits per case, contains BD Chloraprep Hi-Lite Orange, 26 mL Applicator, Vendor PN: 930815NS; and …

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Mar 1, 2023

Medline Sterile Oncology Port Access Tray, Item #DYNDC2239, 20 sterile kits per case, containing Ethicon Biopatch Protective Disk with CHG, Disk with…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Mar 1, 2023

HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous access system for intravenous ther…

Access Vascular, Inc

FDA Devices Moderate Mar 1, 2023

Luminos Agile with software VC10 - A diagnostic imaging system for radiographic and fluoroscopic studies. Model Number: 10502200

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Mar 1, 2023

Luminos dRF with software VD10- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10094200

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Mar 1, 2023

(1) Medline Sterile Maximum Barrier Pack-LF, Item DYNJ0248546C, 6 kits per case, contains BD Chloraprep Hi-Lite Orange, 10.5 mL Applicator, Vendor PN…

MEDLINE INDUSTRIES, LP - Northfield

CPSC Moderate Feb 23, 2023

More than 1.2 Million Mainstays Three-Wick Candles Recalled by Star Soap Star Candle Prayer Candle Due to Fire and Laceration Hazards; Sold Exclusive…

Star Soap Star Candle Prayer Candle, of Ridgefield Park, New Jersey

FDA Drug Moderate Feb 22, 2023

HYDROMORPHONE (a) 1MG/ML IN NS, 50ML, 75 ML, 100ML, 175ML(NDC 00703-0018-01 and NDC 00409-2634-50) ; (b) 5MG/ML IN NS 60ML, 100ML, 250ML; pain, Rx o…

Sentara Infusion Services

FDA Drug Moderate Feb 22, 2023

VANCOMYCIN (a)700 MG NS 140ML, (b) 1000MG IN NS 200ML, abtibiotic, Rx only, use with home pump, Sentara Home Infusion Pharmacy Services, 535 Independ…

Sentara Infusion Services

FDA Drug Moderate Feb 22, 2023

TPN (a) 95GM/AA, 385/DEX, 50GM/LIP 1800ML, (b)TPN AA:100GM DEX:250GM LIP:50GM 2400ML, (c) TPN: AA 80GM ; DEX 320GM ; LIP 50GM IN 2300 ml, Rx only, us…

Sentara Infusion Services

FDA Drug Moderate Feb 22, 2023

TPN (a) 100GM/AA, 285GM/DEX, (b)55GM/LIP 2300ML, (c)55GM/AA 285GM/DEX 50GM/LIP1800ML, (d)TPN AA:100GM DEX:250GM LIP:50GM 2400ML, (e) 55GM DEX:285GM 1…

Sentara Infusion Services

FDA Drug Moderate Feb 22, 2023

CEFOXITIN (a) 1GM IN NS 50ML,(b) 2GM IN NS 100ML, used with a home pump. Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Che…

Sentara Infusion Services

FDA Drug Moderate Feb 22, 2023

LEVOTHYROXINE 25MCG IN NS 1.25ML SYRINGE, Thyroid, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 2…

Sentara Infusion Services

FDA Drug Moderate Feb 22, 2023

TPN 107gm/AA, 200gm/DEX, 50gm/LIP 2250mL, (b) 108GM/AA, 330GM/DEX 3000ML, (c) 108GM/AA, 330GM/DEX, 60GM/LIP 3000ML, (d) 37GM/AA, 160GM/DEX 1450ML, (e…

Sentara Infusion Services

FDA Drug Moderate Feb 22, 2023

CEFEPIME, (a) 2GM IN NS 100ML (b)8GM IN NS 400ML (c) 12GM IN NS 600ML, used with a Curlin or Home pump, Sentara Home Infusion Pharmacy Services, 535 …

Sentara Infusion Services

FDA Drug Moderate Feb 22, 2023

METHADONE (a) 2.5MG IN 5ML NS SYRINGE, (b) 4MG IN 5ML NS SYRINGE, pain, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste…

Sentara Infusion Services

FDA Drug Moderate Feb 22, 2023

HYDROCORTISONE 9a) 2MG IN NS 0.2ML SYRINGE, 9MG IN NS 2ML SYRINGE, steroid, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, …

Sentara Infusion Services

FDA Drug Moderate Feb 22, 2023

NALBUPHINE (a) 1.5MG IN 1.5ML NS, (b) 2.5MG IN 2.5ML NS, SYRINGE, pain, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste …

Sentara Infusion Services

FDA Drug Moderate Feb 22, 2023

Methylprednisolone 12MG IN NS 1.2ML SYRINGE, steroid, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, V…

Sentara Infusion Services

FDA Drug Moderate Feb 22, 2023

ONDANSETRON 8MG IN NS 100ML, antimetic, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320

Sentara Infusion Services

FDA Drug Moderate Feb 22, 2023

PANTOPRAZOLE 30MG IN NS 7.5ML, SYRINGE, antimetic, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 2…

Sentara Infusion Services

FDA Drug Moderate Feb 22, 2023

D5 NS 2300ML, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,

Sentara Infusion Services

FDA Drug Moderate Feb 22, 2023

FLUCONAZOLE 200MG NS 100ML, antifungal, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320

Sentara Infusion Services

FDA Drug Moderate Feb 22, 2023

KYTRIL 350MCG IN 3.5ML NS SYRINGE, antimetic, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320

Sentara Infusion Services

FDA Drug Moderate Feb 22, 2023

0.9% Sodium Chloride, used as a diluent or hydration, packaged volume of (a)1000ML (b)2000ML (c) 720ML, used with Curlin pump, no pump or gravity. S…

Sentara Infusion Services

FDA Drug Moderate Feb 22, 2023

VITAMIN K(PHYTONADIONE) 2.5MG(0.25ML) SYRINGE, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,

Sentara Infusion Services

FDA Drug Moderate Feb 22, 2023

Dextrose 10% 720ML, TPN, Rx only, use with a home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320

Sentara Infusion Services

FDA Drug Moderate Feb 22, 2023

D5W1/2NS W/ 77MEQ OF SOD ACETATE 1000ML, Hydration, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320

Sentara Infusion Services

FDA Drug Moderate Feb 22, 2023

MORPHINE Sulfate (a) 1MG/ML IN NS 350ML, (b) 5MG/ML IN NS 200ML, pain, Rx Only, use with Curlin pump, Sentara Home Infusion Pharmacy Services, 535 In…

Sentara Infusion Services

FDA Drug Moderate Feb 22, 2023

Lactated Ringers packaged in volume of 1000ML, 2500ML, 3000 ML, 3600 ML, 500ML (NDC 00338-0117-03)hydration, Rx Only, use with Curlin pump, Sentara H…

Sentara Infusion Services

FDA Drug Moderate Feb 22, 2023

DOBUTAMINE, (a) 1080MG IN D5W 270ML, (b) 760MG IN D5W 190ML, ionotrop, used with a home pump, Rx only, Sentara Home Infusion Pharmacy Services, 535 I…

Sentara Infusion Services

FDA Drug Moderate Feb 22, 2023

CASPOFUNGIN 50MG IN NS 100ML, used with a HOMEPUMP, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320

Sentara Infusion Services

FDA Drug Moderate Feb 22, 2023

MYCAMINE 100MG IN NS 100ML, antifungal, Rx Only, use with a homepump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesap…

Sentara Infusion Services

FDA Drug Moderate Feb 22, 2023

Sodium Chloride 0.9 % (a) 100ML (MAGNESIUM) (b) 69.3ML, (c) 71.4ML, (d) 77.7ML, (e) 130ML, (f) 210ML, (g) 190ML, (h) 220ML: diluent, Rx Only, use wit…

Sentara Infusion Services

FDA Drug Moderate Feb 22, 2023

Milrinone (a) 104MG IN 0.45% NS 130ML,(b) 108MG IN 0.45% NS 135ML, (c) 120MG IN 0.45% NS 150ML, (d) 136MG IN 0.45% NS 170ML, (e) 144MG IN 0.45% NS 18…

Sentara Infusion Services

FDA Drug Moderate Feb 22, 2023

GANCICLOVIR ( CYTOVENE) (a)1480MG IN NS 296ML, (b) 740 MG IN NS 336 ML, antiviral, Rx Only, use with a Curlin pump, Sentara Home Infusion Pharmacy Se…

Sentara Infusion Services

FDA Drug Moderate Feb 22, 2023

Diphenhydramine 18mg in 3.6ML NS SYRINGE, antihistamine, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake…

Sentara Infusion Services

FDA Drug Moderate Feb 22, 2023

ETHANOL 70% 0.5ML SYRINGE, Cathcare, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320

Sentara Infusion Services

FDA Drug Moderate Feb 22, 2023

TPN (a) 115GM/AA, 215GM/DEX, 25GM/LIP 1150ML, (b)90GM/AA, 215GM/DEX, 25GM/LIP 1150ML, (c) TPN AA: 100GM DEX: 105GM 2700ML, (d) TPN AA: 100GM DEX: 105…

Sentara Infusion Services

FDA Drug Moderate Feb 22, 2023

AMPICILLIN 12GM IN NS 600M, used with a Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,

Sentara Infusion Services