Medical Device Recalls
FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.
13,600 total recalls
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80A; Software Version: NA Product Descrip
ZOLL Medical Corporation
Sterile Procedural Trays, labeled as the following: a. PORT/TRACH INSERTION CDS-3 b. RESIDENT DERM SURG PACK c. THR
MEDLINE INDUSTRIES, LP - Northfield
Olympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and gynecological applications.
Olympus Corporation of the Americas
SofTech Pressure-Sensing Wheelchair Cushions
Aquila Corporation
INOmax DSIR -(delivery system) delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of th
Mallinckrodt, LLC.
smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer,
Smiths Medical ASD, Inc.
Zoll, REF 8700-000869-40, Cool Line (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
ZOLL Circulation, Inc.
Refer to RES
MEDLINE INDUSTRIES, LP - Northfield
The FLUOROspeed is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studie
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
IonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) 2546, f) 2547, g) 2549; dental cement
Voco GmbH
Replacement Battery List Number SUB0000594 found in Plum A+ & Plum A+3 Infusion Systems, List Numbers: a) 11005, b) 1197
ICU Medical Inc
DELTAVEN Y, Safety I.V. Catheter in Pur with closed system a) REF 3832072 b) REF 3810072 c) REF 3842072 d) REF 38520
Delta Med SpA
Medline convenience kit: KIT: DRESSING CHANGE PED DYNDC3359
Medline Industries, LP
Medline convenience kits: BASIC EYE DYNJ905154I TUBAL LIGATION CDS CDS760053K
Medline Industries, LP
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482
Baxter Healthcare Corporation
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584630;
Beaver Visitec International, Inc.
ARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22V
American Contract Systems Inc
CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the ventricles of the brain and can be used with di
Integra LifeSciences Corp.
Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog number: INT CSS Affec
Bayer Medical Care, Inc.
OEC 9800 Systems with 9-inch Image Intensifier
GE OEC Medical Systems, Inc
remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use
Remel, Inc
Description/REF: PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNHS2; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PNHS2;
ARROW INTERNATIONAL, LLC
Sterile Water/Saline: Brand Name: Product Name/Product Code: CARDINAL: 100ML STERILE SALINE BOTTLE/1020, 100ML STERILE
Nurse Assist, LLC
GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b) 5311-01240-012; for
Baxter Healthcare Corporation
FoundationOne Companion Diagnostic (F1CDx)
Foundation Medicine, Inc.
BD PYXIS MEDBANK TWR MN CR-14HH-P, REF: 169-86 containing software version 3.9.1.9
CareFusion 303, Inc.
Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLY
Merit Medical Systems, Inc.
NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010
Cardinal Health 200, LLC
Various PICC Line, Central Line Packs
American Contract Systems, Inc.
Allura Xper FD10C; Catalog number: 722001
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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