RecallHawk

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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