RecallHawk

Medical Device Recalls

FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.

13,600 total recalls

BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P, REF: 169-97 containing software version 3.9.1.9

CareFusion 303, Inc.

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

B Braun Medical Inc

DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Serrated Forceps, Model/Catalog Number: DVF4016-25-S

Katalyst Surgical, LLC

A.L.P.S. mvX- MEDIAL TIBIA PLATE 16H LT-Medial Tibia Plate, 16-Hole, Left Intended for Fixation of fractures of the dis

Tyber Medical

AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.

Aesculap AG

MEDLINE CLEARPRO DOUBLE SWIVEL CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20 EA/2 Inner c

MEDLINE INDUSTRIES, LP - Northfield

MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II

Chromsystems Instruments & Chemicals GmbH

Brand Name: Aesculap Product Name: SEALING CAP FOR 10/12MM TROCARS Model/Catalog Number: EK085P Software Version: N/A

Aesculap Inc

i-STAT EG7+ cartridge. List Number: 03P76-25.

Abbott Point Of Care Inc.

RayCare software, include version number 5A, 5B, 6A, including service packs-An oncology information system used to supp

RAYSEARCH LABORATORIES AB

Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 2103

I.T.S. GmbH

CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS, 1.0MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5069

Carefusion 2200 Inc

Description/REF: HEMODIALYSIS KIT: 2-LUMEN 8 FR X 11 CM/AK-11802-F; HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-22122;

ARROW INTERNATIONAL, LLC

Sterile Procedural Trays, labeled as the following: a. BREAST BIOPSY PACK-LF b. BREAST BIOPSY PACK c. LAPAROTOMY PA

MEDLINE INDUSTRIES, LP - Northfield

Med-Riser MR600 Patient Lift

Med-Mizer, Inc.

Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Dual Hose with CPC Connectors Mod

Zimmer Surgical Inc

ErgoStar CM 55, Model/Catalog Number: MP01855, Airway connector for conduction of respiratory gases between the

Draeger, Inc.

OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Co

Osteomed, LLC

Peri-Guard Repair Patch, Product Codes: a) PG1016 : 10 X 16 CMUS, TS b) PG1225: 12 X 25 CMUS, TS c) PG0404: 4 X 4

Baxter Healthcare Corporation

Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System

NeuroLogica Corporation

Impella 5.5 Set AU; Product Code: 1000361;

Abiomed, Inc.

BD MICROBIOLOGY MAC CONKEY II AGAR (100/CT) 21270 MEDIA.

Mckesson Medical-Surgical Inc. Corporate Office

Environmental Pollutants Profile Test

GET TESTED INTERNATIONAL AB

ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60

Empowered Diagnostics LLC

Vaginal PH Test

GET TESTED INTERNATIONAL AB

ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containing Introducer Product Code 0052-3025-JP. h

Abiomed, Inc.

MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for use in determining ant

Beckman Coulter, Inc.

CRE Pro Wireguided 18-20mm 240cm

Boston Scientific Corporation

Baxter TruSystem 7500 Hybrid Plus (SC), Product Code 1854088

Baxter Healthcare Corporation

BD Pyxis MedStation ES AUX, REF 324

CareFusion 303, Inc.

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