All Recalls

95,075 total recalls in our database

nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical technicians.

NordicNeuroLab AS

🏥 Medical Devices Class I - Dangerous

An error was discovered in the interpretation of certain DICOM header tags that may lead to incorrect orientation labeling, and thus and indirect left-right, up-down or anterior-posterior flipping of images.

Sep 12, 2014 Other Medical Devices View Details →

Arrow-Johans" ECG Adapter for Right Atrial Electrocadiography (RAECG); Product Code: EG-04900

Arrow International

🏥 Medical Devices Class I - Dangerous

Product sterility may be compromised due to unsealed packaging.

Apr 11, 2018 Patient Monitors Nationwide View Details →

Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PHMC

Arrow International

🏥 Medical Devices Class I - Dangerous

Product sterility may be compromised due to unsealed packaging.

Apr 11, 2018 Surgical Instruments Nationwide View Details →

Maximal Barrier Drape; Product Codes: ASK-00376-SU

Arrow International

🏥 Medical Devices Class I - Dangerous

Product sterility may be compromised due to unsealed packaging.

Apr 11, 2018 Other Medical Devices Nationwide View Details →

Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-42703-RV1

Arrow International

🏥 Medical Devices Class I - Dangerous

Product sterility may be compromised due to unsealed packaging.

Apr 11, 2018 Surgical Instruments Nationwide View Details →

Symmetry Olsen monopolar cord: (a) Monopolar Cord, 1/8" Diameter Pin, TUR Connector, 10' (3.0m), REF 92002, QTY 50 (b) Monopolar Cord, Bovie to 90o Female Pin, 10' (3.0m), REF 40-2106, QTY 10 (c) Monopolar Cord, Bovie to 90o Female Pin, 10' (3.0m), REF 40-2110, QTY 10 Designed to bring high frequency electrical power from the electrosurgical generator to the active.

Olsen Medical

🏥 Medical Devices Class I - Dangerous

Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.

May 11, 2018 Diagnostic Equipment View Details →

Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery.

Genesee BioMedical

🏥 Medical Devices Class I - Dangerous

Failure in a retractor blade due to corrosion. In the area of the blade where the bearing/button meets the blade body, corrosion can form, weakening the welded joint and may cause the bearing/button to break.

Feb 26, 2018 Other Medical Devices Nationwide View Details →

Double-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42802-VC and ASK-47702-VC

Arrow International

🏥 Medical Devices Class I - Dangerous

Product sterility may be compromised due to unsealed packaging.

Apr 11, 2018 Surgical Instruments Nationwide View Details →

Echogenic Needle; Product codes: PN-00215-E and PN-00217-E

Arrow International

🏥 Medical Devices Class I - Dangerous

Product sterility may be compromised due to unsealed packaging.

Apr 11, 2018 Surgical Instruments Nationwide View Details →

Spring Wire Guide Introducer Needle; Product Codes: AN-04320 and AN-04418

Arrow International

🏥 Medical Devices Class I - Dangerous

Product sterility may be compromised due to unsealed packaging.

Apr 11, 2018 Surgical Instruments Nationwide View Details →

VPS TipTracker Stylet Accessory; Product codes: RHY-177-TTSAP

Arrow International

🏥 Medical Devices Class I - Dangerous

Product sterility may be compromised due to unsealed packaging.

Apr 11, 2018 Other Medical Devices Nationwide View Details →

ARROWg+ard Blue(R) Central Venous Catheterization Kit; Product Code: ASK-24306-WHC1 and ASK-24306-WHC2

Arrow International

🏥 Medical Devices Class I - Dangerous

Product sterility may be compromised due to unsealed packaging.

Apr 11, 2018 Surgical Instruments Nationwide View Details →

Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip¿, ARROWg+ard Blue PLUS¿ Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Codes: ASK-45703-LDP1, ASK-45703-PBHS, ASK-45703-PHMC

Arrow International

🏥 Medical Devices Class I - Dangerous

Product sterility may be compromised due to unsealed packaging.

Apr 11, 2018 Surgical Instruments Nationwide View Details →

Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-15703-LDP1

Arrow International

🏥 Medical Devices Class I - Dangerous

Product sterility may be compromised due to unsealed packaging.

Apr 11, 2018 Surgical Instruments Nationwide View Details →

Continuous Nerve Block Needle; Product Codes: AB-00090, AB-00150, AB-17040-N, AB-17080-N, AB-17110-N, AB-17140-N, AB-18080-N, AB-18110-N

Arrow International

🏥 Medical Devices Class I - Dangerous

Product sterility may be compromised due to unsealed packaging.

Apr 11, 2018 Surgical Instruments Nationwide View Details →

Respire Pink+ Hard Oral Sleep Apnea Device

Respire Medical

🏥 Medical Devices Class I - Dangerous

Potential for device breakage during use

Sep 1, 2017 Other Medical Devices Nationwide View Details →

P.R.O. Matt: (a) PROMATT PLUS 36 X 76 MATRESS, NYLON, MATERIAL NUMBER PMP3676NZBA (b) PROMATT PLUS 84" MATRESS, NYLON, MATERIAL NUMBER PMP3684NZBA (c) PROMATT PLUS W/SIDEWALLS, 42X80, MATERIAL NUMBER PMS4280NZBA (d) PROMATT PLUS 36IN MATRESS, MATERIAL NUMBER PMP3680NZBA (e) PROMATT WITH SIDEWALLS ASSEMBLY, MATERIAL NUMBER PMS3680NZBA (f) PROMATT PLUS 80IN MATRESS, STRETCH, MATERIAL NUMBER PMP3680SZBA (g) PROMATT PLUS 42IN MATRESS, MATERIAL NUMBER PMP4280NZBA (h) PROMATT PLUS 85cm MATRESS, DURATUB, MATERIAL NUMBER PMPE3480SZBADT Product Usage: Non powered flotation therapy mattress. The device is intended to treat or prevent decubitus ulcers (bed sores).

Joerns Healthcare

🏥 Medical Devices Class I - Dangerous

Joerns Healthcare has identified a potential issue with some of the P.R.O. Matt and ProCair Mattresses. For the identified serial number range of P.R.O. Matt and ProCair Mattresses incorrect connectors (part #s 206-0401 & 206-0405) were provided by a Joerns supplier without the required internal shutoff valves, these shutoff valves prevent air from escaping from the mattress air cells.

May 3, 2018 Other Medical Devices Nationwide View Details →

Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-42703-PHCH

Arrow International

🏥 Medical Devices Class I - Dangerous

Product sterility may be compromised due to unsealed packaging.

Apr 11, 2018 Surgical Instruments Nationwide View Details →

ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-42703-SJH

Arrow International

🏥 Medical Devices Class I - Dangerous

Product sterility may be compromised due to unsealed packaging.

Apr 11, 2018 Surgical Instruments Nationwide View Details →

SnapLock" Catheter/Syringe Adapter; Product Code: AS-05500

Arrow International

🏥 Medical Devices Class I - Dangerous

Product sterility may be compromised due to unsealed packaging.

Apr 11, 2018 Surgical Instruments Nationwide View Details →