Category

Medical Devices Recalls

15,654 medical devices recalls on record from CPSC, FDA, and USDA.

15,654 recalls
High RiskFDA
Kentec Medical, Inc
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-80P-50 (8 fr. 50...
Medical Devices·2,130 affected·Jan 17, 2020
High RiskFDA
Ormco/sybronendo
SnapLink, Ref Part No. 438-2190, L6R SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10, Made in Mexico, CE 0086, Rx Only
Medical Devices·3,632,493 affected·Jan 17, 2020
High RiskFDA
Kentec Medical, Inc
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-Y60P-50 (6 fr. 5...
Medical Devices·4,710 affected·Jan 17, 2020
High RiskFDA
Beckman Coulter Inc.
LabPro Data Management System, UDI: 15099590676872 - Product Usage: The LabPro Data Management System is a Microsoft Windows based softwa...
Medical Devices·177 affected·Jan 17, 2020
High RiskFDA
Covidien Llc
Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item Code: EGIAUSTND
Medical Devices·2,180 affected·Jan 17, 2020
High RiskFDA
Kentec Medical, Inc
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-40P-50 (4 fr. 50...
Medical Devices·480 affected·Jan 17, 2020
High RiskFDA
Kentec Medical, Inc
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-50P-50 (5 fr. 50...
Medical Devices·2,850 affected·Jan 17, 2020
High RiskFDA
Kentec Medical, Inc
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-Y50P-80 (5 fr. 8...
Medical Devices·70 affected·Jan 17, 2020
High RiskFDA
Ormco/sybronendo
SnapLink, Ref Part No. 438-2191, L6L SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10, Made in Mexico, CE 0086, Rx Only
Medical Devices·3,632,493 affected·Jan 17, 2020
High RiskFDA
Abbott Point Of Care Inc.
i-STAT CG4+ cartridge (blue), List No. 03P85-50. UDI (01) 00054749002269 - Product Usage: The i-STAT CG4+ cartridge is intended for the q...
Medical Devices·99,850 affected·Jan 15, 2020
High RiskFDA
Cardinal Health 200, Llc
Monoject Hypodermic Safety Needle 30G X 1/2" Item Code 1183005 - Product Usage: used for general purpose injection and aspiration of flui...
Medical Devices·8,000 affected·Jan 15, 2020
High RiskFDA
Arrow International Inc
10 cc Luer-Slip Loss of Resistance Syringe, Product Code LR-05501
Medical Devices·343,105 affected·Jan 15, 2020
High RiskFDA
Cardinal Health 200, Llc
Monoject 3mL Syringe with Hypodermic Safety Needle, 22G x 1-1/2 . Item Code 11832215 - Product Usage: used for general purpose injection ...
Medical Devices·8,400 affected·Jan 15, 2020
High RiskFDA
Cardinal Health 200, Llc
Monoject Hypodermic Safety Needle 25G x 5/8" Item Code 1182558 - Product Usage: used for general purpose injection and aspiration of flu...
Medical Devices·0 affected·Jan 15, 2020
High RiskFDA
Ormco/sybronendo
Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, Tq +13 degrees, Rx. Manufactured by Ormco Corporation, T...
Medical Devices·2,189 affected·Jan 14, 2020
High RiskFDA
Cme America, Llc
BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe - Product Usage: The system is int...
Medical Devices·5,800 affected·Jan 14, 2020
High RiskFDA
Abbott Point Of Care Inc.
i-STAT G3+ cartridge (blue), List No. 03P78-50, UDI (01) 00054749002283 - Product Usage: The i-STAT G3+ cartridge may be used for the qua...
Medical Devices·4,448,525 affected·Jan 14, 2020
High RiskFDA
Coopervision Inc.
Coopervision Vertex Toric /2 Clear Toric- Power -2.50 -0.75 /90 Soft (hydrophilic) Contact Lens (extended wear)
Medical Devices·216 affected·Jan 13, 2020
High RiskFDA
Philips North America, Llc
Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. The DigiTrak XT Recorder is available in four different config...
Medical Devices·44,442 affected·Jan 13, 2020
High RiskFDA
Teleflex Medical Inc
Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440
Medical Devices·1,764 affected·Jan 13, 2020
High RiskFDA
Coopervision Inc.
Coopervision Vertex Toric /2 Clear Toric- Power +2.25 -0.75/120 Soft (hydrophilic) Contact Lens (extended wear)
Medical Devices·24 affected·Jan 13, 2020
CriticalFDA
Stryker Instruments Div. Of Stryker Corporation
SafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004. The product is a Bovie pencil that is 75 inches long compressed, w...
Medical Devices·15,150 affected·Jan 13, 2020
CriticalFDA
Stryker Instruments Div. Of Stryker Corporation
Telescopic Uncoated (Push Button), Product No. SHK TSPL. The product is a Bovie pencil that is 75 inches long compressed, with a telesco...
Medical Devices·15,150 affected·Jan 13, 2020
High RiskFDA
Cardinal Health
AAMI 3 NONREIN SCRBNURGOWN BNS L, Item Code 90270NB
Medical Devices·7,659,634 affected·Jan 11, 2020
High RiskFDA
Cardinal Health
AAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNA
Medical Devices·7,659,634 affected·Jan 11, 2020
High RiskFDA
Cardinal Health
AAMI 3 ROYALSILK SURGGOWN BNS XL, Item Code 9548NC
Medical Devices·7,659,634 affected·Jan 11, 2020
High RiskFDA
Cardinal Health
AAMI 3 FABRIC REINF SURG GOWN XL, Item Code 9541
Medical Devices·7,659,634 affected·Jan 11, 2020
High RiskFDA
Cardinal Health
AAMI 3 NON-REINF SURG GOWN LG 2 TWL, Item Code ASG9515
Medical Devices·7,659,634 affected·Jan 11, 2020
High RiskFDA
Cardinal Health
AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB
Medical Devices·7,659,634 affected·Jan 11, 2020
High RiskFDA
Cardinal Health
ROYALSILK 3XLARGE/XLONG NS, Gown Item Code 95998N
Medical Devices·7,659,634 affected·Jan 11, 2020
High RiskFDA
Cardinal Health
ROYALSILK 3XLARGE/XLONG, Gown. Item Code 95998
Medical Devices·7,659,634 affected·Jan 11, 2020
High RiskFDA
Cardinal Health
ROYALSILK LARGE, Gown. Item Code 9518
Medical Devices·7,659,634 affected·Jan 11, 2020
High RiskFDA
Cardinal Health
AAMI 3 FABREINF SCRUB SURG GWN L NS, Gown. Item Code 90970NA
Medical Devices·7,659,634 affected·Jan 11, 2020
High RiskFDA
Cardinal Health
ROYALSILK XLARGE, Gown. Item Code 9548
Medical Devices·7,659,634 affected·Jan 11, 2020
High RiskFDA
Cardinal Health
GOWN SURG LG W/TOWEL ST BACK, Item Code 9515
Medical Devices·7,659,634 affected·Jan 11, 2020
High RiskFDA
Cardinal Health
AAMI 3 NON-REINF SURG GWN XL 2 TWL, Gown Item Code ASG9545
Medical Devices·7,659,634 affected·Jan 11, 2020
High RiskFDA
Cardinal Health
AAMI 3 ROYALSILK SURGGOWN BNS L, Gown. Item Code 9518NC
Medical Devices·7,659,634 affected·Jan 11, 2020
High RiskFDA
Cardinal Health
AAMI 3 ROYALSILK SCRBNURGOWN BNS XL, Gown. Item Code 90380NC
Medical Devices·7,659,634 affected·Jan 11, 2020
High RiskFDA
Cardinal Health
AAMI 3 NONREINF SURG GOWN 3XL BNS, Item Code 9585N
Medical Devices·7,659,634 affected·Jan 11, 2020
High RiskFDA
Cardinal Health
AAMI 3 FABRNF SURG GOWN L 2 TOWELS, Item Code ASG9511
Medical Devices·7,659,634 affected·Jan 11, 2020
High RiskFDA
Cardinal Health
AAMI 3 NONREIN SURG GOWN L BNS, Item Code 9515NB
Medical Devices·7,659,634 affected·Jan 11, 2020
High RiskFDA
Biomet 3i, Llc
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 3MM(H) Reference Number: IEHA353
Medical Devices·0 affected·Jan 10, 2020
High RiskFDA
Biomet 3i, Llc
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA466
Medical Devices·0 affected·Jan 10, 2020
High RiskFDA
Biomet 3i, Llc
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 4MM(H) Reference Number: IEHA444
Medical Devices·0 affected·Jan 10, 2020
High RiskFDA
Biomet 3i, Llc
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA566
Medical Devices·0 affected·Jan 10, 2020
High RiskFDA
Biomet 3i, Llc
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 3MM(H) Reference Number: IEHA343
Medical Devices·0 affected·Jan 10, 2020
High RiskFDA
Biomet 3i, Llc
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H) Reference Number: IEHA454
Medical Devices·0 affected·Jan 10, 2020
High RiskFDA
Biomet 3i, Llc
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 6MM(H) Reference Number: IEHA356
Medical Devices·0 affected·Jan 10, 2020