Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur¿ HBc IgM
Medical Devices·6 affected·Jan 2, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE ¿ /IMMULITE ¿ 1000 CEA
Medical Devices·0 affected·Jan 2, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi CEA
Medical Devices·0 affected·Jan 2, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Folic Acid
Medical Devices·0 affected·Jan 2, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur¿ Cyclosporine
Medical Devices·0 affected·Jan 2, 2018
High RiskFDA
Toshiba American Medical Systems Inc
INFX-8000C Fluoroscopic X-Ray Systems
Medical Devices·19 affected·Dec 29, 2017
High RiskFDA
Toshiba American Medical Systems Inc
INFX-8000F Fluoroscopic X-Ray Systems
Medical Devices·17 affected·Dec 29, 2017
High RiskFDA
Toshiba American Medical Systems Inc
INFX-8000H Fluoroscopic X-Ray Systems
Medical Devices·2 affected·Dec 29, 2017
High RiskFDA
Southwest Technologies Inc
HYPOTHERMIA CAP Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), CAP610 (b) Elasto-Gel(TM), CAP610LV (c)...
Medical Devices·15,666 affected·Dec 28, 2017
High RiskFDA
Epimed International
NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile
Medical Devices·140 affected·Dec 28, 2017
High RiskFDA
Little Rapids Corporation
EMS products from Graham Medical, SnugFit(R) Expandable Mattress Cover, Code 72930, UPC 1 07 47036 72930 3
Medical Devices·153 affected·Dec 27, 2017
High RiskFDA
Ormco/sybronendo
Elements Obturation Unit (EOU) used with respective Buchanan Heat Pluggers Device is an endodontic root canal plugger. It is intende...
Medical Devices·25,765 affected·Dec 27, 2017
High RiskFDA
Arrow International Inc
(1) Access Tray, Part Number (PN): ASK-04001-MS; Arrow Multi-Lumen CVC Kit (2) PN: CDC-12703-1A; (3) PN: CDC-15703-1A; (4) PN: CDC-15703-...
Medical Devices·0 affected·Dec 22, 2017
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic ANGLED DRILL, REF 6630902, QTY: 1 EA Rx only
Medical Devices·2 affected·Dec 22, 2017
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
LATARJET EXPERIENCE Sharp Curved Ostetome Product Usage: The Latarjet EXPERIENCE Instability Shoulder Set is intended to provide to t...
Medical Devices·84 affected·Dec 22, 2017
High RiskFDA
Depuy Orthopaedics, Inc.
(1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614; (2) Sigma HP Cemented Trochlea Size 2...
Medical Devices·2,110 affected·Dec 21, 2017
High RiskFDA
W & H Dentalwerk Burmoos Gmbh - Site 1
Foot Controls Model: S-N1 and S-N2 Product Usage: Variable foot control for use with drive units operating mechanical instruments.
Medical Devices·0 affected·Dec 21, 2017
High RiskFDA
Baxter Healthcare Corporation
MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541
Medical Devices·186 affected·Dec 21, 2017
High RiskFDA
Stryker Corporation
3910-090-800 ASSY, PKG, 8.0MM X 90MM DRI-LOK THREADED CANNULA, 5 units per box. The Disposable Cannula device is designed to be used a...
Medical Devices·2 affected·Dec 21, 2017
High RiskFDA
Zimmer Biomet, Inc.
ACE Trochanteric Nail System STER TROC NAIL 180X11X140 STER TROC NAIL 125 DEG X 11MM STER TROC NAIL 130 DEG X 11MM STER TROC NAIL 135...
Medical Devices·3,454 affected·Dec 20, 2017
High RiskFDA
Ad-tech Medical Instrument Corporation
Disposable Drill Kit which includes two drill bits, two drill stops, and two adjustment wrenches, sterile. The drill bits are 30cm long a...
Medical Devices·30 affected·Dec 20, 2017
High RiskFDA
Zimmer Biomet, Inc.
ACE Trochanteric Nail System STER TROC LAG SCR 70 MM The Trochanteric Nail System is intended to treat stable and unstable proximal f...
Medical Devices·3,454 affected·Dec 20, 2017
High RiskFDA
Zimmer Biomet, Inc.
ACE Trochanteric Nail System ACE TROCH NAIL 125 DEG. X 11MM ACE TROCH NAIL 130 DEG. X 11MM ACE TROCH NAIL 135 DEG. X 11MM ACE TROCH N...
Medical Devices·3,454 affected·Dec 20, 2017
High RiskFDA
Zimmer Biomet, Inc.
ACE Trochanteric Nail System STER L H TROC NAIL 320X9X125 STER L H TROC NAIL 340X9X125 STER L H TROC NAIL 360X9X125 STER L H TROC NAI...
Medical Devices·3,454 affected·Dec 20, 2017
High RiskFDA
Nidek Inc.
AUTO REF/KERATOMETER ARK-1s
Medical Devices·63 affected·Dec 20, 2017
High RiskFDA
Zimmer Biomet, Inc.
ACE Trochanteric Nail System STER TROC NAIL 180X13X140 STER TROC NAIL 125 DEG X 13MM STER TROC NAIL 130 DEG X 13MM STER TROC NAIL 135...
Medical Devices·3,454 affected·Dec 20, 2017
High RiskFDA
Zimmer Biomet, Inc.
ACE Trochanteric Nail System TROCH NAIL ST 13X180 125DG STRL TROCH NAIL ST 13X180 130DG STRL TROCH NAIL ST 13X180 135DG STRL The Tr...
Medical Devices·3,454 affected·Dec 20, 2017
High RiskFDA
Zimmer Biomet, Inc.
ACE Trochanteric Nail System ATN LAG SCREW 60MM STERILE ATN LAG SCREW 65MM STERILE ATN LAG SCREW 70MM STERILE ATN LAG SCREW 75MM STER...
Medical Devices·3,454 affected·Dec 20, 2017
High RiskFDA
Integra Lifesciences Corp.
The humeral stems trials are packaged in a kit for Titan Modular Shoulder System under the following labeling: Catalog Number Product ...
Medical Devices·1,619 affected·Dec 20, 2017
High RiskFDA
Zimmer Biomet, Inc.
ACE Trochanteric Nail System STER TROC END CAP STER TROC END CAP 5MM STER TROC END CAP 10MM STER TROC END CAP 15MM STER TROC END CAP...
Medical Devices·3,454 affected·Dec 20, 2017
High RiskFDA
Zimmer Biomet, Inc.
ACE Trochanteric Nail System STER TROC NAIL 125 DEG X 9MM STER TROC NAIL 130 DEG X 9MM STER TROC NAIL 135 DEG X 9MM The Trochanteri...
Medical Devices·3,454 affected·Dec 20, 2017
Medium RiskFDA
Perkinelmer Health Sciences, Inc.
PerkinElmer 226 Sample Collection Device
Medical Devices·164,952 affected·Dec 19, 2017
High RiskFDA
Cook Inc.
Norm-Ject Tuberkulin Syringe, Catalog Number: K-ATS-1000, Global Product Number: G19871 Product Usage: Used to place in vitro fertili...
Medical Devices·1,900 affected·Dec 19, 2017
RecallFDA
Livanova Usa
Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the label is Sorin Group USA, ...
Medical Devices·16 affected·Dec 19, 2017
High RiskFDA
Cook Inc.
Echosight Jansen-Anderson Intratubal Transfer Set, Catalog Number: K-J-JITS-572900, Global Product Number: G17946 Product Usage: Us...
Medical Devices·57 affected·Dec 19, 2017
High RiskFDA
Nipro Medical Corporation
Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is packaged in a film pouch with 24 lines per case. ...
Medical Devices·307,944 affected·Dec 19, 2017
High RiskFDA
Johnson & Johnson Consumer, Inc.
COACH¿ Self-Adhering Sports Wrap (size: 2in)
Medical Devices·0 affected·Dec 18, 2017
High RiskFDA
Johnson & Johnson Consumer, Inc.
Johnson & Johnson BAND-AID¿ Brand First Aid Products SECURE-FLEX¿ Wrap (size: 2in)
Medical Devices·0 affected·Dec 18, 2017
High RiskFDA
Johnson & Johnson Vision Care, Inc.
ACUVUE OASYS for ASTIGMATISM Brand Contact Lenses. Lot no. B00NKM0G. Base Curve 8.6, Refractive Power -3.00D-1.25/90.
Medical Devices·150 affected·Dec 18, 2017
High RiskFDA
Johnson & Johnson Consumer, Inc.
Johnson & Johnson BAND-AID¿ Brand First Aid Products HURT-FREE¿ Wrap (size: 2in)
Medical Devices·0 affected·Dec 18, 2017
High RiskFDA
Terumo Cardiovascular Systems Corp
Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filters. The Cardiovascular ...
Medical Devices·2,677 affected·Dec 18, 2017
High RiskFDA
Johnson & Johnson Consumer, Inc.
Johnson & Johnson BAND-AID¿ Brand First Aid Products HURT-FREE¿ Wrap (size: 1in)
Medical Devices·0 affected·Dec 18, 2017
High RiskFDA
Ge Healthcare, Llc
Uterine Electromyographic Monitor -Monica IF24 Interface System Product Usage: The Monica IF24 CTG Interface Device is an accessory t...
Medical Devices·355 affected·Dec 15, 2017
High RiskFDA
Ge Healthcare, Llc
Uterine Electromyographic Monitor - Monica Novii Wireless Patch System Product Usage: The Novii Interface is an accessory to the Novi...
Medical Devices·1,742 affected·Dec 15, 2017
High RiskFDA
Depuy Spine, Inc.
Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01)10705034209623) and 283910000 (GTIN: (01)10705034209630) ...
Medical Devices·1,972 affected·Dec 15, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
BrightView Model 882480 Product Usage: BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear im...
Medical Devices·1,387 affected·Dec 15, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Precedence 6 Model # 882351 Product Usage: Precedence (cleared as Griffin) is an imaging system combining the acquisition of single p...
Medical Devices·1,387 affected·Dec 15, 2017
High RiskFDA
Kalila Medical
Vado Steerable Sheath 8.8F, REF SS8FMU67, packaged in a lidded tray that is within a pouch which is inserted into a shelf carton, Sterile...
Medical Devices·99 affected·Dec 14, 2017