Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Abbott Molecular
Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing.
Medical Devices·9 affected·Oct 23, 2014
High RiskFDA
Tem Systems Inc
ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.
Medical Devices·1,574 affected·Oct 23, 2014
High RiskFDA
Gyrus Acmi, Incorporated
Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Sing...
Medical Devices·74,792 affected·Oct 21, 2014
High RiskFDA
Biomet Microfixation, Llc
Total Temporomandibular Joint Replacement System- 50mm Rt Standard Ti Mand Reconstruction of the temporomandibular joint
Medical Devices·42 affected·Oct 17, 2014
High RiskFDA
Biomet Microfixation, Llc
Total Temporomandibular Joint Replacement System- 45mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint
Medical Devices·42 affected·Oct 17, 2014
High RiskFDA
Ino Therapeutics (dba Ikaria)
INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nitric oxide for inhalation) therapy gas...
Medical Devices·9 affected·Oct 17, 2014
High RiskFDA
Biomet Microfixation, Llc
Total Temporomandibular Joint Replacement System- 50mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint
Medical Devices·42 affected·Oct 17, 2014
High RiskFDA
Biomet Microfixation, Llc
Total Temporomandibular Joint Replacement System- 50mm Rt Stand Off Ti Mand Reconstruction of the temporomandibular joint
Medical Devices·42 affected·Oct 17, 2014
High RiskFDA
Ethicon, Inc.
Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA.
Medical Devices·2,508 affected·Oct 17, 2014
High RiskFDA
Remel Inc
Oxoid Legionella BCYE Growth Supplement SR0110A, packaged in 100 ml vials, 10/pkg. A growth supplement for the isolation of Legionella.
Medical Devices·16 affected·Oct 17, 2014
CriticalFDA
Siemens Healthcare Diagnostics, Inc.
Rapid Neg Urine Combo Panel Type 1; Catalog number B 1017-167; Siemens Material Number 10444652 MicroScan Rapid panels are designed f...
Medical Devices·2,239 affected·Oct 17, 2014
High RiskFDA
Biomet Microfixation, Llc
Total Temporomandibular Joint Replacement System- 45mm Lft Standard Ti Mand Reconstruction of the temporomandibular joint
Medical Devices·42 affected·Oct 17, 2014
High RiskFDA
Biomet Microfixation, Llc
Total Temporomandibular Joint Replacement System- 50mm Lft Narrow Ti Mand Reconstruction of the temporomandibular joint
Medical Devices·42 affected·Oct 17, 2014
CriticalFDA
Siemens Healthcare Diagnostics, Inc.
Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapid panels are designed for use in determining identification ...
Medical Devices·1,381 affected·Oct 17, 2014
High RiskFDA
Biomet Microfixation, Llc
Total Temporomandibular Joint Replacement System- 50mm Lft Standard Ti Mandi Reconstruction of the temporomandibular joint
Medical Devices·42 affected·Oct 17, 2014
High RiskFDA
Biomet Microfixation, Llc
Total Temporomandibular Joint Replacement System- 55mm Lft Standard Ti Mand Reconstruction of the temporomandibular joint
Medical Devices·42 affected·Oct 17, 2014
High RiskFDA
Biomet Microfixation, Llc
Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand
Medical Devices·42 affected·Oct 17, 2014
High RiskFDA
Biomet Microfixation, Llc
Total Temporomandibular Joint Replacement System- 45mm Rt Stand Off TI Mand Reconstruction of the temporomandibular joint
Medical Devices·42 affected·Oct 17, 2014
RecallFDA
Biomerieux
Etest¿ Ceftaroline (CPT32) US B100. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the anti...
Medical Devices·652 affected·Oct 16, 2014
RecallFDA
Biomerieux
Etest¿ Ceftaroline (CPT32) WW B30. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antim...
Medical Devices·652 affected·Oct 16, 2014
RecallFDA
Biomerieux
Etest¿ Ceftaroline (CPT32) US B30. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antim...
Medical Devices·652 affected·Oct 16, 2014
RecallFDA
Biomerieux
Etest¿ Ceftaroline (CPT32) WWB100. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antim...
Medical Devices·652 affected·Oct 16, 2014
High RiskFDA
Vision Rt Inc
AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radiosurgery and preci...
Medical Devices·7 affected·Oct 15, 2014
High RiskFDA
Depuy Orthopaedics, Inc.
ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in bubble wrap and then sealed inside a polyethylene bag
Medical Devices·3,082 affected·Oct 15, 2014
High RiskFDA
Ge Healthcare, Llc
Discovery NM 630, dual detector free-geometry integrated nuclear imaging system. Models H3100RC, H3100RD, H2401LW. Product Usage: ...
Medical Devices·147 affected·Oct 14, 2014
High RiskFDA
Ge Healthcare, Llc
Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Models H3100NA, H3100PP, H3100RA, H2401LS, H2401LZ, H...
Medical Devices·255 affected·Oct 14, 2014
High RiskFDA
Zimmer, Inc.
Trabecular Metal Tibial Impactor Replacement Pads. Product Usage: TM Tibial Impactor pads are used in conjunction with the TM Tibial ...
Medical Devices·4,961 affected·Oct 14, 2014
High RiskFDA
Ge Healthcare, Llc
Optima NM/CT 640, Models H3100YA, H3100YC. Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine i...
Medical Devices·29 affected·Oct 14, 2014
High RiskFDA
Ge Healthcare, Llc
Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system. Models H3100TP, H3100TN, H3100TT, H3100TR, H3100TW, H3...
Medical Devices·22 affected·Oct 14, 2014
High RiskFDA
Silver Star Brands
Transport Chair and Rollator in 1, Model HE21630011 Burgundy and HE21630011 Blue. This is a walker/rolling chair. Used to assist injur...
Medical Devices·129 affected·Oct 10, 2014
High RiskFDA
Us Infusion Inc Dba Trucare Biomedix-usa
Medstream 81" (206 cm) 20 drop Universal Administration Sets. Disposable IV infusion set with 3 year expiration date.
Medical Devices·62,700 affected·Oct 10, 2014
High RiskFDA
Philips Medical Systems (cleveland) Inc
MX 16-slice CT Scanner System and MX 16-slice CT Scanner System Phase 11 can be used as a whole body computed tomography X-ray system fea...
Medical Devices·708 affected·Oct 9, 2014
CriticalFDA
Customed, Inc
Laparotomy Pack III (4), catalog #900-2492 Used by medical staff to perform patient care procedures such as wound healing, suture remo...
Medical Devices·400 affected·Oct 8, 2014
CriticalFDA
Customed, Inc
Cesarean Pack, Catalog number 900-403. Used by medical staff to perform patient care procedures such as wound healing, suture removals...
Medical Devices·654 affected·Oct 8, 2014
CriticalFDA
Customed, Inc
Laparoscopy Pack, Catalog number 900-3178. Used by medical staff to perform patient care procedures such as wound healing, suture remo...
Medical Devices·96 affected·Oct 8, 2014
CriticalFDA
Customed, Inc
Femoral Pack, catalog #900-2164 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrig...
Medical Devices·92 affected·Oct 8, 2014
CriticalFDA
Customed, Inc
Cysto Tur Pack, Catalog number 900-430 Used by medical staff to perform patient care procedures such as wound healing, suture removal...
Medical Devices·75 affected·Oct 8, 2014
CriticalFDA
Customed, Inc
Peri Gyn Pack, Catalog number 900-1091. Used by medical staff to perform patient care procedures such as wound healing, suture removal...
Medical Devices·740 affected·Oct 8, 2014
CriticalFDA
Customed, Inc
Lithotomy Pack, catalog #900-2167 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irr...
Medical Devices·460 affected·Oct 8, 2014
CriticalFDA
Customed, Inc
OB Pack, catalog #900-254 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wo...
Medical Devices·80 affected·Oct 8, 2014
CriticalFDA
Customed, Inc
OB Pack, Catalog number 900-1717. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irr...
Medical Devices·120 affected·Oct 8, 2014
CriticalFDA
Customed, Inc
O.R. Towels, Catalog number 900-629. Used by medical staff to perform patient care procedures such as wound healing, suture removals, ...
Medical Devices·550 affected·Oct 8, 2014
CriticalFDA
Customed, Inc
Endovenous Custom Pack, Catalog number 900-1937. Used by medical staff to perform patient care procedures such as wound healing, sutur...
Medical Devices·35 affected·Oct 8, 2014
CriticalFDA
Customed, Inc
Wound Closure Tray I, Catalog number 900-063. Used by medical staff to perform patient care procedures such as wound healing, suture r...
Medical Devices·66,250 affected·Oct 8, 2014
CriticalFDA
Customed, Inc
Angiography Pack, Catalog number 900-1488. Used by medical staff to perform patient care procedures such as wound healing, suture remo...
Medical Devices·70 affected·Oct 8, 2014
CriticalFDA
Customed, Inc
Skin Staple Removal, Catalog number 900-782. Used by medical staff to perform patient care procedures such as wound healing, suture re...
Medical Devices·20,960 affected·Oct 8, 2014
CriticalFDA
Customed, Inc
Peri Gyn Pack, Catalog number 900-1061. Used by medical staff to perform patient care procedures such as wound healing, suture removal...
Medical Devices·162 affected·Oct 8, 2014
CriticalFDA
Customed, Inc
Minor Laparotomy Pack, Catalog number 900-450. Used by medical staff to perform patient care procedures such as wound healing, suture ...
Medical Devices·250 affected·Oct 8, 2014