Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Becton Dickinson & Company
3mL Safety-Lok Syringe, Catalog Number 309606, UDI 30382903096061
Medical Devices·428,800 affected·Feb 1, 2019
High RiskFDA
Zimmer Trabecular Metal Technology, Inc.
NexGenTrabecular Metal Tibial Half Block Augment, Right Lateral/Left Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800426 ...
Medical Devices·24 affected·Feb 1, 2019
High RiskFDA
Medline Industries Inc
Semi-Rigid Suction Canister, 3000cc. Model Numbers OR530 and OR530H. For OR530, the product comes in a case with two boxes. One box inc...
Medical Devices·750 affected·Jan 31, 2019
High RiskFDA
U&i Corp.
Velofix SA cervical cage, REF: TSA161207, TSA161208, TSA161209, TSA161210, TSA161407, TSA161408, TSA161409, TSA161410 - Product Usage:The...
Medical Devices·42 affected·Jan 30, 2019
High RiskFDA
Collins Aerospace
TASE 400 Imaging systems
Medical Devices·433 affected·Jan 29, 2019
High RiskFDA
Collins Aerospace
TASE 500 Imaging systems
Medical Devices·433 affected·Jan 29, 2019
High RiskFDA
Spacelabs Healthcare, Inc.
Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2.
Medical Devices·295 affected·Jan 28, 2019
RecallFDA
Livanova Usa Inc.
LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130, 2017-08-15, IPX1, RXOnly, (01)04033817901594 Product Usage: The S5 System is u...
Medical Devices·5 affected·Jan 28, 2019
High RiskFDA
Philips North America, Llc
Fetal Spiral Electrode, Model No. 9898 031 37631
Medical Devices·1,971,925 affected·Jan 25, 2019
High RiskFDA
Maquet Cardiovascular, Llc
AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mister is intended to clear an anastomotic site for improved vi...
Medical Devices·7,880 affected·Jan 24, 2019
High RiskFDA
Atricure, Inc.
COBRA FUSION 150 Ablation System (International Only), Catalog # (REF) 700-001MI
Medical Devices·765 affected·Jan 22, 2019
High RiskFDA
Atricure, Inc.
COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001S
Medical Devices·175 affected·Jan 22, 2019
High RiskFDA
Atricure, Inc.
COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001
Medical Devices·6,176 affected·Jan 22, 2019
High RiskFDA
Atricure, Inc.
COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002
Medical Devices·1,288 affected·Jan 22, 2019
High RiskFDA
Stryker Gmbh
Instrument Tray, Basic T2 Femur Long Catalog #: 1806-9900 Product Usage: Knee Arthroplasty
Medical Devices·17 affected·Jan 21, 2019
High RiskFDA
Bellus Medical
SKINFUSE Resuce Calming Complex Kit containing: SKINFUSE LIFT HG - Product Usage: The SKINFUSE Rescue Calming Complex is intend to be us...
Medical Devices·6,007 affected·Jan 18, 2019
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Medtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer
Medical Devices·731 affected·Jan 17, 2019
High RiskFDA
Djo, Llc
Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in Mexico, DJO, LLC.
Medical Devices·9 affected·Jan 17, 2019
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
MEDTRONIC CARELINK 2090 programmer
Medical Devices·33,007 affected·Jan 17, 2019
RecallFDA
Carolina Liquid Chemistries
CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321
Medical Devices·14 affected·Jan 16, 2019
High RiskFDA
Polymer Technology Systems, Inc.
CHOL+HDL+GLU test strips, REF 2412
Medical Devices·67,643 affected·Jan 16, 2019
High RiskFDA
Polymer Technology Systems, Inc.
Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412
Medical Devices·67,643 affected·Jan 16, 2019
RecallFDA
Carolina Liquid Chemistries
CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321
Medical Devices·20 affected·Jan 16, 2019
High RiskFDA
Westmed, Inc.
Neo-Vent Infant T-Piece Resuscitation Circuit With Infant Mask; Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID con...
Medical Devices·35 affected·Jan 15, 2019
High RiskFDA
Westmed, Inc.
Neo-Vent Infant T-Piece Resuscitation Circuit;Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0415, ...
Medical Devices·625 affected·Jan 15, 2019
High RiskFDA
Arthrex, Inc.
Arthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT) These devices are indicated for resection of soft and osseous tissues in bot...
Medical Devices·2,324 affected·Jan 14, 2019
RecallFDA
Teleflex Medical
RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection device
Medical Devices·76,725 affected·Jan 14, 2019
High RiskFDA
Bio-rad Laboratories, Inc
EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A.
Medical Devices·213 affected·Jan 10, 2019
High RiskFDA
Philips North America, Llc
PageWriter TC70, Product 860315, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pe...
Medical Devices·15,064 affected·Jan 9, 2019
High RiskFDA
Philips North America, Llc
PageWriter TC50, Product 860310, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pe...
Medical Devices·11,332 affected·Jan 9, 2019
High RiskFDA
Convatec, Inc
Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit. Labeled as: xray CH05/40CM and xray CH08/40CM Product Usage: Duo...
Medical Devices·1,231,155 affected·Jan 9, 2019
High RiskFDA
Neusoft Medical Systems Imp & Ex
NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 Multi-Slice CT Scanner System can be u...
Medical Devices·3 affected·Jan 9, 2019
High RiskFDA
Linet Spol. S.r.o.
AVE 2 Birthing Bed
Medical Devices·253 affected·Jan 7, 2019
High RiskFDA
Smith & Nephew, Inc.
SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
Medical Devices·72 affected·Jan 7, 2019
High RiskFDA
Teleflex Medical
Pilling COOLEY SUMP-SUCTION TUBE, REF 351547
Medical Devices·80 affected·Jan 7, 2019
High RiskFDA
Cook Inc.
PTFE Wire Guide, Guidewire, Global Product Number 638813 635413-10
Medical Devices·3,929 affected·Jan 4, 2019
High RiskFDA
Cook Inc.
Wire Guide, Guidewire, Global Product Number G14326
Medical Devices·13,388 affected·Jan 4, 2019
High RiskFDA
Cook Inc.
Urethral Dilator Set, Global Product No. G14185
Medical Devices·13,388 affected·Jan 4, 2019
High RiskFDA
Cook Inc.
Roadrunner Hydrophilic PC Wire Guide, Guidewire, Global Product Number G18629, G17866
Medical Devices·13,388 affected·Jan 4, 2019
High RiskFDA
Cook Inc.
Bentson PTFE Wire Guide, Guidewire, Global Product Number G14589, G14590
Medical Devices·1,079 affected·Jan 4, 2019
High RiskFDA
King Systems Corp. Dba Ambu, Inc.
King LTS-D Kit Size 1, Model Number KLTSD431
Medical Devices·270 affected·Jan 4, 2019
High RiskFDA
Cook Inc.
Heavy Duty PTFE Wire Guide, Guidewire, Global Product Number G14323 G14260 G14260
Medical Devices·146 affected·Jan 4, 2019
High RiskFDA
Conformis, Inc.
iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102
Medical Devices·2 affected·Jan 4, 2019
High RiskFDA
Cook Inc.
Percutaneous Malecot Nephrostomy Set, Global Product No. G16714 G19107 G19108
Medical Devices·13,388 affected·Jan 4, 2019
High RiskFDA
Cook Inc.
Percutaneous Pigtail Nephrostomy Set , Global Product No. G14094 G14095 G14899 G14329
Medical Devices·13,388 affected·Jan 4, 2019
High RiskFDA
Kavo Dental Technologies Llc
cone-beam CT system
Medical Devices·230 affected·Dec 31, 2018
High RiskFDA
Cardinal Health 200, Llc
Curity All Purpose Sponges, Non-woven, 4 Ply, 4" x 4" (10.2 cm x 10.2 cm) Product Code: 8044 - Product Usage: Ideal for applying ointmen...
Medical Devices·10,400 affected·Dec 27, 2018
High RiskFDA
Varian Medical Systems, Inc.
Eclipse(TM) Treatment Planning System with Proton Convolution Superposition algorithm license only The Eclipse Treatment Planning Syst...
Medical Devices·1,450 affected·Dec 26, 2018