Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Icu Medical, Inc.
Diana Automated Compounding System, Diana Onco Plus 1.3, Item No. ASN223 The Diana is an automated compounding device for the accurate, ...
Medical Devices·3 affected·Mar 8, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
IntelliSpace Portal DX/HX/EX AutoSPECT Pro Software Application, Philips Medical Systems, Cleveland, OH. Provides software application...
Medical Devices·33 affected·Mar 4, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Extended Brilliance Workspace NM Special Nuclear medicine image display and processing application suite. AutoSPECT Pro Software Applicat...
Medical Devices·37 affected·Mar 4, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Extended Brilliance Workspace NM Nuclear medicine image display and processing application suite. AutoSPECT Pro Software Application. Phi...
Medical Devices·126 affected·Mar 4, 2016
High RiskFDA
Covidien Llc
Vistec X-Ray Detectable Sponges, 16 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number: 7319
Medical Devices·372,480 affected·Mar 3, 2016
High RiskFDA
Covidien Llc
Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 12" x 12" (30.5 cm x 30.5 cm) Item Number:6534
Medical Devices·350,550 affected·Mar 3, 2016
High RiskFDA
Covidien Llc
Curity All Purpose Sponges, Non-woven, 4 Ply, Soft Pouch, 4" x 4" (10.2 cm x 10.2 cm) Item Number: 8047
Medical Devices·2,418,560 affected·Mar 3, 2016
High RiskFDA
Circulatory Technology Inc
Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38
Medical Devices·72 affected·Mar 3, 2016
High RiskFDA
Covidien Llc
Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 36" (20.3 cm x 91.4 cm Item Number: 6056
Medical Devices·36,040 affected·Mar 3, 2016
High RiskFDA
Covidien Llc
Vistec X-Ray Detectable Sponges, 26 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number: 7321
Medical Devices·199,488 affected·Mar 3, 2016
High RiskFDA
Dynarex Corporation
dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile, Single Use Only Product Usage:containers for ...
Medical Devices·399 affected·Mar 3, 2016
High RiskFDA
Arthrocare Corporation
TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ACH4040-01; TOPAZ MicroDebrider 0.8 mm REF Q6000-01; TOPAZ E...
Medical Devices·26,903 affected·Mar 3, 2016
High RiskFDA
Covidien Llc
Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 18" x 18" (45.7 cm x 45.7 cm) Item Number: 6022
Medical Devices·996,002 affected·Mar 3, 2016
High RiskFDA
Covidien Llc
Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 32" (20.3 cm x 81.3 cm) Item Number: 4037
Medical Devices·28,085 affected·Mar 3, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens SOMATOM Definition: Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.
Medical Devices·1,096 affected·Mar 2, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens SOMATOM Definition, SOMATOM Definition AS, SOMATOM Definition Flash and SOMATOM Definition Edge; Intended to produce cross-sectio...
Medical Devices·1,096 affected·Mar 2, 2016
High RiskFDA
Cardinal Health
Gomco Style Circumcision Clamp Trays is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
Medical Devices·34 affected·Feb 29, 2016
High RiskFDA
Karl Storz Endovision, Inc.
ENDOSCOPE BRUSH- KARL STORZ Flexible Cleaning Brush single-use, non-sterile device for cleaning various models of endoscopes Model Numb...
Medical Devices·16,908 affected·Feb 29, 2016
RecallFDA
Ams Diagnostics, Llc
Medica ISE Module Calibrant A; 500 mL - 140 mmol/L Na+, 125 mmol/L Cl-, buffers and preservatives; For use with ISE Module; Product U...
Medical Devices·9 affected·Feb 29, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc.
The E.CAM gamma camera system Product Usage: The E.CAM gamma camera system is a SPECT system and measures the distribution of radiop...
Medical Devices·3,090 affected·Feb 26, 2016
High RiskFDA
Icu Medical, Inc.
30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Integrated ChemoLock Drip Chamber, Spiros, Hanger, Drop-In Red Cap, Item No. CL 3011 Clere...
Medical Devices·19,250 affected·Feb 25, 2016
High RiskFDA
Icu Medical, Inc.
30" (76 cm) Appx. 6.3 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, 0.2 Micron Filter, ChemoLock, Hanger, Item No. CL3...
Medical Devices·50 affected·Feb 25, 2016
High RiskFDA
Icu Medical, Inc.
30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, ChemoLock, Hanger, Item No. CL3511 st...
Medical Devices·7,500 affected·Feb 25, 2016
High RiskFDA
Icu Medical, Inc.
31" (79 cm) Appx. 3.4 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, Spiros, Bag Hanger, Item No. SL3011 sterile device...
Medical Devices·400 affected·Feb 25, 2016
High RiskFDA
Icu Medical, Inc.
110" (279 cm) Appx 13.8 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, Clave, Rotating Luer, Bag Hanger, Item No. AHCL3...
Medical Devices·350 affected·Feb 25, 2016
High RiskFDA
Ossur H / F
Rebound Air Walker Product Usage: Rebound Air Walkers are indicated for grade 2 and grade 3 ankle sprains, to stabilize fractures, po...
Medical Devices·7,623 affected·Feb 24, 2016
CriticalFDA
Biomerieux Inc
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P640 REF 418579), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susc...
Medical Devices·7,497 affected·Feb 24, 2016
High RiskFDA
Ossur H / F
Unloader Custom Lite Product Usage: Unloader Custom Lite is an external knee braces to provide support for knee instability due to l...
Medical Devices·9 affected·Feb 24, 2016
High RiskFDA
Ossur H / F
Papoose Infant Spine Immobilizer Item # Item Description: PA-100 Papoose PAR-100 Papoose w/replacement pads PO-100 Papoose w/o PO fro...
Medical Devices·401 affected·Feb 24, 2016
CriticalFDA
Biomerieux Inc
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P645 REF 419602), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Suscep...
Medical Devices·1,524 affected·Feb 24, 2016
CriticalFDA
Biomerieux Inc
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P639 REF 418662), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susce...
Medical Devices·180 affected·Feb 24, 2016
High RiskFDA
Ossur H / F
Rebound Cartilage Custom Product Usage: Rebound Cartilage Custom is an external knee brace that provides support for knee instability...
Medical Devices·24 affected·Feb 24, 2016
High RiskFDA
Ossur H / F
Rebound Cartilage Product Usage: Rebound Cartilage is an external knee brace that provides support for knee instability due to ligame...
Medical Devices·1,030 affected·Feb 24, 2016
High RiskFDA
Ossur H / F
Knee Undersleeve Gray Product Usage: Knee undersleeves are worn as an accessory for comfort under knee braces.
Medical Devices·456 affected·Feb 24, 2016
High RiskFDA
Ossur H / F
Back Support Suspenders Clip on Black Back Support Suspenders Sew on Black
Medical Devices·2 affected·Feb 24, 2016
High RiskFDA
Ossur H / F
Unloader XT Product Usage: Unloader XT Extreme is an external knee braces to provide support for knee instability due to ligament inj...
Medical Devices·15 affected·Feb 24, 2016
CriticalFDA
Biomerieux Inc
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P644 REF 418673), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Suscep...
Medical Devices·5,575 affected·Feb 24, 2016
High RiskFDA
Amd Ritmed
IMCO brand Conforming Stretch Gauze Bandages, 4 x 4.1 Yds/10 cm x 3,7 cm, Reorder No. 704-IMC, Bar code 6 86864 04351 5, 96 per case (8 b...
Medical Devices·126 affected·Feb 24, 2016
High RiskFDA
Ossur H / F
Extreme Custom Product Usage: Extreme Custom is an external knee braces to provide support for knee instability due to ligament injur...
Medical Devices·7 affected·Feb 24, 2016
CriticalFDA
Biomerieux Inc
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P642 REF 418604), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Suscep...
Medical Devices·15,006 affected·Feb 24, 2016
High RiskFDA
Ossur H / F
Miami J Collar Product Usage: Miami J collars are applied to patients afflicted with cervical injuries to ensure immobilization.
Medical Devices·15,825 affected·Feb 24, 2016
High RiskFDA
Ossur H / F
NecLoc Extrication Collar Product Usage: Necloc collars are applied to patients afflicted with cervical injuries to ensure immobiliza...
Medical Devices·2,010 affected·Feb 24, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analy...
Medical Devices·35 affected·Feb 23, 2016
High RiskFDA
Synthes (usa) Products Llc
Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile Neuro Plating Sy...
Medical Devices·500 affected·Feb 23, 2016
High RiskFDA
Pentax Medical Company
Video Duodenoscope
Medical Devices·423 affected·Feb 22, 2016
High RiskFDA
Villa Radiology Systems Llc
Apollo: Models: 9784000131, 9784000231, 9784020131, 9784020231, 9784100231, 9784120131, 9784120231, 9784130131 Multi-function x-ray sy...
Medical Devices·66 affected·Feb 19, 2016
High RiskFDA
Villa Radiology Systems Llc
Juno DRF; Model: 709020 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
Medical Devices·66 affected·Feb 19, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
Cios Alpha, mobile X-ray system
Medical Devices·89 affected·Feb 19, 2016