Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Icu Medical, Inc.
7" (18cm) Appx 0.32 ml, Smallbore Ext Set w/Remv MicroCLAVE¿ Clear, NanoClave¿ T-Connector, Clamp, Rotating Luer, Part No. A1000, Item N...
Medical Devices·10,400 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
8" Smallbore Pentafuse Ext Set w/5 NanoClave", 5 Clamps, Rotating Luer, Part No. A1000, Item No. A1070 The ICU Needleless Connector is ...
Medical Devices·50 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
120" 10 Drop Primary Set w/2 BCV-CLAVE¿, Remv 2 Gang CLAVE¿ Stopcock, Remv CLAVE¿ Stopcock, NanoClave¿ T-Connector, Rotating Luer, 2 Ex...
Medical Devices·2,000 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
NanoClave Connector, Part No. A1000, Item No. 011-A1000, 061-A1000, A1000, K7083-001, Z3769 The ICU Needleless Connector is a single u...
Medical Devices·69,100 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
7" (18 cm) Appx 0.33 ml, Smallbore Ext Set w/NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. K7103-001 The ICU Needleless ...
Medical Devices·4,000 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Rotating Luer, Item # B3304-T, Lot # 2791244. The ICU Needleless Connector is ...
Medical Devices·750 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
6" (15 cm) Appx 0.24 ml, Smallbore Ext Set w/MicroCLAVE¿ Clear, Clamp, NanoClave¿ T-Connector, Rotating Luer, Item # A1003, Lot # 277381...
Medical Devices·250 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
6" (15 cm) Appx 0.26 ml, Smallbore Ext Set with NanoClave T-Connector, Clamp, Luer Slip, Part No. A1000, Item No. 011-A1002 The ICU Nee...
Medical Devices·100 affected·Dec 24, 2013
High RiskFDA
Aesculap, Inc.
Aesculap proSA Adjustment Disc Size Large (L) The Miethke proSA Adjustment shunt system is intended to shut cerebrospinal fluid from t...
Medical Devices·79 affected·Dec 23, 2013
High RiskFDA
Mckesson Information Solutions Llc
Horizon Medical Imaging, Picture Archive Communication System (PACS).
Medical Devices·618 affected·Dec 23, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON SC2000 Power Input: 100-240VAC, 1600 Max 50/60Hz; Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain Vie...
Medical Devices·271 affected·Dec 22, 2013
High RiskFDA
Zeiss, Carl Inc
Compensator Slider Lambda 6x20 component (part number 473704-0000-000) utilized on all upright ZEISS microscopes (Axio Imager, Axio Scope...
Medical Devices·335 affected·Dec 20, 2013
High RiskFDA
Optimedica Corporation
Catalys Precision Laser System (United States) - Catalys-U: Catalys Precision Laser System (International) - Catalys I 200-240V ~, 50...
Medical Devices·78 affected·Dec 20, 2013
High RiskFDA
Itc-nexus Dx
Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, on...
Medical Devices·25,965 affected·Dec 19, 2013
High RiskFDA
Steris Corporation
VERIFY¿ SixCess 270FP Challenge Pack, STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060, 440-354-2600. The VERIFY¿ SixCess 270FP...
Medical Devices·94 affected·Dec 19, 2013
High RiskFDA
Ranir Corporation
UP & UP kids' power toothbrush
Medical Devices·601,616 affected·Dec 18, 2013
High RiskFDA
Ranir Corporation
TopCare Clifford THE BIG RED DOG power toothbrush for kids!
Medical Devices·601,616 affected·Dec 18, 2013
High RiskFDA
The Anspach Effort, Inc.
Anspach Carbide Cutting Burrs: 2MM Carbide Fluted Ball, Standard, 8 Flutes - part #QD8-2SB-C-8F, 4MM Carbide Fluted Ball, 10 Flutes - pa...
Medical Devices·28,562 affected·Dec 17, 2013
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Part Number: 650103. The adapter is a socket that accepts t...
Medical Devices·703 affected·Dec 17, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens Artis zee Ceiling Systems. Angiographic x-ray system.
Medical Devices·284 affected·Dec 16, 2013
High RiskFDA
B. Braun Medical, Inc.
B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML Generally used for delivery of antibiotic and local anesthesia medications.
Medical Devices·30 affected·Dec 13, 2013
High RiskFDA
Highland Metals, Inc.
SuperElastic Regular force NiTi lower or upper Natural arches. 0.14 size 10 or 100 count packages. Highland Metals Inc. San Jose, CA ...
Medical Devices·37 affected·Dec 13, 2013
High RiskFDA
Highland Metals, Inc.
SuperElastic Regular force NiTi lower or upper Natural arches. 0.16 size 10 or 100 count packages. Highland Metals Inc. San Jose, CA ...
Medical Devices·9 affected·Dec 13, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
VirtuoSaph¿ Plus Endoscopic Vessel Harvesting System, Part number: VSP550, Sterile***Rx Only*** Product Usage: The VirtuoSaph  Plus ...
Medical Devices·26 affected·Dec 12, 2013
High RiskFDA
Ge Healthcare
Upgrade Kit, Resuscitation, T-Piece, part numbers M1139417, M1192226 and M1223628, labeled in part ***GE Healthcare 8880 Gorman Road Laur...
Medical Devices·561 affected·Dec 12, 2013
High RiskFDA
Ge Healthcare
Stand-Alone Resuscitation, T-Piece, part numbers 2063771-001, 2063772-001, 2063773-001, 2063774-001, 2063775-001, M1226442, M1241420, M12...
Medical Devices·375 affected·Dec 12, 2013
High RiskFDA
Ge Healthcare
Stand-Alone Resuscitation Unit, Bag and Mask, part number M1226444, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723***...
Medical Devices·15 affected·Dec 12, 2013
High RiskFDA
Ge Healthcare
Giraffe¿ Infant Warmers, part number M1118179, labeled in part *** GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com...
Medical Devices·1,970 affected·Dec 12, 2013
High RiskFDA
Toshiba American Medical Systems Inc
TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System.
Medical Devices·8 affected·Dec 11, 2013
High RiskFDA
Coltene Whaledent Inc
Latex Dental Dams labeled as Non-Latex Dental Dams
Medical Devices·32 affected·Dec 11, 2013
High RiskFDA
Zimmer, Inc.
Versys Build-Up Block The VerSys CRC Hip System is indicated for total hip arthroplasty in patients whose bone stock is of poor qualit...
Medical Devices·3 affected·Dec 10, 2013
High RiskFDA
Draeger Medical Systems, Inc.
Draeger Infinity Acute Care System Monitoring Solution
Medical Devices·439 affected·Dec 10, 2013
High RiskFDA
Depuy Orthopaedics, Inc.
PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) Used during primary total knee arthroplasty to improve patien...
Medical Devices·2 affected·Dec 9, 2013
High RiskFDA
Gambro Renal Products, Incorporated
Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Number(s): 101025 (003410510) - Cartridge set, STND PRM LN and...
Medical Devices·306,525 affected·Dec 9, 2013
High RiskFDA
Synergetics Inc
23ga Chow Illuminated Pick, Synergetics, inc., length 7.5 ft, sterile / EO, 56.07.23P. Packed 12 units per box. Manufactured for Synerget...
Medical Devices·38 affected·Dec 9, 2013
High RiskFDA
Synergetics Inc
25ga Endo Illuminator, Synergetics, inc., length 7.0 ft, sterile / EO, 56.02.25 Packed 12 units per box. Manufactured for Synergetics, In...
Medical Devices·96 affected·Dec 9, 2013
High RiskFDA
Synergetics Inc
23ga Mid-Field Endo Illuminator, Synergetics length 7.5 ft, sterile / EO, 56.22.23P. Packed 12 units per box. Manufactured for Synergetic...
Medical Devices·26 affected·Dec 9, 2013
High RiskFDA
Synergetics Inc
23ga Chandelier Infusion Cannula, Synergetics, inc., length 8.0 ft, sterile / EO, 56.30.23P. Packed 12 units per box. Manufactured for Sy...
Medical Devices·240 affected·Dec 9, 2013
High RiskFDA
Synergetics Inc
Stiff 25ga Wide Field Endo Illuminator, Synergetics, inc. length 7.5 ft, sterile / EO, 56.21.25PS. Packed 12 units per box. Manufactured ...
Medical Devices·507 affected·Dec 9, 2013
High RiskFDA
Synergetics Inc
27ga ONE-STEP (tm) Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.02.27P. Packed 12 units per box. Manufactured fo...
Medical Devices·96 affected·Dec 9, 2013
High RiskFDA
Synergetics Inc
Chandelier Infusion Cannula, Synergetics, inc., 20ga, length 7.5 ft, sterile / EO, 56.30.P. Packed 12 units per box. Manufactured for Syn...
Medical Devices·108 affected·Dec 9, 2013
High RiskFDA
Synergetics Inc
25ga Awh Vivid Chandelier, Synergetics, length 7.5 ft, sterile / EO, 56.54.25P. Packed 12 units per box. Manufactured for Synergetics, In...
Medical Devices·108 affected·Dec 9, 2013
High RiskFDA
Synergetics Inc
23ga Aspirating Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.24.23P. Packed 12 units per box. Manufactured for Synerget...
Medical Devices·43 affected·Dec 9, 2013
High RiskFDA
Synergetics Inc
23ga Straight Fixed Extended Illuminated Laser Probe, Synergetics, length 7.5 ft, sterile / EO, 55.62.23P. Packed 12 units per box. Manuf...
Medical Devices·72 affected·Dec 9, 2013
High RiskFDA
Synergetics Inc
Two-Port Vitrectomy (TPV (tm)) Wide Field High Flow End Irrigator, Synergetics, inc., 19ga, length 7.0 ft, sterile / EO, 56.14. Packed 12...
Medical Devices·36 affected·Dec 9, 2013
High RiskFDA
Synergetics Inc
Stiff 25ga Chow Illuminated Pick (Dull), Synergetics, inc., length 8.0 ft, sterile / EO, 56.07.25PS. Packed 12 units per box. Manufactur...
Medical Devices·44 affected·Dec 9, 2013
High RiskFDA
Synergetics Inc
25ga Aspirating Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.24.25P. Packed 12 units per box. Manufactured for Synerget...
Medical Devices·28 affected·Dec 9, 2013
High RiskFDA
Synergetics Inc
Endo Illuminator, Synergetics, inc., 20ga, length 7.0 ft, sterile / EO, 56.02. Packed 12 units per box. Manufactured for Synergetics, Inc...
Medical Devices·72 affected·Dec 9, 2013