Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Medline Industries, Inc.
PICC Tray, STERILE, 12 packs each per case.
Medical Devices·144 affected·Apr 12, 2017
High RiskFDA
Siemens Healthcare Diagnostics Inc
RAPIDPoint¿ 500 Blood Gas Analyzer with v2.4 software for professional use in a point-of-care or laboratory environment. This system test...
Medical Devices·159 affected·Apr 10, 2017
High RiskFDA
B Braun Medical Inc
CytoGuard Closed Luer Connector, Intravenous access 2 cartons of 50 units each (100 units per case)
Medical Devices·417,600 affected·Apr 10, 2017
High RiskFDA
Bausch & Lomb Surgical, Inc.
SoftPort Easy-Load Lens Delivery System Model: EZ-28V Is used for the folding and delivering of the LI61AO, LI61AOV, or LI61SE 3-piece ...
Medical Devices·0 affected·Apr 5, 2017
High RiskFDA
Perouse Medical
DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE; Catalog Number: CL3030- 018SNA- 018SND 0185NA 0185ND; INTERNAL CODE NUMBER: 0185TR- 01...
Medical Devices·18,431 affected·Apr 5, 2017
CriticalFDA
Laserex Systems Inc.
Ellex Tango Reflex with slit lamp Laser Ophthalmic In the SLT mode, the device is intended to be used for selective laser trabeculopl...
Medical Devices·83 affected·Apr 4, 2017
High RiskFDA
Smiths Medical Asd Inc.
Jelco, Hypodermic needle Pro¿ needles 19G X1 1/2" 800/CA Model No. EL 1915 & 19G X 2" 600/CA Model No. SB 5021, Rx Only, Sterile EO.
Medical Devices·736,000 affected·Apr 4, 2017
High RiskFDA
Intersurgical Inc
Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: 1) small pediatric size 2 catalog #8002001, 2) large pe...
Medical Devices·144 affected·Apr 3, 2017
High RiskFDA
Natus Medical Incorporated
Second generation neoBLUE LED Phototherapy Light (neoBLUE 2) sold between 2003 and 2008. Catalog Part Number 010066. Top Assembly Part N...
Medical Devices·4,371 affected·Apr 3, 2017
High RiskFDA
Abbott Medical Optics Inc. (amo)
Healon GV, Part No. 10294701, 10294801, 10200014, 10201014, 10202014, 10203014
Medical Devices·293,867 affected·Apr 1, 2017
High RiskFDA
Abbott Medical Optics Inc. (amo)
Healon Pro, Part No. 10270012
Medical Devices·293,867 affected·Apr 1, 2017
High RiskFDA
Abbott Medical Optics Inc. (amo)
Healon 5 Pro, Part No. 10270015
Medical Devices·293,867 affected·Apr 1, 2017
High RiskFDA
Abbott Medical Optics Inc. (amo)
Healon, Part No. 10290953, 10295210, 10200011, 10200012, 10201012, 10203012, 10213012, 10223012, 10290701, 10294751, 10295701
Medical Devices·293,867 affected·Apr 1, 2017
High RiskFDA
Abbott Medical Optics Inc. (amo)
Healon Duet, Part No. 10290080, 10220010, 10220011 and 10220012
Medical Devices·293,867 affected·Apr 1, 2017
High RiskFDA
C.r. Bard, Inc.
Arctic Sun 5000 Temperature Management System, 100-120 V North America and 100-120 V US
Medical Devices·3,450 affected·Mar 31, 2017
High RiskFDA
Ethicon Endo-surgery Inc
Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM
Medical Devices·792 affected·Mar 31, 2017
High RiskFDA
Smith & Nephew, Inc.
RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 14, REF 71369314, STERILE R, QTY: (1)
Medical Devices·1,126 affected·Mar 30, 2017
High RiskFDA
Smith & Nephew, Inc.
RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 3 INCH, REF 71369208, STERILE R, QTY: (1)
Medical Devices·6,997 affected·Mar 30, 2017
High RiskFDA
Breg Inc
Dressing Shldr XL, P/N 04918 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care...
Medical Devices·2,609 affected·Mar 30, 2017
High RiskFDA
Breg Inc
Dressing M/U XL, P/N 02344 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care c...
Medical Devices·2,609 affected·Mar 30, 2017
High RiskFDA
Breg Inc
Dressing, Knee L/XL, P/N 04708 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Ca...
Medical Devices·2,609 affected·Mar 30, 2017
High RiskFDA
Breg Inc
Dressing Back, P/N 09810 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care col...
Medical Devices·2,609 affected·Mar 30, 2017
High RiskFDA
Breg Inc
Dressing Knee/Shldr, P/N 02328 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Ca...
Medical Devices·0 affected·Mar 30, 2017
High RiskFDA
Smith & Nephew, Inc.
RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 16, REF 71369316, STERILE R, QTY: (1)
Medical Devices·1,004 affected·Mar 30, 2017
High RiskFDA
Smith & Nephew, Inc.
RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 10, REF 71369310, STERILE R, QTY: (1)
Medical Devices·1,535 affected·Mar 30, 2017
High RiskFDA
Breg Inc
Dressing Shldr, P/N 04908 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care co...
Medical Devices·2,609 affected·Mar 30, 2017
High RiskFDA
Breg Inc
Dressing Rect L, P/N 02428 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care c...
Medical Devices·2,609 affected·Mar 30, 2017
High RiskFDA
Smith & Nephew, Inc.
RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 5 INCH, REF 71369408, STERILE R, QTY: (1)
Medical Devices·3,748 affected·Mar 30, 2017
High RiskFDA
Barco N.v.
Optional MDRC-1119 Front Cover Attachment Kit for review display monitors. Product Usage: The product is an optional kit, intended t...
Medical Devices·2,087 affected·Mar 30, 2017
High RiskFDA
Smith & Nephew, Inc.
RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369210, STERILE R, QTY: (1)
Medical Devices·8,067 affected·Mar 30, 2017
High RiskFDA
Abbott Medical Optics Inc. (amo)
AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cutter and Irrigation Sleeve (Model Number NGP0020) Used with t...
Medical Devices·360 affected·Mar 30, 2017
High RiskFDA
Smith & Nephew, Inc.
RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369410, STERILE R, QTY: (1)
Medical Devices·4,033 affected·Mar 30, 2017
High RiskFDA
Smith & Nephew, Inc.
RENOVATION, THIN OSTEOTOME BLADE, 12 MM X 3 INCH, REF 71369212, STERILE R, QTY: (1)
Medical Devices·4,947 affected·Mar 30, 2017
High RiskFDA
Smith & Nephew, Inc.
RENOVATION, THIN OSTEOTOME BLADE, 20 MM X 3 INCH, REF 71369220, STERILE R, QTY: (1)
Medical Devices·2,017 affected·Mar 30, 2017
RecallFDA
Teleflex Medical
Arrow EZ-IO Needle Set 45 mm 15 ga, Ref 9079.
Medical Devices·4,760 affected·Mar 29, 2017
High RiskFDA
Stryker Medical Division Of Stryker Corporation
Medi-Therm Hyper/Hypothermia System, MTA7900
Medical Devices·119 affected·Mar 29, 2017
High RiskFDA
Mizuho Osi
216 Wilson Frame Pads, Model # 5319-37; Used with Radiolucent Wilson Frames, model numbers 5319G and 5321G. General and Plastic Sur...
Medical Devices·216 affected·Mar 28, 2017
High RiskFDA
Aesculap Implant Systems Llc
GE426R; HI-LINE XS DIAMOND BURR X-CRS.I D4.5MM; GE426SU; HI-LINE XS DISP.DIAM.BURR X-CRS.I D4.5MM; GE526R; HI-LINE XS DIAMOND BURR ...
Medical Devices·608 affected·Mar 28, 2017
High RiskFDA
Bard Peripheral Vascular Inc
MR GHIATAS Beaded Breast Localization Wire, Product Code: 477201, 479201 Product Usage: The GHIATAS Beaded Breast Localization Wire c...
Medical Devices·570 affected·Mar 28, 2017
High RiskFDA
Aesculap Implant Systems Llc
GP321R; ELAN 4 2-RING DIAMOND BURR COARSE D2.3; GP322R; ELAN 4 2-RING DIAMOND BURR COARSE D3.0; GP323R; ELAN 4 2-RING DIAMOND BURR ...
Medical Devices·608 affected·Mar 28, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee, Angiographic x-ray system
Medical Devices·3 affected·Mar 28, 2017
High RiskFDA
Arthrex, Inc.
Anthrex Bio-SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching
Medical Devices·0 affected·Mar 24, 2017
High RiskFDA
Arthrex, Inc.
Anthrex PEEK SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching
Medical Devices·0 affected·Mar 24, 2017
High RiskFDA
Craftmatic Industries, Inc.
Craftmatic Model 1 Base for Dual Bed Configurations
Medical Devices·0 affected·Mar 24, 2017
CriticalFDA
Sysmex America Inc
Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073 Japan
Medical Devices·3,682 affected·Mar 23, 2017
High RiskFDA
Toshiba American Medical Systems
Toshiba Medical Radrex - i Digital Radiography X-ray system Radrex-i is intended for use in conjunction with the ceiling suspended tub...
Medical Devices·140 affected·Mar 23, 2017
High RiskFDA
Merit Medical Systems, Inc.
1 mL Medallion¿ Syringe. Catalog Numbers: 701989001, K01-05197P, MSS011-YP, K01-07946P, MSS011, MSS011-LB, MSS011-R, MSS011-Y, MSS011P, M...
Medical Devices·23,032 affected·Mar 23, 2017
CriticalFDA
Philips Electronics North America Corporation
Allura Xper Release 8.2 (Laird chiller is always installed); Allura Xper FD10 722026; Allura Xper FD10/10 722027; Allura Xper FD20/10 bip...
Medical Devices·6,992 affected·Mar 22, 2017