Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Centurion Medical Products Corporation
Centurion CIRCLAMP W/1.3 CM BELL-single-use, disposable instrument used to compress the foreskin of the penis during circumcision of a m...
Medical Devices·204 affected·Aug 28, 2019
High RiskFDA
Ethicon, Inc.
1 STRATAFIX Spiral PDS Plus Violet 18" (45cm) OS-6 Needle, SXPP1B201
Medical Devices·3 affected·Aug 28, 2019
High RiskFDA
Karl Storz Endoscopy
Karl Storz NEURO-FIBERSCOPE, Model # 11282BN1, Flexible Pediatric Neuroscope
Medical Devices·73 affected·Aug 27, 2019
High RiskFDA
Nxstage Medical, Inc.
Low Volume Cartridge IFU (SKU CAR-125-B) used with the following devices: 1) NxStage One, Model NX1000-1; 2) NxStage VersiHD Cycler, ...
Medical Devices·1,803 affected·Aug 27, 2019
High RiskFDA
Ad-tech Medical Instrument Corporation
AD-TECH Drill Sleeve Guides, used with Ad-Tech Placement Kits: (a) REF DSG-90-2.3N (b) REF DSG-6.3-090-2.4N
Medical Devices·315 affected·Aug 27, 2019
High RiskFDA
Philips North America, Llc
IntelliVue 1.4 GHz Remote Antenna Used with Philips MX4O Monitors-The affected product is a 74 foot (22.6m) combined coax and unshielded ...
Medical Devices·1,790 affected·Aug 23, 2019
High RiskFDA
Arjohuntleigh Polska Sp. Z.o.o.
Concerto & Basic Shower Trolly, Model Numbers BAB1000-01 (UDI: (01)05055982788083), BAB1000CON6102 [(01)05056097364483], BAB1007-01 [(01...
Medical Devices·669 affected·Aug 22, 2019
CriticalFDA
Livanova Usa Inc
VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy
Medical Devices·1,687 affected·Aug 22, 2019
High RiskFDA
Conformis, Inc.
iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right
Medical Devices·1 affected·Aug 22, 2019
High RiskFDA
Ctl Medical Corporation
CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H7mm, Part #018.1907.
Medical Devices·39 affected·Aug 21, 2019
High RiskFDA
Zimmer Biomet, Inc.
COMP RVRS Shoulder Baseplates, including Custom Products, Item numbers 115331S 115331 115330S 115330 110040610 110040620 010000589 ...
Medical Devices·219,988 affected·Aug 21, 2019
High RiskFDA
Zimmer Biomet, Inc.
BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM0000097 PM555140 PM555147 PM555319 PM555418 113867 113865 1...
Medical Devices·214,741 affected·Aug 21, 2019
High RiskFDA
Zimmer Biomet, Inc.
Various Hip systems, Item Nos. 104207 104212 104215 11-162809 11-162810 11-162811 11-162812 11-162813 21-103202 21-103203 21-10...
Medical Devices·219,988 affected·Aug 21, 2019
High RiskFDA
Ctl Medical Corporation
CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H8mm, Part #018.1908.
Medical Devices·46 affected·Aug 21, 2019
High RiskFDA
Zimmer Biomet, Inc.
HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item Nos: HAA60-09030 HAA60-09040 HAA60-10030 HAA...
Medical Devices·178,886 affected·Aug 21, 2019
High RiskFDA
Zimmer Biomet, Inc.
Comprehensive RS Cleat CAP, Item No. 110300
Medical Devices·219,988 affected·Aug 21, 2019
High RiskFDA
Zimmer Biomet, Inc.
ACROMIUM FLANGE SET (Custom product) Item No. PM555148 - Product Usage: Arcomium replacement.
Medical Devices·219,988 affected·Aug 21, 2019
High RiskFDA
Zimmer Biomet, Inc.
LT DISC ULNA - HA/PC; RT DISC ULNA - HA/PC; LT DISC HMRL- HA/PC; RT DISC HMRL- HA/PC; DISC XS ULNA POR; DISC SEG ULNA POR; and Custom d...
Medical Devices·217,240 affected·Aug 21, 2019
High RiskFDA
Zimmer Biomet, Inc.
HENNESSY LEFT CONST GLENOID HA, Item No. PM555360 UDI (01)00880304819597(17)260425(10)664030 Product Usage: Constrained Shoulder.
Medical Devices·219,988 affected·Aug 21, 2019
High RiskFDA
Zimmer Biomet, Inc.
Various Custom Products, Item Nos. CP102940 CP102941 CP102942 CP102943 CP102944 CP102945 CP102946 CP102947 CP102948 CP112662 CP...
Medical Devices·219,988 affected·Aug 21, 2019
High RiskFDA
Quality Electrodynamics Llc
TxRx Knee 15 Coil 1.5T QED part number: Q7000057 Siemens Model # 10606829
Medical Devices·21 affected·Aug 20, 2019
High RiskFDA
Quality Electrodynamics Llc
TxRx CP Extremity Coil 3T QED part number: Q7000019 Siemens Model # 10185464
Medical Devices·5 affected·Aug 20, 2019
High RiskFDA
Quality Electrodynamics Llc
TxRx 15CH Knee Coil 3T QED part number: Q7000051 Siemens Model # 10606525
Medical Devices·5 affected·Aug 20, 2019
High RiskFDA
Quality Electrodynamics Llc
TxRx 15Ch Knee Coil 3T QED part number:Q7000008 Siemens Model # 10185460
Medical Devices·2 affected·Aug 20, 2019
High RiskFDA
Quality Electrodynamics Llc
TxRx 15CH Knee Coil 1.5T QED part number:Q7000016 Siemens Model # 10185453
Medical Devices·3 affected·Aug 20, 2019
High RiskFDA
Repro-med Systems, Inc.
20" 2-Needle 26-Gauge 6mm HlgH-Flo Subcutaneous Safety Needle Sets" Product # RMS22606 - Product Usage: RMS HlgH-Flo Subcutaneous Safe...
Medical Devices·1,990 affected·Aug 20, 2019
RecallFDA
Biofire Defense
FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only
Medical Devices·92 affected·Aug 20, 2019
High RiskFDA
Quality Electrodynamics Llc
TxRx 15CH Knee Coil 1.5T QED part number: Q7000050 Siemens Model # 10606524
Medical Devices·3 affected·Aug 20, 2019
High RiskFDA
Becton, Dickinson And Company, Bd Biosciences
BD FACSLyric Flow Cytometer, 3-Laser 12 Color Instrument, REF: 663029, when using BD Trucount Tubes
Medical Devices·22 affected·Aug 19, 2019
High RiskFDA
Becton, Dickinson And Company, Bd Biosciences
BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 662875, when using BD Trucount Tubes
Medical Devices·12 affected·Aug 19, 2019
High RiskFDA
Howmedica Osteonics Corp.
TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 RIGHT Catalog # 5542-A-202 - Product Usage: Triathlon Femoral Distal Augments are used wi...
Medical Devices·159 affected·Aug 19, 2019
High RiskFDA
Becton, Dickinson And Company, Bd Biosciences
BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 662877, when using BD Trucount Tubes
Medical Devices·8 affected·Aug 19, 2019
High RiskFDA
Howmedica Osteonics Corp.
TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 LEFTTriathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during...
Medical Devices·153 affected·Aug 19, 2019
High RiskFDA
Intuitive Surgical, Inc.
da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.
Medical Devices·305 affected·Aug 19, 2019
High RiskFDA
Becton, Dickinson And Company, Bd Biosciences
BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 651164, when using BD Trucount Tubes
Medical Devices·21 affected·Aug 19, 2019
High RiskFDA
Becton, Dickinson And Company, Bd Biosciences
BD FACSLyric Flow Cytometer, 3-Laser 10 Color Instrument, REF: 662878, and 66287808 when using BD Trucount Tubes
Medical Devices·78 affected·Aug 19, 2019
High RiskFDA
Becton, Dickinson And Company, Bd Biosciences
BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 662876, when using BD Trucount Tubes
Medical Devices·1 affected·Aug 19, 2019
High RiskFDA
Becton, Dickinson And Company, Bd Biosciences
BD FACSLyric Flow Cytometer,3-Laser 10 Color Instrument, REF: 659180 and 65918001, when using BD Trucount Tubes
Medical Devices·236 affected·Aug 19, 2019
High RiskFDA
Irrimax Corporation
Irrisept Wound Debridement and Cleansing System. 12 units per case.
Medical Devices·1,031 affected·Aug 16, 2019
High RiskFDA
Normand-info S.a.s.u.
Remisol Advance running on hardware with Windows XP, Windows 7, Windows Server 2003 and Windows Server 2008 operating systems
Medical Devices·6,479 affected·Aug 15, 2019
High RiskFDA
Zimmer Biomet, Inc.
XP-XP Tibial Tray - Interlok 79 mm Item # 195758
Medical Devices·0 affected·Aug 15, 2019
High RiskFDA
Zimmer Biomet, Inc.
XP-XP Tibial Tray - Interlok 65 mm Item # 195752
Medical Devices·857 affected·Aug 15, 2019
High RiskFDA
Zimmer Biomet, Inc.
XP-CR Tibial Tray - Porous Plasma 91 mm Item # 195291
Medical Devices·2 affected·Aug 15, 2019
High RiskFDA
Zimmer Biomet, Inc.
Vanguard XP Tibial Tray 75 mm Item # 195251
Medical Devices·110 affected·Aug 15, 2019
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066001
Medical Devices·88 affected·Aug 15, 2019
High RiskFDA
Zimmer Biomet, Inc.
XP-XP Tibial Tray - Interlok 59 mm Item # 195750
Medical Devices·50 affected·Aug 15, 2019
High RiskFDA
Zimmer Biomet, Inc.
Vanguard XP Tibial Tray 63 mm Item # 195245
Medical Devices·8 affected·Aug 15, 2019
High RiskFDA
Zimmer Biomet, Inc.
XP-CR Tibial Tray - Interlok 75mm Item # 195275
Medical Devices·369 affected·Aug 15, 2019