Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Applied Medical Resources Corp
DR. THAMES - LAP CHOLE, REF: K0880, UDI: (01)30607915139620
Medical Devices·21 affected·Mar 17, 2020
High RiskFDA
Radiometer Medical Aps
safeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1
Medical Devices·269 affected·Mar 17, 2020
High RiskFDA
Applied Medical Resources Corp
Clip Applier Kit, REF: K2887, UDI: (01)30607915139132(17)220822(30)1(10)
Medical Devices·12 affected·Mar 17, 2020
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm Part Number: 72202902
Medical Devices·125,196 affected·Mar 17, 2020
High RiskFDA
Applied Medical Resources Corp
Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110147
Medical Devices·32,760 affected·Mar 17, 2020
High RiskFDA
Radiometer Medical Aps
safeCLINITUBES Blood Sampler;REF 942-969;D957P-70-45x1
Medical Devices·5 affected·Mar 17, 2020
High RiskFDA
Applied Medical Resources Corp
Epix latis GRASPER, 5mm x 45 cm, REF: C4140, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110154
Medical Devices·4,320 affected·Mar 17, 2020
High RiskFDA
Radiometer Medical Aps
safeCLINITUBES Blood Sampler;REF 942-892;D957P-70-100x1
Medical Devices·1,314 affected·Mar 17, 2020
High RiskFDA
Bard Peripheral Vascular Inc
Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 ASP, Sterile - Product Code: DJ4011X - Product Usage: The dev...
Medical Devices·8,170 affected·Mar 17, 2020
High RiskFDA
Rayner Intraocular Lenses Limited
RaySert PLUS RSP01. LOT K030. Expiry of 2024-01 - Product Usage: The single use injectors (Model STWOl and Model RSPOl) are intended to b...
Medical Devices·2,425 affected·Mar 17, 2020
High RiskFDA
Avanos Medical, Inc.
CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit
Medical Devices·1,766 affected·Mar 16, 2020
High RiskFDA
Life Technologies Corporation
Oncomine Dx Target Test DNA Control-IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Ca...
Medical Devices·66 affected·Mar 16, 2020
High RiskFDA
Life Technologies Corporation
Oncomine Dx Target Test RNA/DNA Panel- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens,...
Medical Devices·35 affected·Mar 16, 2020
High RiskFDA
Biomet, Inc.
Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model Number 110028522 - Product Usage: Intended to be used in sur...
Medical Devices·125 affected·Mar 13, 2020
High RiskFDA
Greiner Bio-one North America, Inc.
VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355.
Medical Devices·1,000,800 affected·Mar 12, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Fresenius 2008T Hemodialysis Machine: Part Number Description 190573 2008T HEMODIAL YSIS SYS. OLC/DIASAFE PLUS; 190713 2008T HEMODIAL ...
Medical Devices·101,463 affected·Mar 12, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Fresenius 2008T BlueStar Hemodialysis Machine Part Number Description: 191124 2008T HD SYS. CDX BLUEST AR; 191126 2008T HD SYS. CDX ...
Medical Devices·15,342 affected·Mar 12, 2020
High RiskFDA
Boddingtons Plastics Ltd
Endocuff Vision: models ARV 110, 120, 130, 140 Intended Use: ENDOCUFF VISION is a device attached to the distal end of a colonoscope, ...
Medical Devices·13,202 affected·Mar 11, 2020
High RiskFDA
Biomerieux Inc
The VITEK 2 Gram-positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in-vitro test t...
Medical Devices·1,698 affected·Mar 11, 2020
High RiskFDA
Merit Medical Systems, Inc.
PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT
Medical Devices·1,932 affected·Mar 11, 2020
High RiskFDA
Smiths Medical Asd Inc.
smiths medical medex CBSS-5ML, Triple set, (172/15cm), Model Number DPSHC0092
Medical Devices·150 affected·Mar 10, 2020
High RiskFDA
Smiths Medical Asd Inc.
smiths medical medex CBSS-5ML Zweifach set, Model Number DPSHC0090
Medical Devices·20 affected·Mar 10, 2020
High RiskFDA
Smiths Medical Asd Inc.
smiths medical medex CBSS-5ML, Single Set, (172/15cm), Model Number DPSHC0093
Medical Devices·13,620 affected·Mar 10, 2020
High RiskFDA
Smiths Medical Asd Inc.
smiths medical medex CBSS 5 ml, dreifach proximaler Entnahmeport 60 cm, Model number DPSHC0082
Medical Devices·870 affected·Mar 10, 2020
High RiskFDA
Smiths Medical Asd Inc.
medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d) MX96AE181P1 e) MX96AE211P1
Medical Devices·17,980 affected·Mar 10, 2020
High RiskFDA
Northgate Technologies, Inc.
Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary cal...
Medical Devices·298 affected·Mar 10, 2020
High RiskFDA
Smiths Medical Asd Inc.
smiths medical medex CBSS-5ML, Double set, (172+15cm), Model Number DPSHC0094
Medical Devices·3,620 affected·Mar 10, 2020
High RiskFDA
Smiths Medical Asd Inc.
smiths medical medex CBSS 2-fach Druckmesset mit Option, Model Number DPSHC0076
Medical Devices·3,100 affected·Mar 10, 2020
High RiskFDA
Sysmex America, Inc.
The CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receives magazines containing stained blood smears from SP-50, sele...
Medical Devices·93 affected·Mar 9, 2020
High RiskFDA
Boston Scientific
Sensor Nitinol Wire with Hydrophilic Tip .0383CM FLEX ANG/150CM UPN: M0066703101 box 5 UPN: M0066703100 single unit
Medical Devices·225 affected·Mar 9, 2020
High RiskFDA
Boston Scientific
Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX /150CM UPN: M0066703061 box 5 UPN: M0066703060 single unit
Medical Devices·1,785 affected·Mar 9, 2020
High RiskFDA
Boston Scientific
Sensor Nitinol Wire with Hydrophilic Tip .038 3CM FLEX STR/150CM UPN: M006670309 1box 5 UPN: M0066703090 single unit
Medical Devices·5,565 affected·Mar 9, 2020
High RiskFDA
R82 A/s
Chest Support for R82 Mustang, Model Numbers: 861810, 861820, 861830; and Rabbit Up, Model Numbers: 869810, 869820, 869830
Medical Devices·2,230 affected·Mar 6, 2020
RecallFDA
Linet Americas
AVE 2 Birthing Bed - Product Usage: is designated to be used by mothers ready for spontaneous vaginal delivery and also as aid to search ...
Medical Devices·202 affected·Mar 6, 2020
High RiskFDA
Skytron, Div. The Kmw Group, Inc
Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single monitor mount, 27" max. screen size Part number 3FCM1
Medical Devices·43 affected·Mar 5, 2020
High RiskFDA
Natus Neurology Dba Excel Tech., Ltd. (xltek)
natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph
Medical Devices·40 affected·Mar 5, 2020
High RiskFDA
Philips North America, Llc
TRx4841A 1.4 GHz IntelliVue Tele TRX, Model Number 862439; Includes System Codes 453564007261, 453564007271, 453564007281, 989803196951
Medical Devices·81,626 affected·Mar 5, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation standalone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 7.0, 8.0, 8.1, 9.0, 9.1 - Product U...
Medical Devices·1,389 affected·Mar 4, 2020
High RiskFDA
Capintec Inc
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Me...
Medical Devices·48 affected·Mar 3, 2020
High RiskFDA
Merits Holdings Co. Dba Merits Health Products, Inc.
Merits E604 Pilot Navigator Stairlift - Product Usage: To transport patients up stairs.
Medical Devices·82 affected·Mar 2, 2020
High RiskFDA
Csl Behring Gmbh
Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Siemens Material Num...
Medical Devices·297 affected·Mar 2, 2020
CriticalFDA
Argo Medical Technologies Ltd
ReWalk Personal 6.0, ReWalk Personal 5.0 and ReWalk R Systems orthotically fits to the lower limbs and part of the upper body and is inte...
Medical Devices·350 affected·Feb 28, 2020
High RiskFDA
Cme America Llc
CMEAmerica BodyGuard Wall Charger: Lot number 2019-0364, Mode/Catalogue number 151-143XL, *+B 01151143X L0/$$72019-0364/ 16D20191101/* ...
Medical Devices·27 affected·Feb 27, 2020
High RiskFDA
Gentell, Inc
Gentell Hydrogel Ag 4x4, model no. GEN-11420 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated ...
Medical Devices·20,025 affected·Feb 27, 2020
High RiskFDA
Gentell, Inc
Gentell Hydrogel Ag 4oz. Tube, model no. - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Silver Antimic...
Medical Devices·6,395 affected·Feb 27, 2020
High RiskFDA
Smith & Nephew, Inc.
NAVIO Soft Tissue Protector, included in instrument kits. The NAVIO Tissue Protector is a reusable instrument designed to, when used ...
Medical Devices·348 affected·Feb 27, 2020
High RiskFDA
Gentell, Inc
Gentell Hydrogel Ag 2x2, model no GEN-11220 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated G...
Medical Devices·53,134 affected·Feb 27, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower
Medical Devices·1,807 affected·Feb 27, 2020