Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Biomet, Inc.
A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone, Item Number 233500004 - Product Usage: indicated for fixation of fractures, oste...
Medical Devices·174 affected·Dec 23, 2020
CriticalFDA
Combat Medical Systems, Llc
Valkyrie LTOWB Collection (P/N 80-820, NSN 6515016862423). Blood collection convenience kit. The Valkyrie LTOWB Collection Set inclu...
Medical Devices·531 affected·Dec 23, 2020
High RiskFDA
Tenderneeds Fertility Llc
Premium At Home Pro Series Insemination Kit (SKU 644042787927)
Medical Devices·0 affected·Dec 23, 2020
High RiskFDA
Tenderneeds Fertility Llc
Deluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with Pregnancy & Ovulation Tests, SKU 636391205856
Medical Devices·0 affected·Dec 23, 2020
High RiskFDA
Tenderneeds Fertility Llc
At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900, 636391205924, 636391205863, 636391205931,...
Medical Devices·0 affected·Dec 23, 2020
High RiskFDA
Tenderneeds Fertility Llc
Professional Clinical Artificial Intrauterine Insemination Kit (SKU 636391205962, 636391206013)
Medical Devices·0 affected·Dec 23, 2020
High RiskFDA
Draegar Medical Systems, Inc.
Infinity Acute Care System (IACS) Monitoring Solution: The IACS is intended for multi-parameter, physiologic patient monitoring of adult...
Medical Devices·19,802 affected·Dec 23, 2020
High RiskFDA
Tenderneeds Fertility Llc
At Home Artificial Intrauterine Insemination Flex Set (SKU 636391205870)
Medical Devices·0 affected·Dec 23, 2020
High RiskFDA
Tenderneeds Fertility Llc
Home Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests, SKU midiuikt
Medical Devices·0 affected·Dec 23, 2020
High RiskFDA
Cytocell Ltd.
Aquarius LPH 511-A CRLF2 Distal Probe Green, model no. LPH 511-A The CRLF2 Distal probe, labelled in green, consists of two probes (71...
Medical Devices·72 affected·Dec 22, 2020
High RiskFDA
Omnilife Science Inc.
SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replac...
Medical Devices·2 affected·Dec 21, 2020
High RiskFDA
Omnilife Science Inc.
SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip repla...
Medical Devices·3 affected·Dec 21, 2020
High RiskFDA
Ansh Labs, Llc
AnshLabs - SARS-CoV2 IgM ELISA (u-Capture), IVD, REF: AL-1002, kit contents, Ab PLATE 1 X ! Plate, IgM Sample DIL 1 x 100 mL, ENZ CONJ CO...
Medical Devices·327 affected·Dec 18, 2020
CriticalFDA
Hill-rom, Inc.
Liko Multirall 200 overhead lift- overhead lift is a general-purpose lift with the intended use in healthcare, intensive care and rehabi...
Medical Devices·10,470 affected·Dec 18, 2020
High RiskFDA
Topcon Medical Systems, Inc.
Harmony Referral System (aka Harmony RS)/ Medical Device Data System - Product Usage: intended to be used by trained healthcare professi...
Medical Devices·13 affected·Dec 18, 2020
High RiskFDA
Ge Healthcare, Llc
System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES.
Medical Devices·1,115 affected·Dec 17, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concentrate for Bicarbonate Hemodialyis Part Number: 08-3251-9
Medical Devices·2,280 affected·Dec 17, 2020
High RiskFDA
Bioventus, Llc
EXOGEN Ultrasound Coupling Gel
Medical Devices·115,584 affected·Dec 17, 2020
High RiskFDA
Medtronic Neurosurgery
REF 27219-2 X1, Medtronic, Delta Valve, Neonatal, Performance Level 2.0, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt ...
Medical Devices·0 affected·Dec 16, 2020
RecallFDA
Microbiologics Inc
KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component: KWIK-STIK(TM), Lactobacillus acidophilus derive...
Medical Devices·0 affected·Dec 16, 2020
High RiskFDA
Medtronic Neurosurgery
REF 27219-5 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.5, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt ...
Medical Devices·0 affected·Dec 16, 2020
High RiskFDA
Cook Medical Llc
Disposable Humidification Flask, Reference Part Number K-MINC-CTS-S, Order Number G32707
Medical Devices·56,250 affected·Dec 16, 2020
High RiskFDA
Microbiologics Inc
KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO DISK, Catalog #0894L; Microsporum canis derived from ATCC 3...
Medical Devices·59 affected·Dec 16, 2020
High RiskFDA
Ortho Clinical Diagnostics Inc
VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quantitatively measures total protein (TP) concentration in serum ...
Medical Devices·9,802 affected·Dec 15, 2020
High RiskFDA
K2m, Inc
Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System
Medical Devices·248 affected·Dec 14, 2020
High RiskFDA
Phadia Us Inc
EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measurement of IgG antibodies directed to dsDNA in human serum an...
Medical Devices·365 affected·Dec 14, 2020
High RiskFDA
Brainreader Aps
Neuroreader Medical Image Processing Software - Product Usage: intended to automate the current manual process of identifying, labeling, ...
Medical Devices·43 affected·Dec 14, 2020
High RiskFDA
Qiagen Sciences Llc
therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be eligible for treatmen...
Medical Devices·575 affected·Dec 11, 2020
High RiskFDA
Ortho Clinical Diagnostics Inc
VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide cartridge) Product Code:8058232 (2)VITROS CKMB Slides (18 ...
Medical Devices·41,598 affected·Dec 11, 2020
High RiskFDA
Baxter Healthcare Corporation
VERITAS Collagen Matrix - Product Usage: intended for use in reconstruction of the pelvic floor excluding transvaginal pelvic organ prola...
Medical Devices·192 affected·Dec 11, 2020
High RiskFDA
Ge Healthcare, Llc
GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of r...
Medical Devices·12 affected·Dec 10, 2020
High RiskFDA
Ge Healthcare, Llc
Discovery NM 630 (Model Number H3101RH), NM 830 (Model Number H3910AC), 830 NM Cyber Defense (Model Number H3910AG) - Product Usage: inte...
Medical Devices·81 affected·Dec 10, 2020
High RiskFDA
Ge Healthcare, Llc
Discovery 670 DR (Model H3100BT), NM/CT 870 DR (Model 3100Q and H3100AS), Discovery NM670 Pro (Model 3100XB), Discovery 670 ES (Model H31...
Medical Devices·52 affected·Dec 10, 2020
High RiskFDA
Ge Healthcare, Llc
GE NM/CT 850 system Model Number H3907AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radio...
Medical Devices·24 affected·Dec 10, 2020
High RiskFDA
Ge Healthcare, Llc
GE NM/CT 860 system Model Number H3908AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radio...
Medical Devices·12 affected·Dec 10, 2020
High RiskFDA
Remel Inc
Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049
Medical Devices·637 affected·Dec 10, 2020
High RiskFDA
Ge Healthcare, Llc
Optima NM/CT 640, Model number 3101RL - Product Usage: intended for General Nuclear Medicine imaging procedures for detection of radioiso...
Medical Devices·7 affected·Dec 10, 2020
High RiskFDA
Argon Medical Devices, Inc
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18N, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/C...
Medical Devices·583 affected·Dec 10, 2020
High RiskFDA
Argon Medical Devices, Inc
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19N, 1/19 GA Flexcore Biopsy Needle, 1.7F Introducer Sheath W/C...
Medical Devices·187 affected·Dec 10, 2020
High RiskFDA
Accuray Incorporated
TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an integrated system for the planning and precise delivery of ra...
Medical Devices·8 affected·Dec 10, 2020
High RiskFDA
Riverpoint Medical, Llc
Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24 Taper 1/2 40 mm, undyed, UDI: 10884521151307
Medical Devices·3,060 affected·Dec 9, 2020
High RiskFDA
Becton Dickinson & Company
BD Regional Block Needles 22G x 1.50in (50 units/cs.). Indicated for administration of medications to affect anesthesia or analgesia to a...
Medical Devices·105,880 affected·Dec 9, 2020
High RiskFDA
Becton Dickinson & Co.
BD Phoenix PMIC-107: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to...
Medical Devices·103,475 affected·Dec 8, 2020
High RiskFDA
Becton Dickinson & Co.
BD Phoenix PMIC/ID-108: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging...
Medical Devices·34,825 affected·Dec 8, 2020
High RiskFDA
Becton Dickinson & Co.
BD Phoenix PMIC-108: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to...
Medical Devices·60,425 affected·Dec 8, 2020
High RiskFDA
Becton Dickinson & Co.
BD Phoenix" PMIC-109: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging t...
Medical Devices·31,900 affected·Dec 8, 2020
High RiskFDA
Smiths Medical Asd Inc.
smiths medical portex Loss of Resistance Device, REF 100/398/000
Medical Devices·3,420 affected·Dec 8, 2020
High RiskFDA
Becton Dickinson & Co.
BD Phoenix PMIC/ID-105: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging...
Medical Devices·0 affected·Dec 8, 2020