🔍 RecallPedia
ðŸĨ

Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

37,779 Total Recalls

Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V

Invacare

Class I - Dangerous

The battery wiring harness on affected wheelchairs may become disconnected during shipment from the factory or during wheelchair use traversing large obstacles or after a jolt or impact to the wheelchair. The disconnection of the battery harness results in loss of power to the wheelchair.

Mar 30, 2022 Other Medical Devices Nationwide View Details →

HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4

Devicor Medical Products

Class I - Dangerous

Small patient labels do not match the primary device label. The primary device label accurately identifies the product as 4010-05-08-T4, while the smaller patient label incorrectly identifies the product as 4010-05-08-T3.

Mar 30, 2022 Other Medical Devices Nationwide View Details →

Surgical Suture Kit

Stradis Healthcare

Class I - Dangerous

There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity.

Apr 22, 2022 Surgical Instruments View Details →

Outer Packaging Label: Protekt Sharps Safety Knives - REF: PG 44620MU, Sterile R, Multi-Use 2.2mm Double Bevel Slit, Angled 6 units, Individual Packaging Label: ProTekt Sharps Safety Knives - REF: PG 44620MU,2.2mm double Bevel Slit, Sterile R, Angled 1 unit, Handle Labeling; 2.5mm slit double bevel

International Science & Technology, LP

Class I - Dangerous

Surgical knives may contain incorrect description printed on handles. Specifically, some surgical knife handles may contain a size of "2.5mm" when the actual size is "2.2mm".

Feb 24, 2022 Infusion Pumps Nationwide View Details →

The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor blockade. Substances known to specifically block the P2Y12 receptor include ticagrelor and the thienopyridine class of drugs, including clopidogrel and prasugrel.1-8 The test is based upon the ability of activated platelets to bind fibrinogen. Fibrinogen-coated microparticles aggregate in whole blood in proportion to the number of expressed platelet GP IIb/IIIa receptors. Light transmittance increases as activated platelets bind and aggregate fibrinogen-coated beads. The instrument measures this change in optical signal and reports results in P2Y12 Reaction Units (PRU). The rate of microbead aggregation is more rapid and reproducible if platelets are activated; therefore, the reagent adenosine-5-diphosphate (ADP) is incorporated into the test channel to induce platelet activation. Prostaglandin E1 (PGE1) is included in the reagent mixture to increase the specificity of the PRU result to reflect P2Y12-mediated platelet aggregation. The reagents are formulated such to achieve reaction concentrations of 20 ÂŋM ADP and 22 nM PGE1. In a like manner, two other activators, iso-TRAP (Thrombin Receptor Activating Peptide) with PAR4-AP (PAR4-Activating Peptide) and fibrinogen-coated microparticles are incorporated into a second channel of the test device. The instrument measures the change in transmittance in this channel, calculates the baseline platelet function for the sample, and reports the percent inhibition result for the sample.

Accriva Diagnostics

Class I - Dangerous

Two whole blood Platelet Reactivity tests exist that share the same reagent formulation and are used to obtain P2Y12 Reactivity Unit results. The test without US-FDA market clearance was distributed and it displays BASE results not displayed by the US-FDA market cleared device. A formula is being provided to health care personnel to calculate the percentage of platelet aggregation inhibition.

Mar 30, 2022 Diagnostic Equipment Nationwide View Details →

ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954

MEDLINE INDUSTRIES, LP - Northfield

Class I - Dangerous

Product was shipped from a Medline warehouse to a customer at room temperature instead of refrigerated (ice). If affected product is used, the results from this impacted Calcium reagent will not be provided due to probable Quality Control failure. A delay in diagnosis may be experienced with repeat testing resulting in patient (customer) inconvenience, pain, and cost of the repeat blood draw and testing. All HII1220001954 product shipped/stored at a Medline branch between July 2021 and August 2021 in the identified lots were incorrectly stored and shipped. Six (6) boxes have been shipped to end users at room temperature instead of refrigerated (ice). Five (5) boxes are on hold at a Medline warehouse.

Oct 22, 2021 Other Medical Devices View Details →