Medical device recalls
38685 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2023-01-18FDA-DeviceVentana Medical Systems, Inc.Class IIVENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 08008540001 VENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 07011571001
Internal comparison studies revealed unacceptable, light staining. Light staining affects the borderline of positive versus negative test results. It can cause a reduction in both staining intensity and the percent positivity, which could potentially lead to a false-negative PD-L1 result.
- 2023-01-18FDA-DevicePhilips Respironics, Inc.Class IPhilips Garbin Ventilator, Model Number 1058180B
The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which could result in a reduction in delivered therapy volume or pressure and could cause the device to alarm.
- 2023-01-18FDA-DevicePhilips Respironics, Inc.Class IPhilips Trilogy 200 Ventilator, Model Numbers 1040005, U1040005, 1040005B, U1040005B, CA1032800B, CA1032800, KO1032800, 1032800, R1032804TP, R1032804B, R1032804TPV, 1032804B
The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which could result in a reduction in delivered therapy volume or pressure and could cause the device to alarm.
- 2023-01-18FDA-DevicePhilips Respironics, Inc.Class IPhilips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B, 1054260B, CA1054096B, BT1054260, 1054096B, R1054260, RSL1054260, CA1054096, R1054260B, R1054655TPV, AU1054096, AU1054096B, 1054096B, 1054097, BR1054096, LA1054096, CN1054096, KO1054096, KR1054096, R1054655TP, R1054655B, 1054655, 1054655TPV, 1054655TP, 1054655B
The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which could result in a reduction in delivered therapy volume or pressure and could cause the device to alarm.
- 2023-01-18FDA-DeviceCovidien LPClass IMAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single Use, Rx Only: 13.5cm, Straight Extensions, Kit - Model No. 8888135131; 13.5 cm, Curved Extensions, Kit - Model No. 8888135132; 13.5cm, Pre-Curved, Kit - Model No. 8888135133; 13.5cm, Straight Extensions, IC Tray, Model No. 8888135134; 16cm, Straight Extensions, Kit - Model No. 8888135161; 16cm, Curved Extensions, Kit - Model No. 8888135162; 16 cm, Pre-Curved, Kit - Model No. 8888135163; 16cm, Straig
There is a potential leaking condition within the hub of affected devices, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.
- 2023-01-18FDA-DeviceEmergent Protective Products USA IncClass IRSDL (Reactive Skin Decontamination Lotion) Kit, NSN 6505-21-912-5229. Used to remove and/or neutralize chemical warfare agents and T-2 Toxin from the skin.
Complaints of leaking packets were received.
- 2023-01-11FDA-DeviceDeRoyal Industries IncClass IIDeRoyal Tonsillectomy Tray, REF 89-10698.01
DeRoyal is recalling certain lots of surgical procedure pack products that contain a ConMed Foot Controlled Electrosurgical Suction Coagulator. The recall is due to ConMed receiving reports that the suction ports may be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during use.
- 2023-01-11FDA-DeviceRandox Laboratories Ltd.Class IILiquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2684
Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range
- 2023-01-11FDA-DeviceRandox Laboratories Ltd.Class IILiquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2683
Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range
- 2023-01-11FDA-DeviceRandox Laboratories Ltd.Class IILiquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2682 Control Level 1
Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range
- 2023-01-11FDA-DeviceWindstone Medical Packaging, Inc.Class IIVarious Custom Surgical Instrument Disposable Kits: Part Numbers / Product Description 26000004M Custom Lasik Kit AMS10411A Nasal Endoscopy Pack AMS10710A Ultrasound Tray w/PDI AMS11941 Total Knee Pack AMS12138B Eye Pack AMS12278B Body Pack AMS12341A Hassan Pack AMS12341B Hassan Pack AMS12343A Meldrum Pack AMS12359B Neuro Pack AMS12520 Total Hip Pack AMS12608 Extremity Pack AMS12610 Shoulder Pack AMS12636 Dr. Thompson Pack AMS12689A Custom Pack AMS12753 Breast Pack AMS12754 Abd
Due to Customer Convenience Kits containing 3M Steri-Drape Surgical Drapes that have been recalled by 3M Healthcare.
- 2023-01-11FDA-DeviceAltimate Medical, Inc.Class IIActiveAid 922, Shower/Commode Chair
Device manufactured with a component with affects the foldability of the frame, not allowing it to be secured by the frame strap in the folded position.
- 2023-01-11FDA-DeviceDetect HeadquartersClass IIDetect Covid-19 Test Product/Model Number: 21205
There is an increased chance that the tests from affected lots may give false negative results. Health risks resulting from a false negative result include delay or lack of supportive treatment and lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in increased risk of spread of COVID-19 within the community.
- 2023-01-11FDA-DeviceOrtho-Clinical Diagnostics, Inc.Class IIVITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measurement of intact parathyroid hormone (iPTH) in human serum and plasma (EDTA or heparin) Catalog Number: 6802892
Lower than expected iPTH patient and Quality Control (QC) results, reported negatively biased iPTH results- an average -12% shift in patient sample results
- 2023-01-11FDA-DeviceBiomerieux IncClass IIPPM LOMBARD PRODUCTS T PHOSPHATE BUFFERSTERILE 20X9ML, CATALOG T8035
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- 2023-01-11FDA-DeviceBiomerieux IncClass IIPPM LOMBARD PRODUCTS IR&DB - TSA (32ML) 10PLT, CATALOG M1205-IR
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- 2023-01-11FDA-DeviceBiomerieux IncClass IIPPM LOMBARD PRODUCTS R2A MEDIUM 10PLT, CATALOG M1065
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- 2023-01-11FDA-DeviceBiomerieux IncClass IIPPM LOMBARD PRODUCTS TSA 10PLT, CATALOG M1040
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- 2023-01-11FDA-DeviceBiomerieux IncClass IIPPM LOMBARD PRODUCTS CT&TI-TSA + L & P80 10PLT, CATALOG C6045-TI
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- 2023-01-11FDA-DeviceBiomerieux IncClass IIPPM LOMBARD PRODUCTS CT&IR&DB-TSA + L & P80 10PLT, CATALOG C6045-IR
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- 2023-01-11FDA-DeviceBiomerieux IncClass IIPPM INDUSTRY COMBOURG BACARA 20PLATES 90MM, CATALOG AEB520100
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- 2023-01-11FDA-DeviceBiomerieux IncClass IIDCOUNT SYSTEMS REAGENTS CHEMCHROME V14 (6X1.8ML), CATALOG 306-R1026-01
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- 2023-01-11FDA-DeviceBiomerieux IncClass IIVIDAS CLINICAL VIDAS BRAHMS PROCALCITONIN 60T, CATALOG 30450-01
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- 2023-01-11FDA-DeviceBiomerieux IncClass IIVIDAS CLINICAL VIDAS ESTRADIOL II 60 TESTS, CATALOG 30431-01
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- 2023-01-11FDA-DeviceBiomerieux IncClass IIVIDAS CLINICAL VIDAS PROGESTERONE 60 TESTS, CATALOG 30409-01
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- 2023-01-11FDA-DeviceBiomerieux IncClass IIVIDAS CLINICAL VIDAS LH 60 TESTS, CATALOG 30406-01
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- 2023-01-11FDA-DeviceBiomerieux IncClass IIVIDAS CLINICAL VIDAS HCG 60 TESTS, CATALOG 30405-01
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- 2023-01-11FDA-DeviceBiomerieux IncClass IIETEST CLINICAL COLISTIN CO 256 US B100, CATALOG 537348
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- 2023-01-11FDA-DeviceBiomerieux IncClass IIASTUTE REAGENT NEPHROCHECK LIQUID CONTROLS KIT US, CATALOG 500013
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- 2023-01-11FDA-DeviceBiomerieux IncClass IIVITEK 2 REAGENT AST-XN15 TEST KIT 20 CARDS, CATALOG 423829
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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