Medical device recalls
38750 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2022-05-18FDA-DeviceKarl Storz EndoscopyClass II11272VH-TL 11272VHK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021) 11272VHU-TL 11272VHUK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021)
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
- 2022-05-18FDA-DeviceKarl Storz EndoscopyClass II11272V CMOS VIDEO-CYSTO-URETHROSCOPE REV 11272VA 11272VAK CMOS VIDEO-CYSTO-URETHROSCOPE REV; 11272VU 11272VUK CMOS VIDEO-CYSTO-URETHROSCOPE US; 11272VUA 11272VUAK CMOS VIDEO-CYSTO-URETHROSCOPE US
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
- 2022-05-18FDA-DeviceKarl Storz EndoscopyClass IICYSTO-URETHRO-FIBERSCOPE REF 11272C1 CYSTOSCOPE, 15FR X 370MM, ADULT REF 11272C2 and Kit Number 11272CK2 CYSTO-URETHRO-FIBERSCOPE REF 11272CU1 and Kit Number 11272CUK1
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
- 2022-05-18FDA-DeviceCertified Safety Mfg IncClass IIThe following first aid kits and cabinets containing components Medi-First XS Non-Aspirin, Product #80450, 2 tablets/packet, 25 packets/box; and Sinus Pain & Pressure, Product #81950, 2 tablets/packet, 25 packets/box. Product number and description: (1) K614-020 16PW - Firestone Supplemental - w/Logo; (2) KR614-020 16R - Firestone Supplemental - Refill; (3) K616-033 36M - Class A Office - Metal; (4) KR616-006 36R - Class A Office - Refill; (5) KR616-015 75R - Class A Office - Refill;
First aid kit and cabinet components are being recalled by the supplier due to cGMP deviations at the manufacturer.
- 2022-05-18FDA-DevicebioMerieux, Inc.Class IIVITEK 2 Systems and VITEK 2 with MYLA.
Software issue where results sent to the LIS via HL7 format for antibiotic screen tests and synergy tests do not include the user-corrected or AES-corrected interpretation. This can potentially lead to incorrect final screen/synergy test results at the LIS.
- 2022-05-18FDA-DevicePROTERIXBIOClass IIProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number
FDA review concluded that the test is insufficiently supported by clinical performance data, and results reported may not have been accurate (false positives or false negatives).
- 2022-05-18FDA-DeviceSIMPLIVIA HEALTHCARE LTD.Class IIOnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143
Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of hazardous medications.
- 2022-05-18FDA-DeviceCerapedics, Inc.Class IIIputty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010, PUTTY
Patient chart label contains incorrect Part Number and volume amount.
- 2022-05-18FDA-DeviceKarl Storz EndoscopyClass II11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
- 2022-05-18FDA-DeviceKarl Storz EndoscopyClass II11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 (10-2018)
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
- 2022-05-18FDA-DeviceEthicon, Inc.Class IISTRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A PS-1, product code: SXMD1B100-12].
Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.
- 2022-05-18FDA-DeviceInstrumentation LaboratoryClass IIHemosIL ReadiPlasTin, Part No. 0020301400
Variable and out of specification QC results with HemosIL ReadiPlasTin. IL will remove all lots from the market and convert customers to an alternative prothrombin time (PT) reagent, specifically HemosIL RecombiPlasTin 2G.
- 2022-05-18FDA-DeviceROi CPS LLCClass IIRegard brand CABG Pack A and B - Spartanburg
Kits were packed into shipping boxes incorrectly.
- 2022-05-18FDA-DeviceUSA Medical, LLCClass IIDiagnostic Kit SARS-cCo V Antigen Rapid Test
COVID-19/SARS-CoV-2 Antigen Tests did not receive FDA Emergency Use Authorization, nor were the tests cleared or approved to be commercially distributed.
- 2022-05-18FDA-DeviceOlympus Corporation of the AmericasClass IIBF-1TQ180: EVIS EXERA II Bronchovideoscope
Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization
- 2022-05-18FDA-DeviceOlympus Corporation of the AmericasClass IIBF-MP160F: EVIS EXERA Bronchofibervideoscope
Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization
- 2022-05-18FDA-DeviceOlympus Corporation of the AmericasClass IIBF-3C160: EVIS EXERA Bronchovideoscope
Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization
- 2022-05-18FDA-DeviceOlympus Corporation of the AmericasClass IIBF-MP60: OES Bronchofiberscope
Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization
- 2022-05-18FDA-DeviceWoodside Acquisitions Inc.Class IJoysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
Firm distributed tests which have not been cleared or authorized for marketing or distribution in the United States.
- 2022-05-18FDA-DeviceWoodside Acquisitions Inc.Class IOral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test
Firm distributed tests which have not been cleared or authorized for marketing or distribution in the United States.
- 2022-05-18FDA-DeviceMedtronic Vascular, Inc.Class IIMedtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx Only
Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
- 2022-05-18FDA-DeviceMedtronic Vascular, Inc.Class IIMedtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO, Rx Only for the following model Numbers:ADM04004013P ADM04008013P ADM04008013P ADM04008013P ADM04012013P ADM04015013P ADM04015013P ADM04025013P ADM05004013P ADM05004013P ADM05006013P ADM05006013P ADM05008013P ADM05008013P ADM05020013P ADM06004013P ADM06004013P ADM06006013P ADM06006013P ADM06008013P ADM06012013P ADM06015013P ADM06015013P ADM06015013P ADM06015013P ADM07004013P ADM07006013P ADM07006013P ADM07008013P S
Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
- 2022-05-18FDA-DevicePhilips North America LlcClass IIPhilips Hemodynamic Application, Model Number 722463, Software Version Number: R1.2.2 and R1.2.3. For visualization and analysis of patient hemodynamic data in the Philips Interventional Hemodynamic System.
When a Neonatal patient is admitted, the Non-Invasive Blood Pressure is not set to Neonatal mode on the Philips Xperflex Cardio FC2010 patient monitor. If the NIBP is not set to Neonatal, the cuff inflation pressure applied will be higher than 150 mmHg and the deflation pressure will be higher than 5 mmHg. An applied cuff inflation pressure higher than 150mmHg or a deflation pressure higher than 5 could lead to bruising, mmHg nerve damage or bone deformity for a neonate.
- 2022-05-18FDA-DeviceAmerican Contract Systems, Inc.Class IIACS Cath Lab Pack
Product was sterilized with a higher than specification EO concentration.
- 2022-05-18FDA-DeviceAmerican Contract Systems, Inc.Class IIACS Lap Chole Pack
Product was sterilized with a higher than specification EO concentration.
- 2022-05-18FDA-DeviceAmerican Contract Systems, Inc.Class IIACS IR - Angio Pack
Product was sterilized with a higher than specification EO concentration.
- 2022-05-18FDA-DeviceAmerican Contract Systems, Inc.Class II1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack
Product was sterilized with a higher than specification EO concentration.
- 2022-05-18FDA-DeviceAmerican Contract Systems, Inc.Class II1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray
Product was sterilized with a higher than specification EO concentration.
- 2022-05-18FDA-DeviceMESA BIOTECH, INCClass IAccula SARS-CoV-2 Test, REF: COV4100
SARS-CoV-2 Test has an increased potential for false positive results, which may lead to a delay in correct diagnosis and treatment.
- 2022-05-11FDA-DeviceArthrex, Inc.Class IIK-Wire, 1.35 mm x 170 mm
Products do not meet length and diameter specifications.
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