Medical device recalls
38751 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2021-10-27FDA-DeviceStradis Medical, LLC dba Stradis HealthcareClass IIStandard IUD Insertion Kit
Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
- 2021-10-27FDA-DeviceStradis Medical, LLC dba Stradis HealthcareClass IIFoundation Kit
Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
- 2021-10-27FDA-DeviceStradis Medical, LLC dba Stradis HealthcareClass IIEndometrial Biopsy Kit
Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
- 2021-10-27FDA-DeviceStradis Medical, LLC dba Stradis HealthcareClass IIIUD Insertion Kit
Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
- 2021-10-27FDA-DeviceStradis Medical, LLC dba Stradis HealthcareClass IIIUD Insertion Pack
Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
- 2021-10-27FDA-DeviceStradis Medical, LLC dba Stradis HealthcareClass IITenaculum, Plastic
Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
- 2021-10-27FDA-DeviceSiemens Healthcare Diagnostics, IncClass IIAtellica IM 1600 Analyzer, SMN 11066000
Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater than 350m (1148ft) above sea level. As a result, customers at these altitudes may observe an increased number of Reagent Volume Check Errors.
- 2021-10-27FDA-DeviceSiemens Healthcare Diagnostics, IncClass IIAtellica IM 1300 Analyzer, SMN 11066001
Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater than 350m (1148ft) above sea level. As a result, customers at these altitudes may observe an increased number of Reagent Volume Check Errors.
- 2021-10-27FDA-DevicePhilips Ultrasound IncClass IIEPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232
Ultrasound system software issue can cause an EchoNavigator error notification, leading to an unresponsive system, necessitating system restart, which could lead to therapy/treatment delay and/or unnecessary therapy/treatment. Can occur during ultrasound-guided TEE with EchoNavigator, if secondary screen capture is enabled and user presses other system buttons before secondary capture completed.
- 2021-10-27FDA-DeviceImplant Resource IncClass IIMPR Slotted Mallet, labeling etched onto devices as follows: Medical Products Resource 800.524.5194 www.m-p-r.com MPR-1120-1000 (01)00840001405868
Potential for mallet head to become separated from mallet handle. There is also significant deformations on striking surface that were not expected
- 2021-10-27FDA-DeviceFort Defiance Industries, LLCClass IIP2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641
The rear heater plate and cover assembly that contains the electrical wiring for the heaters does not have sufficient bonding to ground.
- 2021-10-27FDA-DeviceOrtho Clinical Diagnostics IncClass IIVITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)- For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Reagent Pack used in combination with the VITROS Immunodiagnostic Products Anti- SARS-CoV-2 IgG Quantitative Calibrator for the determination of IgG antibodies to SARS-CoV-2. Product Code: 6199
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls Outside of Expected Control Range, potential for delayed results
- 2021-10-27FDA-DeviceSmiths Medical ASD Inc.Class ICADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-0105-50L l. 21-2127-0105-02L m. 21-2127-0105-06L n. 21-2127-0105-50L
Specific Pumps may exhibit intermittent performance in the AILD (Air in Line Detector) function. If an AILD does not sufficiently discern fluid from air in line, an air in line event may not be recognized by the pump and may not alarm to notify the clinician.
- 2021-10-27FDA-DeviceDatascope Corp.Class ICardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) with the below Model Numbers. 1. Cardiosave Hybrid. Model Numbers: 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-35, 0998-00-0800-36, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-0800-33, 0998-UC-0800-52, 0998-UC-0800-53, 0998-UC-0800-55. 2. Cardiosave Rescue. Model Number: 0998-00-0800-83.
A Cardiosave Lithium-Ion Battery Pack used during protocol testing failed to meet the minimum runtime requirement per Getinge internal Product Specification. These nonconforming batteries were inadvertently released to customers.
- 2021-10-20FDA-DeviceBeckman Coulter Inc.Class IIPower Processor 3K, 3K High Speed Stockyards Module Nameplate: PP 3K Stockyard (Refrig) 9707 REF A88116
Missing splash guard which may expose users to hazardous materials. .
- 2021-10-20FDA-DeviceElekta, Inc.Class IIElekta Medical Linear Accelerator (EMLA), configured as follows: a. Elekta Precise Digital Accelerator; b. Elekta Harmony; c. Elekta Synergy; d. Elekta Infinity; e. Versa HD
There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the diode may fail to contain the ejected matter.
- 2021-10-20FDA-DeviceELEKTA SOLUTIONS ABClass IIElekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552093.
There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the diode may fail to contain the ejected matter.
- 2021-10-20FDA-DeviceFlower Orthopedics CorporationClass IIFlower Lag Screw Kit 2.7 mm-intended to be used with 2.7mm lag screws and can be used with any plate that as part of the Flower Small and Medium Implant Set, Flower Ankle Plating Set , Flower Rear Foot/Calcaneus Plating Set , or Flower Upper Extremity Plating Set and uses the medium locking mechanism. Catalog Number: LSK 027
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
- 2021-10-20FDA-DeviceFlower Orthopedics CorporationClass IIFlower Drill Bit Kit 2.7mm- The Drill Bit Kit, 2.7mm (DBK 027) is intended to be used with solid 2.7mm screws and can be used with any the Flower Small and Medium Implant Set Flower Ankle Plating Set , Flower Rear Foot/Calcaneus Plating Set or Flower Upper Extremity Plating Set and uses the medium locking mechanism. Catalog Number: DBK 027
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
- 2021-10-20FDA-DeviceFlower Orthopedics CorporationClass IIFlower Drill Bit Kit 2.4 mm-intended to be used with solid 2.4mm screws and can be used with any plate as part of the Flower Small and Medium Implant Set and uses the small locking mechanism. Catalog Number: DBK 024
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
- 2021-10-20FDA-DeviceFlower Orthopedics CorporationClass IIFlower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and can be used with any plate that has been cleared as part of the Flower Small and Medium Implant Set and uses the small locking mechanism. mechanism. Catalog Number: DBK 020 2013002721
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
- 2021-10-20FDA-DeviceUoc Usa IncClass IIUnited Orthopedics USTAR II Knee System USTAR II Knee System Segment Part, RHS, 25 mm Length, Catalog # 2915-1025
Due to product not meeting specification for concentricity and failing to meet requirements of dynamic fatigue testing.
- 2021-10-20FDA-DeviceDraeger Medical, Inc.Class IIBabylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight. Catalog Number: 8417400
Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 seconds
- 2021-10-20FDA-DeviceDraeger Medical, Inc.Class IIEvita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients. Catalog Number: 8416400
Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 seconds
- 2021-10-20FDA-DeviceIntuitive Surgical, Inc.Class IIIon Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978
Potential for the sheath tip on the biopsy needle to separate from the sheath shaft.
- 2021-10-20FDA-DeviceCentese Inc.Class IIThoraguard Chest Tube Kit, 20 Fr
An adhesive joint in the SmartValve component of the device can become compromised resulting in a leak.
- 2021-10-20FDA-DeviceK2M, IncClass IIChesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068
Units may arrive with missing pins and/or in a state in disassembly. Pins dislodging from the instrument during a procedure may enter the surgical cavity, requiring intraoperative removal or revision surgery.
- 2021-10-20FDA-DeviceSmiths Medical ASD Inc.Class IIsmiths medical medex CBSS-5ML, Double set, (172+15cm), Model Number DPSHC0094
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
- 2021-10-20FDA-DeviceSmiths Medical ASD Inc.Class IIsmiths medical medex CBSS-5ML, Single Set, (172/15cm), Model Number DPSHC0093
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
- 2021-10-20FDA-DeviceSmiths Medical ASD Inc.Class IIsmiths medical medex CBSS-5ML, Triple set, (172/15cm), Model Number DPSHC0092
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
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