Medical device recalls
39180 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2019-07-31FDA-DeviceEpimed International, Inc.Class IIVersa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile ED, REF 181-2112, RX, (01) 108187880213945, LOT 311291155 for epidural or caudal anesthesia
Mislabeled - The product's labeling contains an incorrect size for the catheter included in the kit. The kit contains a 21 gauge catheter, however the labeling states a 12 gauge catheter is included.
- 2019-07-31FDA-DeviceMerge Healthcare, Inc.Class IIMerge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1
Potential for prior thumbnails to not display in reverse chronological order and images may not scroll in reverse chronological order when mammography stacked scrolling is enabled. Merge PACS provides image manipulation tools to enable users to view and compare images such as: linking, MPR, MIP, 3D image fusion/registration of CT, MR and PET; as well as CVR (Color Volume Rendering), measurements (linear distances, angles, areas, SUV, etc.), and annotations (for example, outline and label regions of interest, label spinal vertebrae).
- 2019-07-31FDA-DeviceMerge Healthcare, Inc.Class IIMerge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1
Potential for prior thumbnails to not display in reverse chronological order and images may not scroll in reverse chronological order when mammography stacked scrolling is enabled. Merge PACS provides image manipulation tools to enable users to view and compare images such as: linking, MPR, MIP, 3D image fusion/registration of CT, MR and PET; as well as CVR (Color Volume Rendering), measurements (linear distances, angles, areas, SUV, etc.), and annotations (for example, outline and label regions of interest, label spinal vertebrae).
- 2019-07-31FDA-DeviceMedela IncClass IIIBreast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100
The sterility may be compromised due to a potential breach in the packaging, even though it may appear intact.
- 2019-07-31FDA-DeviceGE Healthcare, LLCClass IIMAC VU360, Model Number 2030360-001, Electrocardiograph
Two issues: 1) The MAC VU360 system may intermittently display an incorrect patient ID or visit number on the screen after scanning the patient s barcode. This may result in the ECG report being assigned to the incorrect patient. 2) The MAC VU360 may have the incorrect patient demographics appear on the patient banner. This may result in the ECG report being assigned to the incorrect patient.
- 2019-07-31FDA-DeviceZyno Medical LLCClass IIZyno Medical Administration Set -105"ADMIN SET 20DP W/FILTER 2YSITES CLMP- For Use with Zyno Medical Infusion pumps or Gravity Feed Product Code: B2-70072-F
Administration sets assembled with inverted pinch clamp cause the fluid from the distal end of the administration set to be pumped to the proximal end of the tubing when secondary set is used with the primary set. Thus, instead of delivering fluid to the patient, blood may be drawn from the patient if there is space in the drug container to hold extra volume of fluid, under the condition that the reversed pinch clamp is not identified
- 2019-07-31FDA-DeviceZyno Medical LLCClass IIZyno Medical Administration Set -105"ADMIN SET 20DP, W/2 Y SITE, CVCLMPS- For Use with Zyno Medical Infusion pumps or Gravity Feed Product Code:B2-70072
Administration sets assembled with inverted pinch clamp cause the fluid from the distal end of the administration set to be pumped to the proximal end of the tubing when secondary set is used with the primary set. Thus, instead of delivering fluid to the patient, blood may be drawn from the patient if there is space in the drug container to hold extra volume of fluid, under the condition that the reversed pinch clamp is not identified
- 2019-07-31FDA-DeviceCooperSurgical, Inc.Class IILEEP Precision Integrated System 120V & LEEP Precision Generator, Model Nos. LP-10-120 & LP-20-120
The products' cut, coagulate, or blend function may not operate with the use of the Foot Pedal.
- 2019-07-31FDA-DeviceInfuTronix LLCClass IINimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage: Administer fluids/medication from a container to a patient through a needle or a catheter.
Potential for tube leakage
- 2019-07-31FDA-DeviceZevex Incorporated (dba MOOG Medical Devices Group)Class IIMOOG Curlin Infusion Administration Set, REF 340-4130-V, Non-DEHP Tubing with Non-Vented Bag Spike and Vented 0.2 Micron Filter with add-on check valve, packaged 20 sets/carton, sterile. The firm name on the label is ZEVEX, Inc., Salt Lake City, UT.
Administration sets leaked at the filter.
- 2019-07-31FDA-DeviceZevex Incorporated (dba MOOG Medical Devices Group)Class IIMOOG Curlin Infusion Administration Set, REF 340-4130, Non-DEHP Tubing with Non-Vented Bag Spike and Vented 0.2 Micron Filter, packaged 20 sets/carton, sterile. Product Usage: Administration set to be used with the Moog Curlin Infusion Pump. The pump can be used for intravenous, intra-arterial, epidural, subcutaneous, or enteral infusions.
Administration sets leaked at the filter.
- 2019-07-31FDA-DeviceCardinal Health 200, LLCClass IIMonoject Blunt Cannula, 22 G x 1-1/2" (0.711 mm x 3.8 cm) Item code: 8881202389
Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
- 2019-07-31FDA-DeviceCardinal Health 200, LLCClass IIMonoject Blunt Cannula, 20 G x 1-1/2" (0.902 mm x 3.8 cm) Item code: 8881202363
Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
- 2019-07-31FDA-DeviceCardinal Health 200, LLCClass IIMonoject Blunt Cannula, 19 G x 1-1/2" (1.067 mm x 3.8 cm) Item code: 8881202355
Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
- 2019-07-31FDA-DeviceCardinal Health 200, LLCClass IIMonoject Blunt Cannula, 16 G x 1-1/2" (1.651 mm x 3.8 cm) Item code: 8881202322
Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
- 2019-07-31FDA-DeviceCardinal Health 200, LLCClass IIMonoject Blunt Cannula, 15 G x 1-1/2" (1.829 mm x 3.8 cm) Item code: 8881202314
Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
- 2019-07-31FDA-DeviceCardinal Health 200, LLCClass IIMonoject" 201 Vet Pak Hypodermic Needle, 16 ga x 1-1/2 Item code: 8881201654
Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
- 2019-07-31FDA-DeviceCardinal Health 200, LLCClass IIMonoject 201 Vet Pak Hypodermic Needle, 18 ga x 1-1/2 Item code: 8881201548
Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
- 2019-07-31FDA-DeviceCardinal Health 200, LLCClass IIMonoject 201 Vet Pak Hypodermic Needle, 19 ga x 1-1/2 Item code: 8881201522
Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
- 2019-07-31FDA-DeviceCardinal Health 200, LLCClass IIMonoject 201 Vet Pak Hypodermic Needle, 20 ga x 1-1/2" Item code: 8881201498
Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
- 2019-07-31FDA-DeviceCardinal Health 200, LLCClass IIMonoject 201 Vet Pak Hypodermic Needle, 22 ga x 1-1/2" Item code: 8881201456
Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
- 2019-07-31FDA-DeviceCardinal Health 200, LLCClass IIMonoject Standard Hypodermic Needle, 20 G x 1-1/2" bulk Item code: 8881200664
Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
- 2019-07-31FDA-DeviceCardinal Health 200, LLCClass IIMonoject Standard Hypodermic Needle, 27 G x 1-1/4" Item code: 8881200508
Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
- 2019-07-31FDA-DeviceCardinal Health 200, LLCClass IIMonoject Standard Hypodermic Needle, 18 G x 1-1/2" Item code: 8881200078
Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
- 2019-07-31FDA-DeviceCardinal Health 200, LLCClass IIMonoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code:8881200045
Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
- 2019-07-31FDA-DeviceCardinal Health 200, LLCClass IIMonoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code: 8881200037
Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
- 2019-07-31FDA-DeviceCardinal Health 200, LLCClass IIMonoject Standard Hypodermic Needle Item code: 8881200029
Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
- 2019-07-31FDA-DeviceCardinal Health 200, LLCClass IIMonoject Standard Hypodermic Needle, 14 G x 1-1/2" Item code: 8881200011
Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
- 2019-07-31FDA-DeviceSpacelabs Healthcare, Inc.Class IISpacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2.
Several reports were received that patient records were printed with the correct patient demographics but containing another patient's waveforms.
- 2019-07-31FDA-DeviceSiemens Medical Solutions USA, IncClass IIArtis zeego, Model Number 10280959
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
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