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.
- 2021-08-25FDA-DeviceBoston Scientific CorporationClass IITheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)
Potential for leaks and loosening at the patient catheter connection
- 2021-08-25FDA-DeviceEthicon Endo-Surgery IncClass IIECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. Product Code: PSEE60A
Mislabeled: Labeled on the package as 60mm contains 45mm devices
- 2021-08-25FDA-DeviceOrtho8, Inc.Class IIEVEXIA LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF(s): EVE-11/EVE-X11, Rx Only, Not Sterile
EVEXIA LUXE DVT PREVENTION DEVICE is marketed without FDA clearance
- 2021-08-25FDA-DeviceOrtho8, Inc.Class IICIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only, Not Sterile IP22, Latex Free,
CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance
- 2021-08-25FDA-DeviceCytocell Ltd.Class IICytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)
May show unexpected locus specific signals in addition to those at 19p13.3. Users may observe faint additional locus specific signals at 9q34
- 2021-08-25FDA-DeviceTeleflex Medical Europe LtdClass IIRUSCH Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF numbers: a) 112082050 b) 112082055 c) 112082060 d) 112082065 e) 112082070 f) 112082075 g) 112082080 h) 112082085 i) 112082090 j) 112082095 k) 112082100
The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.
- 2021-08-25FDA-DeviceTeleflex Medical Europe LtdClass IIRUSCH Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF numbers: a) 112080050 b) 112080055 c) 112080060 d) 112080065 e) 112080070 f) 112080075 g) 112080080 h) 112080085 i) 112080090 j) 112080095 k) 112080100
The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.
- 2021-08-25FDA-DeviceTeleflex Medical Europe LtdClass IIRUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 504550 b) 504555 c) 504560 d) 504565 e) 504570 f) 504575 g) 504580 f) 504585 g) 504590
The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.
- 2021-08-25FDA-DeviceTeleflex Medical Europe LtdClass IIRUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d) 170065 e) 170070 f) 170075 g) 170080 h) 170085 i) 170090 j) 170095
The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.
- 2021-08-25FDA-DevicePhilips North America LlcClass II728333 Spectral CT 7500 -Computed Tomography X-ray system
When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient.
- 2021-08-25FDA-DevicePhilips North America LlcClass II728332 IQon Spectral CT-Computed Tomography X-ray system
When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient.
- 2021-08-25FDA-DevicePhilips North America LlcClass II728327 Ingenuity CT Upgrades-Computed Tomography X-ray system
When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient.
- 2021-08-25FDA-DevicePhilips North America LlcClass IIModel 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-ray system
When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient.
- 2021-08-25FDA-DevicePhilips North America LlcClass II728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades
When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient.
- 2021-08-25FDA-DeviceEpimed InternationalClass IINEO-KATH(TM) Caudal Set, REF 201-2430, Sterile
Potential for stylet to protrude from the distal end of the catheter
- 2021-08-25FDA-DeviceEpimed InternationalClass IINEO-KATH Epidural Catheter Set, REF 200-2430, Sterile
Potential for stylet to protrude from the distal end of the catheter
- 2021-08-25FDA-DeviceCell Marque CorporationClass IIICell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16
Mouse Monoclonal Antibody labelled with an incorrect expiry date of 31 Dec 2023. The correct expiry date is 31 Dec 2022. If used beyond expiry, the material performance is likely to decrease and may be observed as weak or no staining, and there is a potential risk that a false negative result could be recorded and may lead to delay of diagnosis due to retest.
- 2021-08-25FDA-DeviceOPTI Medical Systems, IncClass IIOPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004
The firm identified a precipitation issue which may cause late Ct reactors (a false positive result) with a rate of 5 to 10% for affected vials of RNA Master Mix.
- 2021-08-25FDA-DeviceOstial CorporationClass IIFLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA
Angioplasty system has a manufacturing issue that has the potential to result in difficulty deflating the outer balloon, which may result in increased risk of access site complications.
- 2021-08-25FDA-DeviceHitachi Healthcare Americas CorporationClass IIModel L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic intra-operative and laparoscopic procedures
The screw cover at the tip of the probe may fall off after a cleaning and sterilization process. Users advised to conduct a preventive inspection of the probe before and after sterilization/disinfection/cleaning and before and after an interoperative procedure.
- 2021-08-25FDA-DeviceCooperSurgical, Inc.Class IIOxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following incubator and work chamber products; G185 Standard 110V, G185 SensorTech 110V, G185 Standard 230V, G185 SensorTech 230V, G210 InviCell Standard, G210 InviCell Standard US, G210 Invicell Plus Optional pH and External Monitoring, G603 Work Chamber 115V, & G603 Work Chamber 230V. [CooperSurgical part numbers K22400-110, K22200-110, K22400-230, K22200-230, K59500
Units are displaying output readings that differ from the measurements taken using a Gas Analyzer. When the display is reading a target setting of 5%, an external meter is reading between 3% and 12% and the Incubator does not alarm. May result in loss of embryo during storage.
- 2021-08-25FDA-DevicePhilips Ultrasound IncClass IIEPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx, EPIQ CVxi
Ultrasound system control panel arm swivel lock could fail, which could cause the control panel and monitor to swivel freely while a user is positioning the monitor, or transporting/moving the system, which could lead to patient or user musculoskeletal injury.
- 2021-08-25FDA-DeviceDelta Med SpAClass IIWOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
- 2021-08-25FDA-DeviceDelta Med SpAClass IINEO DELTA SELFSAFE PUR T, I.V. Catheter:
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
- 2021-08-25FDA-DeviceDelta Med SpAClass IINEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b) REF 3738822
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
- 2021-08-25FDA-DeviceDelta Med SpAClass IINEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
- 2021-08-25FDA-DeviceDelta Med SpAClass IINEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
- 2021-08-25FDA-DeviceDelta Med SpAClass IINEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 units
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
- 2021-08-25FDA-DeviceDelta Med SpAClass IINEO DELTA Self Safe, I.V. Catheter REF 3738222
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
- 2021-08-25FDA-DeviceDelta Med SpAClass IIDELTAVEN Y, Safety I.V. Catheter in Pur with closed system a) REF 3832072 b) REF 3810072 c) REF 3842072 d) REF 3852072
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
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