Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2024-05-15FDA-DeviceSPINEART SAClass IIPERLA TL 25D SCREW REF: TLF-DS 45 25-S TLF-DS 45 30-S TLF-DS 45 35-S TLF-DS 45 40-S TLF-DS 45 45-S TLF-DS 55 30-S TLF-DS 55 35-S TLF-DS 55 40-S TLF-DS 55 45-S TLF-DS 65 35-S TLF-DS 65 40-S TLF-DS 65 45-S TLF-DS 65 50-S The PERLA¿ TL system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sac
Due to receiving information regarding difficulties with the insertion of a setscrew inside a screw head. Issues involved, either: 1. The setscrew is not tightened to torque 2. The setscrew is tightened to torque but position askew
- 2024-05-15FDA-DevicePhilips Ultrasound, Inc.Class II5000 Compact Series Ultrasound Systems, Product/REF: 5500 CV/795141, 5500 P/795143, 5500 W/795144, 5500 G/795145, and Product/REF: 5300 W/795146, 5300 P/795147, 5300 G/795148, used with Deluxe and Premium Carts that come with multiport adapters.
Ultrasound system with: 1) transesophageal echocardiography transducer (TEE) connected/not selected 2) 1, 2 non-TEE connected 3) Imaging with non-TEE 4) Selected/not selected imaging transducer removed 5) Transducer connected 6) Non-TEE imaging continues, Then though TEE is unselected, it may have power, no temperature monitoring/control, and may result in temperature above limit and patient burns
- 2024-05-15FDA-DeviceHologic, IncClass IBioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZorb Marker 4cm x 5cm 2) F0404 BioZorb Marker 4cm x 4cm 3) F0331 BioZorb Marker 1cm x 3cm x 3cm 4) F0231 BioZorb Marker 1cm x 3cm x 2cm 5) F0221 BioZorb Marker 1cm x 3cm x 2cm 6) F0304 BioZorb Marker 3cm x 4cm 7) F0303 BioZorb Marker 3cm x 3cm 8) F0203 BioZorb Marker 2cm x 3cm 9) F0202 BioZorb Marker 2cm x 2cm
Safety Information: Complaints describe complications/adverse events that include pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complications from feeling the device in the breast, and the need for additional medical treatment to remove the device
- 2024-05-15FDA-DeviceVyaire Medical, Inc.Class IVyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinTube sample line 240cm is used in the Vyntus CPX. The TwinTube sample line 240cm is connected to the adapter for DVT. Twin Tube Probenschlauch (707004), which is sold outside the US only. Used in breath analysis for metabolic response study.
Potential of the nozzle separating during patient use.
- 2024-05-15FDA-DeviceTandem Diabetes Care, Inc.Class It:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iOS operating system. This cycle intermittently repeats, which leads to excessive Bluetooth communication that may result in pump battery drain and may lead to the pump shutting down sooner than typically expected. Pump shutdown will cause insulin delivery to suspend, which could lead to an under-delivery of insulin and may result in hyperglycemia, including severe hyperglycemia.
- 2024-05-08FDA-DevicePhilips North America LlcClass IIThe Oncology Essentials Package of the Spectral CT imaging system.
Potential for third party oncology marking laser to be reflected off the gantry cover surface, which can potentially lead to misdiagnosis and subsequent incorrect treatment.
- 2024-05-08FDA-DeviceJohnson & Johnson Surgical Vision, Inc.Class IIJohnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber 21 Gauge REF OPOHF21L The irrigation sleeve is a device intended to direct irrigation solution across the shaft of a phacoemulsification tip, allowing the solution to enter the eye during ocular surgery.
Due to a manufacturing variation of the irrigation sleeves which could result in a missing port hole, this non-conformity could lead to insufficient flow to cool the ultrasonic phaco tip, potentially leading to an unstable anterior chamber which could cause possible harms.
- 2024-05-08FDA-DeviceSEDECAL SAClass IIBattery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers: a. SM-20HF-Batt; b. SM-32HF-Batt; c. SM-40HF-Batt; d. SM-50HF-Batt; e. SM-40-HF-B-D-VIR; f. SM-20HF-B-D-KM (AeroDR X30); g. SM-32-HF-B-D-KM (AeroDR X30); h. SM-40HF-B-D-KM (AeroDR X30); i. SM-50HF-B-D-KM (AeroDR X30); j. MobileDiagnost wDR.
Potential interference with the anti-fall system.
- 2024-05-08FDA-DeviceInnomed, Inc.Class IIINNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup
54 MM finisher blade was inadvertently affixed to the shaft of the CupX handle in lieu of the 54 MM starter blade.
- 2024-05-08FDA-DeviceRAYSEARCH LABORATORIES ABClass IIRayStation 15.0.0.430. Radiation Therapy Treatment Planning System.
Potential for reported SSD to be too high.
- 2024-05-08FDA-DeviceRAYSEARCH LABORATORIES ABClass IIRayStation 14.0.0.3338. Radiation Therapy Treatment Planning System.
Potential for reported SSD to be too high.
- 2024-05-08FDA-DeviceRAYSEARCH LABORATORIES ABClass IIRayStation 13.0.0.1547, 13.1.0.144 & 13.1.1.89. Radiation Therapy Treatment Planning System.
Potential for reported SSD to be too high.
- 2024-05-08FDA-DeviceRAYSEARCH LABORATORIES ABClass IIRayStation 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 &12.3.0.119. Radiation Therapy Treatment Planning System.
Potential for reported SSD to be too high.
- 2024-05-08FDA-DeviceRAYSEARCH LABORATORIES ABClass IIRayStation 11.0.0.951, 11.0.1.29, 11.0.3.116 & 11.0.4.15. Radiation Therapy Treatment Planning System.
Potential for reported SSD to be too high.
- 2024-05-08FDA-DeviceRAYSEARCH LABORATORIES ABClass IIRayStation 10.1.0.613 and 10.1.1.54. Radiation Therapy Treatment Planning System.
Potential for reported SSD to be too high.
- 2024-05-08FDA-DeviceRAYSEARCH LABORATORIES ABClass IIRayStation 10.0.0.1154, 10.0.1.52 & 10.0.2.10. Radiation Therapy Treatment Planning System.
Potential for reported SSD to be too high.
- 2024-05-08FDA-DeviceRAYSEARCH LABORATORIES ABClass IIRayStation 9.1.0.933 and 9.2.0.483. Radiation Therapy Treatment Planning System.
Potential for reported SSD to be too high.
- 2024-05-08FDA-DeviceRAYSEARCH LABORATORIES ABClass IIRayStation 9.0.0.113 and 9.0.1.142. Radiation Therapy Treatment Planning System.
Potential for reported SSD to be too high.
- 2024-05-08FDA-DeviceRAYSEARCH LABORATORIES ABClass IIRayStation 8.1.0.47, 8.1.1.8 and 8.1.2.5. Radiation Therapy Treatment Planning System.
Potential for reported SSD to be too high.
- 2024-05-08FDA-DeviceRAYSEARCH LABORATORIES ABClass IIRayStation 8.0.0.61, 8.0.1.10. Radiation Therapy Treatment Planning System.
Potential for reported SSD to be too high.
- 2024-05-08FDA-DeviceRAYSEARCH LABORATORIES ABClass IIRayStation 7.0.0.19. Radiation Therapy Treatment Planning System.
Potential for reported SSD to be too high.
- 2024-05-08FDA-DeviceStryker NeurovascularClass IIThe Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. Device dimensions and configuration are shown on the product label. A rotating hemostasis valve with side-arm adapter is provided with each catheter. The rotating hemostasis valve is typically y shaped with a female luer lock and a manual hemostasis valve.
Stryker Neurovascular is recalling their DAC- Distal Access Catheter -038 136cm, a Distal Access Catheter by removal. The reason for the recall is: the DAC Lot #0000486382 was released with out-of-specification endotoxin results.
- 2024-05-08FDA-DeviceCardinal Health 200, LLCClass IIJackson-Pratt 3-Spring Reservoir with Silicone Adapters, 400mL, REF SU130-475
Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.
- 2024-05-08FDA-DeviceCardinal Health 200, LLCClass IIJackson-Pratt Universal Connector PVC Tubing Anti Reflux Transparent Y, REF SU130-4601
Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.
- 2024-05-08FDA-DeviceCardinal Health 200, LLCClass IIJackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 15Fr., REF SU130-403D
Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.
- 2024-05-08FDA-DeviceCardinal Health 200, LLCClass IIJackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 10Fr., REF SU130-402D
Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.
- 2024-05-08FDA-DeviceCardinal Health 200, LLCClass IIJackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 7Fr., REF SU130-401D
Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.
- 2024-05-08FDA-DeviceNoah MedicalClass IIGalaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy System and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope.
- 2024-05-08FDA-DeviceCovidienClass IIMedtronic Invos, Reusable Sensor Cable for PM7100, REF: PMAC71RSC
manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel
- 2024-05-08FDA-DeviceCovidienClass IIMedtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC
manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel
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