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-DeviceDelta Med SpAClass IIDELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system: a) REF 3814773 b) REF 3835773 c) REF 3825773 d) REF 3837773 e) REF 3846773 f) REF 3831473 g) REF 3842473 h) REF 3821473 i) REF 3832473 j) REF 3833473 k) REF 3821573 l) REF 3831573 m) REF 3833573 n) REF 3824773 o) REF 3804773 p) REF 3845773 q) REF 3811473 r) REF 3836773 s) REF 3843473 t) REF 3800473 v) REF 3842573 w) REF 3832573 x) REF 3847773 y) REF 3800573
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
- 2021-08-25FDA-DeviceDelta Med SpAClass IIDELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF 3842572 c) REF 3821572 d) REF 3833572 e) REF 3831572 f) REF 3810572 g) REF 3852572
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
- 2021-08-25FDA-DeviceDelta Med SpAClass IIDELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272 c) REF 3845272 d) REF 3856272
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
- 2021-08-25FDA-DeviceOlympus Corporation of the AmericasClass IISoltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in urology, lithotripsy, gastroenterological surgery and gynecological surgery
Thermal injury following dusting and fragmenting treatment of ureteral stones when user exceeded the 20W standard presets
- 2021-08-25FDA-DeviceW L Gore & Associates, Inc.Class IIGore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 6 mm, Length 15 cm, Rx Only, Sterile EO, for the following Reference numbers: HPT060015 UDI: (01)00733132606368 HPT060015A UDI: (01)00733132606375
Vascular Grafts containing an inner diameter of 6 mm may be incorrectly labeled as 5 mm and Vascular Grafts containing an inner diameter of 5 mm are incorrectly labeled as 6 mm.
- 2021-08-25FDA-DeviceW L Gore & Associates, Inc.Class IIGore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 cm, Rx Only, Sterile EO, for the following Reference numbers: HPT050010 UDI: (01)00733132606320 HPT050010A UDI: (01)00733132606337
Vascular Grafts containing an inner diameter of 6 mm may be incorrectly labeled as 5 mm and Vascular Grafts containing an inner diameter of 5 mm are incorrectly labeled as 6 mm.
- 2021-08-25FDA-DeviceTornier S.A.S.Class IIThe Aequalis Pyrocarbon Humeral Heads. Shoulder implant component. Sold OUS only: a) Catalog # DWH039 - Diameter 39 mm Height 14 mm Eccentric LOW (1.5) Material PyC/CoCr, b) Catalog # DWH041 - Diameter 41 m m Height 15 mm Eccentric LOW (1.5) Material PyC/CoCr, c) Catalog # DWH043 - Diameter 43 mm Height 16 mm Eccentric LOW (1.5) Material PyC/CoCr, d) Catalog # DWH046 - Diameter 46 mm Height 17 mm Eccentric LOW (1.5) Material PyC/CoCr, e) Catalog # DWH048 - Diameter 48 mm Height 18 mm
Potential patient exposure to the graphite substrate.
- 2021-08-25FDA-DevicePhilips Respironics, Inc.Class IITrilogy Evo Universal, Product number DS2000X11B
Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second issue is described as "Pressure Drift (Continuous Usage).
- 2021-08-25FDA-DevicePhilips Respironics, Inc.Class IITrilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B
Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second issue is described as "Pressure Drift (Continuous Usage).
- 2021-08-25FDA-DevicePhilips Respironics, Inc.Class IITrilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA2100X15B, IN2100X15B, IN2100X19, IT2100X21B, JP2100X16B, LA2100X15B, ND2100X15B, RDE2100X13B, SP2100X26B
Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second issue is described as "Pressure Drift (Continuous Usage).
- 2021-08-25FDA-DevicePhilips Respironics, Inc.Class IITrilogy Evo, Product numbers BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, EE2110X15B, ES2110X15B, EU2110X15B, EU2110X19, FR2110X14B, GB2110X15B, IA2110X15B, IN2110X15B, IN2110X19, IT2110X21B, KR2110X15B, LA2110X15B, LD2110X23B, ND2110X15B, RDE2110X13B, UDS2110X11B
Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second issue is described as "Pressure Drift (Continuous Usage).
- 2021-08-25FDA-DeviceCardinal Health 200, LLCClass IArgyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811). Intended for use to insert an Umbilical Venous Catheter (UVC) into the umbilical artery or vein of neonate. Product Code: 43201
The current Argyle UVC Insertion Tray does not include a specific IFU to operate the Safety Scalpel N11. The Safety Scalpel N11 features a permanent locking feature that will not allow the clinician to unlock the scalpel once the safety shield is closed and pushed forward into a locked position may result in a delay treatment/therapy, which could ultimately result in death.
- 2021-08-18FDA-DeviceEdwards Lifesciences, LLCClass IIEdwards PediaSat Oximetry Catheter Set, REF: XT3515SJ, Exterior Diameter 5.5F, Usable Length 15 cm, Number of Lumens: 3, Rx Only, Sterile EO, UDI: (01)00690103197501 *NOT DISTRIBUTED WITHIN THE US
There is a potential for internal leaks within catheters.
- 2021-08-18FDA-DeviceEdwards Lifesciences, LLCClass IIEdwards PediaSat Oximetry Catheter Set, REF: XT358KTP, Exterior Diameter 5.5F, Usable Length 8 cm, Number of Lumens: 3, Recommended Guidewire Size: GW: 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197556
There is a potential for internal leaks within catheters.
- 2021-08-18FDA-DeviceEdwards Lifesciences, LLCClass IIEdwards PediaSat Oximetry Catheter Set, REF: XT358SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 9 cm, Number of Lumens: 3, Recommended Guidewire Size: GW: 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197525 *NOT DISTRIBUTED WITHIN THE US
There is a potential for internal leaks within catheters.
- 2021-08-18FDA-DeviceEdwards Lifesciences, LLCClass IIEdwards PediaSat Oximetry Catheter Kit, REF: XT358SJ, Usable Length 8 cm, Number of Lumens 3, Exterior Diameter 5.5F, Rx Only, Sterile EO, UDI: (01)00690103197495 *NOT DISTRIBUTED WITHIN THE US
There is a potential for internal leaks within catheters.
- 2021-08-18FDA-DeviceEdwards Lifesciences, LLCClass IIEdwards PediaSat Oximetry Catheter Kit, REF: XT3515SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recommended Guidewire Size 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197532
There is a potential for internal leaks within catheters.
- 2021-08-18FDA-DeviceEdwards Lifesciences, LLCClass IIEdwards PediaSat Oximetry Catheter Kit, REF: XT3515KTP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recommended Guidewire Size 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197563
There is a potential for internal leaks within catheters.
- 2021-08-18FDA-DeviceQURA S.R.L.Class IISpectrum Medical Quantum Standard heat exchanger
Product labeled as sterile may not have been adequately sterilized. In addition, these devices were imported to the US distributor, but the devices are not 510(k) cleared in the US.
- 2021-08-18FDA-DeviceAbbott Laboratories, IncClass IIAlinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasmapheresis screening, and organ donor centers, hospitals, and reference laboratories.
A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/operators.
- 2021-08-18FDA-DeviceBiomet, Inc.Class IIArcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 80 MM Item Number: 11-301354
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
- 2021-08-18FDA-DeviceBiomet, Inc.Class IIArcos Modular Revision Hip System Standard Cone Prox Body, Size C, 80 MM Item Number: 11-301343
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
- 2021-08-18FDA-DeviceBiomet, Inc.Class IIArcos Modular Revision Hip System Standard Cone Prox Body, Size B, 80 MM Item Number: 11-301342
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
- 2021-08-18FDA-DeviceBiomet, Inc.Class IIArcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 70 MM Item Number: 11-301335
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
- 2021-08-18FDA-DeviceBiomet, Inc.Class IIArcos Modular Revision Hip System High Offset Cone Prox Body, Size C, 70 MM Item Number: 11-301333
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
- 2021-08-18FDA-DeviceBiomet, Inc.Class IIArcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 70 MM Item Number: 11-301331
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
- 2021-08-18FDA-DeviceBiomet, Inc.Class IIArcos Modular Revision Hip System Standard Cone Prox Body, Size E, 70 MM Item Number:11-301325
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
- 2021-08-18FDA-DeviceBiomet, Inc.Class IIArcos Modular Revision Hip System Standard Cone Prox Body, Size B, 70 MM Item Number: 11-301322
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
- 2021-08-18FDA-DeviceBiomet, Inc.Class IIArcos Modular Revision Hip System Standard Cone Prox Body, Size A, 70 MM Item Number: 11-301321
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
- 2021-08-18FDA-DeviceBiomet, Inc.Class IIArcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 60 MM Item Number: 11-301315
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
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