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-DeviceKinsman Enterprises IncClass IIEasi-Care Gait Belt Metal Buckle (54", 60", and 72" lengths)
The belt may fail at lower loads than the labeled 600lbs.
- 2021-10-27FDA-DeviceLimacorporate S.p.AClass IIREF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R, 2100099, UDI: (01)08033390018845
There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.
- 2021-10-27FDA-DeviceLimacorporate S.p.AClass IIREF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI: (01)08033390018852
There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.
- 2021-10-27FDA-DeviceMedtronic Xomed, Inc.Class IIMedtronic Sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following product numbers: (1) REF 40A2500, Nucleus Removal Angled Blade, 25 cm x 4.0 mm; (2) REF 40R2000, Nucleus Removal Set, 20 cm x 4.0 mm; (3) REF 40R2500, Nucleus Removal Set, 25 cm x 4.0 mm; (4) REF 40S2000, Nucleus Removal Straight Blade, 20 cm x 4.0 mm; (5) REF 40S2500, Nucleus Removal Straight Bla
There was an increase in complaints related to tip breaks and wobble/vibration.
- 2021-10-27FDA-DeviceMedtronic Xomed, Inc.Class IIMedtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following product numbers: (1) REF 1883080EM, Rotatable Fusion Blade, Quadcut 3.0 mm x 13 cm; (2) REF 1883480EM, Rotatable Fusion Blade, Quadcut, 3.4 mm x 13 cm; (3) REF 1884006EM, Rotatable Fusion Blade, RAD 40; (4) REF 1884012EM, Rotatable Fusion Blade, RAD 12; (5) REF 1884080EM, Rotatable Fusion Blade, T
There was an increase in complaints related to tip breaks and wobble/vibration.
- 2021-10-27FDA-DeviceMedtronic Xomed, Inc.Class IIMedtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following product numbers: (1) REF 1882916, RAD 60 Sinus Blade, 11 cm x 2.9 mm; (2) REF 1883514, RAD 12 Curved Sinus Blade, 11 cm x 3.5 mm; (3) REF 1884013, Powered Tonsillectomy Blade, 11 cm x 4 mm; (4) REF 1884020, Tricut Laryngeal Blade, 22.5 cm x 4 mm; (5) REF 1884032, Tracheal Blade, 37 cm x 4 mm; (6)
There was an increase in complaints related to tip breaks and wobble/vibration.
- 2021-10-27FDA-DeviceSmiths Medical ASD Inc.Class IImedfusion Stopcock, 1-way and 4-way, Model Numbers (REF): a. 081-101BE b. 081-101GE c. 081-101GEE d. 081-101NE e. 081-102NE f. 081-102RE g. 089-101E h. 888-101NE i. 081-102GEE j. 888-101BE k. 888-101GE l. 888-101GEE m. 081-101RE n. 081-102GE o. 081-102BE p. 888-101RE
Product has a lack of sterility assurance
- 2021-10-27FDA-DeviceBard Peripheral Vascular IncClass IICatalog # BEK3411, Ecomomy Jamshidi Bone Marrow Biopsy Tray, 11 G X 4"Biopsy/Aspiration needle, sterile, Qty: 10, Single Use Only, RX only. Exp. Date Lidocaine Vendor lot. CareFusion Intended use to aspirate marrow from either the sternum or the iliac crest. Intraosseous Infusion is recommended only in life-threatening emergencies where vascular access is critical and conventional forms of access are not available or are unobtainable.
Due to misbranded products shipped to customers.
- 2021-10-27FDA-DeviceBard Peripheral Vascular IncClass IICatalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiration Tray, 11 G X 4"Biopsy/Aspiration needle, 15 G Aspiration Needle (Adjustable Length 15/16" -1-7/8") (24mm-48mm) sterile, For Single Use Only, RX only. Exp. Date Lidocaine Vendor lot. CareFusion. Original Jamshidi" Bone Marrow Biopsy/Aspiration Needle: - also referred to as Jamshidi needle Intended use for the posterior iliac crest biopsy technique
Due to misbranded products shipped to customers.
- 2021-10-27FDA-DeviceSmiths Medical ASD Inc.Class IIsmiths medical portex Loss of Resistance Device, REF 100/398/000
The labeling was missing information on sterilization and prohibition of reuse.
- 2021-10-27FDA-DeviceInstrumentation LaboratoryClass IIHemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems, (ACLTOP¿ Family, ACL TOP Family 50 Seriest and ACL Elite¿/Elite Pro) Part Number: 0020302601
Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days
- 2021-10-27FDA-DeviceInstrumentation LaboratoryClass IIHemosIL Liquid Anti-Xa- automated chromogenic assay for in vitro diagnostic use by laboratory professionals in clinical laboratories. The assay provides quantitative results on 3.2% citrated human plasma Part Number: 0020302602
Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days
- 2021-10-27FDA-DeviceInstrumentation LaboratoryClass IIHemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems, (ACL TOP¿ Family, ACL TOP Family 50 Seriest and ACL Elite¿/Elite Pro/8/9/10000) Part Number: 0020302600
Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days
- 2021-10-27FDA-DeviceSmiths Medical ASD Inc.Class IICADD Administration Sets, Model #21-7346-24
Product may have been manufactured with an air filter assembled in an incorrect orientation.
- 2021-10-27FDA-DeviceMedical Action Industries, Inc. 306Class IIKit: Central Line Dres Change 20/Cs
The ChloraPrep 3ml kit component has a shorter expiry date than the labeled kit expiry date.
- 2021-10-27FDA-DeviceADRIA SRLClass IIHerniatome, 17G x 9cm, Cervical Type, Model Number 5091749
The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed.
- 2021-10-27FDA-DeviceADRIA SRLClass IIHerniatome, 17G x 15cm, Lumbar Type, Model Number 5091745
The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed.
- 2021-10-27FDA-DeviceADRIA SRLClass IIHerniatome, 17G x 15cm, Lumbar Type with with 20ga-30cm Introducer, Model Number 5091715
The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed.
- 2021-10-27FDA-DeviceSmith & Nephew, Inc.Class II6.5MMX165MM CANNULATED SCREW
The product label incorrectly indicated that the screws are fully threaded, but the screws contained in the package were partially threaded.
- 2021-10-27FDA-DeviceCanon Medical System, USA, INC.Class IICanon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
A software problem has been identified which could result in the diagnostic imaging system not proceeding to the next actual scan even though automatic start of the next scan is specified. This could result in the diagnostic imaging system failing resulting in rescanning and reinjection of contrast medium.
- 2021-10-27FDA-DeviceGE Healthcare, LLCClass II1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
- 2021-10-27FDA-DeviceGE Healthcare, LLCClass IIOptima MR450w 1.5T nuclear magnetic resonance imaging system
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
- 2021-10-27FDA-DeviceGE Healthcare, LLCClass IISIGNA Artist nuclear magnetic resonance imaging system
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
- 2021-10-27FDA-DeviceGE Healthcare, LLCClass IISIGNA Voyager nuclear magnetic resonance imaging system
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
- 2021-10-27FDA-DeviceGE Healthcare, LLCClass IISIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
- 2021-10-27FDA-DeviceGE Healthcare, LLCClass IIDiscovery MR750 3.0T nuclear magnetic resonance imaging system
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
- 2021-10-27FDA-DeviceGE Healthcare, LLCClass IIDiscovery MR750w 3.0T nuclear magnetic resonance imaging system
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
- 2021-10-27FDA-DeviceGE Healthcare, LLCClass IISIGNA Pioneer nuclear magnetic resonance imaging system
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
- 2021-10-27FDA-DeviceGE Healthcare, LLCClass IISIGNA Architect nuclear magnetic resonance imaging system
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
- 2021-10-27FDA-DeviceGE Healthcare, LLCClass IISIGNA Premier nuclear magnetic resonance imaging system
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
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