Medical device recalls
38845 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2026-04-15FDA-DeviceXTANT Medical Holdings, IncClass IICheck XTANT Medical pedicle screws for correct labeling
Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.
- 2026-04-15FDA-DeviceBeckman Coulter, Inc.Class IIStop using Beckman Coulter MicroScan panels
Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics
- 2026-04-15FDA-DeviceTornier, IncClass IICheck Tornier HRS Max shoulder implant parts
Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with the Tornier HRS Max system.
- 2026-04-15FDA-DeviceMedline Industries, LPClass IStop using affected Medline medical kits
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
- 2026-04-15FDA-DeviceMedline Industries, LPClass IStop using Medline TAVR Pack kits immediately
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
- 2026-04-15FDA-DeviceMedline Industries, LPClass IStop using affected Medline robotic procedure kits
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
- 2026-04-15FDA-DeviceMedline Industries, LPClass IStop using recalled Medline convenience kits
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
- 2026-04-15FDA-DeviceMedline Industries, LPClass IStop using affected Medline angiography kits
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
- 2026-04-15FDA-DeviceMedline Industries, LPClass IStop using Medline GLOVE PACK 7.0 medical kits
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
- 2026-04-15FDA-DeviceMedline Industries, LPClass IStop using affected Medline medical kits
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
- 2026-04-15FDA-DeviceMedline Industries, LPClass IStop using Medline medical convenience kits SKU DYNJ86596
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
- 2026-04-15FDA-DeviceMedline Industries, LPClass IStop using affected Medline procedure kits
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
- 2026-04-15FDA-DeviceMedline Industries, LPClass IStop using affected Medline medical kits
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
- 2026-04-15FDA-DeviceMedline Industries, LPClass IStop using Medline Special Procedure Tray kits
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
- 2026-04-15FDA-DeviceMedline Industries, LPClass IStop using Medline NAMIC RA syringes immediately
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
- 2026-04-15FDA-DeviceMedline Industries, LPClass INAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/FR,RA,W/RES, Medline SKU 70085007; 3. MTO,SYRINGE,10ML,TR/FG,RA,-,PKG, Medline SKU 70085107; 4. SYRINGE,12ML,TR/FR,RA,W/RES, Medline SKU 70087007; 5. MTO,SYRINGE,12ML,TR/FG,RA,W/RES, Medline SKU 70087107; 6. SYRINGE,12ML,TR/FR,RA,W/O,RES,-,PKG, Medline SKU 70088007; 7. SYRINGE,10ML,PP/FR,RA,-,PKG, Medline SKU 70095007; 8. SYRINGE,10ML,PP/FG,RA,-,PKG, Medline SKU 70095107; 9. SY
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
- 2026-04-15FDA-DeviceMedline Industries, LPClass IStop using affected Medline angiographic syringes
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
- 2026-04-15FDA-DeviceMedline Industries, LPClass IStop using recalled Medline catheter lab kits
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
- 2026-04-15FDA-DeviceMedline Industries, LPClass IStop using affected Medline manifold kits
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
- 2026-04-15FDA-DeviceMedline Industries, LPClass IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: CVOR ANGIOGRAPHY PACK-LF, Medline SKU DYNJ42367B
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
- 2026-04-15FDA-DeviceMedline Industries, LPClass IStop using Medline NAMIC angiographic syringes
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
- 2026-04-15FDA-DeviceMedline Industries, LPClass IStop using affected Medline angiographic syringes
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
- 2026-04-15FDA-DeviceSiemens Medical Solutions USA, IncClass IIContact Siemens about your ARTIS imaging system
During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements.
- 2026-04-08FDA-DeviceCardinal Health 200, LLCClass IICheck Cardinal Health Monoject Tuberculin Syringes
The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Syringe (Product Code 1180100777), however the syringes contained within the packages are U-100 Insulin syringes.
- 2026-04-08FDA-DeviceGE Healthcare LLCClass IICheck your GE SIGNA Premier MRI scanner
Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/serviced with ferrous (steel) fittings instead of non-ferrous (brass) fittings on the magnet rear and if system is accessed to perform service while the magnet is ramped, the magnetic field could attract the ferrous fittings potentially resulting in personnel injury.
- 2026-04-08FDA-DeviceOxoid Australia Pty LimitedClass IIStop using Oxoid Microbact 12L Kit lot 4494873
Oxoid Ltd., part of Thermo Fisher Scientific, confirmed that Microbact 12L Kit 20 Tests MB1128A lot 4494873 may identify incorrect organism due to inconclusive result from ambiguous color reactions in wells.
- 2026-04-08FDA-DeviceBurlington Medical, LLCClass IICheck your Burlington Medical Kilt Blockers
Potential for attenuation degradation over time, decreasing the lifespan.
- 2026-04-08FDA-DeviceBurlington Medical, LLCClass IICheck your Burlington Medical Blockers serial number
Potential for attenuation degradation over time, decreasing the lifespan.
- 2026-04-08FDA-DeviceBurlington Medical, LLCClass IICheck your Burlington Medical apron serial number
Potential for attenuation degradation over time, decreasing the lifespan.
- 2026-04-08FDA-DeviceBurlington Medical, LLCClass IICheck Burlington Medical half aprons for material degradation
Potential for attenuation degradation over time, decreasing the lifespan.
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