Browse Device Recalls
35,290 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,290 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 35,290 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 4, 2024 | Medline EYE PACK, REF LYN036EPESB; medical procedure convenience kit | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Leica Biosystems Cryostat Model Number CM1100, Material Number 14046931130, f... | As part of our post market surveillance, we recognized that some customers are using flammable fr... | Class II | LEICA BIOSYSTEMS NUSSLOCH GMBH |
| Sep 4, 2024 | Medline DIALYSIS PACK, REF DYNJ36932A; medical procedure convenience kit | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Centurion EP LAB INSTRUMENT KIT, REF MNS10480; medical procedure convenience kit | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable de... | Anterior locking tabs on the Triathlon Universal Baseplate are out of specification which may pre... | Class II | Howmedica Osteonics Corp. |
| Sep 4, 2024 | bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and b... | The internal power connections at the power inlet of the ultrasound devices can come loose result... | Class II | B-K Medical A/S |
| Sep 4, 2024 | Medline CENTRAL CATHETER INSERTION TRA, REF CVI680C; medical procedure conven... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Leica Biosystems Cryostat Model Number CM1850, Material Numbers: a) 14047131... | As part of our post market surveillance, we recognized that some customers are using flammable fr... | Class II | LEICA BIOSYSTEMS NUSSLOCH GMBH |
| Sep 4, 2024 | Medline TUBAL LIGATION PACK, REF DYNJ66230B; medical procedure convenience kit | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Leica Biosystems Cryostat Model Number CM3050 S, Material Numbers: a) 140470... | As part of our post market surveillance, we recognized that some customers are using flammable fr... | Class II | LEICA BIOSYSTEMS NUSSLOCH GMBH |
| Sep 4, 2024 | Medline brand medical procedure convenience kits, labeled as: 1) THORACENTESI... | XXX | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Leica Biosystems Cryostat Model Number CM1510 S, Material Numbers: a) 491510... | As part of our post market surveillance, we recognized that some customers are using flammable fr... | Class II | LEICA BIOSYSTEMS NUSSLOCH GMBH |
| Sep 4, 2024 | Centurion PEDIATRIC/ADULT TRACHEOSTOMY T, REF TC7895; medical procedure conve... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Leica Biosystems Cryostat Model Number CM1950, Material Numbers: a) 14047742... | As part of our post market surveillance, we recognized that some customers are using flammable fr... | Class II | LEICA BIOSYSTEMS NUSSLOCH GMBH |
| Sep 4, 2024 | Medline brand, medical procedure convenience kits, labeled as: a) RADIOLOG... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline brand medical procedure convenience kits, labeled as: a) UNIVERSAL... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 3, 2024 | Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional image... | Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... | Class II | Philips North America Llc |
| Sep 3, 2024 | Ingenia Ambition S - For use as a diagnostic device to obtain cross-sectional... | Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... | Class II | Philips North America Llc |
| Sep 3, 2024 | (1) Centurion Sterile CirClamp, Reorder #200CR; (2) Centurion CirClamp with ... | Product has been identified as having holes in the packaging. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 3, 2024 | Ingenia Elition S -For use as a diagnostic device to obtain cross-sectional i... | Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... | Class II | Philips North America Llc |
| Sep 3, 2024 | MR 5300 - For use as a diagnostic device to obtain cross-sectional images, sp... | Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... | Class II | Philips North America Llc |
| Sep 3, 2024 | MR 7700 -For use as a diagnostic device to obtain cross-sectional images, sp... | Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... | Class II | Philips North America Llc |
| Sep 3, 2024 | Ingenia 3.0T CX - For use as a diagnostic device to obtain cross-sectional im... | Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... | Class II | Philips North America Llc |
| Sep 3, 2024 | Evolution Upgrade 3.0T - For use as a diagnostic device to obtain cross-secti... | Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... | Class II | Philips North America Llc |
| Sep 3, 2024 | SmartPath to dStream for XR and 3.0T- For use as a diagnostic device to obta... | Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... | Class II | Philips North America Llc |
| Sep 3, 2024 | Ingenia Elition X- For use as a diagnostic device to obtain cross-sectional i... | Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... | Class II | Philips North America Llc |
| Sep 3, 2024 | SmartPath to dStream for 1.5T - For use as a diagnostic device to obtain cros... | Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... | Class II | Philips North America Llc |
| Sep 3, 2024 | Ingenia Ambition X - For use as a diagnostic device to obtain cross-sectional... | Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... | Class II | Philips North America Llc |
| Sep 3, 2024 | Ingenia 1.5T -For use as a diagnostic device to obtain cross-sectional images... | Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... | Class II | Philips North America Llc |
| Sep 3, 2024 | SmartPath to Ingenia Elition X - For use as a diagnostic device to obtain cro... | Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... | Class II | Philips North America Llc |
| Sep 1, 2024 | Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N | Dental implant box incorrectly labels the diameter as 4,5 X 18,0 mm, but the internal label corre... | Class II | SIN SISTEMA DE IMPLANTE NACIONAL S.A |
| Aug 30, 2024 | Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographi... | Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. | Class II | Merit Medical Systems, Inc. |
| Aug 30, 2024 | Monarch Inflation Device 30 atm/bar REF IN2130 Injector And Syringe, Angi... | Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. | Class II | Merit Medical Systems, Inc. |
| Aug 30, 2024 | MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U. | It has been determined that certain Blood Pressure Monitors containing a faulty microchip have fa... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 30, 2024 | Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Inserti... | Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. | Class II | Merit Medical Systems, Inc. |
| Aug 30, 2024 | MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001 | It has been determined that certain Blood Pressure Monitors containing a faulty microchip have fa... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 30, 2024 | LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 9... | Due to an out of tolerance tool being used on monitor/defibrillator systems. | Class II | Physio-Control, Inc. |
| Aug 30, 2024 | The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable st... | Stryker Neurovascular has observed that devices with Out of United States (OUS) approved Instruct... | Class II | Stryker Neurovascular |
| Aug 30, 2024 | Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve Metal Inser... | Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. | Class II | Merit Medical Systems, Inc. |
| Aug 30, 2024 | IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 8... | During a production process, Philips became aware of one IntelliVue power supply with a broken gr... | Class II | Philips North America |
| Aug 30, 2024 | Predict+ is a data-driven, clinical decision support tool that uses machine l... | Predict+ is being recalled for lack of pre-market clearance/approval. | Class II | Blue Ortho |
| Aug 30, 2024 | Monarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal I... | Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. | Class II | Merit Medical Systems, Inc. |
| Aug 30, 2024 | Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis V... | Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. | Class II | Merit Medical Systems, Inc. |
| Aug 30, 2024 | MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT. | It has been determined that certain Blood Pressure Monitors containing a faulty microchip have fa... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 29, 2024 | stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DW... | One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max... | Class II | Tornier, Inc |
| Aug 29, 2024 | Biofinity Toric Multifocal Lenses - Soft Contact lenses Indicated for the cor... | Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience ... | Class II | CooperVision, Inc. |
| Aug 29, 2024 | Good Vibrations Ultrasonic Cleaner Solution, JorVet J0382G Ultrasonic Instrum... | Contaminated equipment and packaging caused Klebsiella oxytoca, Enterobacter asburiae, Enterobact... | Class II | Microcare Medical |
| Aug 29, 2024 | BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction ... | Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience ... | Class II | CooperVision, Inc. |
| Aug 29, 2024 | Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, f... | Devices from one lot of Perform" Reversed Inserts may contain a locking ring that was assembled u... | Class II | Tornier, Inc |
| Aug 29, 2024 | GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalo... | GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (... | Class II | GE Healthcare |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.