Browse Device Recalls
39,949 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,949 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 39,949 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 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 | 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 | 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 | 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 | 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 | Medline brand medical procedure convenience kit, labeled as: a) PAIN PROCEDU... | 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: 1) EYE PACK, ... | 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: 1) NEW LONDO... | 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 AMBULATORY MINI PACK, REF DYNJ82579; 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 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 | Centurion OB TRAY, REF MNS13965A; 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 | Medline brand, medical procedure convenience kits, labeled as: a) CUH OPEN... | 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 DENTAL PACK, REF DYNJ64086B; 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 | The EVSRF catheter is a sterile, single-use disposable medical device for end... | The Venclose" RF Ablation Catheters may have been manufactured with internal wiring error. The r... | Class II | Bard Peripheral Vascular Inc |
| Sep 4, 2024 | Medline CHEST TUBE INSERTION TRAY ADUL, REF CHT1165; 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 | Medline brand medical procedure convenience kits, labeled as: a) TRAY ADD ... | 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) PLASTIC P... | 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) LITHOTOMY... | 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 CM1900, Material Numbers: a) 14045227... | 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 | Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U | There was an increase in complaints indicating an occurrence of system error E1226 "Could not wri... | Class II | Olympus Corporation of the Americas |
| Sep 3, 2024 | GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo n... | GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation d... | Class I | DATEX--OHMEDA, INC. |
| 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 | 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 | 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 | (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 | 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 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 | 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 | 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 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 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 | 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 | 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 | 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 | 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 | Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a st... | The patient label stickers may have the wrong expiration date recorded. The contract manufacturer... | Class III | Trackx Technology Inc |
| Sep 3, 2024 | GE Heathcare Giraffe OmniBed; neo natal incubator | GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation d... | Class I | DATEX--OHMEDA, INC. |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 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 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. |
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.