Browse Device Recalls
2,939 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,939 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 2,939 FDA device recalls in PA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 20, 2019 | Cios Alpha VA20/ VA30 mobile X-Ray systems | DAP chamber may be missing an insulating foil | Class II | Siemens Medical Solutions USA, Inc |
| Jun 20, 2019 | Cios care fusion system | DAP chamber may be missing an insulating foil | Class II | Siemens Medical Solutions USA, Inc |
| Jun 12, 2019 | Artis zee biplane MN, Model Number 10094143 | A tolerance issue in the power supply of the generator control above a specific value may cause g... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 12, 2019 | AXIOM Artis dFC, Model Number 7412807 | A tolerance issue in the power supply of the generator control above a specific value may cause g... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 12, 2019 | AXIOM Artis TC, Model Number 7728350 | A tolerance issue in the power supply of the generator control above a specific value may cause g... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 12, 2019 | AXIOM Artis MP, Model Number 5904466 | A tolerance issue in the power supply of the generator control above a specific value may cause g... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 12, 2019 | AXIOM Artis dBC, Model Number 5917054 | A tolerance issue in the power supply of the generator control above a specific value may cause g... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 12, 2019 | AXIOM Artis FC, Model Number 5904433 | A tolerance issue in the power supply of the generator control above a specific value may cause g... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 12, 2019 | AXIOM Artis BC, Model Number 5904649 | A tolerance issue in the power supply of the generator control above a specific value may cause g... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 12, 2019 | AXIOM Artis BA, Model Number 5904656 | A tolerance issue in the power supply of the generator control above a specific value may cause g... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 12, 2019 | AXIOM Artis dFC, Model Number 7727717 | A tolerance issue in the power supply of the generator control above a specific value may cause g... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 12, 2019 | AXIOM Artis TA, Model Number 7007755 | A tolerance issue in the power supply of the generator control above a specific value may cause g... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 12, 2019 | Artis zee multi, Model Number 10094139 | A tolerance issue in the power supply of the generator control above a specific value may cause g... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 12, 2019 | Artis zeego, Model Number 10280959 | A tolerance issue in the power supply of the generator control above a specific value may cause g... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 12, 2019 | Artis zee biplane, Model Number 10094141 | A tolerance issue in the power supply of the generator control above a specific value may cause g... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 12, 2019 | AXIOM Artis dTA, Model Number 7008605 | A tolerance issue in the power supply of the generator control above a specific value may cause g... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 12, 2019 | Artis zee floor, Model Number 10094135 | A tolerance issue in the power supply of the generator control above a specific value may cause g... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 12, 2019 | AXIOM Artis dFA, Model Number 7555373 | A tolerance issue in the power supply of the generator control above a specific value may cause g... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 12, 2019 | AXIOM Artis dBA, Model Number 7555357 | A tolerance issue in the power supply of the generator control above a specific value may cause g... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 12, 2019 | Artis zee ceiling, Model Number 10094137 | A tolerance issue in the power supply of the generator control above a specific value may cause g... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 12, 2019 | AXIOM Artis dBC, Model Number 7728392 | A tolerance issue in the power supply of the generator control above a specific value may cause g... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 12, 2019 | AXIOM Artis dMP, Model Number 7555365 | A tolerance issue in the power supply of the generator control above a specific value may cause g... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 12, 2019 | Artis zee floor MN, Model Number 10094142 | A tolerance issue in the power supply of the generator control above a specific value may cause g... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 12, 2019 | AXIOM Artis FA, Model Number 5904441 | A tolerance issue in the power supply of the generator control above a specific value may cause g... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 12, 2019 | AXIOM Artis dTC, Model Number 7413078 | A tolerance issue in the power supply of the generator control above a specific value may cause g... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 10, 2019 | Olympus WM-NP2 or WM-DP2 Mobile Workstations with Nurse Control Panel Arm, Mo... | WM-NP/DP2 workstations could become unstable and may fall over if the control panel arm is mounte... | Class II | Olympus Corporation of the Americas |
| Jun 6, 2019 | Siemens Artis zeego--Interventional Fluoroscopic X-Ray System Model Number: ... | Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movabl... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 6, 2019 | Siemens Artis Q.zen biplane-Interventional Fluoroscopic X-Ray System Model N... | Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movabl... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 6, 2019 | Siemens Artis pheno-Interventional Fluoroscopic X-Ray System Model Number: 1... | Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movabl... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 6, 2019 | Siemens Artis Q.zen floor----Interventional Fluoroscopic X-Ray System Model ... | Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movabl... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 6, 2019 | Siemens Artis Q biplane---Interventional Fluoroscopic X-Ray System Model Num... | Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movabl... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 6, 2019 | Siemens Artis Q.zen ceiling-Interventional Fluoroscopic X-Ray System Model N... | Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movabl... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 6, 2019 | Siemens Artis zee ceiling -Interventional Fluoroscopic X-Ray System Model Nu... | Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movabl... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 6, 2019 | Siemens Artis zee biplane-Interventional Fluoroscopic X-Ray System Model Num... | Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movabl... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 6, 2019 | Siemens Artis Q ceiling--Interventional Fluoroscopic X-Ray System Model Numb... | Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movabl... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 6, 2019 | Siemens Artis Q floor --Interventional Fluoroscopic X-Ray System Model Numbe... | Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movabl... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 6, 2019 | Siemens Artis Q zeego ---Interventional Fluoroscopic X-Ray System Model Num... | Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movabl... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 6, 2019 | Siemens Artis zee floor -Interventional Fluoroscopic X-Ray System Model Numb... | Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movabl... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 4, 2019 | SOMATOM go.All, Model No. 11061638 with syngo.CT software versions VA20A, ... | The potential sporadic performance problems may cause scanning workflow interruptions and unexp... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 4, 2019 | SOMATOM go.Up, Model No. 11061628 with syngo.CT software versions VA20A, ... | The potential sporadic performance problems may cause scanning workflow interruptions and unexp... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 4, 2019 | SOMATOM go.Top, Model No. 11061648 with syngo.CT software versions VA20A, ... | The potential sporadic performance problems may cause scanning workflow interruptions and unexp... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 4, 2019 | SOMATOM go.Now, Model No. 11061618 with syngo.CT software versions VA20A, ... | The potential sporadic performance problems may cause scanning workflow interruptions and unexp... | Class II | Siemens Medical Solutions USA, Inc |
| May 28, 2019 | SOMATOM go.Now (Model #11061620), with syngo.CT software versions VA20A, VA20... | The potential sporadic performance problems may result in scanning workflow interruptions and une... | Class II | Siemens Medical Solutions USA, Inc |
| May 28, 2019 | SOMATOM go.Top (Model #1161640), with syngo.CT software versions VA20A, VA20A... | The potential sporadic performance problems may result in scanning workflow interruptions and une... | Class II | Siemens Medical Solutions USA, Inc |
| May 28, 2019 | SOMATOM go.All (Model #11061630), with syngo.CT software versions VA20A, VA20... | The potential sporadic performance problems may result in scanning workflow interruptions and une... | Class II | Siemens Medical Solutions USA, Inc |
| May 28, 2019 | SOMATOM go.Up (Model #11061610) with syngo.CT software versions VA20A, VA20A_... | The potential sporadic performance problems may result in scanning workflow interruptions and une... | Class II | Siemens Medical Solutions USA, Inc |
| May 17, 2019 | Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARR... | Lidstock contains a labeling error. The lidstock shows the catheter cross section of the gauge (... | Class II | Arrow International Inc |
| May 2, 2019 | OAKWORKS Inc.Lithotripsy/Urology Table: CFLU401, Catalog Number: 75216-T01 - ... | Table assembly error with incorrect actuators for the lateral and longitudinal table movements | Class II | Oakworks Inc |
| May 2, 2019 | Revive Reusable Bladder Support, Model No. 0025 - Product Usage: The Revive b... | The product is unable to meet the use life of 31 cycles and may split or crack at the base of the... | Class II | Rinovum Women's Health |
| May 1, 2019 | B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog ... | Potential for the Infusion Pump Administration Set to leak and/or disconnect at the bonded joint ... | Class I | B. Braun Medical, 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.