Browse Device Recalls
2,969 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,969 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 2,969 FDA device recalls in PA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| Apr 23, 2019 | Arrowg+ard Blue Advance JACC Product Code: CDC 41541 JX1A | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrowg+ard Blue Advance JACC Product Code: JRT 43552 HPHNM | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow¿ JACC with Chlorag+ard Technology Product Code: JR 42541 HPHNM | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow¿ JACC with Chlorag+ard Technology Product Code: JR 42063 HPHNM | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrowg+ard Blue Advance JACC Product Code:CDC 42052 JX1A | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrowg+ard Blue Advance JACC Product Code: JRT 43541 HPHNM | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow PICC Kit pre loaded with Arrow¿ VPS Precision Stylet Product Cod... | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow¿ PICC with Chlorag+ard Technology Product Code: CDC 44052 H... | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow¿ PICC with Chlorag+ard¿ Technology Product Code: PR 45541 HPHNL | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow¿ PICC with Chlorag+ard¿ Technology Product Code:PR 45552 HPHNM | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrowg+ard Blue Advance" PICC pre loaded with Arrow¿ VPS" Precision Stylet ... | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow PICC powered by Arrow VPS Stylet Product Code: ASK45041JHVA | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrowg+ard Blue Advance PICC pre loaded with Arrow¿ VPS" Precision Stylet ... | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrowg+ard Blue Advance PICC pre loaded with Arrow¿ VPS" Precision Stylet ... | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow PICC with Chlorag+ard Technology Product Code: CDA 44052 HPK1A | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow PICC Kit Product Code: ASK 45552 RWJ4 | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrowg+ard Blue Advance Midline Product Code: PR 41541 BAS | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrowg+ard Blue Advance PICC Product Code: CDC45541HPK1A | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow¿ JACC with Chlorag+ard Technology Product Code: JR 42041 HPHNM | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrowg+ard Blue Advance JACC Product Code: CDC 42041 JX1A | Lidstock states the incorrect expiration date for the product | Class II | Arrow International 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.