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 |
|---|---|---|---|---|
| Oct 2, 2017 | SOMATOM Go.Up computed tomography (CT) x-ray system table, Model Number: 1106... | The table may become unstable if the nuts on the bolts were not adequately tightened and thus hav... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 28, 2017 | Axiom Artis model Interventional fluoroscopic x-ray foot switch accessory; Mo... | The possibility exists for the wireless foot switch to fail due to impacts by external factors, s... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 28, 2017 | Artis zee and Artis zeego model Interventional fluoroscopic x-ray foot swit... | The possibility exists for the wireless foot switch to fail due to impacts by external factors, s... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 28, 2017 | Artis Q and Q.zen model Interventional fluoroscopic x-ray system wireless foo... | The possibility exists for the wireless foot switch to fail due to impacts by external factors, s... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 21, 2017 | proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System ... | A proSA adjusting pin used to adjust the proSA Adjustable Shunt System does not set the correct v... | Class II | Aesculap Implant Systems LLC |
| Sep 12, 2017 | LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01. Th... | Incorrect service code for properly catching critical defects during self-check. Potential for de... | Class II | Zoll Manufacturing Corp. |
| Sep 8, 2017 | JS Series SterilContainer S2 System | The JS Series SterilContainer S2 System was released to the market place prior to an authorized F... | Class II | Aesculap Implant Systems LLC |
| Sep 5, 2017 | ELAN 4 Drill: ELAN 4 1-RING TWIST DRILL D1.5 ELAN 4 1-RING TWIST DRILL D2.0 ... | ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance. | Class II | Aesculap Implant Systems LLC |
| Sep 5, 2017 | ELAN 4 Burr: ELAN 4 1-RING ROSEN BURR+ D0.6 ELAN 4 1-RING ROSEN BURR+ D0.8 ... | ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance. | Class II | Aesculap Implant Systems LLC |
| Sep 5, 2017 | ELAN 4 Blade: ELAN 4 1-RING PIN CUTTER D1.0 ELAN 4 1-RING NEURO CUTTER+ SOFT... | ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance. | Class II | Aesculap Implant Systems LLC |
| Sep 1, 2017 | The ELAN 4 Air System is intended for high speed cutting, sawing and drilling... | The ELAN 4 Air System was released to the market place prior to an authorized FDA 510K clearance.... | Class II | Aesculap Implant Systems LLC |
| Aug 31, 2017 | Syngo.via systems with SW VB20A | A software update was released on August 22, 2017. Performing this software installation and upgr... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 24, 2017 | AArtis Q/ Q.Zen biplane Artis zee biplane Product Usage: Artis is a family ... | Within a specific number of Artis zee biplane and Artis Q biplane systems, a connection in the ce... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 23, 2017 | Syngo.plaza systems with SW VB20A, Model Number - 10863171, 10863172, 1086317... | When a prior study is being replaced in the workflow step, in certain scenarios (based on the Dis... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 22, 2017 | Artis oneFloor-mounted system for uncompromised imaging; Artis one, Intervent... | The possibility exists for the monitor display of Artis one systems with a DP Transceiver below r... | Class II | Siemens Medical Solutions USA, INC |
| Aug 18, 2017 | A20975A "Working insert, with ramp, one way" (Lots 13ZW to 172W; A20976A "Bri... | Olympus has received complaints about fragments of adhesive which detached from inside the workin... | Class II | Olympus Corporation of the Americas |
| Aug 18, 2017 | Syngo.plaza Picture Archiving and Communication System (PACS) with software v... | Software update to correct several issues that include (1)Potential data loss, (2) Study mix-up, ... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 10, 2017 | Norian Drillable Inject | The contract supplier notified DePuy Synthes on June 16, 2017 that the kit expiration dates do no... | Class II | Synthes USA |
| Aug 10, 2017 | NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega... | The NS357R Vega PS Tibia Trial/Preparation Plateau size T4 may be incorrectly labeled. If the in... | Class II | Aesculap Implant Systems LLC |
| Aug 10, 2017 | Norian Drillable Inject | The contract supplier notified DePuy Synthes on June 16, 2017 that the kit expiration dates do no... | Class II | Synthes USA |
| Aug 7, 2017 | LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 Used in LCP M... | May have difficulty attaching the drill sleeve to the plate. If the drill sleeve will not connect... | Class II | Synthes, Inc. |
| Jul 31, 2017 | Foot Controls impacted for the following devices: OAKWORKS¿ Medical CFPM 3... | The foot control used on the OAKWORKS¿ Inc., CFPM300, CFPM301, CFPM400, CFPM401, CFPMB301, CFUR30... | Class II | Oakworks Inc |
| Jul 26, 2017 | 2.5 mm Reaming Rod, Ball tip with extension, 950 mm, sterile, Part Number: 35... | Possible lack of product sterility due to potential gaps/channeling in the seal of the package. | Class II | Synthes (USA) Products LLC |
| Jul 26, 2017 | 2.5 mm Guide Rod, with smooth tip, 950 mm, sterile, Part Number: 355.042S ... | Possible lack of product sterility due to potential gaps/channeling in the seal of the package. | Class II | Synthes (USA) Products LLC |
| Jul 26, 2017 | 3.0 mm Reaming Rod, with straight ball tip, 950 mm, sterile, Part Number: 351... | Possible lack of product sterility due to potential gaps/channeling in the seal of the package. | Class II | Synthes (USA) Products LLC |
| Jul 26, 2017 | 2.5 mm Titanium Calibrated Reaming Rod, 850 mm, Part Number: 359.083S Ream... | Possible lack of product sterility due to potential gaps/channeling in the seal of the package. | Class II | Synthes (USA) Products LLC |
| Jul 26, 2017 | 2.5 mm Reaming Rod, Ball tip, 1150 mm, sterile, Part Number: 351.708S Ream... | Possible lack of product sterility due to potential gaps/channeling in the seal of the package. | Class II | Synthes (USA) Products LLC |
| Jul 26, 2017 | Light Clip for Oracle Retractor, sterile, Part Number: 03.809.925S Reaming... | Possible lack of product sterility due to potential gaps/channeling in the seal of the package. | Class II | Synthes (USA) Products LLC |
| Jul 26, 2017 | 2.5 mm Reaming Rod, Ball tip, 950 mm, sterile, Part Number: 351.706S Ream... | Possible lack of product sterility due to potential gaps/channeling in the seal of the package. | Class II | Synthes (USA) Products LLC |
| Jul 25, 2017 | ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (... | Finished good kits may contain incorrect components. Kits that should contain a 5 FR 2 lumen cath... | Class II | Arrow International Inc |
| Jul 25, 2017 | ARROW PICC powered by ARROW VPS Stylet, Product Codes: CDC-35052-VPS and CDC-... | Finished good kits may contain incorrect components. Kits that should contain a 5 FR 2 lumen cath... | Class II | Arrow International Inc |
| Jul 25, 2017 | Syngo Imaging version V31 (model # 10014063) is a Picture Archiving and Commu... | Siemens is releasing a letter to inform about potential data loss relevant to diagnosis. | Class II | Siemens Medical Solutions USA, Inc. |
| Jul 21, 2017 | 11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile | The locking mechanism and protective cap were missing from the sterile packed nails of the affect... | Class II | Synthes (USA) Products LLC |
| Jul 10, 2017 | Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device p... | Needle supplier indicated the presence of loose polypropylene foreign matter above release specif... | Class II | Arrow International Inc |
| Jun 28, 2017 | GE Inspection Technologies Blade|line Industrial Cabinet X-ray system | GE Inspection Technologies, LP determined that the Blade|line cabinet x-ray system fails to compl... | Class II | GE Inspection Technologies, LP |
| Jun 21, 2017 | Contiplex Nerve Block Tray. Product Catalog Number: 570205. Local anesthes... | B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing th... | Class II | B. Braun Medical, Inc. |
| Jun 21, 2017 | Pain Management Tray. Product Catalog Number: 560602. Local anesthesia of ... | B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing th... | Class II | B. Braun Medical, Inc. |
| Jun 21, 2017 | Pencan Spinal Needle Tray. Product Catalog Number: 333865. Local anesthes... | B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing th... | Class II | B. Braun Medical, Inc. |
| Jun 21, 2017 | Customer Epidural Anesthesia Tray. Product Catalog Number: 555234. Local ... | B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing th... | Class II | B. Braun Medical, Inc. |
| Jun 21, 2017 | Perifix FX Epidural Anesthesia Tray. Product Catalog Numbers: 551993, 552051,... | B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing th... | Class II | B. Braun Medical, Inc. |
| Jun 21, 2017 | Perifix Single Dose Epidural Anesthesia Tray. Product Catalog Number: 332252.... | B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing th... | Class II | B. Braun Medical, Inc. |
| Jun 21, 2017 | PENCAN Spinal Anesthesia Tray. Product Catalog Number: 560590. Local anes... | B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing th... | Class II | B. Braun Medical, Inc. |
| Jun 21, 2017 | Perifix Epidural AnesthesiaTray. Product Catalog Numbers: 551879, 551994, 552... | B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing th... | Class II | B. Braun Medical, Inc. |
| Jun 21, 2017 | Perifix Continuous Epidural Anesthesia Tray. Product Catalog Numbers: 332075,... | B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing th... | Class II | B. Braun Medical, Inc. |
| Jun 21, 2017 | Spinal & Epidural Anesthesia Tray. Product Catalog Number: 555172. Local ... | B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing th... | Class II | B. Braun Medical, Inc. |
| Jun 12, 2017 | Arrow Glide Thru Peel-Away Sheath/Dilator Introducer | Arrow is recalling additional lots that were identified as part of an active recall. Arrow is rec... | Class II | Arrow International Inc |
| Jun 12, 2017 | Arrow EVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and A... | Arrow is recalling additional lots that were identified as part of an active recall. Arrow is rec... | Class II | Arrow International Inc |
| Jun 6, 2017 | Artis Zee and Zeego, Model Numbers: 10094135, 10094137, 10094141, 10094142, 1... | Potential for liquid entry | Class II | Siemens Medical Solutions USA, Inc |
| Jun 6, 2017 | Artis Q and Q.Zen, Model Numbers:10848280, 10848281, 10848282, 10848353 & 10... | Potential for liquid entry | Class II | Siemens Medical Solutions USA, Inc |
| Jun 6, 2017 | Axiom Artis, Model Numbers: 5904433, 5904441, 5904649, 5904656, 5917054, 7007... | Potential for liquid entry | Class II | Siemens Medical Solutions USA, 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.