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.

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DateProductReasonClassFirm
Oct 26, 2017 Radial Artery Catheterization Kit; Model: AK-04122 The povidone iodine prep pads included in certain kits and trays do not meet the requirements for... Class II Arrow International Inc
Oct 26, 2017 Radial Artery Catheterization Kit; Model: AK-04020 The povidone iodine prep pads included in certain kits and trays do not meet the requirements for... Class II Arrow International Inc
Oct 26, 2017 Radial Artery Catheterization Kit; Model: AK-04220 The povidone iodine prep pads included in certain kits and trays do not meet the requirements for... Class II Arrow International Inc
Oct 24, 2017 ArrowClarke" PleuraSeal¿ Thoracentesis Kit Product packaging may not be completely sealed. Class II Arrow International Inc
Oct 24, 2017 Large Volume Abdominal Paracentesis Kit Product packaging may not be completely sealed. Class II Arrow International Inc
Oct 24, 2017 Pneumothorax Kit Product packaging may not be completely sealed. Class II Arrow International Inc
Oct 17, 2017 Pressure Injectable ARROWg+ard Blue PLUS MultiLumen Central Venous Catheteriz... These finished good kits may contain the incorrect Springwire Guide (SWG). Class II Arrow International Inc
Oct 17, 2017 AGB+ Multi Lumen Central Venous Catheterization Kit; Product Codes: CDC-42703... These finished good kits may contain the incorrect Springwire Guide (SWG). Class II Arrow International Inc
Oct 17, 2017 Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheter... These finished good kits may contain the incorrect Springwire Guide (SWG). Class II Arrow International Inc
Oct 17, 2017 Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and... These finished good kits may contain the incorrect Springwire Guide (SWG). Class II Arrow International Inc
Oct 17, 2017 ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The kit may contain an incorrect catheter component. Kits that should contain a 40cm catheter ma... Class II Arrow International Inc
Oct 17, 2017 Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheteri... These finished good kits may contain the incorrect Springwire Guide (SWG). Class II Arrow International Inc
Oct 17, 2017 Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sh... These finished good kits may contain the incorrect Springwire Guide (SWG). Class II Arrow International Inc
Oct 17, 2017 Central Venous Catheterization Kit with Blue FlexTip Catheter; Product code: ... These finished good kits may contain the incorrect Springwire Guide (SWG). Class II Arrow International Inc
Oct 17, 2017 Multi Lumen Central Venous Catheterization Kit; Product Code: ASK-12703-HH2; ... These finished good kits may contain the incorrect Springwire Guide (SWG). Class II Arrow International Inc
Oct 17, 2017 ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume In... These finished good kits may contain the incorrect Springwire Guide (SWG). Class II Arrow International Inc
Oct 17, 2017 Arrow Multi Lumen CVC Kit (Central venous catheter); Product Code: CDC-15703-... These finished good kits may contain the incorrect Springwire Guide (SWG). Class II Arrow International Inc
Oct 17, 2017 ARROWg+ard Blue Plus Multi Lumen CVC (Central venous catheter); Product Code:... These finished good kits may contain the incorrect Springwire Guide (SWG). Class II Arrow International Inc
Oct 17, 2017 Pressure Injectable Multi Lumen Central Venous Catheterization Kit with Blue ... These finished good kits may contain the incorrect Springwire Guide (SWG). Class II Arrow International Inc
Oct 2, 2017 SOMATOM Go.Now computed tomography (CT) x-ray system table, Model Number: 110... 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
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

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.