Browse Device Recalls
3,010 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,010 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 3,010 FDA device recalls in 2019.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| 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 455... | 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 41552 JX1A | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow¿ JACC with Chlorag+ard¿ Technology Jugular Axillo subclavian Central Ca... | 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 HPHNM | 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 45552 VPS2 | 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 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: CDA 450... | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow PICC Kit Product Code: ASK 45541 RWJ4 | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | LEEP Precision Integrated System 120V, Model LP-10-120 Product Usage: The... | 2.5A slow blow fuses may have been installed in the LEEP RPECISION Generator rather than the appr... | Class II | CooperSurgical, 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 Kit Product Code: ASK 45541 LVH1 | 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 42563 HPHNM | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow¿ JACC with Chlorag+ard¿ Technology Jugular Axillosubclavian Central Cat... | 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 45041 H... | 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 42063 JX1A | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow JACC with Chlorag+ard Technology Jugular Axillo subclavian Central Cath... | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 22, 2019 | Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R | Two of three complaints were initiated due to the customers repeatedly obtaining No Call results ... | Class II | Luminex Corporation |
| Apr 22, 2019 | Cook Salle Intraoperative Pyeloplasty Stent Set PRODUCT/CATALOG NUMBER/GPN: ... | Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instru... | Class II | Cook Inc. |
| Apr 22, 2019 | Cook Kwart Retro-Inject Ureteral Stent Set: PRODUCT/CATALOG NUMBER/GPN: 4.... | Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instru... | Class II | Cook Inc. |
| Apr 19, 2019 | IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be ... | Images may potentially become corrupt while using the system. | Class II | Philips Healthcare Informatics, Inc. |
| Apr 19, 2019 | SureSigns VS4 NBP, SpO2, Product Number 863283. For monitoring the physiolog... | System software inhibits the monitor and as a result does not measure, display and alarm for puls... | Class II | Philips North America, LLC |
| Apr 19, 2019 | SureSigns VS3 NBP, Product Number 863069. For monitoring the physiological p... | System software inhibits the monitor and as a result does not measure, display and alarm for puls... | Class II | Philips North America, LLC |
| Apr 19, 2019 | SureSigns VS3 NBP, SpO2, Rec, Product Number 863072. For monitoring the phys... | System software inhibits the monitor and as a result does not measure, display and alarm for puls... | Class II | Philips North America, LLC |
| Apr 19, 2019 | ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Pr... | Possibility that a suture raw material containing high endotoxin levels was used in the manufact... | Class II | Ethicon, Inc. |
| Apr 19, 2019 | SureSigns VS4 Government Bundle, Product Number 863286. For monitoring the p... | System software inhibits the monitor and as a result does not measure, display and alarm for puls... | Class II | Philips North America, LLC |
| Apr 19, 2019 | SureSigns VS3 NBP, SpO2, Product Number 863071. For monitoring the physiolog... | System software inhibits the monitor and as a result does not measure, display and alarm for puls... | Class II | Philips North America, LLC |
| Apr 19, 2019 | Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120 | Reports of aspirating biopsy needle breakage | Class II | AURIS HEALTH INC |
| Apr 19, 2019 | ETHIBOND EXCEL¿ Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 ... | Possibility that a suture raw material containing high endotoxin levels was used in the manufact... | Class II | Ethicon, Inc. |
| Apr 19, 2019 | Finish Thompson Centrifugal Pump Model #110192-3 (sold as spare part) | There is a potential for an uneven plastic encapsulation of the magnet ring during the molding pr... | Class II | Isopure Corp |
| Apr 19, 2019 | Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a... | There is a potential for an uneven plastic encapsulation of the magnet ring during the molding pr... | Class II | Isopure Corp |
| Apr 19, 2019 | SureSigns VS3 NBP, SpO2, Temp, Rec, Product Number 863074. For monitoring th... | System software inhibits the monitor and as a result does not measure, display and alarm for puls... | Class II | Philips North America, LLC |
| Apr 19, 2019 | SureSigns VS3 NBP, SpO2, Temp, Product Number 863073. For monitoring the phy... | System software inhibits the monitor and as a result does not measure, display and alarm for puls... | Class II | Philips North America, LLC |
| Apr 19, 2019 | Acidified Concentrate Distribution and Storage System (ACDS System) with a Fi... | There is a potential for an uneven plastic encapsulation of the magnet ring during the molding pr... | Class II | Isopure Corp |
| Apr 19, 2019 | SureSigns VS3 NBP Temp, Product Number 863070. For monitoring the physiologi... | System software inhibits the monitor and as a result does not measure, display and alarm for puls... | Class II | Philips North America, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-T 52301 ¿ Sash & Accessory Pack Material: 709000266 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-T 4903 Mercy Med w/o Oxy Material:701066664 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BO-TOP 35503 SGD PACK Material: 701067668 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BO-TOP 20705 SMALL PATIENT 1/4 Material: 701053486R01 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 30907 ECC PUMP PACK Material: 701065770 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BO-TOP 30300 Material:701052623 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge- BEQ-TOP 32100 Adult Custom Pack Material:701054438R01 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BO-T 44201 MAYO PULMONARY PACK Material: 701064834 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Fenestrated Tap Adapter (REF# 5001-90011) Product Usage: The K2M Fenestra... | The products are mislabeled. | Class II | K2M, Inc |
| Apr 18, 2019 | Maquet Getinge-BEQ-T 8025 1/4" ECC Pack with RF32 Material:701055142 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BO-TOP 36504 ADULT ECC PACK Material: 701065765 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-T 8029 PRESSURE PIGTAIL 6" Material: 701055995 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
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.