Browse Device Recalls
251 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 251 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 251 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 7, 2020 | HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Thoracoabdominal, Prod... | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... | Class II | Maquet Cardiovascular, LLC |
| Apr 7, 2020 | HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code... | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... | Class II | Maquet Cardiovascular, LLC |
| Apr 7, 2020 | HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code... | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... | Class II | Maquet Cardiovascular, LLC |
| Apr 7, 2020 | HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code... | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... | Class II | Maquet Cardiovascular, LLC |
| Apr 7, 2020 | HEMASHIELD PLATINUM Woven Double Velour Vascular Graft01 Branch, Product Code... | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... | Class II | Maquet Cardiovascular, LLC |
| Apr 7, 2020 | HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Produ... | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... | Class II | Maquet Cardiovascular, LLC |
| Apr 7, 2020 | Hemashield Gold Knitted Microvel Double Velour Vascular Graft Axillo-bifemora... | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... | Class II | Maquet Cardiovascular, LLC |
| Apr 7, 2020 | HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Cod... | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... | Class II | Maquet Cardiovascular, LLC |
| Apr 7, 2020 | HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code... | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... | Class II | Maquet Cardiovascular, LLC |
| Apr 7, 2020 | HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code... | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... | Class II | Maquet Cardiovascular, LLC |
| Apr 7, 2020 | HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code... | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... | Class II | Maquet Cardiovascular, 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 | 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 |
| Apr 18, 2019 | Maquet Getinge-BEQ-T 27602 709000417 Adult Custom Pack Material: 709000417 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge: (1) Material: 701053941R01 BEQ-TOP 9005 3/8 Custom Pk w/RF... | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-T 9409 Lurie Chlds Large 3/8 Material: 709000428 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 15704 Circulatory Circuit 3/8" Material:701050859R01 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-T 28906 1/4" with Bridge Ancillary P Material: 709000072 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 22702 ECC W/HMOD 30000 Material: 701051179 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 47800 STRINGFELLOW PED Material:701066583 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 31603 CHKD 3/8" ECC Material: 709000516 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge- (1) Material: 701063255R01 BEQ-TOP 25003 3/8 3/8 up to 7l... | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge- (1) Material: 701055490R01 BEQ-TOP 15801 ¿ inch ECC Pack ... | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BO-T 2302 Pediatric Cardiac Surgery Pack Material: 709000006 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-T 3501 LVAD/ 3/8" Material: 701068008 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-T 8803#Circ Circuit Small Patient Material: 701048539 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BO-TOP 30901 CUSTOM CPB PACK Material: 701055372 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 41200 ECC 1/4 PUMP PAC Material: 701063149 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 25503 TMC ¿ with BB & QiD Pedi Material:709000473 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 21506 ECC PACK Material:701064505 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BO-T 41302 PRIMING LINES BUMC Material:701066291 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-T 44200 MAYO PULMONARY P Material: 701064831 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BO-TOP 13901 RAPID RESPONSE Material:701054874 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-T 41303 AV MANIFOLD FOR ECC PA Material:701066551 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BO-T 41301 BUMC ECC PACK Material: 701065209 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-T 8028 PRESSURE PIGTAIL 4" Material: 701055993 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge BEQ-TOP 40010 OPEN HEART PACK Material: -701067364R02 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 30901 CUSTOM CPB PACK Material:701063071 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge- BEQ-TOP 5210 ECC Set - Respiratory Material: 701055604R01 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-T 30914 ECC Pump Pack 1/4" Material: 709000011 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-T 52301 ¿ Sash & Accessory Pack Material:-709000266R01 | 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.