Browse Device Recalls
3,037 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,037 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 3,037 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 1, 2019 | 8 G x 10 CM Jamshidi Crown Bone Marrow biopsy/Aspiration Needle with MAC Cat... | Product Pouches may not be sealed properly and compromise the sterility of the device | Class II | Becton Dickinson & Company |
| Jun 18, 2019 | DeRoyal THE RESOURCE GROUP, CRANI PACK, REF 89-9211.07 custom surgical pack | Custom surgical packs are being recalled because it contains Cardinal Health Blunt Cannulas which... | Class II | DeRoyal Industries Inc |
| Jun 10, 2019 | VAMPIRO V5001-minimally invasive poole suction sleeve that is an accessory in... | Lack of package integrity may compromise sterility | Class II | Santanello Surgical LLC |
| May 2, 2019 | Neff Percutaneous Access Set, Catalog Number NPAS-100-RH-NT | The products may have been manufactured without the bottom seal on the outer packaging, compromis... | Class II | Cook Inc. |
| Apr 30, 2019 | Monoject Blunt Cannula, 19 G x 1-1/2" (1.067 mm x 3.8 cm) Item code: 88812... | Manufacturing defect was found for the cartridge component, which could compromise the sterility ... | Class II | Cardinal Health 200, LLC |
| Apr 30, 2019 | Monoject" 201 Vet Pak Hypodermic Needle, 16 ga x 1-1/2 Item code: 8881201654 | Manufacturing defect was found for the cartridge component, which could compromise the sterility ... | Class II | Cardinal Health 200, LLC |
| Apr 30, 2019 | Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code: 8881200037 | Manufacturing defect was found for the cartridge component, which could compromise the sterility ... | Class II | Cardinal Health 200, LLC |
| Apr 30, 2019 | Monoject Standard Hypodermic Needle, 18 G x 1-1/2" Item code: 8881200078 | Manufacturing defect was found for the cartridge component, which could compromise the sterility ... | Class II | Cardinal Health 200, LLC |
| Apr 30, 2019 | Monoject 201 Vet Pak Hypodermic Needle, 18 ga x 1-1/2 Item code: 8881201548 | Manufacturing defect was found for the cartridge component, which could compromise the sterility ... | Class II | Cardinal Health 200, LLC |
| Apr 30, 2019 | Monoject Blunt Cannula, 20 G x 1-1/2" (0.902 mm x 3.8 cm) Item code: 88812... | Manufacturing defect was found for the cartridge component, which could compromise the sterility ... | Class II | Cardinal Health 200, LLC |
| Apr 30, 2019 | Monoject Blunt Cannula, 15 G x 1-1/2" (1.829 mm x 3.8 cm) Item code: 88812... | Manufacturing defect was found for the cartridge component, which could compromise the sterility ... | Class II | Cardinal Health 200, LLC |
| Apr 30, 2019 | Monoject 201 Vet Pak Hypodermic Needle, 20 ga x 1-1/2" Item code: 8881201498 | Manufacturing defect was found for the cartridge component, which could compromise the sterility ... | Class II | Cardinal Health 200, LLC |
| Apr 30, 2019 | Monoject 201 Vet Pak Hypodermic Needle, 22 ga x 1-1/2" Item code: 8881201456 | Manufacturing defect was found for the cartridge component, which could compromise the sterility ... | Class II | Cardinal Health 200, LLC |
| Apr 30, 2019 | Monoject 201 Vet Pak Hypodermic Needle, 19 ga x 1-1/2 Item code: 8881201522 | Manufacturing defect was found for the cartridge component, which could compromise the sterility ... | Class II | Cardinal Health 200, LLC |
| Apr 30, 2019 | Monoject Blunt Cannula, 22 G x 1-1/2" (0.711 mm x 3.8 cm) Item code: 88812... | Manufacturing defect was found for the cartridge component, which could compromise the sterility ... | Class II | Cardinal Health 200, LLC |
| Apr 30, 2019 | Monoject Standard Hypodermic Needle, 14 G x 1-1/2" Item code: 8881200011 | Manufacturing defect was found for the cartridge component, which could compromise the sterility ... | Class II | Cardinal Health 200, LLC |
| Apr 30, 2019 | Monoject Blunt Cannula, 16 G x 1-1/2" (1.651 mm x 3.8 cm) Item code: 8881202322 | Manufacturing defect was found for the cartridge component, which could compromise the sterility ... | Class II | Cardinal Health 200, LLC |
| Apr 30, 2019 | Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code:8881200045 | Manufacturing defect was found for the cartridge component, which could compromise the sterility ... | Class II | Cardinal Health 200, LLC |
| Apr 30, 2019 | Monoject Standard Hypodermic Needle Item code: 8881200029 | Manufacturing defect was found for the cartridge component, which could compromise the sterility ... | Class II | Cardinal Health 200, LLC |
| Apr 30, 2019 | Monoject Standard Hypodermic Needle, 27 G x 1-1/4" Item code: 8881200508 | Manufacturing defect was found for the cartridge component, which could compromise the sterility ... | Class II | Cardinal Health 200, LLC |
| Apr 30, 2019 | Monoject Standard Hypodermic Needle, 20 G x 1-1/2" bulk Item code: 888120... | Manufacturing defect was found for the cartridge component, which could compromise the sterility ... | Class II | Cardinal Health 200, 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 |
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.