Browse Device Recalls
3,164 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,164 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 3,164 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 18, 2019 | Maquet Getinge-BEQ-T 3502 LVAD 1/4" Material: 701068168R01 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-T 51501 Ochsner ECC Pack Material:709000113 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 27901 SMALL PATIENT CI Material:701052287 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-T 8030 4 in High Flow Pigtail Material: 709000366 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 33704 ECC 1/4" PACK Material: 701054150 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-T 8805 ECC PACK Material: 701053361 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BO-TOP 28903 Adult ECC Pack Material: 709000093 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge- BEQ-TOP 37200 E-Circuit Bioline Heparin Material: 70105... | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 8013 ECC QUADROX iD Pack RF32 Material: 701047962 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 38900 ECC PACK Material: 701056368 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 33501 1/4" ECC PACK Material: 701053754 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-T 8506 Transport Pack Material: 709000146 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 5909 1/4 PACK W QPID Material: 701064992 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 44701 PEDIATRIC ECC Material: 701064825 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-T 25501 3/8" Better Bladder Pack Material: 709000370 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-T 48003 Rotaflow ONLY Support Pack Material:709000490 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge- BEQ-TOP 28901 MCV INFANT ECC Material:701056771R01 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge BO-TOP 48400 OR PACK Material: 701064327R01 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 35503 SGD Pack Material:701068797R01 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 5208 ECC SET CARDIAC Material: 701067350 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge- BEQ-TOP 32200 ECC Pack Material: 701053319R01 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 24202 ADULT ECC Material:701054295 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge- (1)Material: 701065765R01 BO-TOP 36504 Adult ECC Pack (2)Ma... | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-T 37305 1/4+3/8 TABLE LINE Material: 701067577 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-T 3502 LVAD 1/4" Material: 701068168 | 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 Universal Pk Material: 70105... | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 41201 ECC 3/8 PUMP PAC Material: 701064867 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 22701 Material: 701050790 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BO-TOP 15200 OR PACK HMO & RF Material:701050647R01 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 21502# Med City Childr Material: 701050060 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 18, 2019 | Maquet Getinge-BEQ-TOP 5502 ECC Pack Material:701051791R01 | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... | Class II | Maquet Cardiovascular, LLC |
| Apr 1, 2019 | Dornier Diode Laser Fibers:Used with Dornier Medilas D Family Lasers Part Nu... | Pin hole package failures compromising sterility of product | Class II | Dornier Medtech America, Inc. |
| Mar 21, 2019 | ConMed Anchor Tissue Retrieval System", 12 MM, 300 ML (5/BX) Catalog Number:... | Voids in the seal or a partial seal results in an open channel and may compromise the sterility o... | Class II | Conmed Corporation |
| Mar 21, 2019 | ConMed Anchor Tissue Retrieval System, 8 MM, 125 ML (5/BX) Catalog Number:TR... | Voids in the seal or a partial seal results in an open channel and may compromise the sterility o... | Class II | Conmed Corporation |
| Mar 21, 2019 | ConMed Anchor Tissue Retrieval System, 15 MM, 1850 ML (3/BX) Catalog Number:... | Voids in the seal or a partial seal results in an open channel and may compromise the sterility o... | Class II | Conmed Corporation |
| Mar 21, 2019 | ConMed Anchor Tissue Retrieval System, VATS, 15 MM, 1550 ML (3/BX) Catalog N... | Voids in the seal or a partial seal results in an open channel and may compromise the sterility o... | Class II | Conmed Corporation |
| Mar 21, 2019 | ConMed Anchor Tissue Retrieval System 15 MM, 1550 ML (3/BX) Catalog Number: ... | Voids in the seal or a partial seal results in an open channel and may compromise the sterility o... | Class II | Conmed Corporation |
| Mar 21, 2019 | ConMed Anchor Tissue Retrieval System 10 MM, 235 ML, (5/BX) Catalog Number: ... | Voids in the seal or a partial seal results in an open channel and may compromise the sterility o... | Class II | Conmed Corporation |
| Mar 19, 2019 | Performance Series Sagittal Blade, Catalog Number 6125-127-100 Product Usa... | During manufacture, packaging materials for a small portion of the lot may not have been properly... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Mar 1, 2019 | Laparotomy Sponge with the following product description and model numbers: ... | Potential lack of sterility assurance | Class II | Medical Action Industries Inc |
| Feb 18, 2019 | Avitus¿ Bone Harvester w/ Filter Insert - 5mm intended to harvest cancellous... | Breach in the sterile barrier pouch may compromise sterility of the device. | Class II | Avitus Orthopaedics, Inc. |
| Feb 18, 2019 | Avitus¿ Bone Harvester w/ Filter Insert - 8mm intended to harvest cancellou... | Breach in the sterile barrier pouch may compromise sterility of the device. | Class II | Avitus Orthopaedics, Inc. |
| Feb 15, 2019 | Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736 | The product does not meet sterility requirements. Product labeled as sterile was distributed wit... | Class II | COVIDIEN LLC |
| Feb 8, 2019 | Terumo Sur-vet Needle, 25G x 5/8", Product Code 100220 | There is a potential for a loss of package integrity that may compromise the sterility of the pro... | Class II | Terumo Medical Corporation |
| Feb 8, 2019 | Terumo Sur-vet Needle, 22G x 3/4", Product Code 100279 | There is a potential for a loss of package integrity that may compromise the sterility of the pro... | Class II | Terumo Medical Corporation |
| Feb 8, 2019 | Terumo Needle, 30G x 1/2", Product Code NN3013R | There is a potential for a loss of package integrity that may compromise the sterility of the pro... | Class II | Terumo Medical Corporation |
| Feb 8, 2019 | Terumo Needle, 18G x 1", Product Code NN1825R | There is a potential for a loss of package integrity that may compromise the sterility of the pro... | Class II | Terumo Medical Corporation |
| Feb 8, 2019 | Terumo Sur-vet Needle, 22G x 3/4", Product Code 100215 | There is a potential for a loss of package integrity that may compromise the sterility of the pro... | Class II | Terumo Medical Corporation |
| Feb 8, 2019 | Terumo Sur-vet Needle, 22G x 1", Product Code 100211 | There is a potential for a loss of package integrity that may compromise the sterility of the pro... | Class II | Terumo Medical Corporation |
| Feb 8, 2019 | Terumo Sur-vet Needle, 20G x 1", Product Code 100204 | There is a potential for a loss of package integrity that may compromise the sterility of the pro... | Class II | Terumo Medical Corporation |
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.