Browse Device Recalls
3,096 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,096 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 3,096 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 17, 2019 | Pneumothorax Tray, Catalog No. C-UTPTY-1400-WAYNE-112497-IMH, GPN G56537 - Pr... | Lidstock perforation line may be over the sterile area of the tray, when it should be on the lip ... | Class II | Cook Inc. |
| Sep 12, 2019 | CODAN SWAN-LOCK Swabable Needlefree Connector, Catalog #BC1000N, REF 16.7220,... | Individual packages of connectors may have incomplete or bad seals which would compromise sterility. | Class II | Codan US Corporation |
| Aug 30, 2019 | SPROTTE Lumbar with Introducer, labeled as the following: 1. Sprotte 22G... | Problem with packaging sealing process which affects sterility. | Class II | Pajunk GmbH |
| Aug 27, 2019 | Karl Storz, Model # 11161C2, Flexible Neuroscope | During a complaint investigation it was determined that an error was observed within the instruc... | Class II | Karl Storz Endoscopy |
| Aug 27, 2019 | Karl Storz RHINO-LARYNGO-BRONCHO FIBERSCOPE, Model # 11005BC1 | During a complaint investigation it was determined that an error was observed within the instruc... | Class II | Karl Storz Endoscopy |
| Aug 27, 2019 | Karl Storz NEURO-FIBERSCOPE, Model # 11282BN1, Flexible Pediatric Neuroscope | During a complaint investigation it was determined that an error was observed within the instruc... | Class II | Karl Storz Endoscopy |
| Aug 16, 2019 | Irrisept Wound Debridement and Cleansing System. 12 units per case. | Potential defect in the sterile pouch seal, which may result in a lack of sterility assurance. | Class II | IrriMAX Corporation |
| Aug 7, 2019 | CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM REF: PL731SU- Product Usage: Instrume... | possibility of the sterility batch being insufficiently sterilized | Class II | Aesculap Implant Systems LLC |
| Aug 7, 2019 | CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM REF: PL730SU - Product Usage: Instrum... | possibility of the sterility batch being insufficiently sterilized | Class II | Aesculap Implant Systems LLC |
| 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 |
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.