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 24, 2019 | IV START KIT IV8440 | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... | Class II | Centurion Medical Products Corporation |
| Apr 24, 2019 | UVC TRAY UVT875 | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... | Class II | Centurion Medical Products Corporation |
| Apr 24, 2019 | INFUSA PORT KIT DYNDC1840F | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... | Class II | Centurion Medical Products Corporation |
| Apr 24, 2019 | TRIPLE LUMEN BUNDLE KIT ECVC1540 | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... | Class II | Centurion Medical Products Corporation |
| Apr 24, 2019 | STERILE CAP CHANGE KIT DYNDC1946B | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... | Class II | Centurion Medical Products Corporation |
| Apr 24, 2019 | CAP CHANGE KIT DYNDC1496B | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... | Class II | Centurion Medical Products Corporation |
| Apr 24, 2019 | IV SECUREMENT KIT IVS3405 | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... | Class II | Centurion Medical Products Corporation |
| Apr 24, 2019 | Precision TM M8 Adapter, 15 cm, part number M365SC9218150 - Product Usage: Th... | The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... | Class II | Boston Scientific Neuromodulation Corporation |
| Apr 24, 2019 | Flexible Intubation Fiberscope, Model # 11301AB1 | The action is being initiated due to intubation scopes improperly manufactured with a double por... | Class II | Karl Storz Endoscopy |
| Apr 24, 2019 | CENTRAL LINE BUNDLE 16CM MULTIMED ECVC6545 | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... | Class II | Centurion Medical Products Corporation |
| Apr 24, 2019 | INFUSA PORT KIT DYNDC1840E | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... | Class II | Centurion Medical Products Corporation |
| Apr 24, 2019 | Fifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Produ... | The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... | Class II | Boston Scientific Neuromodulation Corporation |
| Apr 24, 2019 | CVC BUNDLE, 20CM, 3L, PI ECVC5120A | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... | Class II | Centurion Medical Products Corporation |
| Apr 24, 2019 | CENTRAL LINE BUNDLE 16CM MULTIMED ECVC6545A | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... | Class II | Centurion Medical Products Corporation |
| Apr 24, 2019 | INVASIVE PROCEDURE TRAY MNS9510 | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... | Class II | Centurion Medical Products Corporation |
| Apr 24, 2019 | CVC BUNDLE, 20CM, 4L, PI ECVC5095 | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... | Class II | Centurion Medical Products Corporation |
| Apr 24, 2019 | TRIPLE LUMEN CVC 20CM BUNDLE STCVC2040 | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... | Class II | Centurion Medical Products Corporation |
| Apr 24, 2019 | CVC BUNDLE VANTEX 7F, 3L, 20CM ECVC6065 | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... | Class II | Centurion Medical Products Corporation |
| Apr 24, 2019 | CVC TRIPLE LUMEN SAFETY BUNDLE ECVC6070 | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... | Class II | Centurion Medical Products Corporation |
| Apr 24, 2019 | CVC BUNDLE WITHOUT CATH CVI4600 | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... | Class II | Centurion Medical Products Corporation |
| Apr 24, 2019 | CVC INSERTION BUNDLE 8.5FR 4L 16CM ECVC6355 | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... | Class II | Centurion Medical Products Corporation |
| Apr 24, 2019 | CVC BUNDLE MULTIMED, 3L, 20CM ECVC6060 | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... | Class II | Centurion Medical Products Corporation |
| Apr 24, 2019 | Cap Change Kit DT20310 | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... | Class II | Centurion Medical Products Corporation |
| Apr 24, 2019 | CVC BUNDLE, 20CM, 3L, PI ECVC5120 | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... | Class II | Centurion Medical Products Corporation |
| Apr 24, 2019 | Neonatal Cap Change Kit DT20315 | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... | Class II | Centurion Medical Products Corporation |
| Apr 24, 2019 | NEONATAL PROCEDURE TRAY PICC CATHETERS CVI4535 | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... | Class II | Centurion Medical Products Corporation |
| Apr 24, 2019 | PICC Line Accessory Kit CVI4285 | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... | Class II | Centurion Medical Products Corporation |
| Apr 24, 2019 | OR VANTEX 7FR 3L 16CM CVC ECVC6665 | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... | Class II | Centurion Medical Products Corporation |
| Apr 24, 2019 | Fifty-five (55) cm 8 Contact Extension Kit, part number M365NM3138550 - Prod... | The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... | Class II | Boston Scientific Neuromodulation Corporation |
| Apr 24, 2019 | PEDIATRIC PICC INSERTION TRAY CVI4450A | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... | Class II | Centurion Medical Products Corporation |
| Apr 24, 2019 | LinearTM 3-4 50 cm 8 Contact Lead Kit, part number M365SC2352500. Leads fun... | The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... | Class II | Boston Scientific Neuromodulation Corporation |
| Apr 24, 2019 | Thirty-five (35) cm 8 Contact Extension Kit, part number M365SC3138350. Pack... | The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... | Class II | Boston Scientific Neuromodulation Corporation |
| Apr 23, 2019 | Stryker Connected OR Cart,120 V Ref Cat. #240-099-155, Qty 1, Rx Only, Manufa... | There is a potential problem with firm s Connected OR Cart, 120V resulting in cart monitor not at... | Class II | Stryker Corporation |
| Apr 23, 2019 | Arrowg+ard Blue Advance JACC Product Code: CDC 41541 JX1A | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrowg+ard Blue Advance JACC Product Code: JRT 43552 HPHNM | 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 42541 HPHNM | 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 42063 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 42052 JX1A | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrowg+ard Blue Advance JACC Product Code: JRT 43541 HPHNM | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow PICC Kit pre loaded with Arrow¿ VPS Precision Stylet Product Cod... | 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: CDC 44052 H... | 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 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:PR 45552 HPHNM | 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 powered by Arrow VPS Stylet Product Code: ASK45041JHVA | 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 | 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 44052 HPK1A | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow PICC Kit Product Code: ASK 45552 RWJ4 | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrowg+ard Blue Advance Midline Product Code: PR 41541 BAS | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
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.