Browse Device Recalls
5,543 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,543 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 5,543 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 5, 2024 | Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | Pump 381 Pump Set (US); Product Code: 1000080; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | Impella CP Smart Assist Set; Product Code: 1000402; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | Impella CP Smart Assist Set APAC; Product Code: 0048-0047; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | Impella 5.5 SmartAssist Set, JP; Product Code: 1000211; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Jul 31, 2024 | Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway St... | Labeling error with a mismatch between the shelf box serial number label and the serial number of... | Class II | Inspire Medical Systems Inc. |
| Jul 31, 2024 | Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper A... | Labeling error with a mismatch between the shelf box serial number label and the serial number of... | Class II | Inspire Medical Systems Inc. |
| Jul 24, 2024 | (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 12 Fr/Ch (4.0 mm) x 4... | The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a r... | Class II | Cardinal Health 200, LLC |
| Jul 24, 2024 | (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve,... | The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a r... | Class II | Cardinal Health 200, LLC |
| Jul 12, 2024 | Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog ... | Due to mislabeling of products | Class II | Meddev Corp |
| Jul 12, 2024 | Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog ... | Due to mislabeling of products | Class II | Meddev Corp |
| Jul 9, 2024 | BD Pyxis QFill Replenishment Station, REF: 138904-01, medication cabinet system | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jul 9, 2024 | DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener | Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires d... | Class II | Smith & Nephew, Inc. |
| Jul 9, 2024 | DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener | Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires d... | Class II | Smith & Nephew, Inc. |
| Jul 9, 2024 | BKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jul 9, 2024 | Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312 | During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model 66118) was incorrect... | Class II | Medtronic Perfusion Systems |
| Jul 3, 2024 | GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circula... | Devices were labeled with an expiration date of four years and ten days rather than the validated... | Class II | W.L. Gore & Associates, Inc. |
| Jul 1, 2024 | Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubb... | mislabeling; EMG RLN monitoring kit labeling contains the incorrect tube size. | Class II | Neurovision Medical Products Inc |
| Jun 27, 2024 | Medline convenience kits containing semi-rigid suction liners labeled as foll... | Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 27, 2024 | Medline convenience kits containing semi-rigid suction liners labeled as foll... | Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 27, 2024 | Medline convenience kits containing semi-rigid suction liners labeled as foll... | Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 27, 2024 | Medline convenience kits containing semi-rigid suction liners labeled as foll... | Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 27, 2024 | Medline convenience kits containing semi-rigid suction liners labeled as foll... | Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 27, 2024 | Medline convenience kits containing semi-rigid suction liners labeled as foll... | Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 27, 2024 | Medline Semi-rigid suction liners labeled as follows: a) SEMI RIGID SUCTION ... | Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 27, 2024 | Medline convenience kits containing semi-rigid suction liners labeled as foll... | Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 27, 2024 | Medline convenience kits containing semi-rigid suction liners labeled as foll... | Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 27, 2024 | Medline convenience kits containing semi-rigid suction liners labeled as foll... | Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 27, 2024 | Medline convenience kits containing semi-rigid suction liners labeled as foll... | Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 27, 2024 | Medline convenience kits containing semi-rigid suction liners labeled as foll... | Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 27, 2024 | Medline convenience kits containing semi-rigid suction liners labeled as foll... | Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 27, 2024 | Medline convenience kits containing semi-rigid suction liners labeled as foll... | Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 27, 2024 | Medline convenience kits containing semi-rigid suction liners labeled as foll... | Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 27, 2024 | Medline convenience kits containing semi-rigid suction liners labeled as foll... | Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 27, 2024 | LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00 | The LinkSymphoKnee Patella Sizing Template was incorrectly labeled. The markings on two arms of t... | Class II | LINK BIO CORP |
| Jun 27, 2024 | Medline convenience kits containing semi-rigid suction liners labeled as foll... | XXX | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 25, 2024 | Multiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatibl... | Due to a manufacturing issue, the product has a out of specification rotation of the digital anal... | Class II | Preat Corp |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P, REF: 169-99 containing software version... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P, REF: 169-97 containing software ver... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-14HH-P, REF: 169-86 containing software version 3.... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P, REF: 169-82 containing software versio... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P, REF: 169-94 containing software version... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P, REF: 169-93 containing software ver... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK MINI CR-4HH-P, REF: 169-115 containing software version 3.9.1.9 | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | Puritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 56... | Any single affected ventilator should only be used for the 10- year labelled service life, but if... | Class I | Covidien |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-2HH-6FM, REF: 169-89 containing software version 3... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, 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.