Browse Device Recalls
5,321 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,321 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 5,321 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P, REF: 169-91 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-10HH-2FM-P, REF: 169-83 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-8HH-1FH-2FM-P, REF: 169-96 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-12HH-1FM-P, REF: 169-85 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-12HH-1FH, REF: 169-84 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-3FH-P, REF: 169-98 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-1FH-3FM-P, REF: 169-92 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-2HH-1FH-P, REF: 169-114 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-4HH-1FH-4FM-P, REF: 169-90 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-2HH-6FH, REF: 169-88 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 MDBNK TWR MN CR-4HH-5FM-P RxNow, REF: 169-131 containing software ve... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 19, 2024 | UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in p... | Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentia... | Class II | Howmedica Osteonics Corp. |
| Jun 19, 2024 | UNITRAX Endoprosthesis Head Component - 38mm. Implantable component used in p... | Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentia... | Class II | Howmedica Osteonics Corp. |
| Jun 19, 2024 | UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in p... | Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentia... | Class II | Howmedica Osteonics Corp. |
| Jun 18, 2024 | SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis.... | Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however t... | Class II | Angiodynamics, Inc. |
| Jun 18, 2024 | ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377 | A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was plac... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 18, 2024 | KIT PEDI CRANI LAMI, Pack Number DYNJ907372A | A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was plac... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 18, 2024 | ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377A | A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was plac... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 18, 2024 | BD Nano 2nd Gen Pen Needles 32G X 4mm (5-count sample contained in Patient Co... | BD Nano 2nd Gen Pen Needle was shipped close to or after the labeled expiration date of February ... | Class II | Embecta Corp. |
| Jun 18, 2024 | CRANIOTOMY PACK, Pack Number DYNJ46552O | A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was plac... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 18, 2024 | SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis.... | Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however t... | Class II | Angiodynamics, 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.