Browse Device Recalls
1,001 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,001 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 1,001 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 19, 2023 | Medline Leg bag, REF DYND12578 | Undeclared latex | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 19, 2023 | Medline Leg bag, REF DYND12574 | Undeclared latex | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 19, 2023 | Medline Leg bag, REF URO12573 | Undeclared latex | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 16, 2023 | (1) Nurse Kit, SKU #EDUC1025, Case UPC 40195327196647, Non-sterile, For Train... | The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 16, 2023 | (1) Nursing Skills kit, SKU #EDUC05038B, Case UPC 40195327019878, Non-sterile... | The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 16, 2023 | Tracheostomy care kits: (1) Medline Tracheostomy Clean and Care Tray with ... | The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 4, 2023 | HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhal... | Product dispositioned for scrap for sterility failure investigation that was inadvertently shippe... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 3, 2023 | MEDLINE ReNewal Ligasure Blunt Tip Sealer/Divider Nano-Coated Compatible wit... | Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 3, 2023 | MEDLINE ReNewal Ligasure Sealer/Divider Nano-Coated Compatible with FT10 Gen... | Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 3, 2023 | MEDLINE ReNewal Ligasure Maryland Jaw Sealer/Divider Nano-Coated Complatible... | Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 3, 2023 | MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/ GEN11 S... | Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 3, 2023 | MEDLINE STERILE IRIS SCISSORS CVD/STD, REF DYNJ04049 | 4.5" Iris Scissors, Sterile, Curved (DYNJ04049) are being recalled due to the potential of the ti... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jul 3, 2023 | Total Hip Kit, REF DYNJ903275S; surgical convenience kit | The prep solution included in the Total Hip Kit expires prior to the expiration date of the Kit. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 23, 2023 | Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 p... | The kits incorrectly contain CirClamp subassembly 345CRSAK which results in the kits containing a... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) OCULOPLAST... | Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits, Model Numbers: DYNJE5900, DYNJE5910, DYNJE5920, DYN... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) TOTAL JOIN... | Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: HYSTERO PACK,... | Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: EAR CDS, Mode... | Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
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.