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 |
|---|---|---|---|---|
| Dec 3, 2024 | ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ROCH-PEA... | Reports of various packaging issues that may result in a breach of the sterile barrier. | Class II | Sklar Instruments |
| Dec 3, 2024 | ECONO STERILE medical procedure kits labeled as: ECONO STERILE" CURETTE EX... | Reports of various packaging issues that may result in a breach of the sterile barrier. | Class II | Sklar Instruments |
| Dec 3, 2024 | ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE BACKHAUS... | Reports of various packaging issues that may result in a breach of the sterile barrier. | Class II | Sklar Instruments |
| Dec 3, 2024 | ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DI... | Reports of various packaging issues that may result in a breach of the sterile barrier. | Class II | Sklar Instruments |
| Nov 29, 2024 | Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a t... | Ostomy skin barrier package contains a pre-cut wafer of 28mm instead of 16mm and/or 35mm pre-cut... | Class II | ConvaTec, Inc |
| Nov 25, 2024 | Eclipse Mini REF 98900 The Eclipse MINI Model 98900 is a portable non-inva... | Due to a manufacturing error the incorrect device serial number was potentially programmed into t... | Class II | Spacelabs Healthcare, Ltd. |
| Nov 25, 2024 | Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive... | Due to a manufacturing error the incorrect device serial number was potentially programmed into t... | Class II | Spacelabs Healthcare, Ltd. |
| Nov 22, 2024 | Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25 | The outer case is mislabeled as 3.0 K, 2.0 Ca instead of 2.0 K, 3.0 Ca. | Class II | Nipro Renal Soultions USA, Corporation |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: 1) PANENDOSCOPY-LF, REF ... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: 1) UMC DR. BAKER SUPPLEM... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: 1) CRANI, REF CDS780089V;... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: 1) FREE FLAP BASIC SET-U... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: 1) ENDOSCOPIC SKULL BASE... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: 1) NEURO BASIN PACK-LF, ... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: 1) NASAL PACK, REF DYNJ6... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: 1) MICRODISECTOMY PACK, ... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: 1) MEM MAXILLOFACIAL PAC... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF, REF... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: 1) VP SHUNT CDS, REF CDS... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: DEEP BRAIN STIMULATION P... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: 1) CERVICAL PACK-LF, REF... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: 1) ENSEMBLE RACHIS-LF, R... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LF, RE... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 18, 2024 | Medline procedure kits labeled as: 1) SHORT TERM INFUSAPORT ACCESS KIT, Re... | Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 18, 2024 | Medline procedure kits labeled as: 1) Port Access Kit, Reorder number CVI5... | Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 18, 2024 | Medline procedure kits labeled as: 1) CENTRAL LINE DRESSING KIT, Reorder n... | Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2024 | mint Lesion, Software Versions: 3.10.0 and 3.10.1. | Some software versions have a malfunction where they may show incorrect orientation labels for a... | Class II | Mint Medical GmbH |
| Nov 15, 2024 | mint Lesion, Software Versions: 3.9.0 through 3.9.5. | Some software versions have a malfunction where they may show incorrect orientation labels for a... | Class II | Mint Medical GmbH |
| Nov 11, 2024 | Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. All... | Potential safety issues in Allura Xper R7.6- R8.1 systems where the Lifetime Extension (LTE) kit ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Nov 6, 2024 | Medline brand, medical procedure convenience kits, labeled as: 1) NEURO CRANI... | Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to cont... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 6, 2024 | Medline brand, medical procedure convenience kits, labeled as: 1) LAMINECTOM... | Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to cont... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 6, 2024 | Medline brand, medical procedure convenience kits, labeled as: 1) SINUS CDS-1... | Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to cont... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 6, 2024 | Medline brand, medical procedure convenience kits, labeled as: 1) MVFF/FIBU #... | Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to cont... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 6, 2024 | ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer ... | Due to finished goods incorrectly packaged and labeled. | Class II | ICU Medical, Inc. |
| Nov 6, 2024 | Medline brand, medical procedure convenience kits, labeled as: 1) CRANIOTOMY,... | Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to cont... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 5, 2024 | GE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomograph... | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... | Class II | GE Healthcare (China) Co., Ltd. |
| Nov 1, 2024 | Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA ins... | The DNA fragments for this specific lot number are too large, resulting in potential background a... | Class II | Kreatech Biotechnology Bv |
| Oct 28, 2024 | Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a de... | Due to incorrect labels applied to devices during servicing. Labels contain the incorrect produc... | Class III | Remote Diagnostic Technologies Ltd. |
| Oct 28, 2024 | AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O | Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UP... | Class II | Boston Scientific Corporation |
| Oct 28, 2024 | AMS Artificial Urinary Sphincter Control Pump | Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UP... | Class II | Boston Scientific Corporation |
| Oct 25, 2024 | ENDO KIT, Medline Kit SKU DYKE1577A, Component Number 57469, 10 per case; Me... | Identified lots of Olympus product may be missing sterile and manufacturing lot numbers and expir... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 23, 2024 | URINALYSIS KIT 4, SKU DYLAB1021; Component No. 503581 | Specimen container included in kits is labeled as sterile, but has been identified to be non-ster... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 23, 2024 | URINE KIT W/BD CUP, SKU DYLAB1001A; Component No. 503581 | Specimen container included in kits is labeled as sterile, but has been identified to be non-ster... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 23, 2024 | URINE KIT, SKU DYKM1845; Component No. 503581 | Specimen container included in kits is labeled as sterile, but has been identified to be non-ster... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 23, 2024 | URINE COLLECTION KIT, SKU DYKM1848A DYKM2005 DYKM2151 DYLAB1004 DYLAB1004... | Specimen container included in kits is labeled as sterile, but has been identified to be non-ster... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 23, 2024 | UA KIT, SKU DYKM1690A; Component No. 503581 | Specimen container included in kits is labeled as sterile, but has been identified to be non-ster... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 23, 2024 | Clean Catch Kit, SKU DYKM1833A; Component No. 503581 | Specimen container included in kits is labeled as sterile, but has been identified to be non-ster... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 23, 2024 | URINE COLLECTION VHC, SKU DYLAB1016; Component No. 503581 | Specimen container included in kits is labeled as sterile, but has been identified to be non-ster... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 23, 2024 | Lab Kit, SKU DYLAB1018; Component No. 503581 | Specimen container included in kits is labeled as sterile, but has been identified to be non-ster... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 21, 2024 | Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing... | Due to improper labeling of products. An intended use on the label has not been reviewed and appr... | Class II | Karl Storz Endoscopy |
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.