Browse Device Recalls
3,276 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,276 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 3,276 FDA device recalls in 2024.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 18, 2024 | GE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systems | GE HealthCare has become aware of the potential that adhesive material might not have been applie... | Class II | GE Medical Systems, SCS |
| Mar 18, 2024 | DURAFLOW 2, 24CM STRAIGHT BASIC KIT -Indicated for use in attaining Long-Term... | Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... | Class II | Angiodynamics, Inc. |
| Mar 18, 2024 | DURAMAX STACKED TIP 28CM STR. BASIC KIT, 1-UP PG- Indicated for use in attain... | Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... | Class II | Angiodynamics, Inc. |
| Mar 18, 2024 | DURAMAX STACKED TIP 24CM STR. BASIC KIT, 1-UP PG Product Number: H78710302... | Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... | Class II | Angiodynamics, Inc. |
| Mar 18, 2024 | DURAMAX STACKED TIP 32CM STR. BASIC KIT, 5-UP PG- Indicated for use in attain... | Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... | Class II | Angiodynamics, Inc. |
| Mar 18, 2024 | DURAFLOW 2, 32CM STRAIGHT BASIC KIT PG-Indicated for use in attaining Long-... | Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... | Class II | Angiodynamics, Inc. |
| Mar 15, 2024 | Palindrome Precision H Chronic Catheter Kit 14.5 Fr/Ch (4.8mm) x 23 cm (Sym... | Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit... | Class II | Covidien LP |
| Mar 15, 2024 | Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang... | Due to complaints of particulates, residue, occlusions, and bent tips for sterile cannulas. | Class II | Alcon Research, LLC |
| Mar 15, 2024 | Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 9119... | Elekta has become aware that Disposable Biopsy Needles (911933) from one batch (837838839) can co... | Class I | Elekta Instrument AB |
| Mar 15, 2024 | PERLA TL 25D SCREW REF: TLF-DS 45 25-S TLF-DS 45 30-S TLF-DS 45 35-S TL... | Due to receiving information regarding difficulties with the insertion of a setscrew inside a scr... | Class II | SPINEART SA |
| Mar 15, 2024 | Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 1... | Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit... | Class II | Covidien LP |
| Mar 15, 2024 | Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in ... | Product was distributed in the United States without proper regulatory approval. | Class II | Baxter Healthcare Corporation |
| Mar 14, 2024 | Sterile surgical convenience kit: Medline Retrograde PK-22025203-LF, Pack ... | Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 14, 2024 | Sterile convenience kit: Medline Birthing Room Pack, Pack #DYNJ38429D, con... | Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 14, 2024 | Nonsterile convenience kits: a. Medline Delivery, Pack #DYNJ901130I, cont... | Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 14, 2024 | Sterile surgical convenience kits: a. Medline Cath Lab Special Procedure,... | Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 14, 2024 | Non-sterile convenience kits: Medline Open Heart CDS, Pack #CDS981759C, co... | Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 14, 2024 | Non-sterile convenience kits: a. Medline CC Drawer 4 IV Circulation, Pack ... | Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 14, 2024 | Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only, | Their is a potential that breast implants lack the lubricious coating that allows them to slide ... | Class II | Allergan Sales, LLC |
| Mar 14, 2024 | VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial sus... | Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kit... | Class I | Biomerieux Inc |
| Mar 14, 2024 | Sterile surgical convenience kit: Medline Neuro IR Pack, Pack #DYNJ56073C,... | Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 14, 2024 | Prelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 mm), 45 cm, STE... | Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator. | Class II | Merit Medical Systems, Inc. |
| Mar 14, 2024 | Non-sterile convenience kits: a. Medline Difficult Airway Tray W/O Cook, ... | Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 14, 2024 | Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Tes... | Due to a manufacturing variation of the irrigation sleeves which could result in a missing port h... | Class II | Johnson & Johnson Surgical Vision, Inc. |
| Mar 14, 2024 | Sterile convenience kits: a. Medline Retrograde PK-22025203-LF, Pack #DYN... | Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 14, 2024 | Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STER... | Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator. | Class II | Merit Medical Systems, Inc. |
| Mar 13, 2024 | Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Numbe... | Received complaints that bottles assembled with one batch of bottle collars can be disassembled i... | Class II | Electro Medical Systems SA |
| Mar 13, 2024 | Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, M... | Surgical system may have inadequately welded top and/or bottom belts in the link 2 of the entry g... | Class II | Intuitive Surgical, Inc. |
| Mar 13, 2024 | Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human ... | Potential for falsely elevated Chol_2, LDLC, and Trig_2 results on the Atellica CH and Atellica C... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 13, 2024 | Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number:... | Received complaints that bottles assembled with one batch of bottle collars can be disassembled i... | Class II | Electro Medical Systems SA |
| Mar 13, 2024 | Brand Name: WATER BOTTLE Product Name: WATER BOTTLE Model/Catalog Number: E... | Received complaints that bottles assembled with one batch of bottle collars can be disassembled i... | Class II | Electro Medical Systems SA |
| Mar 13, 2024 | BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic mark... | Safety Information: Complaints describe complications/adverse events that include pain, infection... | Class I | Hologic, Inc |
| Mar 13, 2024 | Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Numb... | Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing pro... | Class II | Biomet, Inc. |
| Mar 12, 2024 | Ingenia 3.0T CX, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | Intera 1.5T Master/Nova, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | Ingenia Ambition S, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | Ingenia 3.0T, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | Intera 3.0T Quasar Dual, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | GYROSCAN T10-NT, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | Ingenia 1.5T, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | SmartPath to dStream for XR and 3.0T, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | Intera 0.5T Standard, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Co... | Product incorrectly labelled. | Class II | DePuy Orthopaedics, Inc. |
| Mar 12, 2024 | Intera 1.5T Power/Pulsar, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | Ingenia Ambition X, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | MR 5300, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | Achieva 3.0T for PET, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | SmartPath to dStream for 1.5T, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | Evolution Upgrade 3.0T, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | Intera 1.0T Power/Pulsar, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
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.