Browse Device Recalls
35,226 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,226 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 35,226 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 13, 2026 | Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Product Name: ... | Due to incorrect incubation process being performed on product. | Class II | HF Acquisition Co LLC |
| Apr 13, 2026 | Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (X... | Nitrile Exam Glove failed to meet specifications chemical permeation performance. | Class II | O&M HALYARD INC |
| Apr 13, 2026 | LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 ... | Due to a subset of chest compression systems/devices where the service performed on the systems w... | Class II | Jolife AB |
| Apr 13, 2026 | LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 9957... | Some defibrillators serviced between July 2023 through November 2025 were serviced without object... | Class II | Physio-Control, Inc. |
| Apr 10, 2026 | Medline medical convenience kit labeled as EYE TRAY-LF, Medline Kit SKU DYNJ2... | Specific Medline Kits contain Cardinal Health Monoject 1mL Luer Lock Syringes, Tuberculin Print, ... | Class II | Medline Industries, LP |
| Apr 10, 2026 | BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CA... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOL... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHY... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYS... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLO... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Produ... | Out-of-specification endotoxin result that did not meet the acceptance criteria. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Apr 10, 2026 | Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLO... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLO... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIO... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYS... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIO... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOL... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHY... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIO... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | BARD Dynamic Tip Steerable, Product Number 6DYNTP001; | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 9, 2026 | Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 ... | Due to nonconforming products being inadvertently distributed. | Class II | Stryker Corporation |
| Apr 8, 2026 | Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6... | Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) pr... | Class II | Becton, Dickinson and Company |
| Apr 8, 2026 | Swan-Ganz Pacing Catheter, Models: D200F7; | Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) pr... | Class II | Becton, Dickinson and Company |
| Apr 8, 2026 | Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P | Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) pr... | Class II | Becton, Dickinson and Company |
| Apr 8, 2026 | 3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D... | Complaints have been received of systems developing loose, missing, or broken internal bolts over... | Class II | Hologic, Inc |
| Apr 8, 2026 | Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software ... | Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode,... | Class II | Medtronic Neuromodulation |
| Apr 8, 2026 | SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, S... | Complaints have been received of systems developing loose, missing, or broken internal bolts over... | Class II | Hologic, Inc |
| Apr 7, 2026 | BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic use | BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Gene... | Class II | Becton Dickinson & Co. |
| Apr 7, 2026 | BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use | BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Gene... | Class II | Becton Dickinson & Co. |
| Apr 6, 2026 | The intended use is to be paired with a weapon for aiming purposes. | Wilcox is notifying all customers who have purchased a product from the BOSS Xe family that a sof... | Class II | Wilcox Industries Corp. |
| Apr 6, 2026 | INZONE DETACHMENT SYSTEM, REF: M00345100950 | Embolization coil detachment system devices may experience premature battery drain causing device... | Class II | Stryker Neurovascular |
| Apr 6, 2026 | QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, strepto... | Product has the potential for false positive results | Class II | Quidel Corporation |
| Apr 6, 2026 | LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xW... | Stent-assisted coiling device may due to commingling during manufacturing have dimensional noncon... | Class II | MICROVENTION INC. |
| Apr 3, 2026 | Brand Name: Geneva Product Name: Brachytherapy Applicator Product Descripti... | Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) tha... | Class II | Elekta, Inc. |
| Apr 3, 2026 | Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Ap... | Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) tha... | Class II | Elekta, Inc. |
| Apr 3, 2026 | Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavita... | Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) tha... | Class II | Elekta, Inc. |
| Apr 3, 2026 | TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 4... | Due to incorrect functional length on device labeling. | Class II | Grace Medical, Inc. |
| Apr 3, 2026 | Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM. Part Number: 150450... | The external sterile packaging was found adhered to the internal sterile packaging, potentially c... | Class II | DEPUY (IRELAND) |
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.