Browse Device Recalls
39,885 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,885 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 39,885 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-153... | 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in i... | Class I | ARROW INTERNATIONAL, LLC |
| 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 | NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232... | 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in i... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 10, 2026 | Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I,... | 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in i... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 10, 2026 | Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-1519... | 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in i... | Class I | ARROW INTERNATIONAL, LLC |
| 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) |
| Apr 3, 2026 | Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450... | The external sterile packaging was found adhered to the internal sterile packaging, potentially c... | Class II | DEPUY (IRELAND) |
| Apr 3, 2026 | Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 7 CEM. Part Number: 150450... | The external sterile packaging was found adhered to the internal sterile packaging, potentially c... | Class II | DEPUY (IRELAND) |
| Apr 3, 2026 | Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 3 CEM. Part Number: 150450... | The external sterile packaging was found adhered to the internal sterile packaging, potentially c... | Class II | DEPUY (IRELAND) |
| Apr 3, 2026 | Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM. Part Number: 150450... | The external sterile packaging was found adhered to the internal sterile packaging, potentially c... | Class II | DEPUY (IRELAND) |
| Apr 3, 2026 | Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450... | The external sterile packaging was found adhered to the internal sterile packaging, potentially c... | Class II | DEPUY (IRELAND) |
| Apr 3, 2026 | Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM. Part Number: 150450... | The external sterile packaging was found adhered to the internal sterile packaging, potentially c... | Class II | DEPUY (IRELAND) |
| Apr 3, 2026 | Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM. Part Number: 150450... | The external sterile packaging was found adhered to the internal sterile packaging, potentially c... | Class II | DEPUY (IRELAND) |
| Apr 3, 2026 | Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450... | The external sterile packaging was found adhered to the internal sterile packaging, potentially c... | Class II | DEPUY (IRELAND) |
| Apr 2, 2026 | Custom Convenience Kit containing recalled Medline Namic Angiographic Control... | Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to ... | Class I | Windstone Medical Packaging, Inc. |
| Apr 2, 2026 | Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G... | Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may ... | Class I | Cook Incorporated |
| Apr 2, 2026 | Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G... | Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may ... | Class I | Cook Incorporated |
| Apr 2, 2026 | Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 C... | Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may ... | Class I | Cook Incorporated |
| Apr 2, 2026 | One Step UTI in vitro diagnostic test REF: 3374 | The devices were distributed without required FDA premarket clearance or approval. | Class II | DFI Co., Ltd. |
| Apr 2, 2026 | One Step 10A in vitro diagnostic test | The devices were distributed without required FDA premarket clearance or approval. | Class II | DFI Co., Ltd. |
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.