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.

DateProductReasonClassFirm
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.