Browse Device Recalls
65 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 65 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 65 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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 |
| Mar 12, 2026 | Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Po... | Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and re... | Class II | Stryker Sustainability Solutions |
| Sep 24, 2025 | HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F,... | Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting i... | Class II | Stryker Sustainability Solutions |
| Jul 2, 2024 | Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A | Disposable 5 lead cable and lead wire system package that should contain lead systems, lead telem... | Class II | Stryker Sustainability Solutions |
| May 31, 2024 | REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, si... | Mislabeling; tourniquet cuff packaging labeled as dual port single bladder but contains a tourn... | Class II | Stryker Sustainability Solutions |
| May 10, 2024 | Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic E... | Diagnostic electrophysiology (EP) catheters do not meet testing requirements. | Class II | Stryker Sustainability Solutions |
| Jun 21, 2023 | HoverMatt, 39" W x 78" L, REF: HM39SPU-B | 39-inche-wide inflatable air transfer mattress packages contain 34-Inch-wide mattresses, so there... | Class II | Stryker Sustainability Solutions |
| Apr 14, 2023 | REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only N... | Through complaint surveillance, it was identified that reprocessed Deep vein thrombosis (DVT) Com... | Class II | Stryker Sustainability Solutions |
| Mar 1, 2023 | Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5... | Increased incidence of disposable tourniquet cuffs "not able to achieve desired pressure" and "no... | Class II | Stryker Sustainability Solutions |
| Jan 21, 2022 | REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, ... | Mislabeling; dual-bladder tourniquet cuffs are labeled as single-bladder inflatable cuffs. | Class II | Stryker Sustainability Solutions |
| Jan 19, 2021 | Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmon... | Product was distributed without receiving regulatory clearance. | Class II | Stryker Sustainability Solutions |
| Mar 27, 2020 | Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter, REF D087031, OM St. Ju... | A subset of temporary intracardiac ultrasound catheters are labeled with the incorrect expiration... | Class II | Stryker Sustainability Solutions |
| Oct 9, 2019 | Zimmer Tourniquet Cuff 30" (Blue), PLC Dual Port, Single Bladder, Item Number... | Tourniquet cuffs are potentially mislabeled. If used may lead to (1) Device misuse during procedu... | Class II | Stryker Sustainability Solutions |
| Dec 17, 2018 | BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter, REF D134301 Diagnos... | Stryker s Sustainability Solutions division (SSS) has received an increase in reports indicating ... | Class II | Stryker Sustainability Solutions |
| Aug 23, 2018 | Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Cath... | Electrophysiology catheters were identified to be item # D134903 and distributed. It was subseque... | Class II | Stryker Sustainability Solutions |
| Jul 27, 2018 | Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers A... | Affected lots of reprocessed arthroscopic shavers may display the incorrect catalog number and sp... | Class II | Stryker Sustainability Solutions |
| Jun 19, 2018 | Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopi... | Through investigation, it was determined that H12LP Trocars in scope of a previous H12LP recall w... | Class II | Stryker Sustainability Solutions |
| May 8, 2018 | Reprocessed HARMONIC Ace¿ +7, 5mm Diameter Shears with Advanced Hemostasis (H... | Stryker Sustainability Solutions has received an increase in reports indicating that the affected... | Class II | Stryker Sustainability Solutions |
| Mar 29, 2018 | Coronary Sinus (CS) Uni-Directional Diagnostic Electrophysiology (EP) Cathete... | Thrombogenicity test results demonstrated that both the test devices (SSS) and control devices (O... | Class II | Stryker Sustainability Solutions |
| Jan 2, 2018 | Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable D... | An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems. | Class II | Stryker Sustainability Solutions |
| Jan 2, 2018 | Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable D... | An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems. | Class II | Stryker Sustainability Solutions |
| Dec 1, 2017 | 3040-VenaFlow Calf Garment (Aircast) Quick Connect was mislabeled as 3010-PL ... | 3040 compression sleeves being mislabeled as a 3010-PL compression sleeves. | Class II | Stryker Sustainability Solutions |
| Dec 6, 2016 | Reprocessed Electrophysiology Catheter Cables Catalog Number: CB3434CT, D134... | A breach in the sterile packaging may have occurred resulting in potentially non-sterile product. | Class II | Stryker Sustainability Solutions |
| Dec 6, 2016 | Reprocessed Ablation Catheter Cable Catalog Number: CR3425CT, CR3434CT Ab... | A breach in the sterile packaging may have occurred resulting in potentially non-sterile product. | Class II | Stryker Sustainability Solutions |
| Nov 11, 2016 | Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endosco... | An increase in reports indicating that the reprocessed H12LP Trocar adjustable plug may break in ... | Class II | Stryker Sustainability Solutions |
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.