Browse Device Recalls
38 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 38 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 38 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Oct 6, 2016 | Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophy... | The EP Catheters may be mislabeled for French size during reprocessing. | Class II | Stryker Sustainability Solutions |
| Sep 19, 2016 | Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or... | Issue with the process for detection of leaking Pressure Tourniquet Cuffs (PTC). Leaking PTC devi... | Class II | Stryker Sustainability Solutions |
| Jun 1, 2016 | AngioDynamics Soft Vu Omni Flush Angiographic Catheter Model Number: 10732203 | Product defect; tip of two (2) Angiographic Catheters model # 10732203 broke off, prior to being... | Class I | Stryker Sustainability Solutions |
| Apr 28, 2016 | Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters; ... | Mislabeled for size | Class II | Stryker Sustainability Solutions |
| Apr 4, 2016 | Launcher Guiding Catheter Model #LA6EBU30. Used in the coronary or peripher... | Device packaging may not be sealed. | Class II | Stryker Sustainability Solutions |
| Apr 4, 2016 | Mallinckrodt Evac Tracheal Tubes Model #124170-MALLINCKRODT & 124175 | Device packaging may not be sealed. | Class II | Stryker Sustainability Solutions |
| Dec 17, 2015 | Reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet Cuffs Mo... | Reprocessed Stryker Pressure Tourniquet Cuffs were mislabeled, including some labeled as single p... | Class II | Stryker Sustainability Solutions |
| Nov 17, 2015 | The Fuhrman Pleural/Pneumopericardial Drainage Set The Fuhrman Pleural/Pne... | Stryker Sustainability Solutions is recalling the Fuhrman Pleural & Pneumopericardial Drainage Se... | Class I | Stryker Sustainability Solutions |
| Oct 14, 2015 | SSS Reprocessed Zimmer, Synthes, Stryker and Linvatec Drill Bits and Blades ... | It was reported that packaging was not properly sealed. | Class II | Stryker Sustainability Solutions |
| Jul 10, 2015 | Stryker Sustainability Solutions CB5LT Ethicon Endo-Surgery, Inc. Excel T... | Stryker Sustainability Solutions has received reports indicating that devices from one lot (lot# ... | Class II | Stryker Sustainability Solutions |
| Jun 1, 2015 | Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73. I... | Stryker Sustainability Solutions is recalling Trocars because they have received reports indicati... | Class II | Stryker Sustainability Solutions |
| Jun 1, 2015 | Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR7... | Stryker Sustainability Solutions is recalling Trocars because they have received reports indicati... | Class II | Stryker Sustainability Solutions |
| Jun 1, 2015 | Cannula and Seal; 5mm x 100mm and 12mm x 100mm Model #: CTS02 and CTS22. ... | Stryker Sustainability Solutions is recalling Trocars because they have received reports indicati... | Class II | Stryker Sustainability Solutions |
| Oct 18, 2013 | Reprocessed Diagnostic Electrophysiology (EP) Catheters and Diagnostic EP Cat... | Stryker Sustainability Solutions is recalling the Reprocessed Diagnostic Electrophysiology (EP) C... | Class II | Stryker Sustainability Solutions |
| Aug 30, 2012 | STRYKER Sustainability Solutions, AC Power Adaptor for Restep Deep Vein Throm... | Reports that the AC Power Adaptor may not operate due to wires coming loose in the unit. | 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.