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.

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DateProductReasonClassFirm
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.