Browse Device Recalls
240 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 240 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 240 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 17, 2014 | PKG, ASPIRATION NEEDLE, 33CM, P/N 0250080702 Laparoscopic Manual Instruments... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, 3.5MM TROCAR, PYRAMIDAL TIP, SHORT, P/N 0250080692 Laparoscopic Manual ... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, 3MM INSERT, BULLET FORCEPS, 29CM, P/N 0250282057 Laparoscopic Manual In... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, 3MM X 29CM INSERT, RIGHT ANGLE DISSECTOR, LONG JAW, P/N 0250282105 Lapa... | Stryker Endoscopy is recalling Laparoscopic manual instruments and accessories because the parame... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, MIXTER FORCEPS, P/N 0250080249. Laparoscopic Manual Instruments are in... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, ALLIS DOUBLE ROW TEETH, P/N 0250080592 Laparoscopic Manual Instruments ... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, BIPOLAR FORCEPS, MICRO TIP, 33CM, P/N 0250080122 Laparoscopic Manual In... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, 5MM X 33CM, INSERT, FENESTRATED GRASPER, P/N 0250080755 Laparoscopic Ma... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, ALLIGATOR FORCEPS, P/N 0250080316. Laparoscopic Manual Instruments are ... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, ENDO METZENBAUM SCISSORS, CURVED, P/N 0250080267. Laparoscopic Manual ... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, BIPOLAR FORCEPS, FENESTRATED, 33CM, P/N 0250080123 Laparoscopic Manual ... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Jun 20, 2014 | Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip; Steril... | Internal review found that six lots of Disposable StrykeFlow Tips were shipped with a potentially... | Class II | Stryker Endoscopy |
| May 19, 2014 | Shaver Handpiece Sterilization Tray. Model number 272-700-000. For steriliza... | STERRAD 100S parameters provided in the Shaver Handpiece reprocessing guide (P10299 Revision A) d... | Class II | Stryker Endoscopy |
| Apr 16, 2014 | 12-Instrument Sterilization Tray; Product Usage: The 12-Instrument Tray i... | Gravity sterilization parameters provided in the 12 Instrument Sterilization reprocessing guide d... | Class II | Stryker Endoscopy |
| Aug 30, 2013 | Stryker Vision Mounting Arm, for use with other Stryker Endoscopy medical dev... | When positioning the display located on top of the video cart, it is possible for the user to app... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, Vented, Metal Finis... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 2mm X 32cm Regular Tip with 1 Hole, Metal F... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip with No Holes, Non-R... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 3mm X 32cm Regular Tip, Vented, Metal Finis... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 2mm X 34cm Regular Tip with No Hole, Metal ... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 10mm X 32cm Regular Tip, vented, Non-Reflec... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, Vented, Metal Finis... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 5mm X 28cm Regular Tip, vented, Non-Reflect... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip , Non-Vented, Metal ... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 5mm X 32cm Aspiration Needle Tip. Suctio... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 5mm X 45cm Regular Tip, Vented, Metal Finis... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 5mm X 45cm Regular Tip, vented, Non-Reflect... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 5mm X 32cm Tip Hydrodissection Tip, Metal F... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: Vented Tip, 5mm X 45cm Non-Reflective with ... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, vented, Non-Reflect... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 2mm X 32cm Regular Tip with 2 Hole, Metal F... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 3mm X 32cm Regular Tip, Non-Vented, Metal F... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 10mm X 32cm Pool Suction Tip, Metal Finish.... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 5mm X 32cm Hydrodissection Tip, Non-Reflect... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 5mm X 24cm Regular Tip, Vented, Metal Finis... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 5, 2013 | 1488 HD 3-Chip Camera; Model Number 1488-610-122 - HD 3-Chip Camera Head wit... | In certain operating room environments, a colored screen image occurs with the 1488 Cameras that ... | Class II | Stryker Endoscopy |
| Mar 5, 2013 | 1488 HD 3-Chip Inline Camera; Model Number 1488-710-105 - HD 3-Chip Inline C... | In certain operating room environments, a colored screen image occurs with the 1488 Cameras that ... | Class II | Stryker Endoscopy |
| Mar 5, 2013 | 1488 HD 3-Chip Camera; Model Number 1488-210-105 - C-Mount. Product Usa... | In certain operating room environments, a colored screen image occurs with the 1488 Cameras that ... | Class II | Stryker Endoscopy |
| Jun 19, 2012 | Stryker brand Arthroscope and Hardware Set Tray (sterilization tray); Model/P... | The gravity steam, Ethylene Oxide (EO) and STERRAD 100S sterilization methods are being removed f... | Class II | Stryker Endoscopy |
| May 21, 2012 | Formula Shaver Handpiece (with buttons); Formula 180 Shaver Handpiece (with ... | Stryker Endoscopy determined that there may not have been adequate determination of required rout... | Class II | Stryker Endoscopy |
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.