Browse Device Recalls
2,729 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,729 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 2,729 FDA device recalls in 2014.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 17, 2014 | PKG, 3MM INSERT, BIOPSY PUNCH, 20CM, P/N 0250282013 Laparoscopic Manual Inst... | 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 45CM, P/N 0250080113. Laparoscopic Manual ... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.5 mm, Distribut... | The cuff inflation line may detach from the endotracheal tube during use. | Class I | Halyard Health |
| Nov 17, 2014 | PKG, ATRAUMATIC FORCEPS, DOUBLE ACTION, P/N 0250080071. 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, SCHERTL GRASPER, FENESTRATED, 20CM, P/N 0250282006 Laparosc... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, MIXTER FORCEPS, P/N 0250080285. 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, FIXABLE CONE FOR 11MM HASSON, P/N 0250080180. Laparoscopic Manual Inst... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, 5MM INSERT BIOPSY FORCEPS, SPOON W/PIN, 45CM, P/N 0250080581 Laparoscop... | 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, 45CM, P/N 0250080115 nationwide in US and w... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, 5MM X 45CM, INSERT, METZENBAUM CURVED SCISSORS, LONG JAW, P/N 0250080752... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, 5MM SHAFT, NEEDLE HOLDER CURVED LEFT 45CM, P/N 0250080589 Laparoscopic ... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, 10MM PEEK MONOPOLAR HANDLE, P/N 0250080618 Laparoscopic Manual Instrume... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, MIXTER FORCEPS, P/N 0250080010. 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, NEEDLE HOLDER, STRIAGHT, P/N 0250080340. Laparoscopic Manual Instrument... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, PALPATION PROBE GRADUATED 5MM, P/N 0250080135; Laparoscopic Manual Inst... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, MYOMA DRILL 10MM LENGTH 320MM, P/N 0250080134. Laparoscopic Manual Ins... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, GRASPER FORCEPS, NARROW JAW, P/N 0250080287. Laparoscopic Manual Instr... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, 5MM INSERT, HOOK SCISSORS, 45CM, P/N 0250080573 Laparoscopic Manual Ins... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| 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 |
| Nov 14, 2014 | Synthes Small Electric Drive (SED) | May operate solely in reverse mode, not operate in reverse mode when intended, not function or an... | Class II | The Anspach Effort, Inc. |
| Nov 14, 2014 | Powered stretcher chair used during facial and eye surgeries. One chair per p... | The firm is finding that the stretcher chair controllers are moving the chairs involuntarily. | Class II | TransMotion Medical Inc |
| Nov 13, 2014 | Biograph mCT S(64)-4R, System Material Number 10248672. The Siemens Biogra... | Possibility for system display freeze during CT interventional procedures. | Class II | Siemens Medical Solutions USA Inc. |
| Nov 13, 2014 | Oxoid Legionella BCYE Growth Supplement packaged in packs of 10-100ml vials. ... | Use of the product could result in inadequate recovery of Legionella pneumophila which could resu... | Class II | Remel Inc |
| Nov 13, 2014 | ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), a... | HORIBA Medical is recalling the ABX PENTRA 400 Reagent Container because they do not always sit p... | Class II | Horiba Instruments, Inc dba Horiba Medical |
| Nov 13, 2014 | Biograph mCT Flow 40-4R, System Material Number 10529159. The Siemens Biog... | Possibility for system display freeze during CT interventional procedures. | Class II | Siemens Medical Solutions USA Inc. |
| Nov 13, 2014 | Biograph mCT Flow Edge-4R, System Material Number 10528955. The Siemens Bi... | Possibility for system display freeze during CT interventional procedures. | Class II | Siemens Medical Solutions USA Inc. |
| Nov 13, 2014 | Biograph mCT S(40)-4R, System Material Number 10248671. The Siemens Biogra... | Possibility for system display freeze during CT interventional procedures. | Class II | Siemens Medical Solutions USA Inc. |
| Nov 13, 2014 | Illumina MiSeqDx Universal Kit 1.0, PN 15039608 The Illumina MiSeqDx Unive... | It was discovered a software limitation with MiSeq Reporter software (version 2.2.31) when using ... | Class II | Illumina Inc |
| Nov 13, 2014 | FLUTTER Percussor respiratory device, packaged one unit per clear plastic pac... | Customer notification that the device may be difficult to open or close. | Class II | Aptalis Pharmatech Inc. |
| Nov 13, 2014 | Biograph mCT X-4R, System Material Number 10248670. The Siemens Biograph m... | Possibility for system display freeze during CT interventional procedures. | Class II | Siemens Medical Solutions USA Inc. |
| Nov 12, 2014 | The Revolution CT is a multi-slice (256 detector row) CT scanner consisting o... | A required quality control test was not performed during installation associated with the softwar... | Class II | GE Healthcare |
| Nov 12, 2014 | I.M. Hole Locator Instrument. Orthopedic manual surgical instrument. ... | Use of excessive force when impacting may lead to intra-operative femoral fracture. | Class II | DePuy Orthopaedics, Inc. |
| Nov 12, 2014 | Sheridan/CF Cuffed Tracheal Tube, Sterile, Rx only, Teleflex Medical, Researc... | Product Labeling; Units from the affected lot indicates that it contains a size 8mm tracheal tube... | Class II | Teleflex Medical |
| Nov 12, 2014 | BrightView model number: 882478 BrightView X model number: 882480 BrightVie... | Unintended detector and gantry movement due to software issues. | Class II | Philips Medical Systems (Cleveland) Inc |
| Nov 11, 2014 | ADULT/CHILD Radiotransparent Electrode, Part number C100AC-PHILIPS, Rx ONLY, ... | Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED ... | Class I | Heart Sync, Inc. |
| Nov 11, 2014 | ADULT Radiotranslucent Electrode, Part number T100-PHILIPS, Rx ONLY, For use ... | Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED ... | Class I | Heart Sync, Inc. |
| Nov 11, 2014 | Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps REF 8065129101 Sterile ... | The product is sold and labeled as EO sterilized, however the units were not sterilized prior to ... | Class II | Alcon Research, Ltd. |
| Nov 11, 2014 | Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is int... | Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System accessories due to missing p... | Class III | Aesculap, Inc. |
| Nov 11, 2014 | ADULT/CHILD Radiotranslucent Electrode, Part number T100AC-PHILIPS, Rx ONLY, ... | Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED ... | Class I | Heart Sync, Inc. |
| Nov 11, 2014 | ADULT Radiotransparent Electrode, Part number C100-PHILIPS, Rx ONLY, For use ... | Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED ... | Class I | Heart Sync, Inc. |
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.