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, 5MM X 33CM INSERT, RIGHT ANGLE DISSECTOR, LONG JAW, P/N 0250080757 Lapa... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, LUERLOCK, FEMALE, 6MM TUBING, P/N 0250080208. 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, GRASPER FORCEPS, ATRAUMATIC, P/N 0250080323. Laparoscopic Manual Instru... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, ASSY, 5MM PEEK MULTI HANDLE, 45CM, P/N 0250181108 Laparoscopic Manual I... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, OP-BIOPSY FORCEPS, SPOON JAW, P/N 0250080007 Laparoscopic Manual Instru... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, PKG, PERITONEAL SCISSORS, P/N 0250080262. 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, 3MM INSERT, COBRA GRASPER, 20CM, P/N 0250282007 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, TROCAR 5.5MM PYRAMIDAL TIP, P/N 0250080154; Laparoscopic Manual Instrum... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, PORTIO ACORN SMALL ONLY, P/N 0250080139; 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, 3MM INSERT, ALLIGATOR GRASPER, 20CM, P/N 0250282004 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, DORSEY GRASPER, 29CM, P/N 0250282097 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 INSERT, RIGHT ANGLE FORCEP, 33CM, P/N 0250080694 Laparoscopic Manua... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, CANNULA 5.5MM AUTOMATIC VALVE STOP COCK W/O TROCAR, P/N 0250080171. La... | 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, 20CM, P/N 0250282010 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, BIOPSY FORCEPS, SPOON W/PIN, P/N 0250080291. Laparoscopic Manual Instru... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, NEEDLE HOLDER, CURVED LEFT, P/N 0250080341. Laparoscopic Manual Instrum... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, BLAKESLY BIOPSY FORCEPS, SPOON W/PIN, P/N 0250080293. Laparoscopic Manu... | 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, 8.5 mm, Distribut... | The cuff inflation line may detach from the endotracheal tube during use. | Class I | Halyard Health |
| Nov 17, 2014 | PKG, STRONG FORCEPS, FENESTRATED, P/N 0250080320. Laparoscopic Manual Instru... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, 5MM INSERT, RIGHT ANGLE FORCEP, 45CM P/N 0250080729 Laparoscopic Manua... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, METZENBAUM SCISSORS, STRAIGHT, P/N 0250080264. 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, 5MM ROTATING HANDLE, W/RATCHET, INSULATED SHAFT 45CM LENGTH, P/N 0250080... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, 12.5/11MM - 5.5 REDUCER, P/N 0250080204. Laparoscopic Manual Instrum... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, 5MM, 45CM, INSERT, FENESTRATED FORCEPS, P/N 0250080732 Laparoscopic Ma... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, BULLET FORCEPS, TAPERED, SERRATED, SPOON, P/N 0250080041. Laparoscopic... | 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, STRAIGHT, 45CM, P/N 0250080588 Laparoscopic M... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, BLAKESLY BIOPSY FORCEPS, P/N 0250080292. 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, 3MM INSERT, FUNDUS GRASPER, 29CM, P/N 0250282050 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, METZENBAUM SCISSORS, STRAIGHT, P/N 0250080024. Laparoscopic Manual I... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, 3MM INSERT, PERITONEAL SCISSORS, 20CM, P/N 0250282001 Laparoscopic Manu... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, OBTURATOR, 11MM, FOR HASSON CANNULA, P/N 0250080158. Laparoscopic Manu... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, OBTURATOR, 5.5MM FOR HASSON CANNULA, P/N 0250080157; Laparoscopic Manua... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, 5MM INSERT, TENACULUM, 33CM, P/N 0250080698 Laparoscopic Manual Instrum... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, 3MM INSERT, METZENBAUM, CURVED, LONG SCISSORS, 29CM, P/N 0250282047 Lap... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, 3MM INSERT, HOOK SCISSORS, 20CM, P/N 0250282002 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, 5MM X 45CM, INSERT, PERITONEAL SCISSORS, P/N 0250080751 Laparoscopic Ma... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, OPERATING SCISSORS, SERRATED, P/N 0250080247. 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, FIXATION CLAMP 5MM WITH RATCHET, P/N 0250080130 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, 3MM INSERT, BIOPSY FORCEPS, 29CM, P/N 0250282059 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, MARYLAND FORCEPS, CURVED, P/N 0250080248. Laparoscopic Manual Instrume... | 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, 7.0 mm, Distribut... | The cuff inflation line may detach from the endotracheal tube during use. | Class I | Halyard Health |
| Nov 17, 2014 | PKG, TROCAR, 12.5MM, PYRAMIDAL TIP, P/N 0250080422. 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 MULTI-FUNCTION PEEK HANDLE, P/N 0250181106 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, DOLPHIN FORCEPS, SERRATED SPOON, P/N 0250080280. Laparoscopic Manual I... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, 5MM INSERT, ENDO METZENBAUM SCISSORS, CURVED 45CM, P/N 0250080575 Lapar... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, GRASPER FORCEP, BOWEL, P/N 0250080324. 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, FUNDUS FORCEPS, P/N 0250080315. Laparoscopic Manual Instruments are int... | Stryker Endoscopy is recalling Laparoscopic manual instruments and accessories because the parame... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, 3MM X 29CM INSERT, DISSECTING FORCEPS, P/N 0250282110 Laparoscopic Manu... | Stryker Endoscopy is recalling Laparoscopic manual instruments and accessories because the parame... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, CLAW FORCEPS, DOUBLE ACTION, P/N 0250080245. 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, BIPOLAR FORCEPS, MICRO TIP, 33CM, P/N 0250080362. Laparoscopic Manual I... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | 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.