Browse Device Recalls
4,602 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 4,602 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 4,602 FDA device recalls in CA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 17, 2014 | PKG, 5MM INSERT, RETENTION GRASPER, 33CM, P/N 0250080697 Laparoscopic Manual... | 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 45CM, P/N 0250080136 Laparoscopic Manual ... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, GRASPER FORCEPS, SERRATED, P/N 0250080286. 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 INSERT, MARYLAND DISSECTING FORCEPS, CURVED LEFT, 45CM, P/N 00250080... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, 3.5MM CANNULA AUTO VALVE, STOPCOCK, SHORT, P/N 0250080634 Laparoscopic ... | 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 GRASPER, 45CM, P/N 0250080726 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, 3MM INSERT, ATRAUMATIC GRASPER, DOUBLE ACTION, 20CM, P/N 0250282100 Lap... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, 5MM INSERT, ATRAUMATIC GRASPER FORCEPS, SINGLE ACTION, P/N 0250080584 L... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, ATRAUMATIC FORCEPS, DOUBLE ACTION, P/N 0250080311. Laparoscopic Manual ... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, TROCAR, 8MM, PYRAMIDAL TIP, P/N 0250080155. 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, PADDLE, 45CM, P/N 0250080351. 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, MICRO GRASPER, P/N 0250080325. Laparoscopic Manual Instruments are inte... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, HOOK SCISSORS, P/N 0250080020. Laparoscopic Manual Instruments are int... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, BLUNT FORCEPS, BLUNT, SERRATED, SPOON, P/N 0250080313. Laparoscopic Man... | 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, 20CM, P/N 0250282000 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, BLUNT WITH SPOON, GRASPER, 29CM, P/N 0250282055 Laparoscopi... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, GRASPER FORCEPS, TISSUE, P/N 0250080284. Laparoscopic Manual Instrumen... | 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 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 | 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 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 | 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 11, 2014 | Pediatric, 10Fr, Intermittent Urinary Catheters Model: P10 Pouch Label UPC ... | Some of the intermediate boxes within lot 140417-3, were labeled as P8, a French Size 8 pediatric... | Class II | Cure Medical LLC |
| Nov 10, 2014 | CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software... | The firm is informing customers of a software error that might result in an inaccurate display of... | Class III | Medtronic MiniMed Inc. |
| Nov 6, 2014 | Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnost... | Illumina has confirmed a software limitation with MiSeq Reporter software (version 2.2.31) when u... | Class III | Illumina 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.