Browse Device Recalls
4,686 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 4,686 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 4,686 FDA device recalls in CA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Nov 6, 2014 | Abbott Healon EndoCoat Ophthalmic Viscosurgical Device 3% sodium hyaluronate... | AMO has received complaints where the finger grip dislodged while depressing the syringe plunger.... | Class II | Abbott Medical Optics Inc (AMO) |
| Nov 5, 2014 | Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A ... | Potential problem with the cardiac function analysis software (CFA). Incorrect analysis results ... | Class II | Toshiba American Medical Systems Inc |
| Nov 5, 2014 | Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A ... | Potential problem with the cardiac function analysis software (CFA). Incorrect analysis results ... | Class II | Toshiba American Medical Systems Inc |
| Nov 4, 2014 | STERRAD 50, Product Code 10114. The STERRAD Cassettes are used on STERRAD ... | Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak i... | Class II | Advanced Sterilization Products |
| Nov 4, 2014 | STERRAD 100NX, Product Code 10144 The STERRAD Cassettes are used on STERRA... | Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak i... | Class II | Advanced Sterilization Products |
| Nov 4, 2014 | STERRAD 100S, Product Code 10113. The STERRAD Cassettes are used on STERRA... | Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak i... | Class II | Advanced Sterilization Products |
| Nov 4, 2014 | STERRAD 200, Product Code 10118 The STERRAD Cassettes are used on STERRAD ... | Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak i... | Class II | Advanced Sterilization Products |
| Nov 4, 2014 | STERRAD NX, Product Code 10133 The STERRAD Cassettes are used on STERRAD S... | Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak i... | Class II | Advanced Sterilization Products |
| Nov 4, 2014 | Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets; Paradigm Si... | Tubing may detach at the connect/disconnect location on the MiniMed Silhouette and MiniMed Sure-T... | Class II | Medtronic MiniMed Inc. |
| Nov 3, 2014 | 8MM, LARGE HEM-O-LOK CLIP APPLIER; Intended to assist in the accurate cont... | Class II | Intuitive Surgical, Inc. | |
| Nov 3, 2014 | 8MM, ATRIAL RETRACTOR SHORT RIGHT ; Intended to assist in the accurate con... | Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur... | Class II | Intuitive Surgical, Inc. |
| Nov 3, 2014 | 8MM FENESTRATED BIPOLAR FORCEPS,; Intended to assist in the accurate contr... | Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur... | Class II | Intuitive Surgical, Inc. |
| Nov 3, 2014 | 8MM,PROGRASP FORCEPS; Intended to assist in the accurate control of Intuit... | Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur... | Class II | Intuitive Surgical, Inc. |
| Nov 3, 2014 | 8MM, SMALL GRASPING RETRACTOR ; Intended to assist in the accurate control... | Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur... | Class II | Intuitive Surgical, Inc. |
| Nov 3, 2014 | 8MM PERMANENT CAUTERY SPATULA,; Intended to assist in the accurate control... | Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur... | Class II | Intuitive Surgical, Inc. |
| Nov 3, 2014 | 8MM,LARGE NEEDLE DRIVER; Intended to assist in the accurate control of Int... | Deviations in reprocessing steps from those stated in the reprocessing instructions, can cause su... | Class II | Intuitive Surgical, 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.