510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR

Device recalls

Recall records from FDA, newest initiation date first.

Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.

Data as of , the FDA export date. FDA medical device recall database

59,544 records, page 673 of 1191
FDA device recalls, page 673 of 1191
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0669-2015Class IIPKG, BIOPSY FORCEPS, SPOON W/PIN, P/N 0250080291. Laparoscopic Manual Instruments are...Stryker Corp.KOG
Z-0668-2015Class IIPKG, BIOPSY FORCEPS, SPOON W/PIN, P/N 0250080291. Laparoscopic Manual Instruments are...Stryker Corp.KOG
Z-0667-2015Class IIPKG, BIPOLAR FORCEPS, FENESTRATED 45CM, P/N 0250080113. Laparoscopic Manual Instruments...Stryker Corp.KOG
Z-0666-2015Class IIPKG, PALPATION PROBE GRADUATED 5MM 45CM, P/N 0250080136 Laparoscopic Manual Instruments...Stryker Corp.KOG
Z-0819-2015Class IIITrinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test...Trinity Biotech USALIP
Z-0665-2015Class IIPKG, CANNULA, 11MM, AUTOMATIC VALVE STOP COCK, W/O TROCAR, P/N 0250080174. Laparoscopic...Stryker Corp.KOG
Z-0664-2015Class IIPKG, OBTURATOR, 11MM, FOR HASSON CANNULA, P/N 0250080158. Laparoscopic Manual...Stryker Corp.KOG
Z-0663-2015Class IIPKG, TROCAR, 11MM, PYRAMIDAL TIP, P/N 0250080156. Laparoscopic Manual Instruments are...Stryker Corp.KOG
Z-0662-2015Class IIPKG, TROCAR, 8MM, PYRAMIDAL TIP, P/N 0250080155. Laparoscopic Manual Instruments are...Stryker Corp.KOG
Z-0661-2015Class IIPKG, SCHERTEL FORCEPS, BLUNT FENESTRATED, P/N 0250080072. Laparoscopic Manual...Stryker Corp.KOG
Z-0660-2015Class IIPKG, MYOMA DRILL 10MM LENGTH 320MM, P/N 0250080134. Laparoscopic Manual Instruments are...Stryker Corp.KOG
Z-0659-2015Class IIPKG, BIOPSY FORCEPS, PUNCH, P/N 0250080290. Laparoscopic Manual Instruments are intended...Stryker Corp.KOG
Z-0658-2015Class IIPKG, NEEDLE NOSE FORCEPS, P/N 0250080288. Laparoscopic Manual Instruments are intended...Stryker Corp.KOG
Z-0657-2015Class IIPKG, GRASPER FORCEPS, NARROW JAW, P/N 0250080287. Laparoscopic Manual Instruments are...Stryker Corp.KOG
Z-0656-2015Class IIPKG, GRASPER FORCEPS, SERRATED, P/N 0250080286. Laparoscopic Manual Instruments are...Stryker Corp.KOG
Z-0655-2015Class IIPKG, MIXTER FORCEPS, P/N 0250080285. Laparoscopic Manual Instruments are intended for...Stryker Corp.KOG
Z-0654-2015Class IIPKG, GRASPER FORCEPS, TISSUE, P/N 0250080284. Laparoscopic Manual Instruments are...Stryker Corp.KOG
Z-0653-2015Class IIPKG, KELLY FORCEPS, CURVED LEFT, P/N 0250080283. Laparoscopic Manual Instruments are...Stryker Corp.KOG
Z-0652-2015Class IIPKG, MARYLAND FORCEPS, CURVED LEFT, P/N 0250080282. Laparoscopic Manual Instruments are...Stryker Corp.KOG
Z-0651-2015Class IIPKG, BULLET FORCEPS, TAPERED, SERRATED, SPOON, P/N 0250080281. Laparoscopic Manual...Stryker Corp.KOG
Z-0650-2015Class IIPKG, DOLPHIN FORCEPS, SERRATED SPOON, P/N 0250080280. Laparoscopic Manual Instruments...Stryker Corp.KOG
Z-0649-2015Class IIPKG, MICRO SCISSORS, CURVED, P/N 0250080270. Laparoscopic Manual Instruments are...Stryker Corp.KOG
Z-0648-2015Class IIPKG, MICRO SCISSORS, STRAIGHT, P/N 0250080269. Laparoscopic Manual Instruments are...Stryker Corp.KOG
Z-0647-2015Class IIPKG, ATRAUMATIC FORCEPS, DOUBLE ACTION, P/N 0250080071. Laparoscopic Manual Instruments...Stryker Corp.KOG
Z-0646-2015Class IIPKG, ENDO METZENBAUM SCISSORS, CURVED, P/N 0250080267. Laparoscopic Manual Instruments...Stryker Corp.KOG
Z-0645-2015Class IIPKG, MINI METZENBAUM SCISSORS, CURVED LONG, P/N 0250080266. Laparoscopic Manual...Stryker Corp.KOG
Z-0644-2015Class IIPKG, METZENBAUM SCISSORS, CURVED LONG, P/N 0250080265. Laparoscopic Manual Instruments...Stryker Corp.KOG
Z-0643-2015Class IIPKG, METZENBAUM SCISSORS, STRAIGHT, P/N 0250080264. Laparoscopic Manual Instruments are...Stryker Corp.KOG
Z-0642-2015Class IIPKG, METZENBAUM SCISSORS, STRAIGHT, LONG, P/N 0250080263. Laparoscopic Manual...Stryker Corp.KOG
Z-0641-2015Class IIPKG, PKG, PERITONEAL SCISSORS, P/N 0250080262. Laparoscopic Manual Instruments are...Stryker Corp.KOG
Z-0640-2015Class IIPKG, NEEDLE NOSE FORCEPS, P/N 0250080048. Laparoscopic Manual Instruments are intended...Stryker Corp.KOG
Z-0639-2015Class IIPKG, PKG, HOOK SCISSORS, P/N 0250080260. Laparoscopic Manual Instruments are intended...Stryker Corp.KOG
Z-0638-2015Class IIPKG, BABCOCK FORCEPS, PADDLE, P/N 0250080250. Laparoscopic Manual Instruments are...Stryker Corp.KOG
Z-0637-2015Class IIPKG, MIXTER FORCEPS, P/N 0250080249. Laparoscopic Manual Instruments are intended for...Stryker Corp.KOG
Z-0636-2015Class IIPKG, MARYLAND FORCEPS, CURVED, P/N 0250080248. Laparoscopic Manual Instruments are...Stryker Corp.KOG
Z-0635-2015Class IIPKG, OPERATING SCISSORS, SERRATED, P/N 0250080247. Laparoscopic Manual Instruments are...Stryker Corp.KOG
Z-0634-2015Class IIPKG, OP-VIOPSY FORCEPS, SPOON JAW, P/N 0250080246. Laparoscopic Manual Instruments are...Stryker Corp.KOG
Z-0633-2015Class IIPKG, CLAW FORCEPS, DOUBLE ACTION, P/N 0250080245. Laparoscopic Manual Instruments are...Stryker Corp.KOG
Z-0632-2015Class IIPKG, CLAW FORCEPS, P/N 0250080244. Laparoscopic Manual Instruments are intended for...Stryker Corp.KOG
Z-0631-2015Class IIPKG, PENNINGTON FORCEPS, P/N 0250080242. Laparoscopic Manual Instruments are intended...Stryker Corp.KOG
Z-0630-2015Class IIPKG, GRASPER FORCEPS, NARROW JAW, P/N 0250080047 Laparoscopic Manual Instruments are...Stryker Corp.KOG
Z-0629-2015Class IIPKG, BABCOCK FORCEPS, P/N 0250080241. Laparoscopic Manual Instruments are intended for...Stryker Corp.KOG
Z-0628-2015Class IIPKG, ALLIS FORCEPS, P/N 0250080240. Laparoscopic Manual Instruments are intended for...Stryker Corp.KOG
Z-0627-2015Class IIPKG, SPRING HANDLE, P/N 0250080237. Laparoscopic Manual Instruments are intended for...Stryker Corp.KOG
Z-0626-2015Class IIPKG, RING HANDLE, P/N 0250080236. Laparoscopic Manual Instruments are intended for...Stryker Corp.KOG
Z-0625-2015Class IIPKG, AXIAL HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080235. Laparoscopic Manual...Stryker Corp.KOG
Z-0624-2015Class IIPKG, ROTATING HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080234. Laparoscopic Manual...Stryker Corp.KOG
Z-0623-2015Class IIPKG, ROTATING HANDLE, RATCHET, INSULATED/SHAFT, P/N 0250080233. Laparoscopic Manual...Stryker Corp.KOG
Z-0622-2015Class IIPKG, ROTATING HANDLE, RATCHET, INSULATED SHAFT, P/N 0250080231. Laparoscopic Manual...Stryker Corp.KOG
Z-0621-2015Class IIPKG, ROTATING HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080230. Laparoscopic Manual...Stryker Corp.KOG