{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "173917", "product_res_number": "Z-0259-2020", "event_date_initiated": "2019-05-23", "event_date_created": "2019-10-31", "recall_status": "Open, Classified", "res_event_number": "83001", "product_code": "DQX", "product_description": "Various products which were contract sterilized.", "code_info": "Product Number (Lot Code):   1. G26862 (W3915653);   2. 8065751801 (15027297X-2015-06);   3. E7924 (HD1206703);   4. MCFK64 (MBKY190);   5. PCB502090 (16105672, 17525844);   6. PCB602090 (17766962, 17716501, 17505067, 17465154, 17339717, 17191941, 16536005, 15473410, 15441264, 16685888);   7. PCB702090 (16722293);   8. 277-10-50 (12094017);   9. 420024 (73B1500332);   10. 160636 (1202143, 1109213),   11. 160656 (1208163);   12. 7210424 (50506601);   13. AD750-KE40 (169-16), AD750-KE35 (182-16);   14. AD750-KE30 (102-16);   15. AD750-KE35 ( 118-16);   16. 614-481 (648221);   17. 76353200M (208992282, 207180152, 206969148, 206110579);   18. ASHA4250-01 (2004847);   19. GN1000 (9592565);   20. GN1500 (9916746);   21. SK200 (9577286);   22. GN2000 (9909194);   23. 9-AVP2-014 (1204040241);   24. 9-AVP2-016 (1201055704);   25. 401814RMC (35227834);   26. EICA5872-01 (1035512, 1049334, 1046764, 1050636);   27. 1011895H (141110A081);   28. 10031 (AM043619);   29. 424-7020W (17022849);   30. 424-5020W (17144227);   31. 115321 (HUUG0824), 115311 (HUTJ0689);   32. 96830-012 (12071254);   33. 96880-021 (2016120999);   34. OMS-T10BT ( P6J0204X, P6M0586X, P6H0631X);   35. 113230 (HUZH2232, HUZF1409, HUZI1854);   36. 681 (HUWB1603 );   37. S11886001 (HUWB1085);   38. G09691 (5335591);   39. G27023 (5094825);   40. G11672 (5425109, 5201291);   41. KD-V431M-0720 (73V, 72V, 76V);   42. KD-V411M-0730 (71V, 6ZV);   43. 8065750352 (1642344H);   44. 260-120 (15603764);   45. G53025 (4414833);   46. 82-1735 (CNCDBF);   47. 134450 (HUWA0947, HUVJ0726, HUVA1707);   48. CQF7554 (REYF0349);   49. CS40G (F4PE3M, F4PF8T);   50. M00530880 (G65382, G43088);   51. M00530870 (3888336, 788930, G43096, G59523);   52. G22732 (W3627617, W3665361, W353500, W3655212, W3531994);   53. G21765 (W3775367, W3611934);   54. 2124 (MN14080, MN13391);   55. 2296-100-216 (12034017);   56. PCB802090 (17747960);   57. 112750 (HUVJ1411, HUVF1668, HUUJ1326, HUTG1189, HUTE0455, HUSL1081);   58. 70138014 (531003018);   59. 70138001 (619552823);   60. 70138033 (640797753);   61. D-201-12704 (46K);   62. 24009 (2014011549);   63. G25671 (C1305047, C1314474, C1320703);   64. G25672 (C1162486, C1160026);   65. 5614 (20249064);   66. 91-12504 (6000004655);   67. SRK30 (MO27683);   68. 105-5092-150 (A096597);   69. ECR60W (L4EE9G, J4AE6D, K4DP4M, K4CC4H);   70. EC45A (K4CZ96);   71. EGIA45AMT (N2E0120ULX);   72. 30453 (N9L0087);   73. 30453 (N9A14);   74. 30453 (N2F0101LX);   75. 30453 (N2B0429LX);   76. 30453 (N1L0731LX);   77. 30453 (N1H0786LX);   78. 30453 (N1H0728LX);   79. 30453 (N5E0943KX);   80. 30453 (N1H0296LX);   81. 30453 (N1G0663LX);   82. 30453 (N1F0631LX);   83. 30453 (N0L0261);   84. 30453 (N0K0525);   85. 30453 (N1C0147LX);   86. 30453 (N3C0249LX);   87. 30453 (N2K0152LX);   88. 30453 (N2J0639LX);   89. 30453 (N4L0080KX);   90. 30453 (N2B0265LX);   91. 30453 (N1M0234LX);   92. 30453 (N1H0494LX);   93. 30453 (N1D0605LX);   94. 30453 (N9G0020);   95. 30453 (N8C413);   96. 30453 (N3F0179LX);   97. 30453 (N3B0327LX);   98. 30453 (N2F0340LX);   99. 30453 (N3E0189LX);   100. 30453 (N2C0297LX);   101. 30453 (N1L0474LX);   102. 30453 (N1G0249LX);   103. 30453 (N3D0092LX);   104. 30453 (N2F0194LX);   105. 30453 (N1F0422LX);   106. 30453 (N0F0164);   107. 30453 (N2B0529LX);   108. 30453 (N1F0767LX);   109. 173016 (N2F0618X);   110. 174601 (P2J0627X);   111. 30453 (N3C0405LX);   112. 30453 (N3A0707LX);   113. 30453 (N3A0221LX);   114. 30453 (N2K0401LX);   115. 30453 (N2G0538LX);   116. 30453 (N1M0112LX);   117. 30453 (N1H0900LX);   118. ECS33A (J4AT7Z, J4AG4G);   119. VH-3200 (25126202);   120. M00582080 (925804);   121. 711145 (1412697);   122. ATS45 (K4C81P);   123. 168190 (18673916);   124. 1000-90 (ELV32219V, ELV32215V);   125. G12830 (5204864);   126. OMS-XB2 (P6E0652X);   127. 3932 (20769076);   128. G11638 (5138842);   129. G30393 (U2102887, U2018952);   130. CBM320010 (16933371);   131. CBM325010 (15280044);   132. CBM325006 (13530853);   133. CBM330006 (16816611);   134. CBM340010 (17078794);   135. CBM340006 (EH5796);   136. 375-940-000 (12117CE2);   137. G49572 (W3357124, W3908339, W3816378);   138. G48277 (W3905583, W3915008, W3989699);   139. G48278 (W3852820, W3835461, W3856129, W3849232, W3864789);   140. G50977 (W3797199, W3771825, W3763156);   141. G31527 (C1287719, C1212820);   142. G31551 (C1384600);   143. G21613 (W3621261, W3746570, W3920476);   144. G21475 (C1103316, C1136032), G21478 (C1222618, C1264137), G21479 (C1291590, C1231802, C1231802, G21480 (C1176271, C1215997, 1404674, C1406615);   145. G21578 (C1168847, C1193440, G21578 (C1349288);   146. G22190 (C1133441, C1181667);   147. G22206 (C1303007, C1151429);   148. G22212 (C1226620, G22212 (C1333128);   149. G22209 (C1159612, C1195005, C1401555);   150. G22210 (C1263370, C1137419, C1398095);   151. G21575 (C1181665, C1264138, C1269765);   152. G21519 (C1208787, C1213739, C1232416);   153. G21513 (C1301561, C1299682);   154. G21515 ( C1398174, C1407597, C1395555);   155. G49669 (W3887185, W3734144, W3830265, W3926266);   156. G49670 (W3581229);   157. CGG100 (54044, 51496A, 53702, 50866, 27610, 42562);   158. 320401 (17379413);   159. 7741800 (REXC0461);   160. 607780 (REWK0266);   161. 5573 (588107, 589892);   162. 395680 (11007102);   163. TVTOML (3900615, 3899051);   164. 400272 (M10100920, M10120628, M10100810, M10140620);   165. ACE14S (G4RT4H, G4T19L);   166. 180-1022 (FPCANL0268);   167. 1001780-HC (4091671, 5061571);   168. 2078175 (5081171, 5072071, 5090971);   169. 1010483-HJ (5051171);   170. 1005205 (5091561);   171. 1003282 (5092561);   172. 22299M-W30 (6111761);   173. 6201-3-410 (12129012);   174. G24885 (W3853601, W3853606, W3851164, W3867041);   175. 104-4112 (A087529, A038510);   176. 85424 (1088647119);   177. 85418 (1085516308);   178. 711652 (1713264);   179. E1455B-4 (235763X, 226079X, 228816X, 239497X);   180. CD001 (1216048, 1215253, 1199796, 1203175);   181. CFS02 (1233768);   182. C0R47 (1157155, 1193379, 1170526, 1270156, 1161400, 1185534, 1189155, 1187909, 1167792, 1162462, 1162462, 1189155, 1184124, 1215318);   183. CTF04 (1200811, 1212288, 1212288, 1212288, 1200811);   184. CFF04 (1169744);   185. CFF03 (1176603, 1202129, 1215444, 1218641, 1198864);   186. CTF73 (1215460, 1194868, 1224514, 1226721, 1213437);   187. AR-4515 (557146);   188. 10237 (AA5096R08, 10237-02);   189. 518-024 (FLG15L02A);   190. G24974 (W3594401, W3594783);   191. EX071201CS (ANZB1469);   192. ER420 (J4AV0H, H44W8T);   193. LS1037 (S1H0032PX, S1H0019X, S0E0028, S2M0033X);   194. LF1637 (53230080X, 52820157X);   195. 518-018 (FLA15K16A);   196. 518-019 (FLC15L02A);   197. 1423002 (59661500, 59735400);   198. 19716 (50832316);   199. 150-FT-Q (172001);   200. 2296-3-114 (11290017);   201. G21544 (W3535506);   202. 0120-16-1.5 (AA5279F01 );   203. 0120-18-1.7 (AA5299F01 );   204. 15CY50 (6429530);   205. MS100703 (P1F1027, P1J0791);   206. GBC250 (ML-000277, ML-000249, ML-000189, ML-000256, ML-000174, ML-000189, ML-000273, ML-000243, ML-000187, ML-000279, ML-000257, ML-000220, ML-000276);   207. 900-517 (159207);   208. 39171-07047 (16986805);   209. 39171-06047 (16986393);   210. 39171-04027 (17049224);   211. G21586 (C1252525, C1315989, C1302124 );   212. G21466 (1276842, C1261496, C126230);   213. RFX058-115-08 (A455804);   214. 18INFKIT (214140473);   215. G25660 (C1402377 );   216. G25382 (C1401568 );   217. G25380 (C1414580);   218. G25381 (C1260061, C1402671, C1407944, C1407944);   219. G25385 (C1248163, C1323760, C1292424);   220. G25379 (C1405595, C1404673);   221. G25384 (C1125120, C1203676, C1256105), G25386 (C1099170, C1250427);   222. G25383 (C1273638);   223. G25657 (C1354804, C1385183);   224. G25659 (C1366014, 1268288);   225. G25656 (C1311926, C1275747, C1136905, C1256091);   226. G25658 (C1201058, C1208788, C1395563);   227. WA33025A (175W);   228. 17301 (18557220);   229. WA33035A (176W);   230. G22189 (C1125118, C1266773, C1297687, C1307476);   231. OMS-PDBS2 (P3F0171X, P3F0170X, P3D212, P3D0773X, P3C0202X, P2M131, P2J1038, P2D0443, P2C0072, P1J0129, P1G0194, 481955, P8H0561,P4J0179X, P1K0483, P4H0281X, P3E0533X, P2H0933);   232. 175-254 (17063324);   233. PCB8020135 (16734263, 13887299);   234. RSS502 (UA20);   235. RSS002 (TE22);   236. RSS902 (TD11, RN19);   237. RSB501 (TD1113);   238. RSB801 (TA2813, TC2513);   239. RSB701 (TA0713);   240. 920010PK (128795JB, 128795JB, 115548GB, 474366GE);   241. EIC5872-01 (B213000-A);   242. G00213 (3497284);   243. 192-121 (16606789);   244. 7003D (18028705);   245. 134048 (P2F0202X);   246. EICA8875-01 (1045592, 1032335, 1055696, 1033044);   247. EICA7070-01 (1050150);   248. 50325 (1405121), 50330 (1403101);   249. MC*PE28131YB (141219, 141219);   250. MC*PB2813Y (141222, 150119);   251. 174006 (P2D0471X);   252. TCR75 (H44T2L);   253. TRT75 (J4AD0L);   254. TL60 (H44538);   255. G21771 (C1398159, C1415073);   256. G22656 (W3354217, W3798838, W3790897, W3859077);   257. G22657 (W3566556, W3861550);   258. G22654 (W3341373, W3920057, W3914521 );   259. G22655 (W3375861, W3848989, W3806105, W3844678);   260. 518-088 (FSU15E15A);   261. 518-037 ( FQQ15J02A, FQQ15K05A, FQQ15M17A, FQQ14J25A, FQQ14E02A, FQQ15A27A);   262. 518-038 (FQR15K16A, FQR15K01A);   263. G24925 (W3454936);   264. CG417 (130620, 120821, 130830, 130207, 121219, 140717, 131018, 131001, 130725, 120713, 131226, 110804, 100604, 130826, 120512, 140425);   265. GS3508 (151109, 150819);   266. GS3509 (150407, 141117, 150408, 141106, 120327, 101116, 131226, 100527, 120907, 121016, 141001, 140708, 140211, 140929);   267. SU130-1113 (1120469);   268. EICA4845-01 (1061207, 1047446, 1040062);   269. EICA4835-01 (1054511);   270. RS0516M (130612B-CM, 130326C-CM);   271. FG-V421PR (74K);   272. 9010M0 (100071249, 100069621, 100068425, 100067769);   273. G22419 (W3918641, W3845062, W3837781, W3912321);   274. 174213 (P2M0543X );   275. KC-RUMI-35 (164124);   276. 5100-137-133 (11311027);   277. 4627 (19359482);   278. PR-420Q (63K, 65K);   279. FD-410LR (42K, 43K);   280. FD-411UR (44K, 46K);   281. HX-201UR-135L (47V);   282. 10709703 (4799520);   283. G21573 (W3808773, W3924304);   284. G21571 (W3729654);   285. G22062 (W3779758, W3788553);   286. 117009 (HUWA0774, HUVI0127, UWA1728);   287. 81014 (U2471787);   288. OMS-T10SB (P3B0513X, P3F0036X, P2A0939, P1M0208, P3E0229X, P4E0323X, P4D0723X, P4D0154X, P4C0190X, P3B0513X, P4D0720X, P2C0809X, P2A0938, P3G0034X, P2K0820X, P2F0093X, P2F0187X, P3A0676X, P3B0237X, P3L0024X);   289. 3570 (21308654);   290. 540-011 (FRM15J16A);   291. 545-511 (FRK15K13A);   292. 545-513 (FRJ15K20A);   293. G26862 (W3817189, W3912855, W3817181, W3911176);   294. 46805 (18331493);   295. 46-808 (17673839);   296. G22555 (W3603898);   297. 7209509 (G21535);   298. 423-135-01 (FBL14A20A, FBL15C13A, FBL15G14A, CBL15E19C);   299. 410-154 (FBE12L15J, F11E11C, FBE15F11A, FBE13M09A);   300. 414-159 (BF13L14A, FBF14M03A, FBF13A15G, FBF12M03E, FBF15A06A, FBF15D20A);   301. 420-159 (FBH15F03B);   302. 423-001 (FBC13J20B, FBC13J24A, FBC13F18B, FBC14A28A);   303. 414-151 (F08K14B, C08F16F, FAY13M18A, FAY12L05H, F12J26E);  \n304. 417-152 (F08L24A, C08F19A, FAZ14A09B, FAZ14A30A, FAZ13L08A, FAZ13A24D, F10E06B);   305. 410-152 (080319A, 080611F, FBD13F20A, FBD14L19A, FBD14B28C, F12E25A, F11L01E);   306. 425-011 (FBJ12C28G, FBJ12L01D, F11E17D);   307. 420-006 (FBA15A16A, F09L24D, F12J12C, FBA15F01B, 080604B);   308. 72201491 (50422995);   309. 72201490 (50417508);   310. 12401808 (4814340);   311. 12401810 (606786);   312. 12401807 (4814344);   313. 225-118 (16878791);   314. E3310 (S2FE002X, S2GE005X, S2EE007X);   315. VH-3200 (25003515, 25123871, 25113704, 25112172, 25078222, 25003515, 25111149, 25100397, 25004271, 25126067);   316. VH-4000 (25098259); 25101219, 25085248, 25085248, 25029979, 25124269, 25099863, 25034100, 25118688, 25104986, 25124269, 25085248, 25029979, 25034100, 25085248, 25101219, 25085248, 25085248, 25085248, 25103910, 25123811, 25085248, 25070210, 25101219, 25099863, 25085248, 25085248, 25085248, 25085248, 25099863, 25126066, 25099863, 25104986, 25101219, 25103910, 25085248, 25112813, 25104807, 25122851, 25097420, 25104986, 25119805, 25099863, 25097420, 5124269, 25104986, 25101219, 25104986, 25104986, 25085248, 25085248, 25085248, 25104986, 25085248, 25085248, 25099863, 5126066, 25104986, 25123811, 25085248, 25124004, 25090702, 25121223, 25101219, 25119805, 25090702, 25118577, 25070216, 25119001);   317. 10302 (HUUJ0479);   318. VS101011P (P1K0305);   319. VS101500 (P2G0750X);   320. G-260-2545A (79K, 7XK, 78K, 7XK);   321. G-240-2545S (71K, 77K, 78K);   322. 88901 (023250031333060, 023250025944120);   323. 501-116 (FLM15H15A);   324. 501-114 (FMM15L03A);   325. 501-112 (FSM15K30A);   326. 403-8553R (16100646);   327. WWFS35145 (10396727, 10367451);   328. 103-0605-200 (201502217E);   329. G21393 ( C1314141);   330. G22982 (C1175173, 1204976);   331. G24565 (C1210197, C1306730, C1191869, C1349637);   332. G24707 (CF1234331);", "firm_fei_number": "3009711423", "recalling_firm": "Anewmed Corporation", "address_1": "2177 Flintstone Dr Ste O 2177 Flintstone Dr", "address_2": "Ste O", "city": "Tucker", "state": "GA", "postal_code": "30084-5000", "additional_info_contact": "770-263-9633", "reason_for_recall": "The contract sterilizer did not have adequate packaging data to support the 2-year shelf life.", "root_cause_description": "Other", "action": "AnewMed Corporation notified customers on about 05/23/2019 via \"URGENT NOTICE VOLUNTARY RECAL OF MEDICAL DEVICES\" letter sent certified mail.\n\nInstructions included to examine inventory for affected devices and either return them to AnewMed for a credit or destroy them. Customers were also instructed to complete and return the provided Reply Card and indicate whether devices will be return or have been discarded.\n\nQuestions or additional details can be obtained from Rob Bennison or Nykysha Anderson at 770-263-9633, Monday-Friday, 8:30 AM to 4:40 PM Eastern Time.", "product_quantity": "1,749 devices", "distribution_pattern": "Nationwide distribution in the states of AL, CO, FL, IN, KY, MS, NC, OH, SC, TN, TX.", "openfda": { "k_number": [ "K862409", "K913328", "K954913", "K201834", "K901347", "K881787", "K880332", "K913178", "K180128", "K122573", "K040345", "K040100", "K002707", "K072431", "K002962", "K860840", "K090193", "K122089", "K070945", "K241962", "K875323", "K960563", "K023700", "K070212", "K905423", "K960657", "K171897", "K073162", "K101116", "K242597", "K980360", "K001033", "K181351", "K862567", "K923134", "K872220", "K230418", "K933334", "K950534", "K113162", "K230637", "K240818", "K884262", "K980294", "K013092", "K831839", "K935022", "K061670", "K090554", "K070410", "K131710", "K193194", "K880762", "K904477", "K980977", "K832607", "K053268", "K864058", "K992169", "K120137", "K173052", "K972793", "K193571", "K182457", "K914986", "K884647", "K011968", "K934359", "K883579", "K133155", "K252674", "K242824", "K945934", "K942382", "K143252", "K935577", "K130798", "K943390", "K945379", "K083706", "K110479", "K033742", "K153443", "K870664", "K032411", "K221917", "K091825", "K141831", "K094062", "K772021", "K021638", "K182553", "K884183", "K143587", "K913353", "K063372", "K180830", "K850827", "K950352", "K112745", "K213949", "K902207", "K911547", "K232578", "K890207", "K893626", "K161702", "K932801", "K990639", "K021990", "K030019", "K001198", "K914138", "K010511", "K922060", "K040037", "K201760", "K130588", "K213315", "K220137", "K922536", "K122590", "K871850", "K760944", "K862048", "K101011", "K962572", "K810675", "K143316", "K033708", "K171933", "K141218", "K212167", "K914031", "K083738", "K173277", "K933466", "K915496", 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} } ] }