FDA Medical Device Recalls (openFDA)

Anewmed Corporation: Various products which were contract sterilized.

Recall number: Z-0259-2020
Recalling firm: Anewmed Corporation
Product: Various products which were contract sterilized.
Status: Open, Classified
Initiated: 2019-05-23
Posted: not on file
Terminated: not on file
Reason: The contract sterilizer did not have adequate packaging data to support the 2-year shelf life.
Root cause: Other
Action: AnewMed Corporation notified customers on about 05/23/2019 via "URGENT NOTICE VOLUNTARY RECAL OF MEDICAL DEVICES" letter sent certified mail. Instructions 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. Questions 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.
Quantity: 1,749 devices
Distribution: Nationwide distribution in the states of AL, CO, FL, IN, KY, MS, NC, OH, SC, TN, TX.
Lot, serial or model codes: 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); 304. 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);
510(k) numbers: not on file
PMA numbers: not on file
Product code: DQX
Firm FEI: 3009711423
Firm city: Tucker
Firm state: GA
Firm country: not on file

Where this comes from

Register: FDA Medical Device Recalls (openFDA)
Publisher: U.S. Food and Drug Administration (openFDA)
File: device-recall-0001-of-0001.json.zip
sha256: b87518bfe2e8
Size: 288210821 bytes
Published: 2026-09-28
Read: 2026-09-29T08:25:23.626Z
Source file: Source file retained · verify
Refresh due: 2026-10-06

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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