All Recalls

95,038 total recalls in our database

Defective Delivery System: canister unit exhibiting propellant leakage or loss, rendering the product and canister unusable

Nov 25, 2019 Other Drugs Nationwide View Details →

Failed Dissolution Specifications: High out of specification result observed at stability studies.

Dec 10, 2019 Prescription Drugs Nationwide View Details →

Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia)

Oct 29, 2019 Infusion Pumps Nationwide View Details →

Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-attack when connected to the hospital network. An insufficiently secured terminal server may provide an opportunity for a malicious actor that has already penetrated the hospital network to send fraudulent flow sensor correction parameters.

Jul 19, 2019 Infusion Pumps View Details →

May result in readings outside of the expected accuracy range.

Nov 19, 2019 Infusion Pumps Nationwide View Details →

Natrelle Silicone Filled Breast Implants for the following Styles and Sizes: Style 10, Style 15, Style 20, Style 40, Style 45 Style 10/UDI: NATRELLE Style 10-180 Gel Round Mod 10888628001206, NATRELLE Style 10-210 Gel Round Mod 10888628001213, NATRELLE Style 10-240 Gel Round Mod 10888628001220, NATRELLE Style 10-270 Gel Round Mod 10888628001237, NATRELLE Style 10-300 Gel Round Mod 10888628001244, NATRELLE Style 10-330 Gel Round Mod 10888628001251, NATRELLE Style 10-360 Gel Round Mod 10888628001268, NATRELLE Style 10-390 Gel Round Mod 10888628001275, NATRELLE Style 10-420 Gel Round Mod 10888628001282, NATRELLE Style 10-450 Gel Round Mod 10888628001299, NATRELLE Style 10-510 Gel Round Mod 10888628001312, NATRELLE Style 10-800 Gel Round Mod 10888628001374, Style 15/UDI: NATRELLE Style 15-158 Gel Round Mod Plus 10888628001381, NATRELLE Style 15-176 Gel Round Mod Plus 10888628001398, NATRELLE Style 15-194 Gel Round Mod Plus 10888628001404, NATRELLE Style 15-213 Gel Round Mod Plus 10888628001411, NATRELLE Style 15-234 Gel Round Mod Plus 10888628001428, NATRELLE Style 15-265 Gel Round Mod Plus 10888628001435, NATRELLE Style 15-286 Gel Round Mod Plus 10888628001442, NATRELLE Style 15-304 Gel Round Mod Plus 10888628001459, NATRELLE Style 15-339 Gel Round Mod Plus 10888628001466, NATRELLE Style 15-371 Gel Round Mod Plus 10888628001473, NATRELLE Style 15-397 Gel Round Mod Plus 10888628001480, NATRELLE Style 15-421 Gel Round Mod Plus 10888628001497, NATRELLE Style 15-457 Gel Round Mod Plus 10888628001503, NATRELLE Style 15-492 Gel Round Mod Plus 10888628001510, NATRELLE Style 15-533 Gel Round Mod Plus 10888628001527, NATRELLE Style 15-575 Gel Round Mod Plus 10888628001534, NATRELLE Style 15-616 Gel Round Mod Plus 10888628001541, NATRELLE Style 15-659 Gel Round Mod Plus 10888628001558, NATRELLE Style 15-700 Gel Round Mod Plus 10888628001565, NATRELLE Style 15-752 Gel Round Mod Plus 10888628001572, Style 20/UDI: NATRELLE Style 20-230 Gel Round High 10888628001633, NATRELLE Style 20-280 Gel Round High 10888628001657, NATRELLE Style 20-300 Gel Round High 10888628001664, NATRELLE Style 20-325 Gel Round High 10888628001671, NATRELLE Style 20-350 Gel Round High 10888628001688, NATRELLE Style 20-375 Gel Round High 10888628001695, NATRELLE Style 20-400 Gel Round High 10888628001701, NATRELLE Style 20-425 Gel Round High 10888628001718, NATRELLE Style 20-450 Gel Round High 10888628001725, NATRELLE Style 20-475 Gel Round High 10888628001732, NATRELLE Style 20-500 Gel Round High 10888628001749, NATRELLE Style 20-550 Gel Round High 10888628001756, NATRELLE Style 20-600 Gel Round High 10888628001763, NATRELLE Style 20-650 Gel Round High 10888628001770, NATRELLE Style 20-700 Gel Round High 10888628001787, NATRELLE Style 20-750 Gel Round High 10888628001794, NATRELLE Style 20-800 Gel Round High 10888628001800, Style 40/UDI: NATRELLE Style 40-160 Gel Round Mod 10888628001855, NATRELLE Style 40-240 Gel Round Mod 10888628001893, NATRELLE Style 40-340 Gel Round Mod 10888628001947, Style 45/UDI: NATRELLE Style 45-120 Gel Round Extra High 10888628002005, NATRELLE Style 45-160 Gel Round Extra High 10888628002012, NATRELLE Style 45-240 Gel Round Extra High 10888628002036, NATRELLE Style 45-280 Gel Round Extra High 10888628002043, NATRELLE Style 45-320 Gel Round Extra High 10888628002050, NATRELLE Style 45-360 Gel Round Extra High 10888628002067, NATRELLE Style 45-400 Gel Round Extra High 10888628002074, NATRELLE Style 45-460 Gel Round Extra High 10888628002081, NATRELLE Style 45-500 Gel Round Extra High 10888628002098, NATRELLE Style 45-550 Gel Round Extra High 10888628002104, NATRELLE Style 45-600 Gel Round Extra High 10888628002111, NATRELLE Style 45-650 Gel Round Extra High 10888628002128, NATRELLE Style 45-700 Gel Round Extra High 10888628002135, NATRELLE Style 45-800 Gel Round Extra High 10888628002142,

Allergan PLC

🏥 Medical Devices Class I - Dangerous

The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. These 2D barcodes contain a group separators between fixed-length element string in the UDI data chain of the 2D barcode, which is not formatted to the GS1 standard.

Nov 6, 2019 Implants & Prosthetics Nationwide View Details →
🏥 Medical Devices Class I - Dangerous

Potential leak in the balloon extension line. If a leak was present and went undetected during pre-use testing as outlined in the IFU, this would cause the balloon to deflate slowly following placement. If the leak went undetected by attending clinicians during use, it could result in contrast injection into the vascular or cardiac tissue which could result in serious injury or death

Nov 15, 2019 Surgical Instruments Nationwide View Details →

Aespire 7100, Model Numbers: 1. 1009-9000-000-009469 2. 1009-9000-000 3. 1009-9000-000-013913 4. 1009-9000-000-001366 5. 1009-9000-000-009857 6. 1009-9003-000 7. 1009-9000-000-008120 8. 1009-9000-000-009600 9. 1009-9000-000-014290 10. 1009-9000-000-010585 11. 1009-9000-000-004993 12. 1009-9011-000-004795 13. 1009-9000-000-013407 14. 1009-9000-000-004604 15. 1009-9000-000-017674 16. 1009-9000-000-008763 17. 1009-9000-000-008306 18. 1009-9000-000-003277 19. 1009-9000-000-004166 20. 1009-9000-000-008560 21. 1009-9000-000-000299 22. 1009-9000-000-011444 23. 1009-9000-000-003529 24. 1009-9000-000-005666 25. 1009-9000-000-019821 26. 1009-9011-000 27. 1009-9000-000-017345 28. 1009-9000-000-009893 29. 1009-9000-000-007258 30. 1009-9000-000-004959 31. 1009-9000-000-010185 32. 1009-9000-000-016672 33. 1009-9011-000-017769 34. 1009-9000-000-014329 35. 1009-9011-000-020685 36. 1009-9000-000-026022 37. 1009-9011-000-002912 38. 1009-9000-000-014723 39. 1009-9000-000-013385 40. 1009-9000-000-006725 41. 1009-9000-000-005163 42. 1009-9000-000-004022 43. 1009-9000-000-017939 44. 1009-9000-000-000300 45. 1009-9000-000-018855 46. 1009-9000-000-016724 47. 1009-9000-000-010268 48. 1009-9000-000-011595 49. 1009-9000-000-019277 50. 1009-9011-000-023222 51. 1009-9011-000-015929 52. 1009-9000-000-017824 53. 1009-9000-000-008270 54. 1009-9000-000-010416 55. 1009-9000-000-019089 56. 1009-9000-000-013395 57. 1009-9011-000-021989 58. 1009-9000-000-000517 59. 1009-9000-000-002407 60. 1009-9000-000-008415 61. 1009-9000-000-009597 62. 1009-9000-000-010178 63. 1009-9011-000-010400 64. 1009-9011-000-011366 65. 1009-9000-000-012360 66. 1009-9101-000 67. 1009-9000-000-013787 68. 1009-9000-000-006266 69. 1009-9000-000-014915 70. 1009-9000-000-000290 71. 1009-9000-000-013507 72. 1009-9000-000-011600 73. 1009-9000-000-010595 74. 1009-9000-000-009543 75. 1009-9000-000-011111 76. 1009-9000-000-013378 77. 1009-9000-000-000526 78. 1009-9000-000-010536 79. 1009-9000-000-010116 80. 1009-9000-000-005939 81. 1009-9000-000-008216 82. 1009-9000-000-006786 83. 1009-9000-000-012155 84. 1009-9000-000-012379 85. 1009-9000-000-014000 86. 1009-9011-000-022466 87. 1009-9000-000-009912 88. 1009-9000-000-006906 89. 1009-9000-000-004380 90. 1009-9000-000-010245 91. 1009-9000-000-010413 92. 1009-9000-000-013616 93. 1009-9000-000-009428 94. 1009-9000-000-010597 95. 1009-9000-000-020606 96. 1009-9000-000-010059 97. 1009-9000-000-014122 98. 1009-9000-000-016795 99. 1009-9000-000-012149 100. 1009-9000-000-005760 101. 1009-9000-000-009836 102. 1009-9000-000-016818 103. 1009-9000-000-017699 104. 1009-9000-000-004020 105. 1009-9000-000-013953 106. 1009-9000-000-009583 107. 1009-9000-000-007938 108. 1009-9000-000-007336 109. 1009-9000-000-010435 110. 1009-9011-000-016719 111. 1009-9000-000-024098 112. 1009-9011-000-004634 113. 1009-9011-000-016794 114. 1009-9011-000-005431 115. 1009-9000-000-000598 116. 1009-9011-000-005442 117. 1009-9000-000-022792 118. 1009-9000-000-003950 119. 1009-9000-000-013921 120. 1009-9000-000-011116 121. 1009-9000-000-017203 122. 1009-9000-000-003335 123. 1009-9000-000-008264 124. 1009-9000-000-009868 125. 1009-9011-000-015245 truncated text

GE Healthcare

🏥 Medical Devices Class I - Dangerous

Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-attack when connected to the hospital network. An insufficiently secured terminal server may provide an opportunity for a malicious actor that has already penetrated the hospital network to send fraudulent flow sensor correction parameters.

Jul 19, 2019 Other Medical Devices View Details →
🏥 Medical Devices Class I - Dangerous

Potential leak in the balloon extension line. If a leak was present and went undetected during pre-use testing as outlined in the IFU, this would cause the balloon to deflate slowly following placement. If the leak went undetected by attending clinicians during use, it could result in contrast injection into the vascular or cardiac tissue which could result in serious injury or death

Nov 15, 2019 Surgical Instruments Nationwide View Details →