CLASS III ONGOING Device recall · Reported 3 Sep 2025 · FDA Enforcement Report
D5cwc Transducer Probe recalled by Philips Ultrasound
Philips Ultrasound is recalling D5cwc Transducer Probe, distributed nationwide in the US. The recall was initiated on 3 Jul 2025 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2368-2025
- FDA event ID
- 97217
- Recalling firm
- Philips Ultrasound, Reedsville, PA
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 3 Jul 2025
- FDA classified
- 22 Aug 2025
- Reported
- 3 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 3 Jul 2025 | Recall initiated by company | |
| 22 Aug 2025 | Classified by FDA | +50 days |
| 3 Sep 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Product as listed by the FDA
D5cwc Transducer Probe
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Which lots are affected?
Model No. 989605438561, 989605412062; UDI: (01)00884838061354(21)B1XLGQ, (01)00884838061354(21)B2L6LQ, (01)00884838061354(21)B1YGH9, (01)00884838061354(21)F0F143, (01)00884838061354(21)B1YGN1, (01)00884838061354(21)B2Q6W8, (01)00884838061354(21)B2L6MM, (01)00884838061354(21)B2Q6PV, (01)00884838061354(21)B2Q6QF, (01)00884838061354(21)F0FYTZ, (01)00884838061354(21)F04N02, (01)00884838061354(21)B1YGJH, (01)00884838061354(21)B1YGJK, (01)00884838061354(21)B2L6LH, (01)00884838061354(21)B2L6LT, (01)00884838061354(21)F0D4X3, (01)00884838061354(21)B1N4NC, (01)00884838061354(21)B2Q6CZ, (01)00884838061354(21)B1YGHW, (01)00884838061354(21)B2Q6MJ, (01)00884838061354(21)B2Q6ML, (01)00884838061354(21)F0367V, (01)00884838061354(21)F0367Y, (01)00884838061354(21)B1XL7W, (01)00884838061354(21)B1XLF6, (01)00884838061354(21)B2L6LZ, (01)00884838061354(21)B2Q6JJ, (01)00884838061354(21)F07TXW, (01)00884838061354(21)F05L2W, (01)00884838061354(21)B1XLDJ, (01)00884838061354(21)F07XDK, (01)00884838061354(21)B1YGM2, (01)00884838061354(21)F08MVP, (01)00884838061354(21)F0F839, (01)00884838061354(21)F0F83D, (01)00884838061354(21)F0F8TP, (01)00884838061354(21)F02WL4, (01)00884838061354(21)B1XLH1, (01)00884838061354(21)B1YGMH, (01)00884838061354(21)B1YGMV, (01)00884838061354(21)B2Q6DF, (01)00884838061354(21)B1XLFC, (01)00884838061354(21)B1XLBL, (01)00884838061354(21)B1YGNB, (01)00884838061354(21)B2Q6HH, (01)00884838061354(21)B2Q6HK, (01)00884838061354(21)B2Q6HV, (01)00884838061354(21)F0F8TK, (01)00884838061354(21)F0FP71, (01)00884838061354(21)F0GLVW, (01)00884838061354(21)B1XLC5, (01)00884838061354(21)B2Q6WH, (01)00884838061354(21)F003Q6, (01)00884838061354(21)F01BYJ, (01)00884838061354(21)F03681, (01)00884838061354(21)F03X0W, 010088483806135421F029LJ, (01)00884838061354(21)F05GT8, (01)00884838061354(21)F0B0RQ, (01)00884838061354(21)B1YGLG, (01)00884838061354(21)B1YGMM, (01)00884838061354(21)F0D4X0, (01)00884838061354(21)F0FPKV, (01)00884838061354(21)B1YGLN, (01)00884838061354(21)B2Q6H0, (01)00884838061354(21)B2Q6HB, (01)00884838061354(21)B2L6M7, (01)00884838061354(21)B2Q6DP, (01)00884838061354(21)B2Q6VX, (01)00884838061354(21)F0F137, (01)00884838061354(21)B1YGMQ, (01)00884838061354(21)F03VVG, (01)00884838061354(21)B1XL7T, (01)00884838061354(21)B2Q6X5, (01)00884838061354(21)B1XL9R, (01)00884838061354(21)B1YGNQ, (01)00884838061354(21)F0FLK5, (01)00884838061354(21)F0F6XD, (01)00884838061354(21)B1XLCH, (01)00884838061354(21)B1XL9H, (01)00884838061354(21)B1XL9L, (01)00884838061354(21)B1XLB7, (01)00884838061354(21)B1XLBF, (01)00884838061354(21)B2L6MV, (01)00884838061354(21)B1XLDQ, (01)00884838061354(21)B2Q6D1, (01)00884838061354(21)F004N1, (01)00884838061354(21)F0BM0M, (01)00884838061354(21)B1N4PM, (01)00884838061354(21)B1XLGR, (01)00884838061354(21)F04Y3K, (01)00884838061354(21)B2Q6TN, (01)00884838061354(21)B1N4NN, (01)00884838061354(21)B1XL9V, (01)00884838061354(21)F05130, (01)00884838061354(21)F099HZ, (01)00884838061354(21)B1YGN2, (01)00884838061354(21)B2Q6H4, (01)00884838061354(21)B1YGMG, (01)00884838061354(21)B2Q6D9, (01)00884838061354(21)B1YGK3, (01)00884838061354(21)B2Q6QQ, (01)00884838061354(21)B2Q6QT, (01)00884838061354(21)B2Q6QV, (01)00884838061354(21)B1XLHZ, (01)00884838061354(21)B1XLJ0, (01)00884838061354(21)B1YGHF, (01)00884838061354(21)B1YGHH, (01)00884838061354(21)B1YGHQ, (01)00884838061354(21)B1YGHV, (01)00884838061354(21)B1YGJ0, (01)00884838061354(21)B1YGJ1, (01)00884838061354(21)B1YGJ3, (01)00884838061354(21)B1YGJ4, (01)00884838061354(21)B1YGJ5, (01)00884838061354(21)B1YGJ6, (01)00884838061354(21)B1YGJ7, (01)00884838061354(21)B1YGJ9, (01)00884838061354(21)B1YGJJ, (01)00884838061354(21)B1YGJL, (01)00884838061354(21)B1YGM1, (01)00884838061354(21)B1YGM4, (01)00884838061354(21)B1YGM7, (01)00884838061354(21)F001Z0, (01)00884838061354(21)F0042X, (01)00884838061354(21)F005Z0, (01)00884838061354(21)F005Z4, (01)00884838061354(21)F0H874, (01)00884838061354(21)F03LMC, (01)00884838061354(21)F04CBJ, (01)00884838061354(21)B1XLDF, (01)00884838061354(21)B2L6L8, (01)00884838061354(21)B2Q6X6, (01)00884838061354(21)F015T5, (01)00884838061354(21)F05GTB, (01)00884838061354(21)F0BHZH, (01)00884838061354(21)F0F13Z, (01)00884838061354(21)F0F8TR, (01)00884838061354(21)F0FD5J, (01)00884838061354(21)F05Y8F, (01)00884838061354(21)F06ZZX, (01)00884838061354(21)B1XLD4, (01)00884838061354(21)B1XLD5, (01)00884838061354(21)F004N4, (01)00884838061354(21)F03P3D, (01)00884838061354(21)F03VVD, (01)00884838061354(21)F03VVH, (01)00884838061354(21)F0443W, (01)00884838061354(21)F03LM9, (01)00884838061354(21)B1N4N7, (01)00884838061354(21)B2Q6F2, (01)00884838061354(21)F06FD9, (01)00884838061354(21)F08WZK, (01)00884838061354(21)F08WZQ, (01)00884838061354(21)F0FBBG, (01)00884838061354(21)B1XLDR, (01)00884838061354(21)B1XLFY, (01)00884838061354(21)B1XLB5, (01)00884838061354(21)B1XLDX, (01)00884838061354(21)F08RMQ, (01)00884838061354(21)F0BR71, 010088483806135421F0GK3G, (01)00884838061354(21)B1YGL6, (01)00884838061354(21)F04285, (01)00884838061354(21)F0546N, (01)00884838061354(21)F0HW0H, (01)00884838061354(21)F0HXK2, 010088483806135421F0GRT5, (01)00884838061354(21)F0L9BR, (01)00884838061354(21)F0LCHQ, (01)00884838061354(21)B2L6M4, (01)00884838061354(21)F005Z5, (01)00884838061354(21)B2L6M0, (01)00884838061354(21)B2L6N4, (01)00884838061354(21)B2Q6D5, (01)00884838061354(21)B1YGHD, (01)00884838061354(21)F03X0X, (01)00884838061354(21)B2Q6WN, (01)00884838061354(21)B1XLFM, (01)00884838061354(21)B1YGJ2, (01)00884838061354(21)B1YGM5, (01)00884838061354(21)B1YGN0, (01)00884838061354(21)F017DC, (01)00884838061354(21)B1YGLF, (01)00884838061354(21)B2Q6VN, (01)00884838061354(21)B2Q6W6, (01)00884838061354(21)B2Q6WC, (01)00884838061354(21)B2Q6H1, (01)00884838061354(21)F0F6XB, 010088483806135421F023H7, (01)00884838061354(21)B2Q6V7, (01)00884838061354(21)B2Q6VB, (01)00884838061354(21)F0J0F8, (01)00884838061354(21)F0K5PG, (01)00884838061354(21)F03P3F, (01)00884838061354(21)B1XL8J, (01)00884838061354(21)B2Q6QJ, (01)00884838061354(21)B2Q6QN, 010088483806135421F026YV, (01)00884838061354(21)B2Q6GF, (01)00884838061354(21)B2Q6TQ, (01)00884838061354(21)B2Q6VJ, (01)00884838061354(21)F0149C, (01)00884838061354(21)F02CYK, (01)00884838061354(21)F0J2HY, (01)00884838061354(21)B2Q6PC, (01)00884838061354(21)B1XLF8, (01)00884838061354(21)F04DX3, (01)00884838061354(21)B1XLB9, (01)00884838061354(21)B1XLGL, (01)00884838061354(21)F0F83B, (01)00884838061354(21)B1YGMW, (01)00884838061354(21)F08MVW, (01)00884838061354(21)F07TXX, (01)00884838061354(21)B1XLD1, 010088483806135421F0GRT6, (01)00884838061354(21)B2L6M2, (01)00884838061354(21)F05B3C, (01)00884838061354(21)F015T4, (01)00884838061354(21)B2Q6Q7, (01)00884838061354(21)B2Q6QZ, (01)00884838061354(21)F099HP, (01)00884838061354(21)F0B0RT, (01)00884838061354(21)F0B0RY, (01)00884838061354(21)F0C9H4, (01)00884838061354(21)B2Q6H3, (01)00884838061354(21)B2Q6JT, (01)00884838061354(21)B2Q6HP, (01)00884838061354(21)F04VBR, (01)00884838061354(21)B2Q6DX, (01)00884838061354(21)B2Q6HY, (01)00884838061354(21)B2L6LD, (01)00884838061354(21)B2L6LK, (01)00884838061354(21)F0JXPL, (01)00884838061354(21)F05Z71, (01)00884838061354(21)F02CYH, (01)00884838061354(21)F0F836, (01)00884838061354(21)B1XLFW, (01)00884838061354(21)B1YGN5, (01)00884838061354(21)B1YGNR, (01)00884838061354(21)B1XLHN, (01)00884838061354(21)B1YGJZ, (01)00884838061354(21)B2Q6JV, (01)00884838061354(21)F0HXK4, (01)00884838061354(21)F0KJ5X, (01)00884838061354(21)F0KK9C, (01)00884838061354(21)F0KPVD, (01)00884838061354(21)B2Q6FY, (01)00884838061354(21)B2Q6G3, (01)00884838061354(21)B2Q6GT, (01)00884838061354(21)F0258J, (01)00884838061354(21)B2Q6QP, (01)00884838061354(21)F04CR3, (01)00884838061354(21)F04Y3L, (01)00884838061354(21)B1YGNV, (01)00884838061354(21)B2L6M6, (01)00884838061354(21)B2L6ML, (01)00884838061354(21)B2Q6LH, (01)00884838061354(21)F017D4, (01)00884838061354(21)B1XLB0, (01)00884838061354(21)F099HY, (01)00884838061354(21)F0F6XJ, (01)00884838061354(21)B1XLB6, (01)00884838061354(21)B1XLBM, (01)00884838061354(21)B1XLDM, (01)00884838061354(21)B1XLDV, (01)00884838061354(21)B2Q6DN, (01)00884838061354(21)F00TDD, (01)00884838061354(21)F06MDN, (01)00884838061354(21)F06MDP, 010088483806135421F0GQ9M, (01)00884838061354(21)B2Q6JH, (01)00884838061354(21)F00TCP, (01)00884838061354(21)B1XL92, (01)00884838061354(21)B1YGN3, (01)00884838061354(21)B1XL9Q, (01)00884838061354(21)F056HK, (01)00884838061354(21)B1YGLL, (01)00884838061354(21)B1XLD8, 010088483806135421F0GRT4, (01)00884838061354(21)F0F8TJ, (01)00884838061354(21)F0B0T0, (01)00884838061354(21)F015T2, (01)00884838061354(21)F00TDC, (01)00884838061354(21)B2L6M9, (01)00884838061354(21)B2L6MJ, (01)00884838061354(21)F04DX5, (01)00884838061354(21)F0KRR4, (01)00884838061354(21)B2Q6T6, (01)00884838061354(21)B2Q6H9, (01)00884838061354(21)B1XLH2, (01)00884838061354(21)B2L6LN, (01)00884838061354(21)F04N00, (01)00884838061354(21)B2Q6HL, (01)00884838061354(21)F07QBK, (01)00884838061354(21)B2L6MD, (01)00884838061354(21)B1XLG7, (01)00884838061354(21)B2L6ND, (01)00884838061354(21)B1N4PY, (01)00884838061354(21)B1N4NQ, (01)00884838061354(21)B1N4NT, (01)00884838061354(21)B1N4LR, (01)00884838061354(21)B1XLB2, (01)00884838061354(21)B1XL9G, (01)00884838061354(21)B1N4MH, (01)00884838061354(21)B1XLBC, (01)00884838061354(21)F09PDJ, (01)00884838061354(21)F0GN3M, (01)00884838061354(21)B1XL9Y, (01)00884838061354(21)B1YGKF, (01)00884838061354(21)B1YGK8, (01)00884838061354(21)B1YGKJ, (01)00884838061354(21)F0BYZQ, (01)00884838061354(21)B2Q6DD, (01)00884838061354(21)B2Q6QR, (01)00884838061354(21)F0B0RR, (01)00884838061354(21)B1N4PZ, (01)00884838061354(21)B1YGNP, (01)00884838061354(21)B2Q6TV, (01)00884838061354(21)B2Q6TX, (01)00884838061354(21)B2Q6PJ, (01)00884838061354(21)F00LFT, (01)00884838061354(21)F03DWY, (01)00884838061354(21)F05VVL, (01)00884838061354(21)B1N4NP, (01)00884838061354(21)B2Q6F5, (01)00884838061354(21)F07XDL, (01)00884838061354(21)F08MVM, (01)00884838061354(21)F03DWZ, (01)00884838061354(21)F03HV9, (01)00884838061354(21)B1N4PV, (01)00884838061354(21)F0HDML, (01)00884838061354(21)F08CHD, (01)00884838061354(21)F08CHF, (01)00884838061354(21)F08MVN, (01)00884838061354(21)B1N4P2, (01)00884838061354(21)B1YGMJ, (01)00884838061354(21)F0F835, (01)00884838061354(21)F0F6XF, (01)00884838061354(21)F0F6XG, (01)00884838061354(21)F0KVMR, (01)00884838061354(21)F0L9BT, (01)00884838061354(21)F0881J, (01)00884838061354(21)F0F6X9, (01)00884838061354(21)F0F13C, (01)00884838061354(21)F09DLL, (01)00884838061354(21)F0HC8X, 010088483806135421F0258L, 010088483806135421F0258M, (01)00884838061354(21)B2Q6V3, (01)00884838061354(21)B2Q6PF; Serial No. B1XLGQ, B2L6LQ, B1YGH9, F0F143, B1YGN1, B2Q6W8, B2L6MM, B2Q6PV, B2Q6QF, F0FYTZ, F04N02, B1YGJH, B1YGJK, B2L6LH, B2L6LT, F0D4X3, B13LWB, B1N4NC, B2Q6CZ, B1YGHW, B2Q6MJ, B2Q6ML, F0367V, F0367Y, B1C1PD, B1XL7W, B1XLF6, B2L6LZ, B2Q6JJ, F07TXW, B13LXB, F05L2W, B1XLDJ, F07XDK, B1YGM2, F08MVP, F0F839, F0F83D, F0F8TP, F02WL4, B1XLH1, B1YGMH, B1YGMV, B2Q6DF, B1XLFC, B1XLBL, B1YGNB, B2Q6HH, B2Q6HK, B2Q6HV, F0F8TK, F0FP71, F0GLVW, B1C1P2, B1C1P3, F0F6XK, B1C1MM, B13LW2, B1XLC5, B2Q6WH, F003Q6, F01BYJ, F03681, F03X0W, F029LJ, F05GT8, F0B0RQ, B1YGLG, B1YGMM, F0D4X0, F0FPKV, B1YGLN, B2Q6H0, B2Q6HB, B2L6M7, B2Q6DP, B2Q6VX, F0F137, B1YGMQ, F03VVG, B1XL7T, B2Q6X5, B1XL9R, B1YGNQ, F0FLK5, F0F6XD, B1XLCH, B1XL9H, B13LVD, B1XL9L, B1XLB7, B1XLBF, B2L6MV, B1XLDQ, B2Q6D1, B13LV7, F004N1, F0BM0M, B1N4PM, B1XLGR, F04Y3K, B2Q6TN, B1N4NN, B1XL9V, F05130, F099HZ, B1YGN2, B2Q6H4, B1YGMG, B2Q6D9, B1YGK3, B2Q6QQ, B2Q6QT, B2Q6QV, B1XLHZ, B1XLJ0, B1YGHF, B1YGHH, B1YGHQ, B1YGHV, B1YGJ0, B1YGJ1, B1YGJ3, B1YGJ4, B1YGJ5, B1YGJ6, B1YGJ7, B1YGJ9, B1YGJJ, B1YGJL, B1YGM1, B1YGM4, B1YGM7, F001Z0, F0042X, F005Z0, F005Z4, F0H874, B1C1NJ, F03LMC, F04CBJ, B1XLDF, B2L6L8, B2Q6X6, F015T5, F05GTB, F0BHZH, F0F13Z, F0F8TR, F0FD5J, F05Y8F, F06ZZX, B1XLD4, B1XLD5, F004N4, F03P3D, F03VVD, F03VVH, F0443W, F03LM9, B1N4N7, B2Q6F2, F06FD9, F08WZK, F08WZQ, F0FBBG, B1XLDR, B1XLFY, B1XLB5, B1XLDX, F08RMQ, F0BR71, F0GK3G, B1YGL6, F04285, F0546N, F0HW0H, F0HXK2, F0GRT5, F0L9BR, F0LCHQ, B2L6M4, F005Z5, B2L6M0, B2L6N4, B2Q6D5, B1YGHD, F03X0X, B2Q6WN, B1XLFM, B1YGJ2, B1YGM5, B1YGN0, B13LVF, F017DC, B1YGLF, B2Q6VN, B2Q6W6, B2Q6WC, B2Q6H1, F0F6XB, F023H7, B2Q6V7, B2Q6VB, F0J0F8, F0K5PG, F03P3F, B1XL8J, B13LMK, B2Q6QJ, B2Q6QN, F026YV, B2Q6GF, B2Q6TQ, B2Q6VJ, F0149C, F02CYK, F0J2HY, B2Q6PC, B1XLF8, F04DX3, B1XLB9, B1XLGL, F0F83B, B1YGMW, F08MVW, F07TXX, B1XLD1, F0GRT6, B2L6M2, F05B3C, B13LW5, B13LW3, F015T4, B2Q6Q7, B2Q6QZ, F099HP, F0B0RT, F0B0RY, F0C9H4, B2Q6H3, B2Q6JT, B2Q6HP, F04VBR, B2Q6DX, B2Q6HY, B2L6LD, B2L6LK, F0JXPL, B1C1NG, B13LRV, F05Z71, F02CYH, F0F836, B1XLFW, B1YGN5, B1YGNR, B1XLHN, B1YGJZ, B2Q6JV, F0HXK4, F0KJ5X, F0KK9C, F0KPVD, B2Q6FY, B2Q6G3, B2Q6GT, F0258J, B2Q6QP, F04CR3, F04Y3L, B1YGNV, B2L6M6, B2L6ML, B2Q6LH, F017D4, B1XLB0, B1C1NV, F099HY, F0F6XJ, B1XLB6, B1XLBM, B1XLDM, B1XLDV, B2Q6DN, F00TDD, F06MDN, B13LT4, F06MDP, F0GQ9M, B2Q6JH, F00TCP, B1XL92, B1YGN3, B1XL9Q, F056HK, B1YGLL, B1XLD8, F0GRT4, F0F8TJ, F0B0T0, F015T2, F00TDC, B2L6M9, B2L6MJ, F04DX5, F0KRR4, B2Q6T6, B2Q6H9, B13LRL, B13LRX, B13LTF, B1C1NF, B1XLH2, B2L6LN, F04N00, B2Q6HL, F07QBK, B2L6MD, B1XLG7, B2L6ND, B1N4PY, B1N4NQ, B1N4NT, B1N4LR, B1XLB2, B1XL9G, B1N4MH, B1XLBC, F09PDJ, F0GN3M, B1XL9Y, B1YGKF, B1YGK8, B1YGKJ, F0BYZQ, B2Q6DD, B2Q6QR, F0B0RR, B1N4PZ, B1YGNP, B2Q6TV, B2Q6TX, B2Q6PJ, F00LFT, F03DWY, F05VVL, B1N4NP, B2Q6F5, F07XDL, F08MVM, F03DWZ, F03HV9, B1N4PV, F0HDML, F08CHD, F08CHF, F08MVN, B1N4P2, B1YGMJ, F0F835, F0F6XF, F0F6XG, F0KVMR, F0L9BT, F0881J, F0F6X9, F0F13C, F09DLL, F0HC8X, F0258L, F0258M, B2Q6V3, B2Q6PF.
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
46 other products · FDA event 97217This product is part of a recall event; the main page for the event is Transducer L12-5 Transducer Probe recalled by Philips Ultrasound.
More recalls from Philips Ultrasound
All 108| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | Philips L12-5 Ultrasound Transducer recalled by Philips Ultrasound | Philips Ultrasound | Other | Nationwide |
| Device | CLASS III | Philips C9-4 Ultrasound Transducer recalled by Philips Ultrasound | Philips Ultrasound | Other | Nationwide |
| Device | CLASS III | Philips X7-2 Ultrasound Transducer recalled by Philips Ultrasound | Philips Ultrasound | Other | Nationwide |
| Device | CLASS III | Philips 3D6-2 Ultrasound Transducer recalled by Philips Ultrasound | Philips Ultrasound | Other | Nationwide |
| Device | CLASS III | Philips OMNI III TEE Ultrasound Transducer recalled | Philips Ultrasound | Other | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |