Recall archive / FDA device enforcement
Sterile Procedural Trays, labeled as the following: a. C-SECTION OR 30 CDS b. C-SECTION CDS c. C-SECTION CDS d. C-SEC... — FDA record Z-1092-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 17, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Sterile Procedural Trays, labeled as the following: a. C-SECTION OR 30 CDS b. C-SECTION CDS c. C-SECTION CDS d. C-SECTION CDS e. MAJOR ORTHO CDS-LF f. C-SECTION CDS g. C-SECTION CDS h. C-SECTION PROCEDURE i. C-SECTION CDS-LF j. C-SECTION CDS k. C-SECTION CDS l. C-SECTION m. C-SECTION CDS n. C-SECTION PACK-LF o. C-SECTION PACK-LF p. C-SECTION PACK-LF q. C-SECTION PACK-LF r. C-BIRTH PACK-LF s. C SECTION PACK-LF t. C-SECTION PACK-LF u. C SECTION PACK-LF v. C-SECTION PACK-LF w. C SECTION PACK-LF x. C-SECTION PACK-LF y. C-SECTION PACK z. C-SECTION PACK-LF aa. C-SECTION PACK-LF bb. C-SECTION PACK-LF cc. C-SECTION PACK-LF dd. C-BIRTH SETUP PACK-LF ee. C-SECTION PACK-LF ff. C-SECTION PACK-LF gg. C-SECTION PACK-LF hh. C SECTION PACK-LF ii. C-SECTION PACK-LF jj. C-SECTION TRAY kk. C-SECTION PACK ll. C-SECTION PACK-LF mm. C-SECTION PACK nn. C-SECTION PACK oo. C-SECTION pp. C-SECTION PACK qq. SVMMC C-SECTION PACK rr. C-SECTION PACK-LF ss. C-SECTION SETUP PACK tt. C-SECTION PACK uu. C-SECTION PACK vv. C-SECTION PACK *STANDARD* ww. C-SECTION PACK xx. C-SECTION PACK yy. C-SECTION PACK zz. C-SECTION 83305, MERCY REG aaa. CUH C-SECTION PACK-LF bbb. C-SECTION PACK-LF ccc. C-SECTION PACK ddd. C-SECTION PACK eee. C-SECTION PACK fff. C-SECTION PK ggg. C-SECTION hhh. C-SECTION PACK iii. ST JO WEST C-SECTION BASIN-LF jjj. C SECTION PACK kkk. C-SECTION PACK lll. C SECTION PACK mmm. C SECTION DELIVERY nnn. C-SECTION PACK ooo. C-SECTION PACK ppp. C SECTION qqq. WR C SECTION PACK-LF rrr. C-SECTION PACK sss. PK, L&D-C SECTION ttt. C-SECTION PACK HIGHLAND-LF uuu. C- SECTION vvv. C SECTION PACK-LF www. C-SECTION PACK xxx. C-SECTION PACK yyy. C SECTION PACK zzz. PK, L&D-C SECTION aaaa. C SECTION PACK bbbb. C SECTION PACK cccc. C-SECTION PACK dddd. SECTION PACK (CSSJE)642-LF eeee. C-SECTION PACK ffff. C-SECTION PACK-RFD gggg. C-SECTION DELIVERY PACK-LF hhhh. C-SECTION PACK iiii. C SECTION PACK jjjj. C-SECTION PACK kkkk. C SECTION llll. C SECTION PLUS PACK mmmm. C SECTION PACK-6220 nnnn. C-SECTION PACK oooo. C-SECTION PACK pppp. C-SECTION PACK - WCH qqqq. C SECTION WITH BASIN PACK rrrr. PHP C-SECTION PACK-LF ssss. C-SECTION KIT tttt. C SECTION PACK uuuu. C-SECTION vvvv. C-SECTION I PACK-LF wwww. C-SECTION PACK 2 xxxx. C-SECTION PACK-LF yyyy. C-SECTION PACK zzzz. C-SECTION PACK aaaaa. C SECTION PACK bbbbb. C-SECTION PACK ccccc. C SECTION ddddd. C SECTION PACK-LF eeeee. C SECTION PACK-LF fffff. BSMI CSECTION BIRTHING PACK ggggg. C-SECTION PACK hhhhh. C SECTION PACK-LF iiiii. C-SECTION PACK jjjjj. C SECTION PACK kkkkk. C SECTION lllll. PK, L&D-C SECTION mmmmm. C-SECTION PACK nnnnn. C SECTION ooooo. C-SECTION PACK ppppp. C-SECTION SMMC qqqqq. C SECTION PACK rrrrr. C SECTION PACK sssss. C-SECTION PACK ttttt. C SECTION #2 SHARED uuuuu. C SECTION #3 SHARED vvvvv. C SECTION wwwww. C-SECTION PACK xxxxx. CESAREAN BIRTH PACK yyyyy. C SECTION PACK-LF zzzzz. C-SECTION PACK aaaaaa. C-SECTION PACK-LF bbbbbb. C SECTION PACK cccccc. C-SECTION PACK dddddd. C-SECTION eeeeee. C-SECTION ffffff. C...
- Reason
- Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
- Classification
- Class II
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 11,886 cases (27,144 units)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1092-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | a. C-SECTION OR 30 CDS, Item Number: CDS820075W, Case UDI/GTIN: 40195327209798, Unit UDI/GTIN: 10195327209797, Lot Number: 22JBX603,22JBX483; b. C-SECTION CDS, Item Number: CDS830218J, Case UDI/GTIN: 40888277530172, Unit UDI/GTIN: 10888277530171, Lot Number: 22JBV584; c. C-SECTION CDS, Item Number: CDS980747J, Case UDI/GTIN: 40193489923613, Unit UDI/GTIN: 10193489923612, Lot Number: 22JBO006; d. C-SECTION CDS, Item Number: CDS981430C, Case UDI/GTIN: 40193489260879, Unit UDI/GTIN: 10193489260878, Lot Number: 22JMG179; e. MAJOR ORTHO CDS-LF, Item Number: CDS982233G, Case UDI/GTIN: 40193489986212, Unit UDI/GTIN: 10193489986211, Lot Number: 22JMG573; f. C-SECTION CDS, Item Number: CDS982367I, Case UDI/GTIN: 40193489312349, Unit UDI/GTIN: 10193489312348, Lot Number: 22KBE753,22KBC690; g. C-SECTION CDS, Item Number: CDS983117G, Case UDI/GTIN: 40195327192113, Unit UDI/GTIN: 10195327192112, Lot Number: 22IBR943; h. C-SECTION PROCEDURE, Item Number: CDS983450L, Case UDI/GTIN: 40193489372336, Unit UDI/GTIN: 10193489372335, Lot Number: 22KBE444,22IBD865,22IBE112; i. C-SECTION CDS-LF, Item Number: CDS983869I, Case UDI/GTIN: 40888277752734, Unit UDI/GTIN: 10888277752733, Lot Number: 22JDB259; j. C-SECTION CDS, Item Number: CDS983917M, Case UDI/GTIN: 40193489402712, Unit UDI/GTIN: 10193489402711, Lot Number: 22JBO248; k. C-SECTION CDS, Item Number: CDS984354C, Case UDI/GTIN: 40193489738187, Unit UDI/GTIN: 10193489738186, Lot Number: 22JBC335; l. C-SECTION, Item Number: CDS984902K, Case UDI/GTIN: 40195327156924, Unit UDI/GTIN: 10195327156923, Lot Number: 22IBQ711,22IBL648; m. C-SECTION CDS, Item Number: CDS985206B, Case UDI/GTIN: 40889942942078, Unit UDI/GTIN: 10889942942077, Lot Number: 22JBL398; n. C-SECTION PACK-LF, Item Number: DYNJ0173422AF, Case UDI/GTIN: 40195327097579, Unit UDI/GTIN: 10195327097578, Lot Number: 22JMA807; o. C-SECTION PACK-LF, Item Number: DYNJ0188507C, Case UDI/GTIN: 40889942053491, Unit UDI/GTIN: 10889942053490, Lot Number: 22JBY657,22IBI286; p. C-SECTION PACK-LF, Item Number: DYNJ0200274P, Case UDI/GTIN: 40889942054115, Unit UDI/GTIN: 10889942054114, Lot Number: 22IMG322; q. C-SECTION PACK-LF, Item Number: DYNJ0365888N, Case UDI/GTIN: 40195327045273, Unit UDI/GTIN: 10195327045272, Lot Number: 22IMF444,22HMF014; r. C-BIRTH PACK-LF, Item Number: DYNJ0366291M, Case UDI/GTIN: 40889942059615, Unit UDI/GTIN: 10889942059614, Lot Number: 22IME718; s. C SECTION PACK-LF, Item Number: DYNJ0367189M, Case UDI/GTIN: 40193489788298, Unit UDI/GTIN: 10193489788297, Lot Number: 22IMG638,22HMC273; t. C-SECTION PACK-LF, Item Number: DYNJ0367679W, Case UDI/GTIN: 40193489617369, Unit UDI/GTIN: 10193489617368, Lot Number: 22JMI197,22IMD016; u. C SECTION PACK-LF, Item Number: DYNJ0376534Q, Case UDI/GTIN: 40195327237173, Unit UDI/GTIN: 10195327237172, Lot Number: 22IBE468; v. C-SECTION PACK-LF, Item Number: DYNJ0382235G, Case UDI/GTIN: 40889942435020, Unit UDI/GTIN: 10889942435029, Lot Number: 22IBC549,22IBC247,22HBG107; w. C SECTION PACK-LF, Item Number: DYNJ0397841N, Case UDI/GTIN: 40193489824064, Unit UDI/GTIN: 10193489824063, Lot Number: 22IBL780; x. C-SECTION PACK-LF, Item Number: DYNJ04609I, Case UDI/GTIN: 40193489552707, Unit UDI/GTIN: 10193489552706, Lot Number: 22IMA202; y. C-SECTION PACK, Item Number: DYNJ04620S, Case UDI/GTIN: 40195327135851, Unit UDI/GTIN: 10195327135850, Lot Number: 22IMB266; z. C-SECTION PACK-LF, Item Number: DYNJ04724Q, Case UDI/GTIN: 40193489554015, Unit UDI/GTIN: 10193489554014, Lot Number: 22IMF982; aa. C-SECTION PACK-LF, Item Number: DYNJ0508830M, Case UDI/GTIN: 40193489579247, Unit UDI/GTIN: 10193489579246, Lot Number: 22IMD130; bb. C-SECTION PACK-LF, Item Number: DYNJ0551773O, Case UDI/GTIN: 40193489268622, Unit UDI/GTIN: 10193489268621, Lot Number: 22JBS505; cc. C-SECTION PACK-LF, Item Number: DYNJ06584K, Case UDI/GTIN: 40193489420525, Unit UDI/GTIN: 10193489420524, Lot Number: 22JBY658,22IBU471,22HBL261; dd. C-BIRTH SETUP PACK-LF, Item Number: DYNJ0781722T, Case UDI/GTIN: 40193489226356, Unit UDI/GTIN: 10193489226355, Lot Number: 22JMG062; ee. C-SECTION PACK-LF, Item Number: DYNJ07836Q, Case UDI/GTIN: 40195327209552, Unit UDI/GTIN: 10195327209551, Lot Number: 22IBO410; ff. C-SECTION PACK-LF, Item Number: DYNJ0842739K, Case UDI/GTIN: 40193489359634, Unit UDI/GTIN: 10193489359633, Lot Number: 22JDB302; gg. C-SECTION PACK-LF, Item Number: DYNJ0843654G, Case UDI/GTIN: 40889942402855, Unit UDI/GTIN: 10889942402854, Lot Number: 22IDB683,22IDA305; hh. C SECTION PACK-LF, Item Number: DYNJ0923021, Case UDI/GTIN: 40889942099642, Unit UDI/GTIN: 10889942099641, Lot Number: 22JMH549,22IMF460; ii. C-SECTION PACK-LF, Item Number: DYNJ15232M, Case UDI/GTIN: 40195327231744, Unit UDI/GTIN: 10195327231743, Lot Number: 22IMH405; jj. C-SECTION TRAY, Item Number: DYNJ15494G, Case UDI/GTIN: 40193489961196, Unit UDI/GTIN: 10193489961195, Lot Number: 22IBI076; kk. C-SECTION PACK, Item Number: DYNJ15726I, Case UDI/GTIN: 40193489832403, Unit UDI/GTIN: 10193489832402, Lot Number: 22JBU168; ll. C-SECTION PACK-LF, Item Number: DYNJ16672I, Case UDI/GTIN: 40193489990752, Unit UDI/GTIN: 10193489990751, Lot Number: 22JBK965,22IBL997,22HBU474,22HBV462; mm. C-SECTION PACK, Item Number: DYNJ19958P, Case UDI/GTIN: 40193489867733, Unit UDI/GTIN: 10193489867732, Lot Number: 22JMI344,22IMG005,22HME230; nn. C-SECTION PACK, Item Number: DYNJ20135M, Case UDI/GTIN: 40193489905534, Unit UDI/GTIN: 10193489905533, Lot Number: 22JBS400; oo. C-SECTION, Item Number: DYNJ22368I, Case UDI/GTIN: 40193489780513, Unit UDI/GTIN: 10193489780512, Lot Number: 22IBN332; pp. C-SECTION PACK, Item Number: DYNJ24120C, Case UDI/GTIN: 40884389396507, Unit UDI/GTIN: 10884389396506, Lot Number: 22IBF425; qq. SVMMC C-SECTION PACK, Item Number: DYNJ24632K, Case UDI/GTIN: 40195327058624, Unit UDI/GTIN: 10195327058623, Lot Number: 22JLB138,22ILA591; rr. C-SECTION PACK-LF, Item Number: DYNJ26665J, Case UDI/GTIN: 40889942112136, Unit UDI/GTIN: 10889942112135, Lot Number: 22JBW002; ss. C-SECTION SETUP PACK, Item Number: DYNJ27751F, Case UDI/GTIN: 40195327228706, Unit UDI/GTIN: 10195327228705, Lot Number: 22JDA003,22HDC395,22HDA918; tt. C-SECTION PACK, Item Number: DYNJ29034F, Case UDI/GTIN: 40193489461146, Unit UDI/GTIN: 10193489461145, Lot Number: 22IME948; uu. C-SECTION PACK, Item Number: DYNJ30483F, Case UDI/GTIN: 40193489912419, Unit UDI/GTIN: 10193489912418, Lot Number: 22JMB299,22HMB825; vv. C-SECTION PACK *STANDARD*, Item Number: DYNJ30609G, Case UDI/GTIN: 40193489301541, Unit UDI/GTIN: 10193489301540, Lot Number: 22IMG006; ww. C-SECTION PACK, Item Number: DYNJ30610D, Case UDI/GTIN: 40889942491972, Unit UDI/GTIN: 10889942491971, Lot Number: 22HDC051; xx. C-SECTION PACK, Item Number: DYNJ31011D, Case UDI/GTIN: 40889942383413, Unit UDI/GTIN: 10889942383412, Lot Number: 22JBR171; yy. C-SECTION PACK, Item Number: DYNJ32011G, Case UDI/GTIN: 40195327067046, Unit UDI/GTIN: 10195327067045, Lot Number: 22JMH079; zz. C-SECTION 83305, MERCY REG, Item Number: DYNJ32059F, Case UDI/GTIN: 40193489822497, Unit UDI/GTIN: 10193489822496, Lot Number: 22IBV950; aaa. CUH C-SECTION PACK-LF, Item Number: DYNJ32253G, Case UDI/GTIN: 40195327066537, Unit UDI/GTIN: 10195327066536, Lot Number: 22IBJ049; bbb. C-SECTION PACK-LF, Item Number: DYNJ33059B, Case UDI/GTIN: 40193489950947, Unit UDI/GTIN: 10193489950946, Lot Number: 22JBO407,22IBG828,22HBR300; ccc. C-SECTION PACK, Item Number: DYNJ33188B, Case UDI/GTIN: 40888277746283, Unit UDI/GTIN: 10888277746282, Lot Number: 22JMH212,22IMI213; ddd. C-SECTION PACK, Item Number: DYNJ33550B, Case UDI/GTIN: 40889942435686, Unit UDI/GTIN: 10889942435685, Lot Number: 22JMF403; eee. C-SECTION PACK, Item Number: DYNJ33799C, Case UDI/GTIN: 40889942447153, Unit UDI/GTIN: 10889942447152, Lot Number: 22JBI238,22HBG189; fff. C-SECTION PK, Item Number: DYNJ34266B, Case UDI/GTIN: 40888277246516, Unit UDI/GTIN: 10888277246515, Lot Number: 22IBK679; ggg. C-SECTION, Item Number: DYNJ34431G, Case UDI/GTIN: 40193489834957, Unit UDI/GTIN: 10193489834956, Lot Number: 22JBN841; hhh. C-SECTION PACK, Item Number: DYNJ36310K, Case UDI/GTIN: 40193489443456, Unit UDI/GTIN: 10193489443455, Lot Number: 22JMG326; iii. ST JO WEST C-SECTION BASIN-LF, Item Number: DYNJ37027A, Case UDI/GTIN: 40889942418320, Unit UDI/GTIN: 10889942418329, Lot Number: 22JBR330,22HBT598; jjj. C SECTION PACK, Item Number: DYNJ37622C, Case UDI/GTIN: 40884389864235, Unit UDI/GTIN: 10884389864234, Lot Number: 22IBT225; kkk. C-SECTION PACK, Item Number: DYNJ38350J, Case UDI/GTIN: 40195327129959, Unit UDI/GTIN: 10195327129958, Lot Number: 22JMC173,22IME739,22HMD564; lll. C SECTION PACK, Item Number: DYNJ38440C, Case UDI/GTIN: 40195327061792, Unit UDI/GTIN: 10195327061791, Lot Number: 22JMC367,22IMF067; mmm. C SECTION DELIVERY, Item Number: DYNJ39375F, Case UDI/GTIN: 40193489418980, Unit UDI/GTIN: 10193489418989, Lot Number: 22IBG340; nnn. C-SECTION PACK, Item Number: DYNJ40458B, Case UDI/GTIN: 40889942109334, Unit UDI/GTIN: 10889942109333, Lot Number: 22IBS430,22HBH047; ooo. C-SECTION PACK, Item Number: DYNJ40503B, Case UDI/GTIN: 40193489614931, Unit UDI/GTIN: 10193489614930, Lot Number: 22IDB276; ppp. C SECTION, Item Number: DYNJ41268B, Case UDI/GTIN: 40193489487627, Unit UDI/GTIN: 10193489487626, Lot Number: 22IMF995,22IMF998; qqq. WR C SECTION PACK-LF, Item Number: DYNJ41570K, Case UDI/GTIN: 40195327089772, Unit UDI/GTIN: 10195327089771, Lot Number: 22IMF970,22IMG359; rrr. C-SECTION PACK, Item Number: DYNJ42226D, Case UDI/GTIN: 40195327017935, Unit UDI/GTIN: 10195327017934, Lot Number: 22IMG051,22IMG068; sss. PK, L&D-C SECTION, Item Number: DYNJ42476I, Case UDI/GTIN: 40193489266017, Unit UDI/GTIN: 10193489266016, Lot Number: 22JBU242; ttt. C-SECTION PACK HIGHLAND-LF, Item Number: DYNJ42634B, Case UDI/GTIN: 40888277582805, Unit UDI/GTIN: 10888277582804, Lot Number: 22IBD370; uuu. C- SECTION, Item Number: DYNJ42651, Case UDI/GTIN: 40888277003584, Unit UDI/GTIN: 10888277003583, Lot Number: 22IME346,22IME347,22HMC131; vvv. C SECTION PACK-LF, Item Number: DYNJ42850A, Case UDI/GTIN: 40193489880909, Unit UDI/GTIN: 10193489880908, Lot Number: 22JBN852; www. C-SECTION PACK, Item Number: DYNJ42946A, Case UDI/GTIN: 40195327196838, Unit UDI/GTIN: 10195327196837, Lot Number: 22IBV689,22HBH787; xxx. C-SECTION PACK, Item Number: DYNJ43284D, Case UDI/GTIN: 40888277984128, Unit UDI/GTIN: 10888277984127, Lot Number: 22IMG361; yyy. C SECTION PACK, Item Number: DYNJ43732F, Case UDI/GTIN: 40193489549370, Unit UDI/GTIN: 10193489549379, Lot Number: 22IBI952; zzz. PK, L&D-C SECTION, Item Number: DYNJ43746C, Case UDI/GTIN: 40193489310635, Unit UDI/GTIN: 10193489310634, Lot Number: 22JBO122; aaaa. C SECTION PACK, Item Number: DYNJ43810A, Case UDI/GTIN: 40193489298056, Unit UDI/GTIN: 10193489298055, Lot Number: 22IBK239; bbbb. C SECTION PACK, Item Number: DYNJ46508F, Case UDI/GTIN: 40195327111787, Unit UDI/GTIN: 10195327111786, Lot Number: 22JME929; cccc. C-SECTION PACK, Item Number: DYNJ47220C, Case UDI/GTIN: 40889942131359, Unit UDI/GTIN: 10889942131358, Lot Number: 22JMD043; dddd. SECTION PACK (CSSJE)642-LF, Item Number: DYNJ47485C, Case UDI/GTIN: 40193489586597, Unit UDI/GTIN: 10193489586596, Lot Number: 22IMI230; eeee. C-SECTION PACK, Item Number: DYNJ47606B, Case UDI/GTIN: 40193489730693, Unit UDI/GTIN: 10193489730692, Lot Number: 22IBV197; ffff. C-SECTION PACK-RFD, Item Number: DYNJ47761K, Case UDI/GTIN: 40193489896986, Unit UDI/GTIN: 10193489896985, Lot Number: 22IME390; gggg. C-SECTION DELIVERY PACK-LF, Item Number: DYNJ47808F, Case UDI/GTIN: 40195327232604, Unit UDI/GTIN: 10195327232603, Lot Number: 22IMB729; hhhh. C-SECTION PACK, Item Number: DYNJ48272, Case UDI/GTIN: 40888277575371, Unit UDI/GTIN: 10888277575370, Lot Number: 22IBO504,22HMD672; iiii. C SECTION PACK, Item Number: DYNJ48483D, Case UDI/GTIN: 40195327030811, Unit UDI/GTIN: 10195327030810, Lot Number: 22JMI251; jjjj. C-SECTION PACK, Item Number: DYNJ48746A, Case UDI/GTIN: 40889942385691, Unit UDI/GTIN: 10889942385690, Lot Number: 22JMA582; kkkk. C SECTION, Item Number: DYNJ49172G, Case UDI/GTIN: 401934... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Feb 15, 2023
- Recall initiation date
- Nov 17, 2022
- Center classification date
- Feb 6, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.