Reported Feb 15, 2023 · Ongoing

Sterile Procedural Trays, labeled as the following: a. LAPAROTOMY CDS-LF b. LAPAROSCOPY CDS-LF c. BASIC LAPAROSCOPY CDS…

MEDLINE INDUSTRIES, LP - Northfield

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: MEDLINE INDUSTRIES, LP - Northfield · 3 Lakes Dr · Northfield, IL · 60093-2753

Is this the product you have?

  • Sterile Procedural Trays
  • labeled as the followinga. LAPAROTOMY CDS-LF b. LAPAROSCOPY CDS-LF c. BASIC LAPAROSCOPY CDS d. LAPAROSCOPY CDS-LF e. GENERAL LAPAROSCOPY PROCEDURE f. LAP CHOLE CDS g. COLO-RECTAL CDS-LF h. MAJOR PROCEDURE-LF i. HYPOSPADIUS CDS j. LAPAROSCOPY-GENERAL k. LAP CHOLE CDS l. GENERAL LAPAROSCOPY CDS m. MINOR PROCEDURE CDS n. MAJOR CDS o. HERNIA CDS p. MINOR CDS q. MAJOR PROCEDURE CDS r. LAP GASTRIC BYPASS CDS UCC s. GENERAL LAPAROSCOPY CDS t. LAP CHOLE CDS u. CUH MAJOR PROCEDURE CDS v. LAPAROSCOPIC CDS-LF w. GENERAL LAPAROSCOPY CDS-LF x. MAJOR ABDOMINAL CDS y. LAP CHOLE CDS z. GENERAL SURGERY CDS aa. MAJOR ABDOMINAL/GENERAL-LF bb. LAP CHOLE/LAPAROSCOPIC ABD-LF cc. GENERAL LAPAROSCOPY CDS dd. LAPAROSCOPY CDS ee. GENERAL LAPAROSCOPY CDS ff. LAP CHOLE CDS UCC-LF gg. GENERAL LAPAROSCOPY CDS hh. LAPAROSCOPY CDS ii. BARIATRIC PROCEDURE jj. MINOR SURGERY CDS kk. LAP CHOLE CDS ll. ACH MINOR PROCEDURE mm. ACH MINOR PROCEDURE nn. ACH MAJOR ABDOMINAL oo. GENERAL LAPAROSCOPY pp. LAP COLECTOMY PACK-LF qq. MINOR PROCEDURE PACK-LF rr. OPERATIVE LAPAROSCOPY PACK-LF ss. LAP CHOLE PACK-LF tt. MAJOR PROCEDURE PACK-LF uu. GYN MAJOR ABDOMINAL PACK-LF vv. MAJOR ABDOMINAL HARPER PACK-LF ww. LAPAROTOMY PACK-LF xx. LAPAROTOMY PACK-LF yy. MINOR PACK-LF zz. MINOR PROCEDURE PACK-LF aaa. LAP CHOLE PACK bbb. LAP APPY PACK ccc. LAP APPY PACK ddd. OPEN HERNIA APPY PACK eee. LAP CHOLE PACK-LF fff. LAP CHOLE PACK-LF ggg. LAPAROSCOPY PACK-LF hhh. MINOR PACK-LF iii. LAPAROTOMY BASIC PACK-LF jjj. LAP CHOLE PACK-LF kkk. MINOR PACK-LF lll. LAPAROSCOPIC - UNIV mmm. KIDNEY - UNIV nnn. LAP CHOLE PACK-LF ooo. LASER LAP PACK ppp. LAP CHOLE PACK-LF qqq. MAJOR LAPAROTOMY PACK-LF rrr. LAP CHOLE PACK-LF sss. MINOR PACK-LF ttt. MAJOR ABDOMINAL PACK-LF uuu. DAVINCI PACK-LF vvv. LAP CHOLE PACK www. LAPAROSCOPY PACK-GYN xxx. LAP CHOLE PACK yyy. MINOR PACK zzz. LAP CHOLE PACK-LF aaaa. MAJOR PACK bbbb. LAP CHOLE PACK-LF cccc. LAPAROSCOPY PACK-LF dddd. LAPAROSCOPY PACK-LF eeee. MINOR PACK-LF ffff. LAP CHOLE III-LF gggg. ROBOTICS PACK-LF hhhh. MINOR PACK iiii. PELVIC LAPAROSCOPY PACK-LF jjjj. LAP CHOLE PACK-LF kkkk. UNIVERSAL LAPAROSCOPY PACK-LF llll. LAPAROSCOPY PACK mmmm. LAPAROTOMY PACK-LF nnnn. LAPCHOLE II PACK-LF oooo. LAP CHOLE PACK-LF pppp. MINOR PACK-LF qqqq. MAJOR LAP PACK-LF rrrr. MINOR PROCEDURE CUSTOM PACK-LF ssss. MINOR PACK-LF tttt. LAPAROSCOPY PACK-LF uuuu. MONTEFIORE MVH LAPAROTOMY PACK vvvv. MINOR PACK-LF wwww. LAPAROSCOPY PK/ALTAMONTE xxxx. LAPAROSCOPY PK yyyy. LAP CHOLE PACK-LF zzzz. PPM-ICD PACK-LF aaaaa. STANDARD PACK-LF bbbbb. LAP CHOLE PACK ccccc. LAP TRAY-LF ddddd. MINOR PACK eeeee. BARIATRIC PACK #117-RF fffff. GENERAL LAPAROSCOPY PACK ggggg. TORNETTA ACETABULUM/PE PK hhhhh. MLD PACK iiiii. LAP CHOLE TRAY-LF jjjjj. SET UP PACK-LF kkkkk. LAPAROSCOPY PACK-LF lllll. MAJOR LAPAROTOMY PACK mmmmm. MVFF/FIBU #54-RF nnnnn. MAJOR GENERAL PACK ooooo. LAPAROSCOPY PACK ppppp. MINOR PACK-LF qqqqq. LAP CHOLE TRAY rrrrr. MINOR OPEN-RF-LF sssss. LAPAROSCOPY-RF-LF ttttt. MAJOR OPEN-RF-LF uuuuu. MONTEFIORE MVH MINOR PACK vvvvv. GLENNON GENERAL MAJOR PACK-LF wwwww. LAP CHOLE PACK xxxxx. MINOR PACK-LF yyyyy. MAJOR SET UP PACK-LF zzzzz. SCC RECTAL PACK aaaaaa. MINI LAPAROTOMY #16-RF bbbbbb. LAP CHOLE PACK cccccc. LAPAROSCOPY TRAY SC-LF dddddd. MINOR PACK eeeeee. LAP CHOLE PACK ffffff. SET UP PACK gggggg. LAPAROSCOPY PACK-LF hhhhhh. GENERAL LAPAROSCOPY PACK iiiiii. MAJOR ABDOMINAL PACK jjjjjj. OSC MINOR PACK-LF kkkkkk. MINOR SURGERY PACK llllll. BASIC LAPAROTOMY mmmmmm. GENERAL RECTAL PACK-LF nnnnnn. LAP CHOLE PACK-LF oooooo. LAP CHOLE PACK pppppp. LAPAROTOMY PK qqqqqq. LAPAROSCOPIC GALLBLADDER PACK rrrrrr. LAP CHOLE ssssss. LAPAROSCOPY tttttt. LAPAROTOMY uuuuuu. MINOR PACK vvvvvv. MINOR PACK wwwwww. MAJOR PACK xxxxxx. MINOR PACK yyyyyy. PEDIATRIC LAP PACK zzzzzz. MINOR PROCEDURE PACK-LF aaaaaaa. LAPAROSCOPY PACK bbbbbbb. LAPAROSCOPY PACK-LF ccccccc. PEDIATRIC LAP PACK-LF ddddddd. MINOR PACK-LF eeeeeee. MINOR ABDOMINAL PROCEDURPK-LF fffffff. GENERAL LAPAROS
Lot codes and dates

26 of 26 products

Products covered by this recall
Model / numberBarcodesProduct as published
1088438901832340884389018324LAPAROTOMY CDS-LF, Item Number: CDS860091A, Case UDI/GTIN: 40884389018324, Unit UDI/ , Lot Number: 22KMA029,22IMI179,22IME690
1019348948521940193489485210LAPAROSCOPY CDS-LF, Item Number: CDS860235I, Case UDI/GTIN: 40193489485210, Unit UDI/ , Lot Number: 22JMB557
1019532720960540195327209606BASIC LAPAROSCOPY CDS, Item Number: CDS920080S, Case UDI/GTIN: 40195327209606, Unit UDI/ , Lot Number: 22JBO105
1019348920329540193489203296LAPAROSCOPY CDS-LF, Item Number: CDS920126AB, Case UDI/GTIN: 40193489203296, Unit UDI/ , Lot Number: 22JMD700
1019532725550340195327255504GENERAL LAPAROSCOPY PROCEDURE, Item Number: CDS930125V, Case UDI/GTIN: 40195327255504, Unit UDI/ , Lot Number: 22JBH334,22JBA038
1088994210816940889942108160LAP CHOLE CDS, Item Number: CDS930235K, Case UDI/GTIN: 40889942108160, Unit UDI/ , Lot Number: 22IMD079
1019532706286640195327062867COLO-RECTAL CDS-LF, Item Number: CDS941345K, Case UDI/GTIN: 40195327062867, Unit UDI/ , Lot Number: 22IBT398,22HBW953
1019532725530540195327255306MAJOR PROCEDURE-LF, Item Number: CDS980255U, Case UDI/GTIN: 40195327255306, Unit UDI/ , Lot Number: 22JBW968
1019532725144440195327251445HYPOSPADIUS CDS, Item Number: CDS980372K, Case UDI/GTIN: 40195327251445, Unit UDI/ , Lot Number: 22JBV275
1088994242856440889942428565LAPAROSCOPY-GENERAL, Item Number: CDS980746I, Case UDI/GTIN: 40889942428565, Unit UDI/ , Lot Number: 22JBR293,22JBB178,22JBB179
1019348997673140193489976732LAP CHOLE CDS, Item Number: CDS981016D, Case UDI/GTIN: 40193489976732, Unit UDI/ , Lot Number: 22KBD660
1019348999501540193489995016GENERAL LAPAROSCOPY CDS, Item Number: CDS981537F, Case UDI/GTIN: 40193489995016, Unit UDI/ , Lot Number: 22JBU287
1088994291360240889942913603MINOR PROCEDURE CDS, Item Number: CDS981793D, Case UDI/GTIN: 40889942913603, Unit UDI/ , Lot Number: 22IBO676
1019532714499940195327144990MAJOR CDS, Item Number: CDS981883T, Case UDI/GTIN: 40195327144990, Unit UDI/ , Lot Number: 22IBV913
1088994262097540889942620976HERNIA CDS, Item Number: CDS982375I, Case UDI/GTIN: 40889942620976, Unit UDI/ , Lot Number: 22JBD868
1019348992870940193489928700MINOR CDS, Item Number: CDS982384F, Case UDI/GTIN: 40193489928700, Unit UDI/ , Lot Number: 22KMA015,22JMC842
1019532721234640195327212347MAJOR PROCEDURE CDS, Item Number: CDS982414O, Case UDI/GTIN: 40195327212347, Unit UDI/ , Lot Number: 22IBE734
1019348986146440193489861465LAP GASTRIC BYPASS CDS UCC, Item Number: CDS982608J, Case UDI/GTIN: 40193489861465, Unit UDI/ , Lot Number: 22JBJ960
1019348932187640193489321877GENERAL LAPAROSCOPY CDS, Item Number: CDS982611I, Case UDI/GTIN: 40193489321877, Unit UDI/ , Lot Number: 22JBE552
1019348936292340193489362924LAP CHOLE CDS, Item Number: CDS983099J, Case UDI/GTIN: 40193489362924, Unit UDI/ , Lot Number: 22KBE143,22JBC456
Amount recalled
42,593 cases (117,470 units)

This recall covers 38 products

The agency filed one notice per product. You are reading one of them; the other 37 are below.

25 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:40 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.