Z-2321-2023Class II

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following...

Name: Z-2321-2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following...
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2023-05-15
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2023-05-15 / Open, Classified / root cause: manufacturing process

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PEDIATRIC CATH ANGIO PACK, Model Number... on 2023-05-15. FDA classified it as Class II and gives the reason as "Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2321-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-15
Posted: 2023-08-03
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PEDIATRIC CATH ANGIO PACK, Model Number: DYNJ54755B; b. PEDIATRIC MAX BARRIER KIT-LF, Model Number: DYNJ40306A; c. PERC PACK-LF, Model Number: DYNJ0774759P; d. PERCUTANEOUS VASCULAR CDS, Model Number: DYNJ902261D; e. PERIPHERAL NERVE BLOCK KIT/P, Model Number: DYNJRA1747; f. PERIPHERAL PACK, Model Number: DYNJ44960D; g. PERIPHERAL ULTRASOUND CATHETER, Model Number: DYNDV2285, MNS9865; h. PERIPHERAL VASCULAR GRAFT PACK, Model Number: DYNJ904401B; i. PERMACATH-LF, Model Number: DYNJ42262D; j. PHLEBECTOMY PACK, Model Number: DYNJ47502B; k. PHYSIATRY PACK, Model Number: DYNJ67414; l. PICC INSERT KIT-LESS THAN 3 FR, Model Number: PHS41739A; m. PICC INSERTION PACK, Model Number: DYNJ60038; n. PICC LINE DOUBLE LUMEN CDS, Model Number: CDS982858F; o. PICC LINE INSERTION, Model Number: DYNJ39885A; p. PICC LINE INSERTION WRO-LF, Model Number: DYNJ41873B; q. PICC LINE TRAY, Model Number: DYNJ52688A; r. PICC LINE TRIPLE LUMEN CDS, Model Number: CDS982859F; s. PICC LINEPACK (PCLUI)642-LF, Model Number: DYNJ47717; t. PICC PACK, Model Number: DYNJ55723A, DYNJ60990; u. PICC PROCEDURE PACK, Model Number: DYNJ59067; v. PICC TRAY, Model Number: DYNJ49177F; w. PIV WITH ULTRASOUND KIT, Model Number: DYNDC2399A; x. PK GEN-RECIPIENT, Model Number: DYNJ41114C; y. PK GEN-TRANSPLANT, Model Number: DYNJ54894A; z. PK, GEN-TRANSPLANT, Model Number: DYNJ54894A; aa. PK, GEN-TRANSPLANT-DONOR, Model Number: DYNJ54982A; bb. PORT INSERTION PACK, Model Number: CVI4765; cc. PORT PACK, Model Number: DYNJ56857B, DYNJ68990; dd. POWERGLIDE PLACEMENT KIT, Model Number: DYNDA1468C; ee. PREMIER PROCEDURE PACK, Model Number: DYNJ64393; ff. PREP KIT, Model Number: DYNJRA1155B, DYNJRA1200B; gg. PREP TRAY, Model Number: DYNJRA1498; hh. PROCEDURE PACK, Model Number: DYNJ55063A, DYNJ57674A, DYNJ59795A, DYNJ62588, DYNJ64372, DYNJ64372A, DYNJ68968; ii. PUH AV FISTULA CDS, Model Number: CDS984329J; jj. PURPLE PACK, Model Number: DYNJ62197; kk. PV INTERVENTIONAL PACK-LF, Model Number: DYNJ45757F; ll. PV PACK, Model Number: DYNJ46549J; mm. RAD CVC TRAY, Model Number: DYNJ35574A, DYNJ54131; nn. RAD ONC LITHOTOMY PACK, Model Number: DYNJ60698B; oo. RADIOFREQUENCY ABLATION PACK, Model Number: DYNJ63155A; pp. RADIOLOGY PACK, Model Number: DYNJ42172A; qq. RADIOLOGY PACK-LF #108402, Model Number: DYNJ58225B; rr. RADIOLOGY SPECIALS PACK, Model Number: PHS479840M; ss. RADIOLOGY TRAY, Model Number: MNS11625; tt. RECIPIENT PACK, Model Number: DYNJ41114B; uu. REGIONAL SINGLE SHOT KIT, Model Number: DYNJRA1256; vv. RFA PACK, Model Number: DYNJ57149, DYNJ67899; ww. RIGHT HEART TRAY, Model Number: DYNJ40379C; xx. ROBOT, Model Number: DYNJ906112; yy. ROBOTIC GYN SSC, Model Number: DYNJ60009A; zz. ROBOTIC PROSTATECTOMY, Model Number: DYNJ905826B, DYNJ905826C, DYNJ905826D, DYNJ905826F; aaa. RRMC AORTIC GRAFT PACK-2, Model Number: DYNJ33546J; bbb. RR-SPECIAL PROCEDURE PACK-LF, Model Number: DYNJ0785821M, DYNJ0785821N, DYNJ0785821O; ccc. SCLEROTHERAPY KIT, Model Number: DYNJ62434A; ddd. SLUH LIVER TRANSPLANT PACK-LF, Model Number: DYNJ0369434M; eee. SMH VASCULAR CDS, Model Number: CDS984584L; fff. SPECIAL PROCEDURE PACK, Model Number: DYNJ53135B, DYNJ53135C; ggg. SPECIAL PROCEDURE PACK-LF, Model Number: DYNJ0416535U, DYNJ0416535Y; hhh. SPECIALS PACK, Model Number: DYNJ67504A; iii. SPECIALS TRACE PACK, Model Number: DYNJ57303A, DYNJ57303B; jjj. SSC GU ROBOTIC PACK, Model Number: DYNJ64027; kkk. ST CHARLES PORT PACK, Model Number: DYNJ49833J; lll. STERILE INJECTION PACK, Model Number: DYNDA2805; mmm. SUPPORT TRAY W/CHLORAPREP, Model Number: DYNJRA0958; nnn. SVMMC AV FISTULA PACK, Model Number: DYNJ48153C; ooo. SVMMC VASCULAR MAJOR PA
Product code: LRO General Surgery Tray
Reason for recall: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Medline notified customers beginning on 05/15/2023, via mail and email with letter. Customers with Medline Probe Cover Kits were instructed to check inventory for affected kits, destroy any affected kits, and complete and return the response form. Distributors were instructed to notify their customers and have them document and destroy affected kits. Customers with the non-sterile and sterile procedural kits were instructed to quarantine kits, complete and return the response form and, once updated labels are received, over label and discard the affected ultrasound gel product within the kits. Distributors were instructed to notify customers of the recall and have customers return any affected product for return to Medline. Medline identified additional units of Medline Probe Cover Kits and notified customers on 06/22/2023. Customers were instructed to quarantine kits, complete and return the response form and, once updated labels are received, over label and discard the affected ultrasound gel product within the kits.
Quantity in commerce: 233,638 kits
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.
Product codes and lots: All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ54755B, UPC Number: 088994292536. b. Model Number: DYNJ40306A, UPC Number: 088994260192. c. Model Number: DYNJ0774759P, UPC Number: 019532724613. d. Model Number: DYNJ902261D, UPC Number: 088994275524. e. Model Number: DYNJRA1747, UPC Number: 019348946400. f. Model Number: DYNJ44960D, UPC Number: 019348983324. g. Model Number: DYNDV2285, UPC Number: 019348919454; Model Number: MNS9865, UPC Number: 065316029443. h. Model Number: DYNJ904401B, UPC Number: 019348968343. i. Model Number: DYNJ42262D, UPC Number: 088994269795. j. Model Number: DYNJ47502B, UPC Number: 019348964922. k. Model Number: DYNJ67414, UPC Number: 019348996464. l. Model Number: PHS41739A, UPC Number: 088994290680. m. Model Number: DYNJ60038, UPC Number: 088827779327. n. Model Number: CDS982858F, UPC Number: 088827773921. o. Model Number: DYNJ39885A, UPC Number: 088994253993. p. Model Number: DYNJ41873B, UPC Number: 019348956306. q. Model Number: DYNJ52688A, UPC Number: 088994284356. r. Model Number: CDS982859F, UPC Number: 088827773920. s. Model Number: DYNJ47717, UPC Number: 088827751458. t. Model Number: DYNJ55723A, UPC Number: 088994286553; Model Number: DYNJ60990, UPC Number: 019348953847. u. Model Number: DYNJ59067, UPC Number: 088994293004. v. Model Number: DYNJ49177F, UPC Number: 088827777434. w. Model Number: DYNDC2399A, UPC Number: 088994244693. x. Model Number: DYNJ41114C, UPC Number: 019532726173. y. Model Number: DYNJ54894A, UPC Number: 019348921355. z. Model Number: DYNJ54894A, UPC Number: 019348921355. aa. Model Number: DYNJ54982A, UPC Number: 019348980895. bb. Model Number: CVI4765, UPC Number: 019348995318. cc. Model Number: DYNJ56857B, UPC Number: 019348989314; Model Number: DYNJ68990, UPC Number: 019348987261. dd. Model Number: DYNDA1468C, UPC Number: 088994284317; Model Number: DYNDA1468C, UPC Number: 10889942843176. ee. Model Number: DYNJ64393, UPC Number: 019348980963. ff. Model Number: DYNJRA1155B, UPC Number: 019348958371; Model Number: DYNJRA1200B, UPC Number: 019348956827. gg. Model Number: DYNJRA1498, UPC Number: 019348979574. hh. Model Number: DYNJ55063A, UPC Number: 019348968054; Model Number: DYNJ57674A, UPC Number: 088827777174; Model Number: DYNJ59795A, UPC Number: 019348956698; Model Number: DYNJ62588, UPC Number: 019348966983; Model Number: DYNJ64372, UPC Number: 019348980722; Model Number: DYNJ64372A, UPC Number: 019348988468; Model Number: DYNJ68968, UPC Number: 019348987039. ii. Model Number: CDS984329J, UPC Number: 088994286535. jj. Model Number: DYNJ62197, UPC Number: 019348963300. kk. Model Number: DYNJ45757F, UPC Number: 088827779258. ll. Model Number: DYNJ46549J, UPC Number: 019348933778. mm. Model Number: DYNJ35574A, UPC Number: 088438953806; Model Number: DYNJ54131, UPC Number: 088994246680. nn. Model Number: DYNJ60698B, UPC Number: 019532706789. oo. Model Number: DYNJ63155A, UPC Number: 019348931402. pp. Model Number: DYNJ42172A, UPC Number: 019348950271. qq. Model Number: DYNJ58225B, UPC Number: 088827777898. rr. Model Number: PHS479840M, UPC Number: 019348968272. ss. Model Number: MNS11625, UPC Number: 065316032213. tt. Model Number: DYNJ41114B, UPC Number: 088994269269. uu. Model Number: DYNJRA1256, UPC Number: 019348951155. vv. Model Number: DYNJ57149, UPC Number: 088994272160; Model Number: DYNJ67899, UPC Number: 019348945449. ww. Model Number: DYNJ40379C, UPC Number: 088994281455. xx. Model Number: DYNJ906112, UPC Number: 019348965663. yy. Model Number: DYNJ60009A, UPC Number: 019348964887. zz. Model Number: DYNJ905826B, UPC Number: 019348978095; Model Number: DYNJ905826C, UPC Number: 019348940758; Model Number: DYNJ905826D, UPC Number: 019532702352; Model Number: DYNJ905826F, UPC Number: 019532721705. aaa. Model Number: DYNJ33546J, UPC Number: 019348956435. bbb. Model Number: DYNJ0785821M, UPC Number: 019348956435; Model Number: DYNJ0785821N, UPC Number: 019348956435; Model Number: DYNJ0785821O, UPC Number: 019532726373. ccc. Model Number: DYNJ62434A, UPC Number: 019348936627. ddd. Model Number: DYNJ0369434M, UPC Number: 019532729542. eee. Model Number: CDS984584L, UPC Number: 088994270130. fff. Model Number: DYNJ53135B, UPC Number: 019348966082; Model Number: DYNJ53135C, UPC Number: 019348946843. ggg. Model Number: DYNJ0416535U, UPC Number: 019348956435; Model Number: DYNJ0416535Y, UPC Number: 019348956435. hhh. Model Number: DYNJ67504A, UPC Number: 019532700961. iii. Model Number: DYNJ57303A, UPC Number: 088827778321; Model Number: DYNJ57303B, UPC Number: 019348936064. jjj. Model Number: DYNJ64027, UPC Number: 019348977993. kkk. Model Number: DYNJ49833J, UPC Number: 019532705946. lll. Model Number: DYNDA2805, UPC Number: 019348984614. mmm. Model Number: DYNJRA0958, UPC Number: 088994261890. nnn. Model Number: DYNJ48153C, UPC Number: 088994276562. ooo. Model Number: DYNJ43777G, UPC Number: 088994291573. ppp. Model Number: DYNJ63339A, UPC Number: 019348929531; Model Number: DYNJ63339B, UPC Number: 019348984061. qqq. Model Number: DYNJ53319C, UPC Number: 019348963449. rrr. Model Number: DYNJ63340, UPC Number: 019348974116. sss. Model Number: DYNJ906391B, UPC Number: 019348981688. ttt. Model Number: DYNDH1190, UPC Number: 088994249424. uuu. Model Number: DYKM2125, UPC Number: 019532704487. vvv. Model Number: DYNJ58424, UPC Number: 088994285183. www. Model Number: DYNJ37099C, UPC Number: 019348956435. xxx. Model Number: DYNJ59062, UPC Number: 088994294165. yyy. Model Number: TVS4300A, UPC Number: 081698202335. zzz. Model Number: TVS4500A, UPC Number: 081698202337; Model Number: TVS4500B, UPC Number: 019532722356. aaaa. Model Number: ULT2175B, UPC Number: 019348958303; Model Number: ULT2175C, UPC Number: 10653160344353. bbbb. Model Number: DYNDV2537, UPC Number: 019532718408. cccc. Model Number: DYNDC2099, UPC Number: 088827729567. dddd. Model Number: DYNJ56535, UPC Number: 088994265334. eeee. Model Number: DYNDH1319, UPC Number: 088994279547. ffff. Model Number: DYNDV2385A, UPC Number: 019532729876. gggg. Model Number: IVS3485A, UPC Number: 065316099015; Model Number: IVS3840A, UPC Number: 019348947673. hhhh. Model Number: DYNDV2038B, UPC Number: 019348991983; Model Number: IVS3300, UPC Number: 065316030766; Model Number: IVS3495A, UPC Number: 065316099305. iiii. Model Number: IVS3820, UPC Number: 065316034231. jjjj. Model Number: DYNDV2371, UPC Number: 019348943086. kkkk. Model Number: DYNJ56507B, UPC Number: 019348944347; Model Number: DYNJ64930, UPC Number: 019348923168. llll. Model Number: DYNDH1112, UPC Number: 10889942277360. mmmm. Model Number: IV8635D, UPC Number: 065316099026. nnnn. Model Number: DYNDV2502, UPC Number: 019532701409. oooo. Model Number: DYNDH1204, UPC Number: 088994251983; Model Number: DYNDH1468A, UPC Number: 019348944003; Model Number: DYNJRA0389, UPC Number: 088438972552; Model Number: DYNDH1204, UPC Number: 10889942519835. pppp. Model Number: DYNJ61433, UPC Number: 019348956517. qqqq. Model Number: DYNJ60006A, UPC Number: 019348981007. rrrr. Model Number: DYNJ51638B, UPC Number: 019348994641; Model Number: DYNJ51638C, UPC Number: 019532703956. ssss. Model Number: DYNDH1492, UPC Number: 019348943446. tttt. Model Number: DYNJ904401B, UPC Number: 019348968343. uuuu. Model Number: DYNJ902259A, UPC Number: 088994225654. vvvv. Model Number: CDS982895I, UPC Number: 088994220768. wwww. Model Number: DYNJ902261D, UPC Number: 088994275524. xxxx. Model Number: DYNJ43593A, UPC Number: 088994225559; Model Number: DYNJ53475D, UPC Number: 019348954775. yyyy. Model Number: VC-PK, UPC Number: 019532717689. zzzz. Model Number: DYNJ63268B, UPC Number: 019348930511; Model Number: DYNJ66079, UPC Number: 019348931744. aaaaa. Model Number: DYNJ61148A, UPC Number: 019348954925. bbbbb. Model Number: DYNJ32397B, UPC Number: 088438991665; Model Number: DYNJ54139A, UPC Number: 088994256499; Model Number: DYNJ59094, UPC Number: 088994293350; Model Number: DYNJ65189C, UPC Number: 019532707200. ccccc. Model Number: DYNJS3005, UPC Number: 088438909956. ddddd. Model Number: DYNJ55841B, UPC Number: 088827775768. eeeee. Model Number: DYNJ64190A, UPC Number: 019348943563. fffff. Model Number: DYNJ0309084D, UPC Number: 088994288526; Model Number: DYNJ38682C, UPC Number: 088994289719; Model Number: DYNJ51248B, UPC Number: 088994287340; Model Number: DYNJ59662A, UPC Number: 019348954814; Model Number: DYNJ59681, UPC Number: 088827777552; Model Number: DYNJ61264, UPC Number: 019348955447. ggggg. Model Number: DYNJ59631, UPC Number: 088827776402. hhhhh. Model Number: DYNDA2076, UPC Number: 088994270850. iiiii. Model Number: DYNJ38264C, UPC Number: 019348956435. jjjjj. Model Number: DYNJ57736A, UPC Number: 088827777970. kkkkk. Model Number: DYNJ59751A, UPC Number: 019348959856. lllll. Model Number: DYNJ20094J, UPC Number: 019348956435; Model Number: DYNJ20094K, UPC Number: 019348956435. mmmmm. Model Number: DYNJ56260B, UPC Number: 019348956982. nnnnn. Model Number: DYNJ64666A, UPC Number: 019348931726. ooooo. Model Number: DYNJ901392D, UPC Number: 019348953951. ppppp. Model Number: DYNJ59246, UPC Number: 088827776729. qqqqq. Model Number: DYNJ53349A, UPC Number: 088994257453. rrrrr. Model Number: DYNJ35988G, UPC Number: 019348956435; Model Number: DYNJ35988I, UPC Number: 019348956435; Model Number: DYNJ35988J, UPC Number: 019532702466. sssss. Model Number: DYNJ56392, UPC Number: 088994264067; Model Number: DYNJ56392A, UPC Number: 019532726140.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2321-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2290-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2291-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2292-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2293-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2294-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2295-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2296-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2297-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2298-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2299-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2300-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2301-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2302-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2303-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2304-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2305-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2306-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2307-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2308-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2309-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2310-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2311-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2312-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2313-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2314-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2315-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2316-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2317-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2318-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2319-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2320-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2321-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2322-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2323-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2324-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2325-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2326-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2327-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2328-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2329-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2330-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2331-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2332-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2333-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2334-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2335-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2336-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2337-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2338-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2339-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03

Product code LRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)