Lower risk Drug recall · FDA · Published September 21, 2017
Medline Suture Removal Tray Recall: Subpotent Iodine Risk
Medline recalls sterile suture removal trays with iodine levels below label claims. These trays may not effectively disinfect wounds. Affected units include specific pack numbers and lots from Mexico.
Lower-risk recall
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Contact the company
Recalling firmMedline Industries IncThree Lakes Drive · Northfield, IL 60093
What happened, in plain English
Medline is recalling sterile suture removal trays that contain less iodine than labeled. This could lead to ineffective wound disinfection during medical procedures. Users should check their product details to see if they are affected. Read more at govinfonow.com/recall/41175-medline-suture-removal-tray-recall-subpotent-iodine-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41175-medline-suture-removal-tray-recall-subpotent-iodine-risk · Updated October 7, 2026 · FDA enforcement record: FDA #D-0264-2018
Cite this page
“Medline Suture Removal Tray Recall: Subpotent Iodine Risk.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41175-medline-suture-removal-tray-recall-subpotent-iodine-risk. Based on FDA recall #D-0264-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0264-2018%22&limit=1).
Why it’s dangerous
The iodine concentration in the Povidone-Iodine prep pads is below the labeled 0.85% level. This means the disinfectant may not work as intended, potentially leading to inadequate wound cleaning and increased infection risk.
Who’s affected
Healthcare professionals using Medline Suture Removal Trays with specific pack numbers and lots sold in Mexico are most at risk. Patients receiving procedures using these trays may also be affected.
How to tell if you have this one
Check for pack numbers starting with DYND70900 or specific lots listed in the recall notice. These trays were packaged in Mexico for Medline Industries, Inc. in Mundelein, IL.
- Brand
Medline- Category
Drug
All 68 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0252-2018 | Aplicare Povidone-Iodine Prep Pad, Antiseptic, Sterile Solution, Active Ingredient: Povidone-iodine USP 10%. Aplicare, INC., Meriden, CT 06450 USA. NDC: 52380-0111-1; Part # P-1001; Lots: 58471; 59003; 59723; 60373; 60807; 61187; 61523; 61998; 63974; 64701; 65864 Part # P-1001-8S Lots: 58368; 58371; 58472; 58499; 58686; 58687; 58688; 58816; 58817; 58818; 59002; 59004; 59333; 59334; 59335; 59574; 59724; 59725; 60157; 60237; 60374; 60375; 60507; 60586; 61101; 61368; 61427; 61618; 61750; 61751; 61999; 62067; 62224; 62226; 62557; 62558; 62954; 62955; 63441; 63442; 63443; 63507; 63508; 64002; 64129; 64243; 64245; 64592; 64840; 65081; 65327; 65583; 65681; 65882; 66026; 66040; 66110; 66193; Part # P-1011 Lots: 66549; 66916 Part # P-1011-8S Lots: 66404; 66580; 66622; 66709; 66856 | 11,750 cases |
| D-0253-2018 | Medline CC Drawer 4 IV Circulation Pack, Contains Rx, Single Use Only, contains 2 Prep Pad PVPs. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093; Pack Number: ACC010254A; Lots: 17HD4376; 17HD1709; 17HD1709 | 51 cases |
| D-0254-2018 | Medline Vaginal Delivery CDS Pack, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093; Pack Number: CDS830006I; Lots: 17IB3974 | 2 cases |
| D-0255-2018 | Medline Vitrectomy CDS Pack, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093; Pack Number: CDS984258F; Lots: 177B1083 | 5 cases |
| D-0256-2018 | Medline RAD NECK ENT TRAY Pack, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093; Pack Number: DYKA1220; Lots: 17FA1301 | 4 cases |
| D-0257-2018 | Medline Newborn Kit. Packaged for Medline Industries, Inc., Northfield, IL 60093; Pack Number: DYKL1133; Lots: 17IA0348; 17GA0975; 17IA0348 | 288 cases |
| D-0258-2018 | Medline Concordia Trunk Kit. Packaged for Medline Industries, Inc., Northfield, IL 60093; Pack Number: DYKM1403; Lots: 17BA1782 | 21 cases |
| D-0259-2018 | Medline Concordia Nurse Bag Kit. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093; Pack Number: DYKM1425; Lots: 17BA1030 | 51 cases |
| D-0260-2018 | Medline Pediatric IV Kit. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093; Pack Number: DYKP1000A; Lots: 17AA2252 | 50 cases |
| D-0261-2018 | Medline CNTRL Line Removal Kit Scripps. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093; Pack Number: DYKSCRIPPSCL1; Lots: 17HA1756 | 375 cases |
| D-0262-2018 | Medline Trunk Kit, Non-sterile. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060; Pack Number: DYKTRUNK1; Lots: 17FA0227; 17FA0470; 17FA1431; 17HA0258; 17HA0259 | 231 cases |
| D-0263-2018 | Medline TRAY, CATHETER CARE, LIDDED. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093; Pack Number: DYND12110; Lots: 16KA2117; 16LA1083; 15GA1298; 16KA0905; 16KA2117; 16BA0141 | 1,000 cases |
| D-0264-2018 | Medline Suture Removal Tray. Sterile. Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; Pack Number: DYND70900; Lots: 17GB6098; 16KB8714; 17GB5103; 17EB4268; 17BB3409; 17SB1821; 17OB8226; 16QB7895; 17EB7214; 16LB5336; 17QB4767; 17MB3722; 17PB7167; 17EB0363; 17DB2103; 17FB2572 Pack Number: DYND70900H; Lots: 16KB8714; 16KB8714; 17EB4268; 17OB8226; 17OB8226; 17EB0363; 17EB0363; 17EB4268; 17EB4268; 16WB5947; 17GB6098; 17GB6098; 17QB4767; 17QB4767; 17MB3722; 17MB3722; 16SB7791; 16TB0404; 17GB6098; 17EB7214; 17EB0363; 17BB3409; 17PB7167; 17PB7167; 17EB7214; 17GB6098; 17PB7167; 17PB7167; 17EB4268; 17EB0363; 17PB7167; 17QB4767; 17QB4767; 17QB4767; 17EB7214; 17EB7214; 17OB8226; 17QB4767; 17BB3409; 17EB7214; 17QB4767; 17QB4767; 17QB4767; 17GB6098; 17GB6098; 17PB7167; 16TB0404; 17PB7167; 17QB4767; 17QB4767; 16WB5947; 17BB3409 | 65,563 cases |
| D-0265-2018 | Medline IV Start Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; Pack Number: DYND74077; Lots: 16GB2754; 17GB3103; 16IB7722; 17EB6063 Pack Number: DYND74077H; Lots: 17EB6063; 17GB3103 | 10,375 cases |
| D-0266-2018 | Medline Central Line Dressing Change Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; Pack Number: DYND74661; Lots: 177B1602; 17RB9139; 16WB5199; 17CB7720; 17CB5841; 167B0074; 16GB8853; 16JB0621; 17EB4904; 16TB9798; 165B0465 Pack Number: DYND74661H; Lots: 17EB4904; 17CB5841; 17CB1032; 165B0465; 16WB5199; 17RB9139; 17CB7720; 16JB0621; 16TB9798; 177B1602; | 14,675 cases |
| D-0267-2018 | Medline Incision and Drainage Tray Kit, Sterile, Single use only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060; Pack Number: DYNDA1046H; Lots: 16LA0907 | 11 cases |
| D-0268-2018 | Medline I&D Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; Pack Number: DYNDA1109; Lots: 178B0923 | 40 cases |
| D-0269-2018 | Medline Sheath Removal Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60063; Pack Number: DYNDA1356; Lots: 17DB2820 | 40 cases |
| D-0270-2018 | Medline Wound Closure Tray, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093; Pack Number: DYNDA1465; Lots: 17HB4903; 17CB8548 | 80 cases |
| D-0271-2018 | Medline General Purpose Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093; Pack Number: DYNDA1591; Lots: 17GB5136; 17PB2138 | 700 cases |
| D-0272-2018 | Medline DC Line Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; Pack Number: DYNDC1971; Lots: 175B1999; Pack Number: DYNDC1971H; Lots: 17OB8570; 175B1999 | 363 cases |
| D-0273-2018 | Medline Dressing Change Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; Pack Number: DYNDC2282; Lots: 16CB5897; 16PB9981 | 280 cases |
| D-0274-2018 | Medline INCISION AND DRAINAGE TRAY Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; Pack Number: DYNDD1039; Lots: 17GB4725; 17HB4905 | 60 cases |
| D-0275-2018 | Medline Circumcision Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093; Pack Number: DYNDF1012E; Lots: 17SB5574 | 80 cases |
| D-0276-2018 | Medline Catheter Insertion Kit, Sterile. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; Pack Number: DYNDINSERTKIT; Lots: 17SB3347; 175B1052; 16JB3251; 16IB2940; 17CB4925 | 4,100 cases |
| D-0277-2018 | Medline All Purpose Instrument Tray, Sterile. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; Pack Number: DYNDL1488; Lots: 177B0657; 17QB3332 | 250 cases |
| D-0278-2018 | Medline General Purpose Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060; Pack Number: DYNDL1648; Lots: 17FA0144 | 56 cases |
| D-0279-2018 | Medline Laceration Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093; Pack Number: DYNDL1688; Lots: 17HB3112 | 600 cases |
| D-0280-2018 | Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060; Pack Number: DYNDR1018A; Lots: 17RB8658; 17HB1913 | 700 cases |
| D-0281-2018 | Medline GHS Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060; Pack Number: DYNDR1056; Lots: 17RB9450 | 1100 cases |
| D-0282-2018 | Medline Staple Remover Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60060; Pack Number: DYNDR1067; Lots: 17PB4605 Pack Number: DYNDR1067H; Lots: 17PB4605 | 248 cases |
| D-0283-2018 | Medline General Purpose Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060; Pack Number: DYNDR1071; Lots: 17FA1640 | 80 cases |
| D-0284-2018 | Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060; Pack Number: DYNDR1109; Lots: 17NB0789; 17EB4269 Pack Number: DYNDR1109H; Lots 17EB4269 | 1,133 cases |
| D-0285-2018 | Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060; Pack Number: DYNDR1111; Lots: 17FB1191; 17HB1905 Pack Number: DYNDR1112A; Lots 177B0660; 175B2485 | 3800 cases |
| D-0286-2018 | Medline Staple Remover Kit, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060; Pack Number: DYNDR1118; Lots: 17SB4219; 175B2486 | 600 cases |
| D-0287-2018 | Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; Pack Number: DYNDR1157; Lots: 177B0661 Pack Number: DYNDR1157H; Lots: 177B0661; 17QB1693 | 3,089 cases |
| D-0288-2018 | Medline NICC Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; Pack Number: DYNDR1161; Lots: 17RB9449 Pack Number: DYNDR1161H; Lots: 17RB9449 | 346 cases |
| D-0289-2018 | Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; Pack Number:DYNDR1165; Lots: 15HB6327; 15HB4355 | 700 cases |
| D-0290-2018 | Medline Skin Staple Remover Kit, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; Pack Number: DYNDR1184; Lots: 175B2484; 17HB1903 | 550 cases |
| D-0291-2018 | Medline Straight Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; Pack Number: DYNDR1186; Lots: 17EB0360; 177B1719 Pack Number: DYNDR1186H; Lots: 16PB7974; 17EB0360 | 10,298 cases |
| D-0292-2018 | Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; Pack Number: DYNDR1195; Lots: 17AB1899 | 100 cases |
| D-0293-2018 | Medline Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093; Pack Number: DYNDR1199; Lots 16XB4041; 175B2487; 17PB8309 | 100 cases |
| D-0294-2018 | Medline Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; Pack Number: DYNDS1010; Lots 15EB9408 | 1,250 cases |
| D-0295-2018 | Medline General Purpose Instrument Set, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; Pack Number: DYNDS1014; Lots 17GB3416; 176B2045 | 3,300 cases |
| D-0296-2018 | Liberator Medical Supply Catheter Insertion Tray, Sterile, Single Use Only. Distributed by: Liberator Medical Supply, INC. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; Pack Number: DYNDT1022E; Lots 17QB4402; 17TB1979 | 20,430 cases |
| D-0297-2018 | Medline Irrigation W/Piston SYR Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093; Pack Number: DYNDT1094 and DYNDT1094H | 2,336 cases |
| D-0298-2018 | Medline IV Start Kit, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093; Pack Number: DYNDV1609; Lots 17GB1216 | 350 cases |
| D-0299-2018 | Medical Equipment Affiliates IV Start Kit, Sterile, Single Use Only. Packaged in Mexico for Medical Equipment Affiliates., Tahlequah, OK 74464; Pack Number: DYNDV39010; Lots 17QB8612 | 5,400 cases |
| D-0300-2018 | Medline Debridement Tray, Sterile, Single Use Only. Assembled in USA by Medline Industries, Inc., Mundelein, IL 6060; Pack Number: DYNDW1032 | 90 cases |
| D-0301-2018 | Medline Skin Biopsy Pack-LF, Sterile, Single Use Only. Packaged in USA by Medline Industries, Inc., Northfield, IL 60093; Pack Number: DYNJ0394028; Lots 17HK3191 | 120 cases |
| D-0302-2018 | Medline Incision and Drainage Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060; Pack Number: DYNJ07147; Lots 1160B1635; 17RB8957; 16WB2198; 16GB6023; 16KB1547; 17DB1855 Pack Number: DYNJ07147H; Lots 17DB1855; 16WB2198; 17RB8957 | 2,369 cases |
| D-0303-2018 | Medline Pacemaker Implant Pack, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060; Pack Number: DYNJ32856C; Lots 17SB6210; 17FB5359; 17SB6208 | 66 cases |
| D-0304-2018 | Medline Hip Replacement, Kit, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Northfield, IL 60093; Pack Number: DYNJ48244B; Lots 17FB2504; 17HB2544 | 88 cases |
| D-0305-2018 | Medline Incision Drainage Kit, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060; Pack Number: P888943; Lots 17RB8662 Pack Number: P888943H; Lots 17RB8662 | 149 cases |
| D-0306-2018 | Medline Anesthesia Kit, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Northfield, IL 60093; Pack Number: DYNJAA6606; Lots 178B1823; 17HB2055 | 60 cases |
| D-0307-2018 | Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060; Pack Number: MDS701550; Lots 16GB7687; 17HB5153; 16IB0427; 17GB3906; 17AB1937; 17CB7737; 16JB1136; 16JB1137 Pack Number: MDS701550H; Lots 16QB4583; 16IB0427; 17CB7737; 16MB6165; 17GB3906; 17AB1937; 16GB7687; 16JB1137; 17HB5153 | 49,587 cases |
| D-0308-2018 | Medline Incision and Drainage Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060; Pack Number: MDS70815; Lots 16LB2959; 173B1289; 17HB4108; 17FB6679; 16JB8627 Pack Number: MDS70815H; Lots 17FB6679 | 808 cases |
| D-0309-2018 | Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060; Pack Number: MDS708550; Lots 17GB4997; 17TB7125; 17RB7896; 17HB3784; 17HB4133; 17RB7895; 17FB1724; 17FB2572; Pack Number: MDS708550H; Lots 17GB4997; 17RB7896; 17PB5544; 17FB1724; 16JB1135; 17TB7125; 16SB9345; 17FB2572; 17FB2571; 17RB7895; 17HB3784; 16NB7654; 17FB1721; 16LB8439; 17HB4133; 16WB1269; 16NB8410; 15VB7079 | 98,901 cases |
| D-0310-2018 | Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060; Pack Number: MDS708555; Lots 17SB5603; 17PB8319; 177B2065; 17DB2104; 17RB9448; 17RB9451; 17PB8314; 17HB5104; 16XB1090; 17QB0860; 16OB0307; 17DB2777; 16UB2803; Pack Number: MDS708555H; Lots 17PB8319; 173B2496; 16UB2803; 16XB1090; 16SB4453; 16RB1126; 17DB2777; 17QB0860; 16TB8928; 17PB8314; 16IB3745; 17RB9451; 17DB2104; 164B2214; 16KB5659 | 195,448 cases |
| D-0311-2018 | Professional Hospital Supply Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Professional Hospital Supply, Inc., 41980 Winchester Rd., Temecula, CA 92590; Pack Number: P524151; Lots 17HB5103; 17RB8741 | 450 cases |
| D-0312-2018 | Medline Suture Removal Pack Latex Safe, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093; Pack Number: P734457; Lots 17GB5158; 17RB8681; 17FB0926 | 663 cases |
| D-0313-2018 | Professional Hospital Supply Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Professional Hospital Supply, Inc., 41980 Winchester Rd., Temecula, CA 92590; Pack Number: P888899; Lots 17RB8659; 17GB5162 Pack Number: P888899H; Lots 17RB8659 | 779 cases |
| D-0314-2018 | Medline Skin Stapler RMVR, Tray Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; Pack Number: P888937; Lots 177B0658; 17QB8268 Pack Number: P888937H; Lots 17QB8268 | 592 ases |
| D-0315-2018 | Medline Incision Drainage Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; Pack Number: P888943; Lots 17RB8662 Pack Number: P888937H; Lots 17QB8268 | — |
| D-0316-2018 | Medline Abdominal Surgery II Pack-LF, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093; Pack Number: PHS541637005 | 144 cases |
| D-0317-2018 | Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060; Pack Number: SD-1010; Lots 17CB8694; 17MB4778; 16KB5621 | 9,000 cases |
| D-0318-2018 | Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060; Pack Number: Z302-R; Lots 177B2075; 17RB9452; 17QB2640; 17CB4220 Pack Number: Z302-RH; Lots 177B2075; 17QB2640; 17RB9452; 17CB4220; 17NB1933; 17MB0084; 16LB3367 | 34,495 cases |
| D-0319-2018 | Medline Incision & Drainage Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093; Pack Numbers: DYNDA1076, DYNDA1076H | 73 cases |
What to do — step by step
Check Product Details
Identify your pack number and lot numbers from the product label to see if they match the recalled items listed in the notice.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 5.9 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0264-2018 (September 21, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0264-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.