Open, ClassifiedPosted Feb 17, 2026·Initiated Jan 7, 2026
Medline Convenience Kits:
1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104;
2) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104A;
3) KIT OPHTHALMOLOGY CORNEAL TRAN, Model Number: DYKMBNDL159;
4) KIT OPHTHALMOLOGY CATARACT, Model Number: DYKMBNDL180;
5) KIT OPHTHALMOLOGY EYE MUSCLE, Model Number: DYKMBNDL42;
6) KIT SURG ONC PORT INSERTION, Model Number: DYKMBNDL43B;
7) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84B;
8) KIT OPTHAMOLOGY BASIC, Model Number: DYKMBNDL98;
9) KIT OPTHAMOLOGY BASIC, Model Number: DYKMBNDL98A;
10) KIT OPTHAMOLOGY BASIC, Model Number: DYKMBNDL98B;
11) MINOR EYE PACK, Model Number: DYNJ17219C;
12) PEDS EYE/MUSCLE PACK, Model Number: DYNJ38791M;
13) EYE PACK, Model Number: DYNJ41207C;
14) OPHTHALMIC PACK, Model Number: DYNJ42043I;
15) BREAST RECONSTRUCTION-HOULE, Model Number: DYNJ44852J;
16) CUSTOM EYE PACK HA-LF, Model Number: DYNJ45585C;
17) EYE PLASTIC PACK, Model Number: DYNJ47859B;
18) EYE PLASTIC PACK, Model Number: DYNJ47859C;
19) CATARACT PACK, Model Number: DYNJ53019A;
20) CATARACT PACK, Model Number: DYNJ54869A;
21) VITRECTOMY PACK, Model Number: DYNJ55280B;
22) NDNW-EYE PACK, Model Number: DYNJ61779C;
23) EYE PK, Model Number: DYNJ62306;
24) VITRECTOMY, Model Number: DYNJ64220;
25) OSC BREAST PACK, Model Number: DYNJ65808C;
26) MILLS CATARACT PACK, Model Number: DYNJ67973A;
27) EYE PACK, Model Number: DYNJ68367B;
28) CATARACT PACK, Model Number: DYNJ68875D;
29) CATARACT PACK, Model Number: DYNJ68875F;
30) CATARACT PACK, Model Number: DYNJ68875G;
31) OPHTHO PLASTIC, Model Number: DYNJ902256C;
32) RETINAL, Model Number: DYNJ907495;
33) CATARACT, Model Number: DYNJ909924;
34) COMBO EYE, Model Number: DYNJ909925;
35) VITRECTOMY, Model Number: DYNJ909929
Reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Eye TrayDistribution: Worldwide distribution - US Nationwide.Recall #Z-1420-2026
Open, ClassifiedPosted Feb 17, 2026·Initiated Jan 7, 2026
Medline Convenience Kits:
1) SPINAL CDS, Model Number: CDS940087AG;
2) SPINAL CDS, Model Number: CDS940087AI;
3) TOTAL HIP CDS-LF, Model Number: CDS980832Q;
4) TOTAL HIP CDS-LF, Model Number: CDS980832R;
5) TOTAL HIP CDS-LF, Model Number: CDS980832S;
6) TOTAL KNEE CDS-LF, Model Number: CDS980833Q;
7) TOTAL KNEE CDS-LF, Model Number: CDS980833R;
8) TOTAL HIP PROCEDURE, Model Number: CDS980865V;
9) TOTAL HIP PROCEDURE, Model Number: CDS980865W;
10) TOTAL HIP PROCEDURE, Model Number: CDS980865X;
11) TOTAL HIP PROCEDURE, Model Number: CDS980865Y;
12) TOTAL KNEE CDS, Model Number: CDS981454K;
13) TOTAL KNEE CDS, Model Number: CDS981454L;
14) KNEE ARTHROSCOPY CDS, Model Number: CDS981502K;
15) TOTAL KNEE, Model Number: CDS981505O;
16) TOTAL KNEE, Model Number: CDS981505P;
17) TOTAL KNEE, Model Number: CDS981505Q;
18) TOTAL KNEE, Model Number: CDS981505R;
19) OR LAMINECTOMY CDS, Model Number: CDS981858F;
20) LAMI FUSION, Model Number: CDS982035W;
21) ARMC TOTAL KNEE CDS, Model Number: CDS982281O;
22) ARMC TOTAL KNEE CDS, Model Number: CDS982281P;
23) ARMC TOTAL KNEE CDS, Model Number: CDS982281S;
24) TOTAL HIP CDS, Model Number: CDS983036K;
25) TOTAL KNEE CDS, Model Number: CDS983042K;
26) LOWER EXTREMITY CDS, Model Number: CDS983049K;
27) ZALE SPINE CDS, Model Number: CDS983182G;
28) TOTAL KNEE CDS, Model Number: CDS983297M;
29) SITTING CERVICAL CDS, Model Number: CDS983480G;
30) SHOULDER CDS, Model Number: CDS983581K;
31) SHOULDER ARTHROSCOPY CDS, Model Number: CDS983838G;
32) TOTAL HIP CDS, Model Number: CDS983840I;
33) TOTAL JOINT CDS-LF, Model Number: CDS983863D;
34) SHOULDER ARTHROSCOPY CDS, Model Number: CDS983879C;
35) TOTAL JOINT, Model Number: CDS983903D;
36) GB TOTAL KNEE, Model Number: CDS984147K;
37) GB LOWER EXTREMITY, Model Number: CDS984156L;
38) LOWER EXTREMTIY, Model Number: CDS984254K;
39) LOWER EXTREMTIY, Model Number: CDS984254L;
40) LOWER EXTREMTIY, Model Number: CDS984254M;
41) LAMI MICRODISC-LF, Model Number: CDS984527I;
42) EXTREMITY CDS-LF, Model Number: CDS984607G;
43) EXTREMITY CDS-LF, Model Number: CDS984607I;
44) HANA/FRACTURE TABLE CDS-LF, Model Number: CDS984610C;
45) TOTAL JOINT CDS, Model Number: CDS985202B;
46) TOTAL JOINT CDS, Model Number: CDS985202C;
47) TRAUMA-LF, Model Number: CDS985279K;
48) ARTHROSCOPY CDS, Model Number: CDS985316A;
49) EXTREMITY CDS, Model Number: CDS985317C;
50) EXTREMITY CDS, Model Number: CDS985317D;
51) EXTREMITY CDS, Model Number: CDS985317F;
52) EXTREMITY CDS, Model Number: CDS985317G;
53) KNEE ARTHROSCOPY CDS, Model Number: CDS985425J;
54) TOTAL HIP PACK (CDSOPM834)-LF, Model Number: CDSOPM834W;
55) JOINT ASPIRATION KIT, Model Number: DYKM1161;
56) TOTAL KNEE SUPPLEMENT PACK NS, Model Number: DYKM2106;
57) KIT ORTHRO TOTAL HIP DR. NANDI, Model Number: DYKMBNDL137;
58) KIT NEUR FUS LUM POST CRANDALL, Model Number: DYKMBNDL138A;
59) KIT NEURO CRANIOTOMYANEURYSM R, Model Number: DYKMBNDL141;
60) KIT NEURO CRANIOTOMYANEURYSM R, Model Number: DYKMBNDL141A;
61) KIT NEURO CRANIOTOMYANEURYSM R, Model Number: DYKMBNDL141B;
62) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142C;
63) KIT NEURO CRANIOTOMY ACOUSTIC, Model Number: DYKMBNDL143;
64) KIT NEURO CRANIOTOMY FOR TUMOR, Model Number: DYKMBNDL144;
65
Open, ClassifiedPosted Feb 17, 2026·Initiated Jan 7, 2026
Medline Convenience Kits:
1) ARTHROSCOPY CDS, Model Number: CDS984609B;
2) ARTHROSCOPY TRAYS, Model Number: DYNJ22501G;
3) ARTHROSCOPY PACK, Model Number: DYNJ32715F;
4) CHS ARTHROSCOPY PACK, Model Number: DYNJ50834C;
5) ARTHROSCOPY TRAY-LF, Model Number: DYNJ51069
Reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Arthrogram TrayDistribution: Worldwide distribution - US Nationwide.Recall #Z-1422-2026
Open, ClassifiedPosted Feb 17, 2026·Initiated Jan 7, 2026
Medline Surgical Drapes:
1) SHEET,DRAPE,40X58,STERILE, Model Number: DYNJP2410;
2) DRAPE,SHEET,ECONOMY,40X58",ST,20/CS, Model Number: DYNJP2411;
3) SHEET,DRAPE, 40X70,STERILE, Model Number: DYNJP2412;
4) DRAPE,MEDIUM,TAPE,40X70",ST,50/CS, Model Number: DYNJP2412T;
5) SHEET,DRAPE,53X77,STERILE, Model Number: DYNJP2414;
6) DRAPE,SHEET,3/4,53X77",ST,20/CS, Model Number: DYNJP2414R;
7) DRAPE,SHEET,ULTRAGARD,20/CS, Model Number: DYNJP2414UG;
8) DRAPE,RNF,53X77",ST,20/CS, Model Number: DYNJP2416;
9) SHEET,DRAPE,70X85,STERILE, Model Number: DYNJP2417;
10) DRAPE,FILM SHEET,44X65",ST,20/CS, Model Number: DYNJP2418;
11) DRAPE,SHEET,70X100",ST,12/CS, Model Number: DYNJP2419;
12) LEGGINGS,33X49",XL,PAIR,ST,CLR,20/CS, Model Number: DYNJP2462;
13) DRAPE,CHEST,FENESTRATION,15X10",ST,12/CS, Model Number: DYNJP2491;
14) DRAPE,MINOR PROC,6X6" FEN, ST,10/CS, Model Number: DYNJP2492;
15) SHEET, DRAPE, SPLIT, ST,10/CS, Model Number: DYNJP2498;
16) DRAPE,LAPAROTOMY,T-SHEET,ST,12/CS, Model Number: DYNJP3003;
17) DRAPE,LAPAROTOMY,T,ULTRAGARD,12/CS, Model Number: DYNJP3003UG;
18) DRAPE,LAPAROTOMY,POUCH,ST,12/CS, Model Number: DYNJP3008;
19) DRAPE,LAPAROTOMY,POUCH ULTRAGARD,12/CS, Model Number: DYNJP3008UG;
20) DRAPE,LAPAROTOMY,T,PEDIATRIC,ST,10/CS, Model Number: DYNJP3009;
21) DRAPE,LAPAROTOMY,ABDOMINAL,ST,12/CS, Model Number: DYNJP3101;
22) DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS, Model Number: DYNJP3102A;
23) DRAPE,LAP,CHOLE,W/TROUGH ULTRAGARD,12/CS, Model Number: DYNJP3102UG;
24) DRAPE,ABDOMINAL,MAJOR,ST,8/CS, Model Number: DYNJP3103;
25) DRAPE,ABDOMINAL,MAJOR,PCH/TRGH,ST,8/CS, Model Number: DYNJP3109;
26) DRAPE,TOP,102X53",ST,14/CS, Model Number: DYNJP4002;
27) DRAPE,CARDIOVASCULAR,SPLIT,ST,8/CS, Model Number: DYNJP4003;
28) DRAPE,ANGIO,BRACH,ECLIPSE,38X44,ST,40/CS, Model Number: DYNJP4106;
29) DRAPE,FEMORAL ANGIOGRAPHY,W/POUCH,8/CS, Model Number: DYNJP4119;
30) DRAPE,TOP,ARMCOVERS,106X59,STERILE,20/CS, Model Number: DYNJP4215;
31) DRAPE,UNDERBUTTOCK,PCH,ST,20/CS, Model Number: DYNJP6002;
32) DRAPE,UNDERBUTTOCK,GRAD POUCH,PORT,20/CS, Model Number: DYNJP6006;
33) DRAPE,EENT,SPLIT,ST,8/CS, Model Number: DYNJP7001;
34) SHEET,T,THYROID,ST,12/CS, Model Number: DYNJP7003;
35) DRAPE,EXTREMITY,89X128",ST,12/CS, Model Number: DYNJP8002;
36) DRAPE,EXTREMITY,ULTRAGARD,12/CS, Model Number: DYNJP8002UG;
37) T-DRAPE,EXTREMITY,ST,6/CS, Model Number: DYNJP8003;
38) T-DRAPE,EXTREMITY,ULTRAGARD,6/CS, Model Number: DYNJP8003UG;
39) DRAPE,HAND,ST,18/CS, Model Number: DYNJP8005;
40) DRAPE,HAND,ULTRAGARD,18/CS, Model Number: DYNJP8005UG;
41) DRAPE,HIP,W/POUCH,ST,5/CS, Model Number: DYNJP8201;
42) DBD-DRAPE,HIP,W/POUCHES, ULTRAGARD, Model Number: DYNJP8201UG;
43) DRAPE,ORTHOMAX,HIP,W/POUCH,6/CS, Model Number: DYNJP8211;
44) SHEET,ORTHO,SPLIT,ST,10/CS, Model Number: DYNJP8301;
45) DRAPE,SPLIT,77X120",10/CS, Model Number: DYNJP8304A;
46) ULTRAGARD SPLIT DRAPE,10/CS, Model Number: DYNJP8304UG;
47) DRAPE,SHOULDER,BEACH CHAIR,ST,5/CS, Model Number: DYNJP8412;
48) DRAPE,SHOULDER,BEACH CH,ULTRAGARD,5/CS, Model Number: DYNJP8412UG;
49) DRAPE,SHOULDER,BEACH CHAIR,ST,5/CS, Model Number: DYNJP8414;
50) DRAPE,LITHOTOMY,ST,8/CS, Model Number: DYNJP9001;
51) DRAPE,LAVH,ST,8/CS, Model Number: DYNJP9103;
52) DRAPE,VETERINARY,CUSTOM,SM,20/CS, Model Number: MED901;
53) DRAPE,VETERINARY,CUSTOM,M,20/CS, Model Number: MED902;
54) DRAPE,VETERINARY,CUSTOM,L,20/CS, Model Number: MED903
Open, ClassifiedPosted Feb 17, 2026·Initiated Jan 7, 2026
Medline Surgical Gowns:
1) GOWN,NONRNF,L,30/CS, Model Number: DYNJP2001;
2) GOWN,SIRUS,NONRNF,SETINSLV,L,20/CS, Model Number: DYNJP2001S;
3) GOWN,ECLIPSE,NONRNF,XL,ST,30/CS, Model Number: DYNJP2002;
4) GOWN,SIRUS,NONRNF,SETINSLV,XL,20/CS, Model Number: DYNJP2002S;
5) GOWN,SIRUS,NONRNF,XLN/XL,20/CS, Model Number: DYNJP2002SL;
6) GOWN,NONRNF,2XL,18/CS, Model Number: DYNJP2003;
7) GOWN,SIRUS,NONRNF,SETINSLV,2XL,18/CS, Model Number: DYNJP2003S;
8) GOWN,SIRUS,NONRNF,XLN/2XL,18/CS, Model Number: DYNJP2003SL;
9) GOWN,NONRNF,3XL,18/CS, Model Number: DYNJP2004;
10) GOWN,SIRUS,NONRNF,3XL,18/CS, Model Number: DYNJP2004S;
11) GOWN,NONRNF,SM,30/CS, Model Number: DYNJP2005;
12) GOWN,SIRUS,NONRNF,SM,30/CS, Model Number: DYNJP2005S;
13) GOWN,NONRNF,4XL,18/CS, Model Number: DYNJP2009;
14) GOWN,SIRUS,NONRNF,4XL,18/CS, Model Number: DYNJP2009S;
15) GOWN,ECLIPSE,FABRNF,L,30/CS, Model Number: DYNJP2101;
16) GOWN,SIRUS,FABRNF,L,20/CS, Model Number: DYNJP2101S;
17) GOWN,ECLIPSE,FABRNF,XL,30/CS, Model Number: DYNJP2102;
18) GOWN,SIRUS,FABRNF,XL,20/CS, Model Number: DYNJP2102S;
19) GOWN,ECLIPSE,FABRNF,2XL,18/CS, Model Number: DYNJP2103;
20) GOWN,SIRUS,FABRNF,2XL,18/CS, Model Number: DYNJP2103S;
21) GOWN,ECLIPSE,POLYRNF,L,30/CS, Model Number: DYNJP2201;
22) GOWN,SIRUS,POLYRNF,SETINSLV,L,20/CS, Model Number: DYNJP2201S;
23) GOWN,ECLIPSE,POLYRNF,XL,30/CS, Model Number: DYNJP2202;
24) GOWN,SIRUS,POLYRNF,SETINSLV,XL,20/CS, Model Number: DYNJP2202S;
25) GOWN,ECLIPSE,POLYRNF,2XL,18/CS, Model Number: DYNJP2203;
26) GOWN,SIRUS,POLYRNF,SETINSLV,2XL,18/CS, Model Number: DYNJP2203S;
27) GOWN,ECLIPSE,POLYRNF,XLN/L,28/CS, Model Number: DYNJP2204;
28) GOWN,SIRUS,POLYRNF,XLN/LG,20/CS, Model Number: DYNJP2204S;
29) GOWN,ECLIPSE,POLYRNF,XLN/XL,28/CS, Model Number: DYNJP2205;
30) GOWN,SIRUS,POLYRNF,XLN/XL,20/CS, Model Number: DYNJP2205S;
31) GOWN,ECLIPSE,POLYRNF,XLN/2XL,18/CS, Model Number: DYNJP2206;
32) GOWN,SIRUS,POLYRNF,XLN/2XL,18/CS, Model Number: DYNJP2206S;
33) DBQ-GOWN,PREVENTION PLUS,LN/L,ST,24/CS, Model Number: DYNJP2301P;
34) DBQ-GOWN,PREVENTION PLUS,XLN/XL,ST,24/CS, Model Number: DYNJP2302P;
35) DBD-GOWN,PREVENTION PLUS,XLN/2XL,ST,22/C, Model Number: DYNJP2303P;
36) DBD-GOWN,PREVENTION PLUS,L,ST,24/CS, Model Number: DYNJP2306P;
37) DBQ-GOWN,PREVENTION PLUS,XL,ST,24/CS, Model Number: DYNJP2307P;
38) DBQ-GOWN,PREVENTION PLUS,2XL,ST,22/CS, Model Number: DYNJP2308P;
39) GOWN,ORBIS,LVL 3,LRG/XLONG,ST,24/CS, Model Number: DYNJP2361P;
40) GOWN,ORBIS,LVL 3,XLONG/XLARGE,ST,24/CS, Model Number: DYNJP2362P;
41) GOWN,ORBIS,LVL 3,XLNG/XXLARGE,ST,22/CS, Model Number: DYNJP2363P;
42) GOWN,ORBIS,LVL 3,LARGE,ST,24/CS, Model Number: DYNJP2366P;
43) GOWN,ORBIS,LVL 3,XLARGE,ST,24/CS, Model Number: DYNJP2367P;
44) GOWN,ORBIS,LVL 3,XXLARGE,ST,22/CS, Model Number: DYNJP2368P;
45) GOWN,ORBIS,LVL 3,4XL,ST,20/CS, Model Number: DYNJP2369P;
46) GOWN,SIRUS,NONRNF,RAGLAN,L,ST,32/CS, Model Number: DYNJP2401;
47) GOWN,SIRUS,NONRNF,RAGLAN,XL,ST,30/CS, Model Number: DYNJP2402;
48) GOWN,SIRUS,NONRNF,RAGLAN,2XL,ST,28/CS, Model Number: DYNJP2403;
49) GOWN,SIRUS,FABRNF,RAGLAN,L,ST,30/CS, Model Number: DYNJP2501;
50) GOWN,SIRUS,FABRNF,RAGLAN,XL,ST,28/CS, Model Number: DYNJP2502;
51) GOWN,SIRUS,FABRNF,RAGLAN,2XL,ST,28/CS, Model Number: DYNJP2503;
52
Open, ClassifiedPosted Feb 17, 2026·Initiated Jan 7, 2026
Medline Surgical Packs:
1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG;
2) PACK,SHOULDER,DRAPE,POUCH,10/CSModel Number: DYNJP8401
Reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: General Surgery TrayDistribution: Worldwide distribution - US Nationwide.Recall #Z-1425-2026
Open, ClassifiedPosted Feb 17, 2026·Initiated Dec 31, 2025
Brand Name: Prodisc
Product Name: Prodisc C SK
Model/Catalog Number: PDSL6
Software Version: N/A
Product Description: Total cervical disc replacement
Component: No
Reason: Products were mislabeled as the 6mm product but included the 5 mm product.
Root cause: Process control
Recalling firm: Centinel Spine, Inc.Type: Prosthesis, Intervertebral DiscDistribution: US Nationwide distribution in the states of AL, CA, CO, LA, NY, OR, TN, TX.Recall #Z-1426-2026
Open, ClassifiedPosted Feb 17, 2026·Initiated Jan 21, 2026
MOLLI 2 System
System includes:
MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker
UDI (GTIN): 00850024195028
MS-00009 (Pack of 10) - MOLLI Introducer (12cm, 14G) and MOLLI Marker
UDI (GTIN): 00850024195134
MP2001 - MOLLI 2 Wand
UDI (GTIN): 00850024195141
MP2015A - MOLLI OncoPen
UDI (GTIN): 00850024195219
MT2001 - MOLLI 2 Tablet
UDI (GTIN): 00850024195158
The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. the MOLLI Marker is located and surgically removed with the target tissue.
Reason: Due to a need to update the product labeling (Instructions for Use IFU) as a result of the magnetized surgical tools dislodging markers using during target tissue removal procedures.
Root cause: Under Investigation by firm
Recalling firm: Stryker CorporationType: Marker, Radiographic, ImplantableDistribution: Worldwide - U.S. Nationwide distribution including in the states of AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, HI ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WV, WI, and WY. The countries of Canada, Singapore, Panama, Jamaica, and Cayman Islands.Recall #Z-1427-2026
Open, ClassifiedPosted Feb 13, 2026·Initiated Dec 18, 2025
Teslatome Bipolar Sphincterotomes
REF: TESLA-B2535-260
Model Number: G60784
UDI-DI code: 00827002607842
REF: TESLA-B2535-450
Model Number: G60785
UDI-DI code: 00827002607859
These devices are used for cannulation of the ductal system and for sphincterotomy. If preloaded, the device also aids in bridging difficult strictures during ERCP. It is indicated for sphincterotome-aided, wire-guided selective cannulation of the biliary ducts.
Reason: Due to product that may contain a void in the material that separates the wire guide and cutting wire lumens, which may cause an inappropriate path of current during cutting.
Root cause: Under Investigation by firm
Recalling firm: Wilson-Cook Medical Inc.Type: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)Distribution: U.S. Distribution to states of: CA, CO, IN, and NC.Recall #Z-1362-2026
Open, ClassifiedPosted Feb 13, 2026·Initiated Jan 16, 2026
MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2) 31815.
MediHoney Gel dressing with Active Leptospermum Honey provides a moist environment conducive to wound healing and is indicated for light to moderately exuding wounds.
Reason: Potential packaging failures, which could lead to a breach in the sterile barrier.
Root cause: Under Investigation by firm
Recalling firm: Integra LifeSciences Corp. (NeuroSciences)Type: Dressing, Wound, DrugDistribution: Worldwide - US Nationwide distribution in the states of TX, MI, FL, IN, MO, CA, VA, NJ, PA, SC, TN, RI, NY and the countries of Australia, Austria, Bahrain, Canada, Finland, France, Germany, Greece, Guam, Guernsey, Hungary, Iran (Islamic Republic of), Iraq, Ireland, Israel, Italy, Korea (the Republic of), Kuwait, Lebanon, Madagascar, Malaysia, Netherlands (the), New Zealand, Norway, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovenia, Spain, Switzerland, Tunisia, Uganda, United Arab Emirates (the), United Kingdom of Great Britain and Northern Ireland (the), Virgin Islands (U.S.).Recall #Z-1363-2026
Open, ClassifiedPosted Feb 13, 2026·Initiated Jan 16, 2026
MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045.
MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE LEPTOSPERMUM HONEY supports and aids autolytic debridement and is indicated for the management of moderately to heavily exuding wounds
Reason: Potential packaging failures, which could lead to a breach in the sterile barrier.
Root cause: Under Investigation by firm
Recalling firm: Integra LifeSciences Corp. (NeuroSciences)Type: Dressing, Wound, DrugDistribution: Worldwide - US Nationwide distribution in the states of TX, MI, FL, IN, MO, CA, VA, NJ, PA, SC, TN, RI, NY and the countries of Australia, Austria, Bahrain, Canada, Finland, France, Germany, Greece, Guam, Guernsey, Hungary, Iran (Islamic Republic of), Iraq, Ireland, Israel, Italy, Korea (the Republic of), Kuwait, Lebanon, Madagascar, Malaysia, Netherlands (the), New Zealand, Norway, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovenia, Spain, Switzerland, Tunisia, Uganda, United Arab Emirates (the), United Kingdom of Great Britain and Northern Ireland (the), Virgin Islands (U.S.).Recall #Z-1364-2026
Open, ClassifiedPosted Feb 13, 2026·Initiated Jan 16, 2026
Private Label CVS. Model Number: CVS405406.
Helps maintain a moist wound environment, which has shown to be conducive to wound healing. Intended for minor scalds & burns, minor cuts, lacerations & minor abrasions.
Reason: Potential packaging failures, which could lead to a breach in the sterile barrier.
Root cause: Under Investigation by firm
Recalling firm: Integra LifeSciences Corp. (NeuroSciences)Type: Dressing, Wound, DrugDistribution: Worldwide - US Nationwide distribution in the states of TX, MI, FL, IN, MO, CA, VA, NJ, PA, SC, TN, RI, NY and the countries of Australia, Austria, Bahrain, Canada, Finland, France, Germany, Greece, Guam, Guernsey, Hungary, Iran (Islamic Republic of), Iraq, Ireland, Israel, Italy, Korea (the Republic of), Kuwait, Lebanon, Madagascar, Malaysia, Netherlands (the), New Zealand, Norway, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovenia, Spain, Switzerland, Tunisia, Uganda, United Arab Emirates (the), United Kingdom of Great Britain and Northern Ireland (the), Virgin Islands (U.S.).Recall #Z-1365-2026
Open, ClassifiedPosted Feb 13, 2026·Initiated Dec 31, 2025
Medline Industries IV Administration and Extension Sets:
1) DBD-IV ADMIN SET,60DRP,1NEEDLE-FREE VALV, Model Number: DYNDTB0529;
2) IV ADMIN SET, 10DRP, 1NF, 92, Model Number: DYNDTB1029;
3) DBD-IVEXTSET2.4ML2 NEEDLE-FREEVLVE,35, Model Number: DYNDTB1516;
4) DBD-IV ADMIN SET, 15DRP, 1 INJECT PORT,, Model Number: DYNDTB1530;
5) DBD-IV ADMIN SET, 15DRP, ROLLER CLAMP, 6, Model Number: DYNDTB1539;
6) DBD-IV ADMIN SET, 15DRP, 3 NF, 109, Model Number: DYNDTB1545;
7) IV ADMIN SET, 20DRP, 3 NF, 109, Model Number: DYNDTB2045;
8) DBD-IVADMINSET60DRP2NEEDLE-FREEVLVE96, Model Number: DYNDTB0512;
9) DBD-IVADMINSET,60DRP3 NEEDLE-FREE VLVE11, Model Number: DYNDTB0555;
10) IV ADMIN SET, 10DRP, NF,INJ, 96, Model Number: DYNDTB1022;
11) DBD-IV ADMIN SET, 15DRP, 2NF, 96, Model Number: DYNDTB1512;
12) DBD-IV ADMIN SET, 15DRP, 1NF, 92, Model Number: DYNDTB1529;
13) DBD-IV ADMIN SET, 15DRP, ROLLER CLAMP, 9, Model Number: DYNDTB1537;
14) DBD-IV ADMIN SET, 15DRP, SECOND, 40, Model Number: DYNDTB1540;
15) IV ADMIN SET, 20DRP, 1NF, 92, Model Number: DYNDTB2029;
16) DBD-IV EXT SET, 6.5, 1.1ML, M LUERLOCK,, Model Number: DYNDTB5077;
17) IV ADMIN SET, 10DRP, 3 NF, 109, Model Number: DYNDTB1045;
18) DBD-IVADMISET15DRP4NEEDLEFREE VLVESTPCK1, Model Number: DYNDTB1545D;
19) IV ADMIN SET15DRPFLWCTRL1NEEDLEFREE VA, Model Number: DYNDTB2524;
20) IV ADMIN SET, 10DRP, 2NF, 96, Model Number: DYNDTB1012;
21) IV ADMIN SET, 20DRP, 2NF, 96, Model Number: DYNDTB2012;
22) IV ADMIN SET, 20DRP, NF,INJ, 96, Model Number: DYNDTB2022;
23) DBD-IV EXT SET,SMBORE EXT,8,M LUERLOCK,1, Model Number: DYNDTB5081
Reason: Under circumstances involving exposure to particular chemicals and mechanical forces, the male luer connectors for the specified IV Administration and Extension sets may leak, crack, and/or break during use, which may result in a delay in patient treatment, blood loss, infection, an air embolism, and/or underdosage of medication.
Root cause: Process control
Recalling firm: Medline Industries, LPType: Set, Administration, IntravascularDistribution: Worldwide distribution - US Nationwide and the country of Bahamas.Recall #Z-1366-2026
Open, ClassifiedPosted Feb 13, 2026·Initiated Dec 12, 2025
Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060
Reason: Due to damage to outer tray that can potentially compromise the sterile barrier
Root cause: Process control
Recalling firm: Bard Peripheral Vascular IncType: Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 DaysDistribution: Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of Argentina, Australia, Brazil, Canada, Chile, Hong Kong, India, Japan, Korea, Mexico, Malaysia, Singapore, Thailand, Uruguay, Vietnam.Recall #Z-1367-2026
Open, ClassifiedPosted Feb 13, 2026·Initiated Jan 13, 2026
Brand Name: Spectrum IQ
Product Name: Infusion Pump
Model/Catalog Number: 3570009
Software Version: N/A
Product Description: Infusion Pump, one unit per carton
Component: N/A
Reason: Pumps were released without full testing being performed, including occlusion alarm testing.
Root cause: Employee error
Recalling firm: Baxter Healthcare CorporationType: Pump, InfusionDistribution: States: Ohio
Countries: United StatesRecall #Z-1368-2026
Open, ClassifiedPosted Feb 13, 2026·Initiated Dec 15, 2025
Estrone RIA, REF: DSL8700
Reason: The affected Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability. Only in some (very rare) cases may the issue occur.
Root cause: Equipment maintenance
Recalling firm: Immunotech A.S.Type: Radioimmunoassay, EstroneDistribution: Worldwide - US Nationwide distribution in the state of NC and the countries of Germany, Argentina, Netherlands, Hungary, Austria, Belgium, France, Italy.Recall #Z-1369-2026
Open, ClassifiedPosted Feb 13, 2026·Initiated Dec 31, 2025
Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.
Reason: A systematic positive bias of up to 20% was identified across the reportable potassium range, resulting in false elevation results of patient samples when using Medica s capillary tubes.
Root cause: Nonconforming Material/Component
Recalling firm: Medica CorporationType: Electrode, Ion Specific, PotassiumDistribution: International distribution to the countries of Russia, Bulgaria, Kazakhstan, Ukraine, Pakistan, Belarus.Recall #Z-1370-2026
Open, ClassifiedPosted Feb 12, 2026·Initiated Dec 30, 2025
da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45
Reason: Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete visualization loss, without fault, instruments remain active, could lead to instrument contact with tissue, resulting in injury/bleeding; may require alternate surgical modality.
Root cause: Process change control
Recalling firm: Intuitive Surgical, Inc.Type: System, Surgical, Computer Controlled InstrumentDistribution: US Nationwide distribution in the states of KS, AZ, MA, FL, MI, NC, IL, DC, TX, KY, MS, CA, MN, NV, NY, WI, ID, GA, CT, SC, UT, VA.Recall #Z-1355-2026
Open, ClassifiedPosted Feb 12, 2026·Initiated Jan 20, 2023
Surepulse VS Cap Extra Small
REF: SP-159-A1
component of VS Newborn Heart Rate Monitor
Reason: Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Root cause: Labeling Change Control
Recalling firm: SUREPULSE MEDICAL LTDType: OximeterDistribution: Worldwide - US Nationwide distribution in the states of CT, TX and the countries of United Kingdom of Great Britain and Northern Ireland, Netherlands, United Arab Emirates.Recall #Z-1356-2026
Open, ClassifiedPosted Feb 12, 2026·Initiated Jan 20, 2023
Surepulse VS Cap Small
REF: SP-160-A1
component of VS Newborn Heart Rate Monitor
Reason: Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Root cause: Labeling Change Control
Recalling firm: SUREPULSE MEDICAL LTDType: OximeterDistribution: Worldwide - US Nationwide distribution in the states of CT, TX and the countries of United Kingdom of Great Britain and Northern Ireland, Netherlands, United Arab Emirates.Recall #Z-1357-2026