Open, ClassifiedPosted May 5, 2025·Initiated Apr 10, 2025
CADD-Solis Infusion Pump Models:
1) PUMP KIT, CADD-SOLIS, MDL 2110,
V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-51;
2) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0402-51;
3) PUMP KIT, CADD-SOLIS, YELLOW,
MODEL 2110 1/EA, Model Number: 21-2112-0100-51;
4) PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW KEYPAD, MODEL 2110, NA ENGLISH 1/EA, Model Number: 21-2112-0300-01;
5) PUMP KIT, CADD-SOLIS HPCA PIB,
MODEL 2110, NA ENGLISH 1/EA, Model Number: 21-2111-0300-01;
6) PUMP KIT, CADD-SOLIS, MDL 2110,
V4.1, CE ENGLISH 1/EA, Model Number: 21-2111-0401-51;
7) PUMP KIT, CADD-SOLIS, MODEL 2110, CE ENGLISH 1/EA, Model Number: 21-2111-0100-51;
8) PUMP KIT, CADD-SOLIS, MDL 2110, V4.1, YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0401-51;
9) PUMP KIT, CADD-SOLIS, MDL 2100, CE ENGLISH 1/EA, Model Number: 21-2101-51;
10) PUMP KIT, CADD-SOLIS, MDL 2110, V4.0, CE ENGLISH 1/EA, Model Number: 21-2111-0400-51;
11) PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, OUS ENGLISH
1/EA, Model Number: 21-2111-0300-50;
12) PUMP, TRIAL/LOANER, CADD-
SOLIS, MODEL 2100 1/EA, Model Number: 21-2101-00;
13) PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110 TRIAL/LOANER, NA
ENGLISH 1/EA, Model Number: 21-2111-0300-00;
14) PUMP KIT, CADD-SOLIS, MDL 2110,
TRIAL/LOANER, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-78;
15) PUMP, TRIAL/LOANER, CADD-
SOLIS, MODEL 2110 1/EA, Model Number: 21-2111-0100-00;
16) PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110,TRIAL/LOANER, NA ENGLISH
1/EA, Model Number: 21-2112-0300-00;
17) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, TRIAL/LOANER YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0402-78;
18) PUMP, DEMO, CADD-SOLIS, MODEL 2100, NOT FOR HUMAN
USE 1/EA, Model Number: 21-2101-249;
19) PUMP KIT, CADD-SOLIS, MDL 2110, TRIAL/LOANER, V4.1, CE ENGLISH 1/EA, Model Number: 21-2111-0401-78;
20) PUMP KIT, CADD-SOLIS, YELLOW,
MDL 2100 1/EA, Model Number: 21-2102-51;
21) PUMP KIT, CADD-SOLIS, MDL 2110, V4.1, NFHU, YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0401-249;
22) PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NFHU, NA ENGLISH
1/EA, Model Number: 21-2111-0300-231;
23) PUMP KIT, CADD-SOLIS, MDL 2110, V4.1, TRIAL/LOANER YELLOW, CE
ENGLISH 1/EA, Model Number: 21-2112-0401-78;
24) PUMP KIT, CADD-SOLIS, MDL 2110,
V4.0, YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0400-51;
25) PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, OUS ENGLISH 1/EA, Model Number: 21-2112-0300-50;
26) PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110 TRIAL/LOANER, NA
ENGLISH 1/EA, Model Number: 21-2111-0300-00;
27) PUMP, TRIAL/LOANER, CADD- SOLIS, MODEL 2110 1/EA, Model Number: 21-2111-0100-00;
28) PUMP KIT, CADD-SOLIS, MODEL 2110, CE ENGLISH 1/EA, Model Number: 21-2111-0100-51;
29) PUMP, CADD-SOLIS, MODEL 2110, CE ENGLISH OUS 1/EA, Model Number: 21-2111-0100-50;
30) PUMP KIT, CADD-SOLIS, MDL 2100, CE ENGLISH 1/EA, Model Number: 21-2101-51;
31) PUMP KIT, CADD-SOLIS HPCA, YELLOW KEYPAD, MODEL 2110, CE
ENGLISH, OUS 1/EA, Model Number: 21-2112-0100-50;
32) PUMP, TRIAL/LOANER, CADD- SOLIS, MODEL 2100 1/EA, Model Number: 21-2101-00;
33) PUMP KIT, CADD-SOLIS, MDL 2110, v4.0, YELLOW, ENGLISH 1/EA, Model Number: 21-2112-0400-01.
Reason: There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
Root cause: Under Investigation by firm
Recalling firm: Smiths Medical ASD, Inc.Type: Pump, Infusion, PcaDistribution: Worldwide - US Nationwide distribution.Recall #Z-1681-2025
Open, ClassifiedPosted May 5, 2025·Initiated Apr 10, 2025
CADD Solis VIP Ambulatory Infusion Pump Models:
1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL
MODE, 1/EA, Model Number: 21-2127-0105-01;
2) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, PHARMGUARD
ENABLED, 1/EA, Model Number: 21-2120-0105-01;
3) PUMP KIT, CADD-SOLIS VIP, MDL
2120, NA ENGLISH 1/EA, Model Number: 21-2120-0103-01;
4) PUMP, CADD-SOLIS VIP, MDL
2120, ENGLISH 1/EA, Model Number: 21-2120-0102-51;
5) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, PHARMGUARD
ENABLED 1/EA, Model Number: 21-2120-0104-01;
6) PUMP KIT, CADD-SOLIS VIP, MDL
2120, CE GLOBAL ENGLISH 1/EA, Model Number: 21-2120-0103-51;
7) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE 1/EA, Model Number: 21-2127-0104-01;
8) PUMP KIT, CADD-SOLIS VIP, MDL 2120, TRIAL/LOANER, NA ENGLISH, PHARMGUARD, 1/EA, Model Number: 21-2120-0105-00;
9) PUMP, CADD-SOLIS VIP, MDL 2120, TRIAL/LOANER CE GLOBAL
ENGLISH 1/EA, Model Number: 21-2120-0103-78;
10) PUMP, CADD-SOLIS VIP, MDL 2120, ENGLISH, TRIAL/LOANER
1/EA, Model Number: 21-2120-0102-78;
11) PUMP, CADD-SOLIS VIP, MDL 2120, NFHU, NA ENGLISH,
PHARMGUARD ENABLED 1/EA, Model Number: 21-2120-0104-231;
12) PUMP, CADD-SOLIS VIP, MDL
2120, ENGLISH, NFHU 1/EA, Model Number: 21-2120-0102-249;
13) PUMP, CADD-SOLIS VIP, MDL 2120, NFHU CE GLOBAL ENGLISH
1/EA, Model Number: 21-2120-0103-249;
14) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, FACTORY LIBRARY 1/EA, Model Number: 21-2125-0104-01;
15) PUMP, CADD-SOLIS VIP, MDL
2120, ENGLISH, NFHU 1/EA, Model Number: 21-2120-0102-249.
Reason: There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
Root cause: Under Investigation by firm
Recalling firm: Smiths Medical ASD, Inc.Type: Pump, InfusionDistribution: Worldwide - US Nationwide distribution.Recall #Z-1682-2025
Open, ClassifiedPosted May 5, 2025·Initiated Apr 2, 2025
Washer Disinfector Aquadis 56; Model Number: 56A
Reason: The frequency inverter is not programmed by supplier according to specification which causes the circulation pump to start earlier than expected, resulting in additional wear and tear, earlier than expected, on the axial seal in the pump housing.
Root cause: Under Investigation by firm
Recalling firm: Getinge Disinfection AbType: Disinfector, Medical DevicesDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Bangladesh, Brazil, Canada, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Italy, Japan, Kenya, Korea, Kuwait, Latvia, Lithuania, Malaysia, Mauritania, Mexico, Netherlands, New Caledonia, Nigeria, Norway, Oman, Pakistan, Philippines, Poland, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Syria, Thailand, Turkey, Turkmenistan, United Arab Emirates, United Kingdom, Vietnam, Zambia.Recall #Z-1720-2025 Open, ClassifiedPosted May 5, 2025·Initiated Apr 2, 2025
Washer Disinfector Aquadis 56; Model Number: 56M
Reason: The frequency inverter is not programmed by supplier according to specification which causes the circulation pump to start earlier than expected, resulting in additional wear and tear, earlier than expected, on the axial seal in the pump housing.
Root cause: Under Investigation by firm
Recalling firm: Getinge Disinfection AbType: Disinfector, Medical DevicesDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Bangladesh, Brazil, Canada, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Italy, Japan, Kenya, Korea, Kuwait, Latvia, Lithuania, Malaysia, Mauritania, Mexico, Netherlands, New Caledonia, Nigeria, Norway, Oman, Pakistan, Philippines, Poland, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Syria, Thailand, Turkey, Turkmenistan, United Arab Emirates, United Kingdom, Vietnam, Zambia.Recall #Z-1721-2025 Open, ClassifiedPosted May 5, 2025·Initiated Apr 7, 2025
Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line STerm , Adt/Pedi Intub CO2 Line STerm Lng , Adt/Pedi Intub CO2 Line High Humidity , Adt/Pedi Intub CO2 Line LTerm Lng , Adt/Pedi Intub CO2 Line LTerm , Neo/Inf Intub CO2 Line LTerm , Neo/Inf Intub CO2 Line High Humidity , Neo/Inf Intub CO2 Line LTerm Lng , VitaLine H Set Adult/Pediatric , VitaLine H Set Infant/Neonatal , FilterLine Set Long Adult/Pediatric , FilterLine H Set Long Adult/Pediatric , FilterLine H Set Long Infant/Neonatal , Trade Compliant: FilterLine H, Adult/Ped , Trade Compliant: FilterLine H, Infant/Neo , FilterLine Set Adult/Pedi , FilterLine H Set Adult/Pedi and FilterLine H Set Infant/Neonatal. Carbon dioxide gas analyzer.
Reason: Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible.
Root cause: Unknown/Undetermined by firm
Recalling firm: Philips North America LlcType: Analyzer, Gas, Carbon-Dioxide, Gaseous-PhaseDistribution: Worldwide distribution - US Nationwide and the countries of AE, AL, AO, AR, AT, AU, AW, BD, BE, BG, BH, BO, BR, BW, BY, CA, CD, CH, CI, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, ET, FI, FJ, FO, FR, GA, GB, GF, GH, GI, GP, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IR, IS, IT, JO, JP, KE, KG, KR, KW, LB, LK, LT, LU, LV, LY, MA, MC, MM, MO, MQ, MT, MU, MV, MX, MY, MZ, NC, NG, NL, NO, NP, NZ, OM, PA, PE, PF, PG, PH, PK, PL, PM, PR, PS, PT, PY, QA, RE, RO, RS, RU, RW, SA, SE, SG, SI, SK, SN, SY, TH, TN, TR, TT, TW, TZ, UA, UY, VA, VN, YT, ZA.Recall #Z-1722-2025 Open, ClassifiedPosted May 2, 2025·Initiated Mar 27, 2025
Intraocular lens. enVista Monofocal IOL, All models starting with EE;
enVista Aspire IOL, All models starting with EA;
enVista Monofocal Toric IOL, All models starting with ETE;
enVista Aspire Toric IOL, All models starting with ETA;
Reason: In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S.
Root cause: Process control
Recalling firm: Bausch & Lomb Surgical, Inc.Type: Intraocular LensDistribution: Worldwide distribution. US Nationwide including PR and GU, and the countries of CAN, AUS, AUT, BEL, BGR, IC, HRV, CZE, FRA, DEU, GRC, HUN, ITA, NLD, POL, PRT, ROU, ESP, GBR, NZL, HKG.Recall #Z-1679-2025
Open, ClassifiedPosted May 2, 2025·Initiated Mar 27, 2025
Intraocular Lens. enVista Envy IOL, All models starting with EN;
enVista Envy Toric IOL, All models starting with ETN.
Reason: In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S.
Root cause: Process control
Recalling firm: Bausch & Lomb Surgical, Inc.Type: Lens, Multifocal IntraocularDistribution: Worldwide distribution. US Nationwide including PR and GU, and the countries of CAN, AUS, AUT, BEL, BGR, IC, HRV, CZE, FRA, DEU, GRC, HUN, ITA, NLD, POL, PRT, ROU, ESP, GBR, NZL, HKG.Recall #Z-1680-2025
Open, ClassifiedPosted May 2, 2025·Initiated Apr 7, 2025
Bio 1 Granules for Filling 1 mm (2 cm), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)
Reason: Vials of implant bone granules may contain less product then specified on labeling.
Root cause: Process control
Recalling firm: SCIENCE & BIO MATERIALSType: Filler, Bone Void, Calcium CompoundDistribution: US Nationwide distribution.Recall #Z-1718-2025
Open, ClassifiedPosted May 2, 2025·Initiated Mar 24, 2025
Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830
Reason: A single lot of the ImmunoCard STAT! Crypto/Giardia Test Kit was inadvertently stored in Medline warehouses at temperatures outside of the labeled storage requirements.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Giardia Spp.Distribution: US Nationwide distribution.Recall #Z-1719-2025
Open, ClassifiedPosted May 1, 2025·Initiated Mar 19, 2025
Medline Sterile Water, USP, 100mL, REF RDI30295
Reason: It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Dressing, Wound, DrugDistribution: Worldwide distribution - US Nationwide and the countries of Panama and Canada.Recall #Z-1705-2025
Open, ClassifiedPosted May 1, 2025·Initiated Mar 19, 2025
Medline Sterile 0.9% Normal Saline, USP, 100mL, REF RDI30296
Reason: It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Dressing, Wound, DrugDistribution: Worldwide distribution - US Nationwide and the countries of Panama and Canada.Recall #Z-1706-2025
Open, ClassifiedPosted May 1, 2025·Initiated Mar 19, 2025
Medline procedure kits, labeled as: T AND A PACK -LF, REF DYNJ85792
Reason: It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Ear, Nose, And Throat Surgical TrayDistribution: Worldwide distribution - US Nationwide and the countries of Panama and Canada.Recall #Z-1707-2025
Open, ClassifiedPosted May 1, 2025·Initiated Mar 19, 2025
Medline procedure kits, labeled as: NON STERILE I&D KIT, REF DYKM1438
Reason: It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Laparoscopy KitDistribution: Worldwide distribution - US Nationwide and the countries of Panama and Canada.Recall #Z-1708-2025
Open, ClassifiedPosted May 1, 2025·Initiated Mar 19, 2025
Medline procedure kits, labeled as:
1) STERILE PREP KIT, REF DYNDA1359A;
2) STRL EK SINGLE PACK, REF DYNDA1360B;
3) SHEATH REMOVAL TRAY, REF DYNDC1311C;
4) SENSITIVE SKIN WEEKLY VAD, REF DYNDC3185;
5) NURSING SKILLS, REF EDUC05015A;
6) NURSING SUPPLY BAG, REF EDUC1024A.
Reason: It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: General Surgery TrayDistribution: Worldwide distribution - US Nationwide and the countries of Panama and Canada.Recall #Z-1709-2025
Open, ClassifiedPosted May 1, 2025·Initiated Mar 19, 2025
Medline procedure kits, labeled as: PLASTICS SUTURE TRAY, REF SUT13535
Reason: It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Tray, SurgicalDistribution: Worldwide distribution - US Nationwide and the countries of Panama and Canada.Recall #Z-1710-2025
Open, ClassifiedPosted May 1, 2025·Initiated Mar 19, 2025
Medline procedure kits, labeled as:
1) WOUND CARE TRAY, REF DYNDA1412A;
2) LACERATION TRAY, REF DYNDL1263A.
Reason: It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Wound Dressing KitDistribution: Worldwide distribution - US Nationwide and the countries of Panama and Canada.Recall #Z-1711-2025
Open, ClassifiedPosted May 1, 2025·Initiated Mar 19, 2025
Medline procedure kits, labeled as: REDDY JOINT BATH, REF MMJB001A
Reason: It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Patient Personal Hygiene KitDistribution: Worldwide distribution - US Nationwide and the countries of Panama and Canada.Recall #Z-1712-2025
Open, ClassifiedPosted May 1, 2025·Initiated Mar 19, 2025
Medline procedure kits, labeled as: OL OCULAR, REF DYNJ906183K
Reason: It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Eye TrayDistribution: Worldwide distribution - US Nationwide and the countries of Panama and Canada.Recall #Z-1713-2025
Open, ClassifiedPosted May 1, 2025·Initiated Mar 19, 2025
Medline procedure kits, labeled as: HAND, REF DYNJ902002J
Reason: It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Orthopedic TrayDistribution: Worldwide distribution - US Nationwide and the countries of Panama and Canada.Recall #Z-1714-2025
Open, ClassifiedPosted May 1, 2025·Initiated Apr 4, 2025
Brand Name: Powered Laser Surgical Instrument
Product Name: SOLTIVE Pro SuperPulsed Laser System
Model/Catalog Numbers: TFL-SLS, TFL-PLS
Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to ureteroscopy, PCNL, and potential soft tissue applications.
Component: No
Reason: Preset treatment parameters are not consistently being used in accordance with the IFU.
Root cause: Unknown/Undetermined by firm
Recalling firm: Olympus Corporation of the AmericasType: Powered Laser Surgical InstrumentDistribution: Worldwide distribution - US Nationwide and the countries of AU, CA, SG, DE, JP, HK.Recall #Z-1715-2025