Open, ClassifiedPosted Dec 12, 2024·Initiated Oct 31, 2024
Hybrid Recon software on Hermes Medical Imaging Suite version 6.1
Hybrid Recon software versions affected are 4.0.0x and 5.0.0
Reason: Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study.
Root cause: Device Design
Recalling firm: Hermes Medical Solutions ABType: System, Tomography, Computed, EmissionDistribution: U.S.: CA, CT, FL, HI, KY, MA, MD, MO, NJ. NY, OH, TN, TX, VA, and WA
O.U.S.: Germany, and United KingdomsRecall #Z-0678-2025 CompletedPosted Dec 11, 2024·Initiated Oct 10, 2022
Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide
Model/Catalog Number: F0101
Reason: IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set
Root cause: Labeling Change Control
Recalling firm: Hologic, IncType: Guide, Surgical, InstrumentDistribution: US Nationwide distribution.Recall #Z-0669-2025 Open, ClassifiedPosted Dec 11, 2024·Initiated Nov 14, 2024
BD Pyxis MedStation ES, REF: 323
Reason: Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2) Potential for a different medication (medication pulled in error) to be refilled/loaded, which may lead to may lead to low inventory or a stockout.
Root cause: Software design
Recalling firm: CareFusion 303, Inc.Type: Cabinet, Table And Tray, AnesthesiaDistribution: Worldwide - US Nationwide distribution including in the states of OK, LA, FL, AR, VA, KY, PA, AL, NC, CA, MN, AK, TX, MI, ME, OH, OR, NY, IL, RI, GA, WI, NH, KS, CO, WA, MO, MD, AZ, SC, NV, WV, NM, IN, NJ, TN, DE, MT, MA, VT, DC, NE, CT, ID, WY, MS, UT, HI, IA, SD, ND, GU, MP, PR and the countries of CA, BR, JP, ES, NZ, AU, FR, AR, MX, IT, CL, TR, SA, MY, CH, IE, TH, SG, KW, BE, DE, PT, QA, MA, FI, AE, EG, BS, GB, BM, GR, BH, KR, MC, PL, LB, HK, IN, IL, MO, IQ, TN, NO, PH, CO, TW, CN, JO, OM.Recall #Z-0670-2025
Open, ClassifiedPosted Dec 11, 2024·Initiated Nov 14, 2024
BD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324
Reason: Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2) Potential for a different medication (medication pulled in error) to be refilled/loaded, which may lead to may lead to low inventory or a stockout.
Root cause: Software design
Recalling firm: CareFusion 303, Inc.Type: Cabinet, Table And Tray, AnesthesiaDistribution: Worldwide - US Nationwide distribution including in the states of OK, LA, FL, AR, VA, KY, PA, AL, NC, CA, MN, AK, TX, MI, ME, OH, OR, NY, IL, RI, GA, WI, NH, KS, CO, WA, MO, MD, AZ, SC, NV, WV, NM, IN, NJ, TN, DE, MT, MA, VT, DC, NE, CT, ID, WY, MS, UT, HI, IA, SD, ND, GU, MP, PR and the countries of CA, BR, JP, ES, NZ, AU, FR, AR, MX, IT, CL, TR, SA, MY, CH, IE, TH, SG, KW, BE, DE, PT, QA, MA, FI, AE, EG, BS, GB, BM, GR, BH, KR, MC, PL, LB, HK, IN, IL, MO, IQ, TN, NO, PH, CO, TW, CN, JO, OM.Recall #Z-0671-2025
Open, ClassifiedPosted Dec 11, 2024·Initiated Nov 14, 2024
BD Pyxis CII Safe ES, REF: 1116-00
Reason: Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2) Potential for a different medication (medication pulled in error) to be refilled/loaded, which may lead to may lead to low inventory or a stockout.
Root cause: Software design
Recalling firm: CareFusion 303, Inc.Type: Cabinet, Table And Tray, AnesthesiaDistribution: Worldwide - US Nationwide distribution including in the states of OK, LA, FL, AR, VA, KY, PA, AL, NC, CA, MN, AK, TX, MI, ME, OH, OR, NY, IL, RI, GA, WI, NH, KS, CO, WA, MO, MD, AZ, SC, NV, WV, NM, IN, NJ, TN, DE, MT, MA, VT, DC, NE, CT, ID, WY, MS, UT, HI, IA, SD, ND, GU, MP, PR and the countries of CA, BR, JP, ES, NZ, AU, FR, AR, MX, IT, CL, TR, SA, MY, CH, IE, TH, SG, KW, BE, DE, PT, QA, MA, FI, AE, EG, BS, GB, BM, GR, BH, KR, MC, PL, LB, HK, IN, IL, MO, IQ, TN, NO, PH, CO, TW, CN, JO, OM.Recall #Z-0672-2025
Open, ClassifiedPosted Dec 11, 2024·Initiated Nov 8, 2024
Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog number A16972, for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma.
Reason: The reason for the recall is that EDTA and lithium heparin plasma samples that are stored in the DxI 9000 Access Immunoassay Analyzer sample wheel for a prolonged period before performing the intact PTH (parathyroid hormone) test may produce falsely decreased intact parathyroid hormone results. This could lead to a missed diagnosis, a delay in treatment, or inappropriate clinical management, depending upon the patient s clinical condition.
Root cause: Process design
Recalling firm: Beckman Coulter Inc.Type: Radioimmunoassay, Parathyroid HormoneDistribution: Foreign distribution to Albania, Australia, Austria, Bahrain, Belgium, Brazil, C¿te
d'Ivoire, Croatia, Czechia, Egypt, France, Germany, Ghana,
Hungary, India, Ireland, Israel, Italy, Kazakhstan, Kuwait,
Malaysia, Netherlands, New Zealand, Poland, Portugal,
Slovakia, South Africa, S. Korea, Spain, Switzerland, Taiwan,
United Kingdom of Great Britain and Northern Ireland.Recall #Z-0673-2025
Open, ClassifiedPosted Dec 11, 2024·Initiated Nov 1, 2024
Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT6100-XL, AT6200, and AT6200-XL
Reason: Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Association for the Advancement of Medical Instrumentation) Level 3 protection requirements.
Root cause: Nonconforming Material/Component
Recalling firm: Cardinal Health 200, LLCType: Gown, Isolation, SurgicalDistribution: US Nationwide. Canada, UAERecall #Z-0674-2025 Open, ClassifiedPosted Dec 11, 2024·Initiated Nov 1, 2024
Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back, Product Codes AT6588-2XL, AT6588-BD, AT6588-XL, AT6688-2XL, AT6688-BD, and AT6688-XL
Reason: Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Association for the Advancement of Medical Instrumentation) Level 3 protection requirements.
Root cause: Nonconforming Material/Component
Recalling firm: Cardinal Health 200, LLCType: Gown, Isolation, SurgicalDistribution: US Nationwide. Canada, UAERecall #Z-0675-2025 Open, ClassifiedPosted Dec 10, 2024·Initiated Nov 5, 2024
Microscissor Tip (Disposable); Microline Catalog #: 3122.
Reason: A lot of ReNew Microscissor Tips exhibited a 2% rate of failure in terms of the heat shrink breaking off.
Root cause: Under Investigation by firm
Recalling firm: Microline Surgical, Inc.Type: Electrosurgical, Cutting & Coagulation & AccessoriesDistribution: Worldwide - US Nationwide in the state of OK and the country of Japan.Recall #Z-0663-2025
Open, ClassifiedPosted Dec 9, 2024·Initiated Nov 6, 2024
ChemoLock Close Vial Spike REF CL-80
The Chemolock Closed System Transfer Device prevents the transfer of environmental contaminants. The Chemolock is needle free and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytotoxic medications for healthcare personnel.
Reason: Due to finished goods incorrectly packaged and labeled.
Root cause: Packaging process control
Recalling firm: ICU Medical, Inc.Type: Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer SystemDistribution: Worldwide - U.S. Nationwide distribution in the state of IL and the country of Canada.Recall #Z-0652-2025
Open, ClassifiedPosted Dec 6, 2024·Initiated Oct 30, 2023
DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing:
1. DKS Large Obturator Trocar (Model Number 330.017)
2. DKS Large Lighted Cannula (Model Number 330.011)
3. DKS Large Kerrison (330.015)
4. DKS Small Obturator Trocar (330.013)
5. DKs Small Lighted Cannula (330.014)
6. DKS Small Kerrison (330.016)
Reason: Units were not intended for commercial distribution and inadvertently distributed.
Root cause: No Marketing Application
Recalling firm: Folsom Metal Products, Inc.Type: Rongeur, ManualDistribution: US distribution to KS, LA, MI, NY, TX.Recall #Z-0650-2025
Open, ClassifiedPosted Dec 6, 2024·Initiated Oct 30, 2023
Small DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing:
1. DKS Small Obturator Trocar (Model Number 330.013)
2. DKs Small Lighted Cannula (Model Number 330.014)
3. DKS Small Kerrison (330.016)
Reason: Units were not intended for commercial distribution and inadvertently distributed.
Root cause: No Marketing Application
Recalling firm: Folsom Metal Products, Inc.Type: Rongeur, ManualDistribution: US distribution to KS, LA, MI, NY, TX.Recall #Z-0651-2025
Open, ClassifiedPosted Dec 5, 2024·Initiated Aug 23, 2024
Non-ablative Fractional Laser Systems, Model: WFB-01
Reason: Model WFB-01 sold to US customers before Aug 23, 2022 has been found to have a software bug (6 units). All WFB-01 models sold to US customers found to have labeling non-compliances (22 units)
Root cause: Radiation Control for Health and Safety Act
Recalling firm: WINGDERM ELECTRO-OPTICS LTD.Type: Powered Laser Surgical Instrument With MicrobeamFractional OutputDistribution: Worldwide DistributionRecall #Z-0555-2025
Open, ClassifiedPosted Dec 5, 2024·Initiated Aug 23, 2024
Diode Laser Hair Removal model: WLA-01
Reason: All model WLA-01 systems sold to US customers are found to have labeling non-compliances
Root cause: Radiation Control for Health and Safety Act
Recalling firm: WINGDERM ELECTRO-OPTICS LTD.Type: Powered Laser Surgical InstrumentDistribution: Worldwide DistributionRecall #Z-0556-2025
Open, ClassifiedPosted Dec 5, 2024·Initiated Oct 31, 2024
EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190
Reason: High-level disinfection ("HLD") with Acecide-C disinfectant in the Olympus OER-Pro Automated Endoscope Reprocessor ("AER") has been removed as a compatible reprocessing method from the Instructions for Use when reprocessing the GIF-1THI90 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE ( GIF-1TH190 ).
Root cause: Under Investigation by firm
Recalling firm: Olympus Corporation of the AmericasType: Gastroscope And Accessories, Flexible/RigidDistribution: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV.Recall #Z-0620-2025
Open, ClassifiedPosted Dec 5, 2024·Initiated Nov 6, 2024
BD BBL Sensi Disc Ampicillin 2 g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicillin 2 g (AM-2) are used for semi-quantitative in vitro susceptibility testing by the agar disc diffusion test procedure of common, rapidly growing and certain fastidious bacterial pathogens.
Catalog Number: 231263
Reason: BD identified through potency testing as part of a stability test request to monitor Ampicillin AM-2 due to decrease in potency results of 65% at 18 months, may result in falsely resistant result for ampicillin susceptibility
Root cause: Under Investigation by firm
Recalling firm: Becton Dickinson & Co.Type: Susceptibility Test Discs, AntimicrobialDistribution: Worldwide - US Nationwide distribution in the states of CA, GA, IL, KY, MA, MD, NE, PA and the countries of Canada, Belgium, Singapore, Malaysia.Recall #Z-0621-2025
Open, ClassifiedPosted Dec 5, 2024·Initiated Oct 9, 2024
MEDLINE convenience kits labeled as:
1) TRACH TOTE, REF DYNJ85691;
2) TRACHEOSTOMY, REF DYNJ902123J
Reason: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Tracheotomy Care KitDistribution: US Nationwide distribution.Recall #Z-0622-2025
Open, ClassifiedPosted Dec 5, 2024·Initiated Oct 9, 2024
MEDLINE medical convenience kits labeled as:
1) ACETABULAR PACK-LF, REF DYNJ0572894I;
2) LOCAL BASIC, REF DYNJ34418L;
3) LOCAL BASIC, REF DYNJ34418M;
4) MINI LOCAL, REF DYNJ900287D
Reason: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Spinal Epidural Anesthesia KitDistribution: US Nationwide distribution.Recall #Z-0623-2025
Open, ClassifiedPosted Dec 5, 2024·Initiated Oct 9, 2024
MEDLINE convenience kits labeled as:
1) ANGIO PACK #2, REFDYNJ39185D;
2) CV MINOR CATH LAB PACK, REFDYNJ44997J;
3) PLASTIC PACK, REFDYNJ58409C;
4) GENDER AFFIRMING SURGERY, REFDYNJ66252A;
5) ST CHARLES PORT, REFDYNJ909591
Reason: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Cardiac Catheterization KitDistribution: US Nationwide distribution.Recall #Z-0624-2025
Open, ClassifiedPosted Dec 5, 2024·Initiated Oct 9, 2024
MEDLINE convenience kits labeled as:
1) MAJOR VASCULAR-LF, REF CDS840232L;
2) AVF-LF, REF CDS840233I;
3) GENERAL AAA #11-RF, REF CDS840261AB;
4) HEART CDS, REF CDS840387T;
5) OPEN HEART CDS PART A, REF CDS840402AF;
6) OPEN HEART CDS PART A, REF CDS840402AI;
7) HEART PACK, REF CDS840459R;
8) CAROTID-LF, REF CDS860039K;
9) CAROTID-LF, REF CDS860039L;
10) OPEN HEART ADULT KIT, REF CDS981319AD;
11) BAPTIST AAA, REF CDS982400M;
12) ZALE PUMP CDS, REF CDS983187G;
13) PEDIATRIC CARDIAC CDS-LF, REF CDS983481G;
14) MAJOR VASCULAR, REF CDS983489K;
15) CAROTID, REF CDS983495N;
16) CAROTID ENDARTERECTOMY CDS-LF, REF CDS983637I;
17) AV FISTULA, REF CDS983638K;
18) PERIPHERAL VASCULAR CDS, REF CDS983723I;
19) ACH OPEN HEART, REF CDS983773J;
20) VASCULAR, REF CDS984255K;
21) VASCULAR CDS, REF CDS984275I;
22) OPEN HEART CDS, REF CDS984276O;
23) OPEN HEART CDS, REF CDS984355G;
24) OPEN HEART CDS, REF CDS984355I;
25) SMH VASCULAR CDS, REF CDS984584M;
26) VASCULAR CDS-LF, REF CDS984594G;
27) VASCULAR CDS-LF, REF CDS984594I;
28) VASCULAR, REF CDS985355F;
29) SJ BYPASS LEG CUSTOM PACK-LF, REF DYNJ0042944J;
30) SJ BYPS LEG CSTM PK RFID-LF, REF DYNJ0042944K;
31) AV FISTULA PACK-LF, REF DYNJ0131782G;
32) AV FISTULA PACK-LF, REF DYNJ0131782I;
33) AV FISTULA PACK-LF, REF DYNJ0131782J;
34) AV FISTULA PACK-LF, REF DYNJ0131782K;
35) VASCULAR PACK, REF DYNJ02467M;
36) OPEN HEART PACK A & B, REF DYNJ0283397U;
37) VASCULAR PACK-LF, REF DYNJ0421380P;
38) MAJOR VASCULAR PACK-LF, REF DYNJ0488546J;
39) SJ CARDIAC A PACK RFID-LF, REF DYNJ0619768M;
40) SJ PACEMAKER PACK RFID-LF, REF DYNJ0619848O;
41) PACEMAKER PACK-LF, REF DYNJ0826630N;
42) AV SHUNT PACK-LF, REF DYNJ0842516G;
43) GENERAL ENDO PACK-LF, REF DYNJ0842873K;
44) PACEMAKER PACK-LF, REF DYNJ0843217M;
45) PACEMAKER PACK-LF, REF DYNJ0843217N;
46) PACEMAKER PACK-LF, REF DYNJ0867353I;
47) PACEMAKER PACK-LF, REF DYNJ0867353J;
48) CAROTID ARTERY PACK-LF, REF DYNJ0882509L;
49) CAROTID ARTERY PACK-LF, REF DYNJ0882509N;
50) VASCULAR PACK-LF, REF DYNJ0901358J;
51) VASCULAR PACK-LF, REF DYNJ0901358K;
52) HEALTH ALL VASCULAR PACK-LF, REF DYNJ19538F;
53) OPEN HEART A&B PK-LF, REF DYNJ20888K;
54) OPEN HEART A&B PK-LF, REF DYNJ20888L;
55) GEN FEM POP #14-RF, REF DYNJ21877W;
56) CABG PACK A&B, REF DYNJ21971AD;
57) VASCULAR PACK, REF DYNJ22350L;
58) SVMMC CORE OPEN HEART PACK-LF, REF DYNJ22971T;
59) OPEN HEART SUPPLEMENT A, REF DYNJ24591AB;
60) SVMMC OPEN HEART ADD ON PACK, REF DYNJ24634O;
61) SVMMC PERMANENT PACING PACK, REF DYNJ24746I;
62) GENERAL CAROTID/AV TRAY #15-RF, REF DYNJ27432AC;
63) PACEMAKER PACK, REF DYNJ30928O;
64) VASCULAR PACK, REF DYNJ31902N;
65) DB CAROTID PACK-LF, REF DYNJ33579F;
66) DB ENDOVASCULAR AAA PACK-LF, REF DYNJ33689I;
67) PACEMAKER ICD PK, REF DYNJ34795K;
68) OPEN HEART PACK A&B, REF DYNJ35854D;
69) PACEMAKER PACK, REF DYNJ36025D;
70) RRMC PACEMAKER PACK, REF DYNJ36337G;
71) OPEN HEART PACK, REF DYNJ37284J;
72) PACEMAKER PACK, REF DYNJ37557D;
73) PEDIATRIC CARDIAC MINOR, REF DYNJ37618D;
74) ACH CABG ADD-ON, REF DYNJ38175L;
75) PACEMAKER SET UP PACK, REF DYNJ38232B;
76) PACEMAKER PACK-LF, REF DYNJ38643F;
77) PACEMAKER PACK-LF, REF DYNJ38702A;
78) HOLY CROSS VASCULAR LIMB PK-, REF DYNJ39439K;
79) HOLY CROSS VASCULAR LIMB PK-, REF DYNJ39439L;
80) CARDIOVASCULAR PACK, REF DYNJ42921G;
81) CABG PACK-LF, REF DYNJ43207K;
82) HEART DRAPING PACK-LF, REF DYNJ43214F;
83) VASCULAR PACK, REF DYNJ43276I;
84) SVMMC VASCULAR MAJOR PACK, REF DYNJ43777J;
85) OPEN HEART PACK A AND B, REF DYNJ43858B;
86) SVMMC CAROTID PACK, REF DYNJ43861F;
87) MAJOR VASCULAR PACK, REF DYNJ44161G;
88) MINOR VASCULAR PACK, REF DYNJ44164F;
89) VASCULAR ACCESS PACK, REF DYNJ44172D;
90) AV FISTULA PACK, REF DYNJ44704J;
91) AAA PACK, REF DYNJ44847I;
92) CARDIAC VASCULAR PACK, REF DYNJ44854M;
93) CASTRO CABG-COMPONENT PACK, REF DYNJ44857S;
94) CASTRO CABG-COMPONENT PACK, REF DYNJ44857T;
95) CASTRO CABG-COMPONENT PACK, REF DYNJ44857U;
96) FIST