Open, ClassifiedPosted Apr 4, 2025·Initiated Feb 19, 2025
Wayson Hydrocolloid Models:
1) Model Number: CUR5103, DBD-BNDG,WTRPRF,HYDRCLLD,CLR,2.36X3.93",
2) Model Number: MJ18004, DBD-MEIJER,BANDAGE,HYDROCOLLOID,HEEL,OVL
3) Model Number: MJ18005, MEIJER,BANDAGE,HYDROCOLLOID,ALLPURP,10CT
4) Model Number: MJ76126V1, DBD-MEIJER,HYDROCOLLOID,FINGER&TOE,8CT
5) Model Number: RA0353818V1, BANDAGE,BLISTER, RITEAID,6EA/BX, 24BX/CS
Reason: There is a potential for the sterility of the device to be compromised.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Dressing, Wound, HydrophilicDistribution: Worldwide Distribution: US (Nationwide) and OUS (Foreign) to countries of: Bermuda, Canada, Panama, SingaporeRecall #Z-1530-2025
Open, ClassifiedPosted Apr 4, 2025·Initiated Feb 19, 2025
Wayson Hydrocolloid Models:
1) MJ BANDAGE HYDROCOLLOID HEEL OVAL 6CT, Model Number: MJ18004V2;
2) MJ BANDAGE HYDROCOLLOID ALL PURP 10CT, Model Number: MJ18005V2;
3) MJ BNDG HYDROCOLLOID FINGER TOE 8CT, Model Number: MJ76126V2;
4) WALMART,BANDAGE,HYDROCOLLOID,HEEL,6CT, Model Number: WAL1901;
5) WALMART,HYDROCOLLOID,TOE,8CT, Model Number: WAL1902;
Reason: There is a potential for the sterility of the device to be compromised.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Dressing, Wound, OcclusiveDistribution: Worldwide Distribution: US (Nationwide) and OUS (Foreign) to countries of: Bermuda, Canada, Panama, SingaporeRecall #Z-1531-2025
Open, ClassifiedPosted Apr 4, 2025·Initiated Feb 20, 2025
IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek Pouch, 5 Tyvek Pouches per shelf box, 10 shelf boxes per case box.
IVX Station Reconstitution Transfer Set is used for the reconstitution of drug vials in hospital pharmacies. It is indicated for use with the IVX Station Pharmacy Compounding System.
Reason: IVX Station Reconstitution Transfer Sets were shipped in advance of the IVX Station upgrade and not intended for clinical use but are engineering devices intended for use during set up and system calibration. The items were not shipped in a validated packing configuration and sterility cannot be ensured.
Root cause: Process control
Recalling firm: Omnicell, Inc.Type: Set, I.V. Fluid TransferDistribution: Distributed in the US to AlabamaRecall #Z-1532-2025
Open, ClassifiedPosted Apr 3, 2025·Initiated Mar 12, 2025
Brand Name: VentStar
Product Name: VentStar Flex 220
Model/Catalog Number: MP00355
Software Version: Not applicable
Product Description: Breathing circuit for conveying breathing gases between an anesthesia machine or ventilator and adult patients. The breathing circuit is intended for single use only.
Component: Not applicable
Reason: The potential for cracks forming in the breathing circuit hose.
Root cause: Under Investigation by firm
Recalling firm: Draeger, Inc.Type: Circuit, Breathing (W Connector, Adaptor, Y Piece)Distribution: Domestic: Nationwide Distribution.
International - following countries:
Austria, Belgium, Bulgaria, China, Croatia, Czech Republic, France, Germany, Ghana, Greece, Guatemala, Hungary, India, Italy, Japan, Panama, Philippines, Portugal, Singapore, South Africa, Spain, Sweden, United KingdomRecall #Z-1493-2025
Open, ClassifiedPosted Apr 3, 2025·Initiated Mar 12, 2025
Brand Name: ID Circuit
Product Name: ID Circuit Flex 220
Model/Catalog Number: MP01347
Software Version: Not applicable
Product Description: Breathing circuit for conveying breathing gases between an anesthesia machine or ventilator and adult
Component: Not applicable
Reason: The potential for cracks forming in the breathing circuit hose.
Root cause: Under Investigation by firm
Recalling firm: Draeger, Inc.Type: Set, Tubing And Support, Ventilator (W Harness)Distribution: Domestic: Nationwide Distribution.
International - following countries:
Austria, Belgium, Bulgaria, China, Croatia, Czech Republic, France, Germany, Ghana, Greece, Guatemala, Hungary, India, Italy, Japan, Panama, Philippines, Portugal, Singapore, South Africa, Spain, Sweden, United KingdomRecall #Z-1494-2025
Open, ClassifiedPosted Apr 3, 2025·Initiated Mar 12, 2025
Brand Name: Anesthesia Circuit Kit
Product Name: Anesthesia Circuit Kit Flex 1
Model/Catalog Number: MP02737
Software Version: Not applicable
Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only
Component: Not applicable
Reason: The potential for cracks forming in the breathing circuit hose.
Root cause: Under Investigation by firm
Recalling firm: Draeger, Inc.Type: Anesthesia Breathing Circuit Kit (Adult & Pediatric)Distribution: Domestic: Nationwide Distribution.
International - following countries:
Austria, Belgium, Bulgaria, China, Croatia, Czech Republic, France, Germany, Ghana, Greece, Guatemala, Hungary, India, Italy, Japan, Panama, Philippines, Portugal, Singapore, South Africa, Spain, Sweden, United KingdomRecall #Z-1495-2025
Open, ClassifiedPosted Apr 3, 2025·Initiated Mar 12, 2025
Brand Name: Anesthesia Circuit Kit
Product Name: Anesthesia Circuit Kit Flex 2
Model/Catalog Number: MP02738
Software Version: Not applicable
Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only
Component: Not applicable
Reason: The potential for cracks forming in the breathing circuit hose.
Root cause: Under Investigation by firm
Recalling firm: Draeger, Inc.Type: Anesthesia Breathing Circuit Kit (Adult & Pediatric)Distribution: Domestic: Nationwide Distribution.
International - following countries:
Austria, Belgium, Bulgaria, China, Croatia, Czech Republic, France, Germany, Ghana, Greece, Guatemala, Hungary, India, Italy, Japan, Panama, Philippines, Portugal, Singapore, South Africa, Spain, Sweden, United KingdomRecall #Z-1496-2025
Open, ClassifiedPosted Apr 3, 2025·Initiated Mar 12, 2025
Brand Name: Anesthesia Circuit Kit
Product Name: Anesthesia Circuit Kit Flex 6
Model/Catalog Number: MP02744
Software Version: Not applicable
Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only
Reason: The potential for cracks forming in the breathing circuit hose.
Root cause: Under Investigation by firm
Recalling firm: Draeger, Inc.Type: Anesthesia Breathing Circuit Kit (Adult & Pediatric)Distribution: Domestic: Nationwide Distribution.
International - following countries:
Austria, Belgium, Bulgaria, China, Croatia, Czech Republic, France, Germany, Ghana, Greece, Guatemala, Hungary, India, Italy, Japan, Panama, Philippines, Portugal, Singapore, South Africa, Spain, Sweden, United KingdomRecall #Z-1497-2025
Open, ClassifiedPosted Apr 3, 2025·Initiated Mar 12, 2025
Brand Name: Anesthesia Circuit Kit
Product Name: Anesthesia Circuit Kit Flex (P)2
Model/Catalog Number: MP02752
Software Version: Not applicable
Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only
Component: Not applicable
Reason: The potential for cracks forming in the breathing circuit hose.
Root cause: Under Investigation by firm
Recalling firm: Draeger, Inc.Type: Anesthesia Breathing Circuit Kit (Adult & Pediatric)Distribution: Domestic: Nationwide Distribution.
International - following countries:
Austria, Belgium, Bulgaria, China, Croatia, Czech Republic, France, Germany, Ghana, Greece, Guatemala, Hungary, India, Italy, Japan, Panama, Philippines, Portugal, Singapore, South Africa, Spain, Sweden, United KingdomRecall #Z-1498-2025
Open, ClassifiedPosted Apr 3, 2025·Initiated Mar 12, 2025
Brand Name: Anesthesia Circuit Kit
Product Name: Anesthesia Circuit Kit Flex EPA
Model/Catalog Number: MP17103
Software Version: Not applicable
Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only
Reason: The potential for cracks forming in the breathing circuit hose.
Root cause: Under Investigation by firm
Recalling firm: Draeger, Inc.Type: Anesthesia Breathing Circuit Kit (Adult & Pediatric)Distribution: Domestic: Nationwide Distribution.
International - following countries:
Austria, Belgium, Bulgaria, China, Croatia, Czech Republic, France, Germany, Ghana, Greece, Guatemala, Hungary, India, Italy, Japan, Panama, Philippines, Portugal, Singapore, South Africa, Spain, Sweden, United KingdomRecall #Z-1499-2025
Open, ClassifiedPosted Apr 3, 2025·Initiated Mar 4, 2025
Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only
Reason: product mix-up; Vascular stent labeled as one size but contains a different size.
Root cause: Employee error
Recalling firm: Cordis US CorpType: Stent, IliacDistribution: US Distribution to states of: AR, AZ, FL, NJ, TN; and OUS Foreign country of: JapanRecall #Z-1510-2025
Open, ClassifiedPosted Apr 3, 2025·Initiated Mar 4, 2025
Cordis, REF: C09060ML, Smart Control Vascular Stent System ILIAC, 9mm X 60mm 6F, SterileEO, Rx Only
Reason: product mix-up; Vascular stent labeled as one size but contains a different size.
Root cause: Employee error
Recalling firm: Cordis US CorpType: Stent, IliacDistribution: US Distribution to states of: AR, AZ, FL, NJ, TN; and OUS Foreign country of: JapanRecall #Z-1511-2025
Open, ClassifiedPosted Apr 3, 2025·Initiated Mar 7, 2025
PDSPLUSVIO30IN(75CM)USP6-0(M0.7)D/AC-1MP
Reason: Identified curing issues with the silicone during the needles manufacturing process.
Root cause: Process control
Recalling firm: Ethicon Endo Surgery, LLCType: Suture, Surgical, Absorbable, PolydioxanoneDistribution: Worldwide Distribution: US (Nationwide) and OUS (Foreign) to countries of: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Germany, India, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Norway, Panama, Singapore, Spain, Taiwan, Uruguay.Recall #Z-1513-2025
Open, ClassifiedPosted Apr 3, 2025·Initiated Mar 7, 2025
PDSIIVIO30IN(75CM)USP6-0(M0.7)D/AC-1
Reason: Identified curing issues with the silicone during the needles manufacturing process.
Root cause: Process control
Recalling firm: Ethicon Endo Surgery, LLCType: Suture, Surgical, Absorbable, PolydioxanoneDistribution: Worldwide Distribution: US (Nationwide) and OUS (Foreign) to countries of: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Germany, India, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Norway, Panama, Singapore, Spain, Taiwan, Uruguay.Recall #Z-1514-2025
Open, ClassifiedPosted Apr 3, 2025·Initiated Mar 7, 2025
PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
Reason: Identified curing issues with the silicone during the needles manufacturing process.
Root cause: Process control
Recalling firm: Ethicon Endo Surgery, LLCType: Suture, Surgical, Absorbable, PolydioxanoneDistribution: Worldwide Distribution: US (Nationwide) and OUS (Foreign) to countries of: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Germany, India, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Norway, Panama, Singapore, Spain, Taiwan, Uruguay.Recall #Z-1515-2025
Open, ClassifiedPosted Apr 3, 2025·Initiated Mar 7, 2025
ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH
Reason: Identified curing issues with the silicone during the needles manufacturing process.
Root cause: Process control
Recalling firm: Ethicon Endo Surgery, LLCType: Suture, Surgical, Absorbable, PolydioxanoneDistribution: Worldwide Distribution: US (Nationwide) and OUS (Foreign) to countries of: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Germany, India, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Norway, Panama, Singapore, Spain, Taiwan, Uruguay.Recall #Z-1516-2025
Open, ClassifiedPosted Apr 3, 2025·Initiated Feb 26, 2025
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes:
C63519 / 14987666545058
C63520 / 14987666545065
The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.
Reason: Beckman Coulter has determined that device software versions V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3. have a defect due of which, when all constituent tests of a calculated result are rerun, either manually ordered by the operator at the analyzer or automatically triggered by predefined rules in System Configuration, the calculated result will not be recalculated using the constituent tests rerun results. The system will report only the calculated result using the initial constituent tests results to the operator and LIS/Remisol. The issue was identified by Beckman Coulter internal engineering testing. The defect may cause a delay in reporting patient results.
Root cause: Software design
Recalling firm: Beckman Coulter Inc.Type: Analyzer, Chemistry (Photometric, Discrete), For Clinical UseDistribution: Worldwide Distribution: U.S. (nationwide) to states of: AL, CA, CO, GA, ID, IL, IN, LA, MA, AI, MN, MS, MT, NC, NM, NV, NY, OK, OR, PA, PR, SC, TN, TX, WA, and WI; O.U.S. (foreign) to countries of: Australia, Belgium, Bosnia/Herzegovina, Canada, Croatia, Egypt, Ethiopia, France, Germany, Ghana, India, Italy, Republic of Korea, Lebanon, Libya, Malaysia, Netherlands, North Macedonia, Oman, Paraguay, Philippines, Poland, Qatar, Saudi Arabia, Seychelles, Slovakia, South Africa, Spain and SwitzerlandRecall #Z-1517-2025
Open, ClassifiedPosted Apr 2, 2025·Initiated Feb 24, 2025
Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007
Reason: Single-use battery-powered blood pressure monitor, for use on neonates and infants, due to vibratory noise, may not adequately detect changes in blood pressure per specification. Containment actions: 1) Ventilator lines not to touch the isolette (e.g. mattress, side rails, pillow) or patient, 2) Move affected monitor to patient's foot.
Root cause: Software design
Recalling firm: PYRAMES INCType: System, Measurement, Blood-Pressure, Non-InvasiveDistribution: US distribution to states of: MA and CARecall #Z-1508-2025
Open, ClassifiedPosted Apr 2, 2025·Initiated Feb 20, 2025
BD Connecta BD Luer-Lok 360, REF 394910
UDI-DI code: 00382903949106
Connecta Plus 1 and Connecta Plus 3 2-way and 3-way Stopcocks are control valves for use in IV. therapy and hemodynamic pressure monitoring.
Reason: Due to specific lots of luer-lok devices were shipped to the U.S. market with an Outside US Instruction for Use (IFU)
Root cause: Labeling Change Control
Recalling firm: BD SWITZERLAND SARLType: Stopcock, I.V. SetDistribution: U.S.: AK, AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, OH, OK, OR, PA, SC, TN. TX, UT, VA, WA, WV
O.U.S.: N/ARecall #Z-1509-2025
Open, ClassifiedPosted Apr 1, 2025·Initiated Jan 9, 2025
A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
Reason: Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.
Root cause: Under Investigation by firm
Recalling firm: Medtronic NeuromodulationType: Pump, Infusion, Implanted, ProgrammableDistribution: Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canary Islands, Czech Republic, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, Portugal, Puerto Rico, Spain, Sweden, Switzerland, United Kingdom.Recall #Z-1506-2025