Open, ClassifiedPosted Aug 29, 2025·Initiated Jul 29, 2025
WATCHMAN TruSeal Access System ANT, US, Material Number (UPN) M635TU70040; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
Reason: Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress.
This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.
Root cause: Under Investigation by firm
Recalling firm: Boston Scientific CorporationType: Catheter, PercutaneousDistribution: Worldwide.Recall #Z-2433-2025 Open, ClassifiedPosted Aug 29, 2025·Initiated Jul 29, 2025
WATCHMAN FXD Curve Access System Sgl, US, Material Number (UPN) M635TU80010; intended to provide vascular and transseptal access for the family of
WATCHMAN FLX LAAC Devices with Delivery Systems.
Reason: Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress.
This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.
Root cause: Under Investigation by firm
Recalling firm: Boston Scientific CorporationType: Catheter, PercutaneousDistribution: Worldwide.Recall #Z-2434-2025 Open, ClassifiedPosted Aug 29, 2025·Initiated Jul 29, 2025
WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
Reason: Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress.
This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.
Root cause: Under Investigation by firm
Recalling firm: Boston Scientific CorporationType: Catheter, PercutaneousDistribution: Worldwide.Recall #Z-2435-2025 Open, ClassifiedPosted Aug 29, 2025·Initiated Jul 29, 2025
WATCHMAN TruSteer Access System, US, Material Number (UPN) M635TU90050;intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
Reason: Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress.
This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.
Root cause: Under Investigation by firm
Recalling firm: Boston Scientific CorporationType: Catheter, PercutaneousDistribution: Worldwide.Recall #Z-2436-2025 Open, ClassifiedPosted Aug 28, 2025·Initiated Jul 14, 2025
Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models
401150RH, 401206RH, 401207RH, 401210RH, 401211RH, 401212RH, 401222RH, 401223RH, 401226RH, 401227RH, 401228RH, 401260RH, 401261RH, 401271RH, 401305RH, 401306RH, 401309RH, 401310RH, 401311RH, 401312RH, 401317RH, 401353RH, 401357RH, 401381RH, 401392RH, 401399RH, 401400RH, 401425RH, 401430RH, 401433RH, 401434RH, 401435RH, 401436RH, 401438RH, 401441RH, 401442RH, 401445RH, 401443RH, 401444RH, 401448RH, 401449RH, 401450RH, 401451RH, 401453RH, 401466RH, 401468RH, 401474RH, 401475RH, 401859RH, 401860RH, 401863RH, 401864RH, 401865RH, 401876RH, 401877RH, 401878RH, 401890RH, 401891RH, 401892RH, 401893RH, 401966RH, 401967RH, 401979RH, 401994RH, 401996RH, 402004RH, 402008RH, 402009RH, 402010RH, 402011RH, 402012RH
Reason: Specific lots of reprocessed electrophysiology catheters may contain small residual particulates.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Catheter, Recording, Electrode, ReprocessedDistribution: US Nationwide.Recall #Z-2460-2025
Open, ClassifiedPosted Aug 28, 2025·Initiated Jun 18, 2025
Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF: 119314;
SureStep Foley Tray System Lubri-Sil I.C. Complete Care, REF: A319514A;
Bard Silver Lubri-Sil Foley Tray Temperature Sensing with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 14Fr, REF: 29000J14, 29030J14, 29000J14S;
Bard Silver Lubri-Sil Foley Tray Temperature Sensing, Complete Care with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 14Fr, REF: 29030J14S
Reason: Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladder, of urine and may include pelvic or abdominal pain, flank pain, bladder dysfunction, obstructive uropathy, acute kidney injury and/or hydronephrosis.
Root cause: Process design
Recalling firm: C.R. Bard IncType: Catheter, Retention Type, BalloonDistribution: Worldwide - US Nationwide distribution in the states of IA, PA, AR, OR, MN, IN, WV, OK, AL, MD, HI, GA, AZ, MA, FL, CA and the countries of Japan.Recall #Z-2462-2025
Open, ClassifiedPosted Aug 28, 2025·Initiated Jan 17, 2025
Brand Name: HOMEDICS
Product Name: Air Compression Leg Massager
Model/Catalog Number: SR-160HJ
Product Description: Powered Inflatable Tube Massager used on the leg.
The Air Compression Leg Massager is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The Air Compression Leg Massager simulates kneading and stroking of tissues by using an inflatable garment.
Reason: Regulatory documentation error and misleading color packaging claim.
Root cause: Error in labeling
Recalling firm: Zhejiang Luyao Electronics Technology Co., Ltd.Type: Massager, Powered Inflatable TubeDistribution: Worldwide distribution - US Nationwide and the country of Canada.Recall #Z-2463-2025
Open, ClassifiedPosted Aug 28, 2025·Initiated Jul 14, 2025
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as:
1) HEART PACK - 205947, MODEL/ITEM NUMBER ANCV78BC;
2) VASCULAR PACK - 232024, MODEL/ITEM NUMBER ANVA82AB;
3) OFF PUMP CABG PACK - 170316, MODEL/ITEM NUMBER BHOP48O;
4) OFF PUMP CABG PACK - 170316, MODEL/ITEM NUMBER BHOP48P;
5) PEDIATRIC OPEN HEART PACK - 170212, MODEL/ITEM NUMBER BHPH18F;
6) PEDIATRIC OPEN HEART PACK - 170212, MODEL/ITEM NUMBER BHPH18G;
7) CABG ACCESSORY PACK, MODEL/ITEM NUMBER HGCB98F;
8) CV SET UP PACK, MODEL/ITEM NUMBER HGCV05K;
9) OPEN HEART PACK B - COMPONENTS, MODEL/ITEM NUMBER HGOH99H;
10) STRADLE TABLE PACK - 301659, MODEL/ITEM NUMBER MHCV10AM;
11) MINOR VASCULAR PACK, MODEL/ITEM NUMBER MTVS73D;
12) AV GRAFT RCH 0246952, MODEL/ITEM NUMBER RCAV40C;
13) OPEN HEART PART 1 RCH 0247159, MODEL/ITEM NUMBER RCOH61G;
14) CARDIO 612968, MODEL/ITEM NUMBER TNCA08T;
15) CV B PACK, MODEL/ITEM NUMBER TNCB10AM;
16) A-V FISTULA - 206042, MODEL/ITEM NUMBER UDAV16AD;
17) CAROTID PACK - 206045, MODEL/ITEM NUMBER UDCP24AF;
18) FEM POP PACK - 206052, MODEL/ITEM NUMBER UDFP36AH;
19) CARDIOVASCULAR SUPPLY (PS 907285), MODEL/ITEM NUMBER UICD62AN;
20) SFCH PEDS CARDIAC SUPPLY PACK (PS131653), MODEL/ITEM NUMBER UICS88S;
21) SFCH ECMO PACK (PS 107116), MODEL/ITEM NUMBER UIPD03Q;
22) THORACIC SETUP (PS 035700), MODEL/ITEM NUMBER UITC53AL;
23) VASCULAR PACK, MODEL/ITEM NUMBER UIVA75J;
24) CABG ACCESSORY PACK 175619, MODEL/ITEM NUMBER UMCA14E;
25) OPEN HEART ACCESS PACK 175628, MODEL/ITEM NUMBER UMOH42E;
26) OPEN HEART ACCESS PACK 175628, MODEL/ITEM NUMBER UMOH42F;
27) OPEN HEART ACCESS PACK 175628, MODEL/ITEM NUMBER UMOH42G.
Reason: During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Root cause: Under Investigation by firm
Recalling firm: American Contract Systems IncType: Cardiovascular Procedure KitDistribution: US distribution to states of: IL and LARecall #Z-2464-2025 Open, ClassifiedPosted Aug 28, 2025·Initiated Jul 14, 2025
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as:
1) LAP CHOLE PACK, Model/Item Number CILC69L;
2) LAP CHOLE PACK, Model/Item Number HNLC80J;
3) LAP CHOLE PACK, Model/Item Number JKLC55H;
4) LAPAROSCOPY PACK, Model/Item Number LLLA21K;
5) GENERAL LAPAROSCOPY MPH, Model/Item Number MPGL15G;
Reason: During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Root cause: Under Investigation by firm
Recalling firm: American Contract Systems IncType: Laparoscopy KitDistribution: US distribution to states of: IL and LARecall #Z-2465-2025 Open, ClassifiedPosted Aug 28, 2025·Initiated Jul 14, 2025
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as:
1) CYSTO, Model/Item Number ASCY24A;
2) CYSTO PACK, Model/Item Number BUCY78E;
3) CYSTO PACK, Model/Item Number LMCP22T;
4) TUR BASIN PACK, Model/Item Number LMTU31T;
5) CYSTO, Model/Item Number SACY80S;
6) UROLOGY PACK, Model/Item Number SPUR64F.
Reason: During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Root cause: Under Investigation by firm
Recalling firm: American Contract Systems IncType: Endoscope Introducer KitDistribution: US distribution to states of: IL and LARecall #Z-2466-2025 Open, ClassifiedPosted Aug 28, 2025·Initiated Jul 14, 2025
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as:
1) A-C SUPPLEMENT PACK - 205946, Model/Item Number ANCV67X;
2) KIDNEY PERFUSION PACK - 208439, Model/Item Number ANKP15AD;
3) LAPCHOLAPPY PACK, Model/Item Number FYLA38G;
4) CYSTO PACK, Model/Item Number HSCY13M;
5) PICC DRESSING CHANGE KIT, Model/Item Number HSDR10K;
6) MIDLINE CHANGE KIT, Model/Item Number HSMD20H;
7) SHOULDER ARTHOSCOPY PACK, Model/Item Number PDSA12D;
8) PDA LF SJW, Model/Item Number SWPD12K;
9) AAA PACK - 206038, Model/Item Number UDAA63AH;
10) BASIC CAB PACK - 206043, Model/Item Number UDBC35AF;
11) BASIC HEART PACK - 206044, Model/Item Number UDBH37AX;
12) FREE FLAP DRAPE PACK (PS 907864), Model/Item Number UIFF72AD;
13) PROCUREMENT PACK, Model/Item Number UIPC89D;
14) THYROID PACK (PS 096552), Model/Item Number UITR45W;
15) TRAUMA PACK 175634, Model/Item Number UMTR17B;
16) TRAUMA PACK 175634, Model/Item Number UMTR17C.
Reason: During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Root cause: Under Investigation by firm
Recalling firm: American Contract Systems IncType: General Surgery TrayDistribution: US distribution to states of: IL and LARecall #Z-2467-2025 Open, ClassifiedPosted Aug 28, 2025·Initiated Jul 14, 2025
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as:
1) SFCH CRANI PACK (PS 132432), MODEL/ITEM NUMBER UICR10W;
2) SFCH SHUNT PACK (PS 139798), MODEL/ITEM NUMBER UISH55V.
Reason: During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Root cause: Under Investigation by firm
Recalling firm: American Contract Systems IncType: Neurological TrayDistribution: US distribution to states of: IL and LARecall #Z-2468-2025 Open, ClassifiedPosted Aug 28, 2025·Initiated Jul 14, 2025
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as:
1) BORN ON ARRIVAL KIT, Model/Item Number LLBN11C;
2) LABOR & DELIVERY PACK, Model/Item Number LLLD19I.
Reason: During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Root cause: Under Investigation by firm
Recalling firm: American Contract Systems IncType: Labor And Delivery KitDistribution: US distribution to states of: IL and LARecall #Z-2469-2025 Open, ClassifiedPosted Aug 28, 2025·Initiated Jul 14, 2025
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as:
1) LAPAROSCOPY PACK, MODEL/ITEM NUMBER EVLP61I;
2) PELVISCOPY, MODEL/ITEM NUMBER EVPV29G.
Reason: During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Root cause: Under Investigation by firm
Recalling firm: American Contract Systems IncType: Gynecological Laparoscopic KitDistribution: US distribution to states of: IL and LARecall #Z-2470-2025 Open, ClassifiedPosted Aug 28, 2025·Initiated Jul 14, 2025
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as:
1) ROBOT HYST PACK, MODEL/ITEM NUMBER GRRB10E;
2) VAG HYST PACK, MODEL/ITEM NUMBER SPVH62P.
Reason: During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Root cause: Under Investigation by firm
Recalling firm: American Contract Systems IncType: Hysterectomy KitDistribution: US distribution to states of: IL and LARecall #Z-2471-2025 Open, ClassifiedPosted Aug 28, 2025·Initiated Jul 14, 2025
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as:
1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH40N;
2)TOTAL KNEE DAN MYER, MODEL/ITEM NUMBER CCKM67F;
3)HIP PROTHESIS PACK, MODEL/ITEM NUMBER HSTH03N;
4)DTC ANTERIOR HIP PACK (PS 209459), MODEL/ITEM NUMBER MIAH65B;
5)DR WHIDD0N TOTAL HIP CPP, MODEL/ITEM NUMBER MPWH01B;
6)KNEE ARTHROSCOPY, MODEL/ITEM NUMBER SPKA57T;
7)ANTERIOR HIP PACK, MODEL/ITEM NUMBER WVAH40H.
Reason: During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Root cause: Under Investigation by firm
Recalling firm: American Contract Systems IncType: Orthopedic TrayDistribution: US distribution to states of: IL and LARecall #Z-2472-2025 Open, ClassifiedPosted Aug 28, 2025·Initiated Jul 21, 2025
STA Satellite. Product Code: All references. All software versions.
The STA Satellite is a fully automated benchtop analyzer capable of simultaneously performing clotting, chromogenic, and immunologic assays.
Reason: Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
Root cause: Mixed-up of materials/components
Recalling firm: Diagnostica Stago, Inc.Type: System, Multipurpose For In Vitro Coagulation StudiesDistribution: Worldwide - US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, LA, MD, ME, MN, MO, MT, NC, OH, OK, OR, PA, PR, SD, VT, WI, WY and the countries of Algeria, Argentina, Austria, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, France, French Polynesie, Guadeloupe, India, Iran, Israel, Jordan, Korea, Kuwait, Lebanon, Malaysia, Mexico, Morocco, Netherlands, Oman, Paraguay, Peru, Republique Tcheque, Romania, Saudi Arabia, Serbia, South Africa, Switzerland, Taiwan, Thailand, Tunisia, Turquie, United Arab Emirates, Uruguay, Vietnam.Recall #Z-2473-2025
Open, ClassifiedPosted Aug 28, 2025·Initiated Jul 21, 2025
STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US.
The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.
Reason: Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
Root cause: Mixed-up of materials/components
Recalling firm: Diagnostica Stago, Inc.Type: Assay, HeparinDistribution: Worldwide - US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, LA, MD, ME, MN, MO, MT, NC, OH, OK, OR, PA, PR, SD, VT, WI, WY and the countries of Algeria, Argentina, Austria, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, France, French Polynesie, Guadeloupe, India, Iran, Israel, Jordan, Korea, Kuwait, Lebanon, Malaysia, Mexico, Morocco, Netherlands, Oman, Paraguay, Peru, Republique Tcheque, Romania, Saudi Arabia, Serbia, South Africa, Switzerland, Taiwan, Thailand, Tunisia, Turquie, United Arab Emirates, Uruguay, Vietnam.Recall #Z-2474-2025
Open, ClassifiedPosted Aug 28, 2025·Initiated Jul 21, 2025
STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US.
The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.
Reason: Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
Root cause: Mixed-up of materials/components
Recalling firm: Diagnostica Stago, Inc.Type: Assay, HeparinDistribution: Worldwide - US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, LA, MD, ME, MN, MO, MT, NC, OH, OK, OR, PA, PR, SD, VT, WI, WY and the countries of Algeria, Argentina, Austria, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, France, French Polynesie, Guadeloupe, India, Iran, Israel, Jordan, Korea, Kuwait, Lebanon, Malaysia, Mexico, Morocco, Netherlands, Oman, Paraguay, Peru, Republique Tcheque, Romania, Saudi Arabia, Serbia, South Africa, Switzerland, Taiwan, Thailand, Tunisia, Turquie, United Arab Emirates, Uruguay, Vietnam.Recall #Z-2475-2025
Open, ClassifiedPosted Aug 28, 2025·Initiated Jul 21, 2025
STA - Fibrinogen 5. Model/Catalog Number: 00674.
The STA - Fibrinogen 5 kit is intended for use with the analyzers of the STA-R, STA Compact and STA Satellite families for the quantitative determination of fibrinogen levels in human citrated plasma by the clotting
method of Clauss.
Reason: Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
Root cause: Mixed-up of materials/components
Recalling firm: Diagnostica Stago, Inc.Type: System, Fibrinogen DeterminationDistribution: Worldwide - US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, LA, MD, ME, MN, MO, MT, NC, OH, OK, OR, PA, PR, SD, VT, WI, WY and the countries of Algeria, Argentina, Austria, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, France, French Polynesie, Guadeloupe, India, Iran, Israel, Jordan, Korea, Kuwait, Lebanon, Malaysia, Mexico, Morocco, Netherlands, Oman, Paraguay, Peru, Republique Tcheque, Romania, Saudi Arabia, Serbia, South Africa, Switzerland, Taiwan, Thailand, Tunisia, Turquie, United Arab Emirates, Uruguay, Vietnam.Recall #Z-2476-2025