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Recalls affecting South Carolina

Data last updated: September 10, 2026 at 1:16 PM UTC

16,856 recalls found

Just announced

Straight from FDA press releases — not yet formally classified or risk-graded
UnclassifiedUndeclaredAnnounced September 4, 2026

Business Pill, Branch Manager for Mendietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

Grant-Valkaria, Florida - SUPPLX.com is voluntarily recalling Business Pill and Branch Manager for Men, products marketed as dietary supplements for male sexual enhancement, because FDA laboratory analysis confirmed that both products contain yohimbine that is not declared on the product labels.

Company contact: (321) 341-9501 · SupplxRecall@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaAnnounced September 4, 2026

Foods AliveMoringa Leaf Powder

Potential to be contaminated with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

Foods Alive Inc of Angola, IN, is recalling its 8-ounce packages of organic moringa leaf powder because they have the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

B. Braun0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

Full report
Drugs

Recalling firm: B. Braun Medical Inc.

“On September 3, 2026 firm updated their press release to include additional contaminants.” FOR IMMEDIATE RELEASE – September 3, 2026– Bethlehem, PA, B. Braun Medical Inc (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container, to the hospital/healthcare facility/user level due to presence of particulate matter identified as iron…

Company contact: recalls@bbraunusa.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusE. coliAnnounced September 3, 2026

Great ValueOrganic Triple Berry Blend

Possible E. Coli Contamination

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Frutas y Hortalizas del Sur S.A.

September 02, 2026. Frutas y Hortalizas del Sur S.A., San Carlos, Chile expands its July 3, 2026, recall of frozen organic IQF blueberries to include one lot of Great Value frozen Organic Triple Berry Blend 10 OZ because of potential contamination with Escherichia coli O145:H28 (E. coli O145) .

Company contact: Info.foodsafety@comfrut.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

American Regent, Inc.Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial

Presence of particulate matter and lack of sterility assurance

Full report
Food & Beverages

Recalling firm: American Regent, Inc.

FOR IMMEDIATE RELEASE – September 3, 2026 – New Albany, OH, American Regent, Inc. is conducting a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vials to the consumer level. Customer complaints were received for leaking and cracked vials, resulting in lack of assurance of sterility.

View FDA’s announcement (opens in a new tab)
UnclassifiedAllergenMilkUndeclaredAnnounced August 31, 2026

Little TemptationsChocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

Full report
Food & BeveragesAllergens

Recalling firm: Crystal Temptations

Crystal Temptations of North Arlington, NJ is recalling Halloween Chocolatey Eyeballs because they contain undeclared MILK allergens. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

View FDA’s announcement (opens in a new tab)
UnclassifiedUndeclaredAnnounced August 31, 2026

LipofitLipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

FOR IMMEDIATE RELEASE - August 27, 2026 - Davie, Florida – Ana Salazar Modela Tu Cuerpo Inc. is recalling Lipofit Extreme Fat Burner 2.0, Lot 25M12F, expiration date 09/2027, to the consumer level.

Company contact: (954) 305-1004 · yandrydy@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced August 31, 2026

KofinasGarlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

Full report
Food & BeveragesIngredients

Recalling firm: LMSI LLC

Cincinnati, OH (Aug. 29, 2026) - LMSI LLC/ Kofinas Olive Oil is issuing a voluntary recall of its Garlic Mediterranean infused extra virgin olive oil for using a garlic essential oil not approved for culinary use. The flavored oil was bottled in glass bottles in 500 ml, 250 ml, and 100 ml sizes.

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaE. coliAnnounced August 29, 2026

Everything SproutsRobust Radish Mix, 5oz Cups

Potential to be contaminated with Shiga toxin-producing Escherichia coli (STEC) or Salmonella.

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

Everything Sprouts, LLC, based in Minneapolis, MN is expanding its voluntary recall of sprouts to include certain lots of Robust Radish Sprout Mix because it has the potential to be contaminated with Shiga toxin producing Escherichia coli (STEC) or Salmonella bacteria.

Company contact: everythingsproutsmn@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaAnnounced August 29, 2026

MartinaMangoes

Potential contamination with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

MAMARONECK, NY, AUG. 28, 2026 - Panorama Produce is recalling 302 boxes of size 9 (nine) mangoes because they may be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIOGRAPHY PACK-LF DYNJ0854485S DEEP BRAIN STIMULATION PACK DYNJ0842793G NEURO ACCESSORY PACK DYNJ55385A NEURO ANGIO PACK DYNJ51697B DYNJ56509G DYNJ56509I DYNJ68063 DYNJ68845 DYNJ68845A DYNJ68845B NEURO CERVICAL PACK DYNJ0101287I DYNJ0101287L NEURO PACK DYNJ82103 DYNJ82103A NEURO TRAY DYNJ67075 DYNJ67075A DYNJ67075B NEURO VASCULAR PACK DYNJ62960B NEURO VP SHUNT PACK-LF DYNJ0843121J DYNJ0843121K NEUROLOGICAL CATH PACK DYNJ63434A DYNJ63434C NEURORADIOLOGY PK DYNJ40420D RADIOLOGY ANGIO MAJOR PACK-LF DYNJ62858A RADIOLOGY NEURO DRAPE PAC DYNJ61449 RRMC ANGIO PACK DYNJ36338B

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
99062
Lot/product code:
DYNJ0854485S UDI-DI 10193489250558 Lot 21BMA604 DYNJ0842793G UDI-DI 10195327293666 Lots 22LDA183 23EDB049 23HDC042 23JDA988 24DDA005 DYNJ55385A UDI-DI 10193489762129 Lot 21ALA184 DYNJ51697B UDI-DI 10889942893652 Lots 21ABE325 21CBH476 21DBV407 21HBH690 21JBN408 21LBL194 21VBB105 22DBL109 22EBH117 22FBS410 22JBM660 22LBJ592 22NBG350 23BBR238 23CBH111 23DBN366 23GBE252 23HBP266 DYNJ56509G UDI-DI 10193489832082 Lots 21BBQ398 21BBR321 21CBO123 21DBM014 DYNJ56509I UDI-DI 10193489947113 Lots 21HBI572 21HBK163 DYNJ68063 UDI-DI 10193489872040 Lot 21FBN698 DYNJ68845 UDI-DI 10193489481006 Lot 21JBZ479 DYNJ68845A UDI-DI 10195327058104 Lot 22CBF908 22EBS916 DYNJ68845B UDI-DI 10195327211806 Lot 22HBL865 DYNJ0101287I UDI-DI 10193489434033 Lots 21CDA247 21EDA767 21GDC130 21HDA996 21KDA985 21LDA070 22BDA782 22CDC182 22EDB032 22GDA474 22IDB680 22KDB540 DYNJ0101287L UDI-DI 10195327567064 Lots 23LDB486 24BDB244 24FDA276 24FDB664 24HDC055 DYNJ82103 UDI-DI 10195327170998 Lots 22EMI175 22GMA639 DYNJ82103A UDI-DI 10195327260910 Lot 22KMH267 DYNJ67075 UDI-DI 10193489388473 Lot 21LLA292 DYNJ67075A UDI-DI 10195327054533 Lots 22CLB355 22DLA398 22ELA122 22ELA567 22FLA224 22HLA108 22HLB180 22ILB148 22KLA076 22LLA785 23ALA638 DYNJ67075B UDI-DI 10195327470852 Lots 23JLA177 23JLB271 23LLA274 24ALA492 24HLA695 24ILA933 24KLA029 24LLA559 25ALA880 DYNJ62960B UDI-DI 10193489911558 Lot 21HBD207 DYNJ0843121J UDI-DI 10193489444605 Lots 21ADB535 21CDC104 21FDC074 21HDB833 21HDC829 21LDA977 22ADB259 22BDB407 22EDB544 22GDA480 22HDB045 22KDA482 DYNJ0843121K UDI-DI 10195327286491 Lots 22KDB422 23DDB255 23EDB879 23GDA826 23IDC125 23JDA989 24ADC199 24BDB803 24GDB414 DYNJ63434A UDI-DI 10193489234886 Lots 21CBL981 21DBI016 21GBC948 21GBP926 21IBN513 21KBE479 21LBB983 22ABX228 22BBA201 22FBD018 22FBO659 22FBT491 22GBA743 22HBC353 22JBH927 22OBK976 DYNJ63434C UDI-DI 10195327445072 Lots 23GBQ452 23KBU655 DYNJ40420D UDI-DI 10193489925258 Lots 22BLB191 22DLA630 23ALA110 DYNJ62858A UDI-DI 10193489777550 Lot 21BMD592 DYNJ61449 UDI-DI 10193489567342 Lots 22LMD608 23EMG292 DYNJ36338B UDI-DI 10193489294071 Lots 21BMA293 21CMB071 21DMD790
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CRANIOTOMY PACK-LF DYNJ0101292F DYNJ0101292G HYBRID PACK DYNJ65925A LAMINECTOMY DYNJ905156L DYNJ905156M DYNJ905156N DYNJ905156O DYNJ905156P MAJOR EXTREMITY DYNJ905159F DYNJ905159I DYNJ905159J DYNJ905159K NEURO CERVICAL PACK DYNJ0101287J DYNJ0101287K NEURO SPINE PACK DYNJ81612C POSTERIOR SPINE PACK-LF DYNJ0843339L DYNJ0843339M DYNJ0843339N SPINE PACK DYNJ30150F

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
99062
Lot/product code:
DYNJ0101292F UDI-DI 10193489434040 Lots 21CDC411 21EDA768 21EDC107 21HDA937 21HDC815 21IDC204 21KDA780 22ADA317 22ADC159 22BDA066 22CDA470 22EDB043 22EDB214 22IDA695 DYNJ0101292G UDI-DI 10195327286255 Lots 22KDB031 23BDA768 23DDA637 23EDA187 23HDB829 23JDA057 23LDA727 24ADA469 24ADC048 24HDA453 DYNJ65925A UDI-DI 10193489427264 Lots 21BLA577 21DLA194 21DLA397 DYNJ905156L UDI-DI 10193489397369 Lots 21EBI411 DYNJ905156M UDI-DI 10193489908961 Lots 21HBC497 21HBT672 DYNJ905156N UDI-DI 10193489996371 Lots 21LBQ932 22BBB708 22DBP992 22DBQ776 22FBQ287 DYNJ905156O UDI-DI 10195327219949 Lots 22HBR341 22HBW892 22KBC930 22KBC932 22KBK539 23DBD118 23DBD666 23EBC709 DYNJ905156P UDI-DI 10195327405847 Lots 23GBH099 23GBH829 23GBH830 23HBK732 23JBS610 23JBS704 23LBD615 23LBO186 24ABQ915 24CBD453 DYNJ905159F UDI-DI 10193489397475 Lots 21CBF265 21FBF870 21HBK984 21HBO573 21JBD205 21LBC602 22BBQ673 22CMH568 22EMD159 22GMG564 DYNJ905159I UDI-DI 10195327219987 Lots 22JMF458 22LMH325 23DMI033 23EMF058 DYNJ905159J UDI-DI 10195327406028 Lots 23FMC192 23FMG785 23GMI481 23HMF747 23IMG923 23IMI383 23JMA274 DYNJ905159K UDI-DI 10195327556884 Lots 23LMF481 24BMA401 24CMJ402 DYNJ0101287J UDI-DI 10195327286484 Lots 23ADA628 23EDA927 23GDA587 23HDC199 DYNJ0101287K UDI-DI 10195327500177 Lot 23JDC525 DYNJ81612C UDI-DI 10195327536145 Lot 24BBB406 DYNJ0843339L UDI-DI 10193489345544 Lots 21EDC223 21FDB611 DYNJ0843339M UDI-DI 10193489964615 Lots 21HDB435 21IDB916 21KDC093 22BDA178 22DDA738 22EDA069 22EDB876 22HDC322 22JDA142 22KDB701 DYNJ0843339N UDI-DI 10195327286552 Lots 23ADA251 23BDB752 23DDB611 23FDA191 23HDB830 23IDB329 23JDA990 23LDA449 DYNJ30150F UDI-DI 10889942186679 Lot 24BBE416
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CATARACT FULL BODY DYNJ85743 MAJOR VASCULAR PACK DYNJ81610C MINIMALLY INVASIVE PACK-LF DYNJ0843063L PEDIATRIC CATH ANGIO PACK DYNJ54755J PERIPHERAL ARTERIOGRAM RAD DYNJ61383C POSTERIOR SPINE PACK-LF DYNJ0843339O UPPER EXTREMITY DYNJ61907A VISCERAL ANGIOGRAM PACK-LF DYNJ0429121L

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
99062
Lot/product code:
DYNJ85743 UDI-DI 10195327542337 Lots 24ABP082 24BBA479 DYNJ81610C UDI-DI 10195327556938 Lot 24BBB405 DYNJ0843063L UDI-DI 10195327567071 Lots 23LDB992 24BDA641 24BDA782 24FDA795 24GDB014 24HDB074 DYNJ54755J UDI-DI 10195327549909 Lots 24ABJ741 24CBI600 24EBA488 24FBM084 24GBN355 24HBH571 DYNJ61383C UDI-DI 10195327593346 Lot 24CLA801 DYNJ0843339O UDI-DI 10195327567057 Lots 24CDB480 24DDA248 24GDB068 DYNJ61907A UDI-DI 10195327542450 Lot 24ABP069 DYNJ0429121L UDI-DI 10195327587697 Lot 24BMH315
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO DRAPE PACK (ADLUG)642-LF DYNJ47665D ANGIO PACK DYNJ30565D ANGIOGRAPHY PACK-LF DYNJ0854485V ARTERIOGRAM DYNJ28082D DYNJ28082F CARDIAC CATH DYNJ67349 CARDIAC CATH PACK DYNJ57874C CATH I PLUS-LF DYNJSCL100 CATH III PLUS-LF DYNJSCL300 CATH LAB ANGIOGRAPHY PACK DYNJ50779F CATH LAB PACK DYNJ41088B DYNJ48085 CATH LAB TRAY DYNJ37389N DYNJ37389O CATH PACK DYNJ62595A DYNJ69997 EP DRAPE PACK-LF DYNJ47645B HOSPITAL REGIONAL DE CONCEPCIO DYNJ67918A INTERVENTIONAL PACK DYNJ56666C INTERVENTIONAL RAD PACK DYNJ44100L INTERVENTIONAL RADIOLOGY PACK DYNJ43664 INTERVENTIONAL RADIOLOGY PK-LF DYNJ0516014AF OR HYBRID-MRMC DYNJ907758A VMA TRAY DYNJ62376A

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
99062
Lot/product code:
DYNJ47665D UDI-DI 10193489952827 Lots 21HBJ571 21JBD819 21LBA976 22BBP310 22CBW541 22CMH003 22DMD476 22EMA241 22FMF056 22HMC694 22HME818 22IMC158 22IMG796 22JMD311 22LMD944 22NBC196 23AMB219 DYNJ30565D UDI-DI 10193489905205 Lots 21FDB653 21GDB275 DYNJ0854485V UDI-DI 10195327096885 Lots 22CMB440 22EMF763 22HMA699 22HMG186 22IMD134 22LME930 23BMC883 23CMB807 23CMI020 DYNJ28082D UDI-DI 10193489268676 Lots 21ABN806 21BBP110 21DBL217 21EBS784 21FBU514 DYNJ28082F UDI-DI 10193489949452 Lots 21HBM290 21IBQ174 21KBO096 21KBO098 DYNJ67349 UDI-DI 10193489895728 Lots 23JMA721 24BMF147 DYNJ57874C UDI-DI 10193489976618 Lot 24ABM611 DYNJSCL100 UDI-DI 10884389625583 Lot 24ABM801 DYNJSCL300 UDI-DI 10884389625606 Lot 24ABM802 DYNJ50779F UDI-DI 10193489436068 Lots 21DME914 21EMF097 21GMB502 21JMA420 22BMA533 22BMB246 22DMA002 22DMD984 22DMI243 22EMG746 22GMB725 22HMH063 22IME310 22KMA626 23AME217 23BME137 23DMH595 23EMI849 23FMJ773 23JMB530 23LMH087 24BMF696 24CMJ355 24DMA986 DYNJ41088B UDI-DI 10889942632794 Lot 21ABG127 DYNJ48085 UDI-DI 10888277546035 Lot 24AMF987 DYNJ37389N UDI-DI 10193489306019 Lots 21ABN379 21CBU277 21DBP810 DYNJ37389O UDI-DI 10193489925302 Lots 21FBL377 21GBD005 21HBN337 21JBW141 21JBW142 21LBG627 22ABH544 22CBF313 22DBD511 22DBE512 22FBS027 DYNJ62595A UDI-DI 10193489364262 Lots 21ABH085 21ABI181 21ABV975 21BBO277 21CBU091 21EBA810 DYNJ69997 UDI-DI 10195327004743 Lots 22DBK793 22IBD718 22IBE297 22OBC253 DYNJ47645B UDI-DI 10193489952834 Lots 21GBM457 21IBV915 21KBF627 21LBA512 21LME436 22DMI445 22EMD836 22FMC418 22GME258 22KMD663 DYNJ67918A UDI-DI 10195327042776 Lots 21LBP804 22CBZ026 22CBZ027 22OBG779 DYNJ56666C UDI-DI 10193489876079 Lots 21GMD986 21IMF632 21KMI417 22BMG174 22EMC819 22GMA609 22HMB858 22IME607 22JMI267 22LMA954 22LMH272 23BMH725 DYNJ44100L UDI-DI 10193489808810 Lots 20LMF752 21AMD830 21BMB938 21DMB287 21FMA141 21GMF673 21HMF024 21JMH879 21LMD528 22AME658 22CMD992 22DME753 22EMI131 22FMD999 22GMA910 22HMG804 22KMC260 22LMF595 DYNJ43664 UDI-DI 10888277065475 Lot 22FBP452 DYNJ0516014AF UDI-DI 10193489346978 Lots 21ABD076 21FBH595 21HBP277 21IBX390 21KBK660 22BBF662 22CBA986 22CBQ787 22DBI149 22FMC751 22FMF379 22IMA038 22IMH722 DYNJ907758A UDI-DI 10193489978384 Lot 21KBQ655 DYNJ62376A UDI-DI 10193489933598 Lot 24ABP679
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CENTRAL LINE TRAY DYNJ41089 FISTULAGRAM PACK DYNJ62827A FISTULOGRAM PACK DYNJ47899A INVASIVE LINE INSERTION DYNJ44123B NON VASCULAR PACK DYNJ68037A VASCULAR ACCESS PACK-LF DYNJ0101291F

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
99062
Lot/product code:
DYNJ41089 UDI-DI 10884389891360 Lot 21BBB592 DYNJ62827A UDI-DI 10193489306606 Lot 24BBN289 DYNJ47899A UDI-DI 10889942574681 Lots 21GBI377 21IBL299 21LBE099 21LBU529 22JBV803 DYNJ44123B UDI-DI 10195327381653 Lots 23FBR833 23GBN041 23HBW014 23JBO264 23JBW218 23KBI873 DYNJ68037A UDI-DI 10195327003630 Lots 21JBQ304 21LBQ205 22ABN185 22DBT349 22EBL611 22HBH550 22IBN880 22JBH689 22KBS987 22OBA368 23ABD642 23BBH830 23DBL865 23EBT367 23FBM946 23GBT261 DYNJ0101291F UDI-DI 10195327286644 Lots 22KDB751 23EDA119 23EDB388 23FDA396 23GDA313 23HDA759 23LDB909 24ADB667 24GDA294 24HDB515
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. PICC LINEPACK (PCLUI)642-LF DYNJ47717A

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
99062
Lot/product code:
DYNJ47717A UDI-DI 10193489454529 Lots 21CMD153 21EMC033 21HMB521 21HMF278 21IME100 21IMG896 21JMG286 22AME235 22BMH056 22EMF125 22GMI215 22JME782 22LMC139 22LMC336
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. FTMC C-SECTION TRAY-LF DYNJ54603B

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
99062
Lot/product code:
DYNJ54603B UDI-DI 10195327458188 Lot 24ABO124
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled February 26, 2026

Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Princeton, NJ, Manufactured by: Macleods Pharmaceuticals Ltd., Sarigam, Valsad, Guajarat, INDIA NDC 33342-401-44

Weaker than it should be Drug

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0403-2026
Lot/product code:
Lot 16240062A, exp date 3/2026
Recalling firm:
MACLEODS PHARMA USA, INC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

Medline Kits: 1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775; 2) DBD-MTS LHK BHS BAPTIST. LOUISVI, Model Number: 60022026; 3) MTO LEFT HEART KIT SUMMA BARBERT, Model Number: 60022673; 4) MTS LH KIT-UNIV OF MIAMI PG, Model Number: 60030817; 5) MTS LEFT HEART KIT SPRINGFIELD R, Model Number: 60031245; 6) MTS PERIPHERAL KIT SPRINGFIELD R, Model Number: 60031247; 7) MTS LEFT HEART KIT-COLISEUM MED, Model Number: 60031928; 8) MTS LEFT HEART KIT -2-CALIFORNIA, Model Number: 60033011; 9) MTS LEFT HEART KIT JOHN MUIR CON, Model Number: 60040273; 10) MTS EP MANIFOLD KIT TEXAS HLTH P, Model Number: 60041268; 11) MTS 3V MANIFOLD KIT-SPARROW HOSP, Model Number: 60050097; 12) MTS LEFT HEART KIT FORT SANDERS, Model Number: 60060387; 13) MTS LEFT HEART KIT-GOOD SAMARITA, Model Number: 60070435; 14) DBD-MTS ANGIO KIT-MOUNT HOOD MED, Model Number: 60070521; 15) MTS LFT HRT KIT-GRAND VIEW PG, Model Number: 60071743; 16) MTS CUSTOM MANIFOLD KIT-INGALLS, Model Number: 60090078; 17) MTS CATH LAB KIT - HEARTLAND PG, Model Number: 60090542; 18) MTS LEFT HEART KIT-W.C.A PG, Model Number: 60100071; 19) MTS MANIFOLD KIT-GENESYS REG MED, Model Number: 60100254; 20) MTS 4V W/PRO STA-ST.JOHNS REG ME, Model Number: 60100439; 21) MTS LEFT HEART KIT JEANES HOSPIT, Model Number: 60101773; 22) MTS LEFT HEART KIT-ST. MARYS OF, Model Number: 60131099; 23) DBD-MTS LEFT HEART KIT-LEHIGH VA, Model Number: 60132653; 24) MTS LEFT HEART KIT (3V DT WASTE), Model Number: 60138326; 25) MTS LF HRT KIT-PRESBYTERIAN UNIV, Model Number: 60160148; 26) MTS LEFT HEART KIT-PENINSULA REG, Model Number: 60160428; 27) MTS LEFT HEART KIT BARNES ST.PET, Model Number: 60161135; 28) MTO OR ENDO KIT - PARK RIDGE HOS, Model Number: 60163618; 29) MTS 3V W/DT-CORPUS CHRISTI M.C., Model Number: 60181531; 30) MTS 3V PERC MANIFOLD KIT WEST. A, Model Number: 60182137; 31) MTO CATH KIT PAMPA REGIONAL MED, Model Number: 60182661; 32) MTO HOPKINS LEFT HEART HOWARD CO, Model Number: 60183662; 33) MTS-CARDIOLOGY KIT-HARLINGEN MED, Model Number: 60184001; 34) MTS PERCEPTOR KIT METHODIST. RIC, Model Number: 60185432; 35) MTS LEFT HEART KIT SADDLEBACK ME, Model Number: 60191312; 36) MTS-CARD MAN KIT MARIAN MED CENT, Model Number: 60194273; 37) LEFT HEART KIT SOUTHERN HILLS HO, Model Number: 60195202; 38) MTS DR KHAIRALLAH LEFT HEART KIT, Model Number: 60200189; 39) MTS,4V,DIAG,KIT UNIV OF CONNECTICUT, Model Number: 60210014; 40) MTO L/H KIT-UNIV OF CLEVELAND -, Model Number: 60210047; 41) MTS LEFT HEART KIT-BAPTIST HLTH, Model Number: 60230503; 42) MTS CAN KIT ACCESSOIRE DIAGNOSTI, Model Number: 60700527; 43) MTS LEFT HEART W/SYRINGE-EMORY U, Model Number: 600503712; 44) MTS ACCESSORY KIT SAINT JOSEPH L, Model Number: 601010412; 45) MTS 3 PORT WHITE KIT LEESBURG RE, Model Number: 601222712; 46) MTS PEDS LFT RT HRT-SUNRISE HO, Model Number: 601905414; 47) MTS LHK ST. LOUIS CARDIO INST, Model Number: 606119072; 48) LHK CENTURA HLTH CORP (ST. ANTHO, Model Number: 6010030361; 49) MTS LHK CHAMPLAIN VALLEY, Model Number: 6010128411; 50) MTS LHK VANDERBILT COFFEE HARTON, Model Number: 6019705921; 51) DBD-LHK EPIC SURGERY CENTER LLC, Model Number: 6020410581; 52) DBD-MTS LHK MS HEALTHCARE MGMT, Model Number: 6061073001; 53) LHK - WESLEY MEDICAL CENTER, Model Number: 6010088152A; 54) IR ANGIOGRAPHY PACK-LF, Model Number: DYNJVB1077D; 55) RADIOLOGY SPECIALS TRAY, Model Number: DYNJVB1302B; 56) ANGIO LEFT HEART PACK, Model Number: DYNJ40632D; 57) ANGIO RIGHT HEART PACK, Model Number: DYNJ40633C; 58) ANGIO TRAY, Model Number: DYNJ43278C; 59) CARDIAC LEG PACK, Model Number: DYNJ44065C; 60) EP PACK, Model Number: DYNJ55512A; 61) VASCULAR PACK, Model Number: DYNJ58522A; 62) PERIPHERAL CATH, Model Number: DYNJ59220C; 63) CARDIAC CATH - NO SYR, Model Number: DYNJ62409A; 64) C V MINOR PACK, Model Number: DYNJ64862B; 65) ENDOVASCULAR PACK, Model Number: DYNJ65926

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98599
Lot/product code:
1) 60021775, UDI-DI: 10193489041385(each), 20193489041382(case), Lot Number: 183372; 2) 60021775, UDI-DI: 10193489041385(each), 20193489041382(case), Lot Number: 185190; 3) 60022026, UDI-DI: 10193489087253(each), 20193489087250(case), Lot Number: 106008; 4) 60022026, UDI-DI: 10193489087253(each), 20193489087250(case), Lot Number: 117378; 5) 60022673, UDI-DI: 10193489041538(each), 20193489041535(case), Lot Number: 176180; 6) 60030817, UDI-DI: 10193489041972(each), 20193489041979(case), Lot Number: 185193; 7) 60031245, UDI-DI: 10193489042214(each), 20193489042211(case), Lot Number: 183374; 8) 60031247, UDI-DI: 10193489042238(each), 20193489042235(case), Lot Number: 174370; 9) 60031247, UDI-DI: 10193489042238(each), 20193489042235(case), Lot Number: 184424; 10) 60031247, UDI-DI: 10193489042238(each), 20193489042235(case), Lot Number: 185080; 11) 60031928, UDI-DI: 10193489042276(each), 20193489042273(case), Lot Number: 185195; 12) 60033011, UDI-DI: 10193489042429(each), 20193489042426(case), Lot Number: 181365; 13) 60040273, UDI-DI: 10193489042832(each), 20193489042839(case), Lot Number: 179872; 14) 60040273, UDI-DI: 10193489042832(each), 20193489042839(case), Lot Number: 183375; 15) 60041268, UDI-DI: 10193489043051(each), 20193489043058(case), Lot Number: 140365; 16) 60041268, UDI-DI: 10193489043051(each), 20193489043058(case), Lot Number: 170084; 17) 60050097, UDI-DI: 10193489043242(each), 20193489043249(case), Lot Number: 176186; 18) 60060387, UDI-DI: 10193489043693(each), 20193489043690(case), Lot Number: 183376; 19) 60060387, UDI-DI: 10193489043693(each), 20193489043690(case), Lot Number: 185194; 20) 60060387, UDI-DI: 10193489043693(each), 20193489043690(case), Lot Number: 187370; 21) 60070435, UDI-DI: 10193489044133(each), 20193489044130(case), Lot Number: 183377; 22) 60070435, UDI-DI: 10193489044133(each), 20193489044130(case), Lot Number: 187371; 23) 60070521, UDI-DI: 10193489044164(each), 20193489044161(case), Lot Number: 185196; 24) 60071743, UDI-DI: 10193489044348(each), 20193489044345(case), Lot Number: 176190; 25) 60090078, UDI-DI: 10193489044829(each), 20193489044826(case), Lot Number: 185197; 26) 60090542, UDI-DI: 10193489044867(each), 20193489044864(case), Lot Number: 181373; 27) 60090542, UDI-DI: 10193489044867(each), 20193489044864(case), Lot Number: 185198; 28) 60100071, UDI-DI: 10193489044959(each), 20193489044956(case), Lot Number: 176193; 29) 60100071, UDI-DI: 10193489044959(each), 20193489044956(case), Lot Number: 185189; 30) 60100254, UDI-DI: 10193489045024(each), 20193489045021(case), Lot Number: 185188; 31) 60100439, UDI-DI: 10193489045130(each), 20193489045137(case), Lot Number: 181369; 32) 60100439, UDI-DI: 10193489045130(each), 20193489045137(case), Lot Number: 185203; 33) 60101773, UDI-DI: 10193489045451(each), 20193489045458(case), Lot Number: 181364; 34) 60131099, UDI-DI: 10193489046717(each), 20193489046714(case), Lot Number: 181370; 35) 60131099, UDI-DI: 10193489046717(each), 20193489046714(case), Lot Number: 185204; 36) 60132653, UDI-DI: 10193489047332(each), 20193489047339(case), Lot Number: 181381; 37) 60138326, UDI-DI: 10193489047653(each), 20193489047650(case), Lot Number: 185205; 38) 60160148, UDI-DI: 10193489048704(each), 20193489048701(case), Lot Number: 183382; 39) 60160148, UDI-DI: 10193489048704(each), 20193489048701(case), Lot Number: 185207; 40) 60160428, UDI-DI: 10193489048773(each), 20193489048770(case), Lot Number: 181100; 41) 60161135, UDI-DI: 10193489049046(each), 20193489049043(case), Lot Number: 177936; 42) 60161135, UDI-DI: 10193489049046(each), 20193489049043(case), Lot Number: 185208; 43) 60163618, UDI-DI: 10193489049251(each), 20193489049258(case), Lot Number: 140392; 44) 60181531, UDI-DI: 10193489049619(each), 20193489049616(case), Lot Number: 185209; 45) 60182137, UDI-DI: 10193489049695(each), 20193489049692(case), Lot Number: 185522; 46) 60182137, UDI-DI: 10193489049695(each), 20193489049692(case), Lot Number: 187343; 47) 60182661, UDI-DI: 10193489049794(each), 20193489049791(case), Lot Number: 176203; 48) 60183662, UDI-DI: 10193489050080(each), 20193489050087(case), Lot Number: 181371; 49) 60184001, UDI-DI: 10193489050110(each), 20193489050117(case), Lot Number: 177939; 50) 60184001, UDI-DI: 10193489050110(each), 20193489050117(case), Lot Number: 185210; 51) 60185432, UDI-DI: 10193489050325(each), 20193489050322(case), Lot Number: 184739; 52) 60191312, UDI-DI: 10193489050820(each), 20193489050827(case), Lot Number: 185212; 53) 60194273, UDI-DI: 10193489051094(each), 20193489051091(case), Lot Number: 133064; 54) 60195202, UDI-DI: 10193489051322(each), 20193489051329(case), Lot Number: 181368; 55) 60195202, UDI-DI: 10193489051322(each), 20193489051329(case), Lot Number: 187374; 56) 60200189, UDI-DI: 10193489051513(each), 20193489051510(case), Lot Number: 176208; 57) 60200189, UDI-DI: 10193489051513(each), 20193489051510(case), Lot Number: 181375; 58) 60200189, UDI-DI: 10193489051513(each), 20193489051510(case), Lot Number: 185213; 59) 60210014, UDI-DI:… (truncated, 13411 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

Medline Kits: 1) ANGIO CATH PACK-MARY IMMACULAT, Model Number: DYNJ24517D

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98599
Lot/product code:
1) DYNJ24517D, UDI-DI: 10193489812510(each), 40193489812511(case), Lot Number: 25CBA224
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543A

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98599
Lot/product code:
1) DYNJ37543A, UDI-DI: 10193489919561(each), 40193489919562(case), Lot Number: 24DDA193
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Number: PK-CF0533 Product Description: An assembly of devices intended to generate and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure.

Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98454
Lot/product code:
Model: PK-CF0533; UDI: 00821925035867; Lot Numbers: All unexpired;
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US.

A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98461
Lot/product code:
Part Number: 03.424.126-US. GTIN: 10886982335951. Lot Number: 68982P8.
Recalling firm:
Synthes (USA) Products LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3005 Product Description: The OLYMPUS Everest Bipolar Cutting Forceps are intended to be passed through a 5 mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the bipolar outputs of compatible generators.

Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98454
Lot/product code:
Model: 3005; UDI: 00821925035881; Lot Number: All unexpired
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

Medline Namic Syringes: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB;

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98599
Lot/product code:
1) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 25GBK394; 2) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 25GBN659; 3) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 25GBO446; 4) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 25GBO586; 5) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 25GBQ523
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

Medline Kits: 1) ARTHROSCOPY PACK, Model Number: DYNJ82440

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98599
Lot/product code:
1) DYNJ82440, UDI-DI: 10195327196240(each), 40195327196241(case), Lot Number: 24BMD005
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

Medline Kits: 1) D AND C PACK, Model Number: DYNJ41254B

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98599
Lot/product code:
1) DYNJ41254B, UDI-DI: 10888277882003(each), 40888277882004(case), Lot Number: 25FBA224
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

Medline Kits: 1) ARTHROGRAM TRAY, Model Number: DYNJ07425; 2) TOL NEURO ANGIO PACK, Model Number: DYNJ38610I 3) ANGIOGRAPHY PACK, Model Number: DYNJ45234A 4) C.I.C.N. ANGIO PACK, Model Number: DYNJ53064B 5) DR. ALLEYNE NEURO PACK, Model Number: DYNJ63779A 6) NEURO CTM IR PACK, Model Number: DYNJ87817

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98599
Lot/product code:
1) DYNJ07425, UDI-DI: 10080196866465(each), 40080196866466(case), Lot Number: 23DBP927; 2) DYNJ07425, UDI-DI: 10080196866465(each), 40080196866466(case), Lot Number: 23EBS362; 3) DYNJ38610I, UDI-DI: 10198459323102(each), 40198459323103(case), Lot Number: 25DBM593; 4) DYNJ38610I, UDI-DI: 10198459323102(each), 40198459323103(case), Lot Number: 25GBO740; 5) DYNJ45234A, UDI-DI: 10193489782554(each), 40193489782555(case), Lot Number: 23LBU617; 6) DYNJ45234A, UDI-DI: 10193489782554(each), 40193489782555(case), Lot Number: 23HBK865; 7) DYNJ53064B, UDI-DI: 10193489789164(each), 40193489789165(case), Lot Number: 24BMC721; 8) DYNJ53064B, UDI-DI: 10193489789164(each), 40193489789165(case), Lot Number: 24EMF715; 9) DYNJ53064B, UDI-DI: 10193489789164(each), 40193489789165(case), Lot Number: 24AMI140; 10) DYNJ63779A, UDI-DI: 10193489355840(each), 40193489355841(case), Lot Number: 25HBM008; 11) DYNJ87817, UDI-DI: 10198459069185(each), 40198459069186(case), Lot Number: 24HBF527; 12) DYNJ87817, UDI-DI: 10198459069185(each), 40198459069186(case), Lot Number: 25BBL663; 13) DYNJ87817, UDI-DI: 10198459069185(each), 40198459069186(case), Lot Number: 25CBN143; 14) DYNJ87817, UDI-DI: 10198459069185(each), 40198459069186(case), Lot Number: 25EBJ520; 15) DYNJ87817, UDI-DI: 10198459069185(each), 40198459069186(case), Lot Number: 25FBC657
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

Medline Kits: 1) GENERAL LAPAROSCOPY, Model Number: CDS930027Y

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98599
Lot/product code:
1) CDS930027Y, UDI-DI: 10198459303128(each), 40198459303129(case), Lot Number: 25EBE671
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

Medline Kits: 1) BREAST PACK, Model Number: DYNJ66777D

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98599
Lot/product code:
1) DYNJ66777D, UDI-DI: 10195327365196(each), 40195327365197(case), Lot Number: 24JBX593
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

Medline Kits: 1) HYSTEROSCOPY PACK, Model Number: DYNJ48399C; 2) SLING PACK, Model Number: DYNJ62849B

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98599
Lot/product code:
1) DYNJ48399C, UDI-DI: 10195327172626(each), 40195327172627(case), Lot Number: 24CBU779; 2) DYNJ62849B, UDI-DI: 10195327514884(each), 40195327514885(case), Lot Number: 24BBS275
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3006 Product Description: The OLYMPUS Everest Bipolar Cutting Forceps are intended to be passed through a 5 mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the bipolar outputs of compatible generators.

Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98454
Lot/product code:
Model: 3006; UDI: 00821925035898; Lot Numbers: All unexpired;
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

Medline Kits: 1) ANGIOGRAPHY PACK-LF, Model Number: DYNJQ0505M; 2) ANGIO PACK, Model Number: DYNJT2021G; 3) ANGIOGRAPHY PACK, Model Number: DYNJ31377B; 4) ANGIO PACK, Model Number: DYNJ51279; 5) ANGIOGRAPHY PACK II, Model Number: DYNJ52447; 6) CATH ANGIO PACK, Model Number: DYNJ53369C; 7) ANGIO PACK, Model Number: DYNJ53591A; 8) ANGIOGRAPHIC PACK, Model Number: DYNJ57516; 9) ANGIOGRAPHY TRAY-LF, Model Number: DYNJ58722A; 10) ANGIO TRAY W/CHLORAPREP, Model Number: DYNJ62742; 11) CEREBRAL ANGIOGRAM, Model Number: DYNJ67876; 12) CSU CATH MANIFOLD KIT, Model Number: VASC1170A

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98599
Lot/product code:
1) DYNJQ0505M, UDI-DI: 10889942846900(each), 40889942846901(case), Lot Number: 23KBL880; 2) DYNJQ0505M, UDI-DI: 10889942846900(each), 40889942846901(case), Lot Number: 24ABA125; 3) DYNJQ0505M, UDI-DI: 10889942846900(each), 40889942846901(case), Lot Number: 23IBA898; 4) DYNJT2021G, UDI-DI: 10193489608816(each), 40193489608817(case), Lot Number: 24CMH245; 5) DYNJ31377B, UDI-DI: 10889942106691(each), 40889942106692(case), Lot Number: 25LBQ639; 6) DYNJ31377B, UDI-DI: 10889942106691(each), 40889942106692(case), Lot Number: 25GBF384; 7) DYNJ51279, UDI-DI: 10889942145300(each), 40889942145301(case), Lot Number: 25DBQ486; 8) DYNJ51279, UDI-DI: 10889942145300(each), 40889942145301(case), Lot Number: 25CBT538; 9) DYNJ52447, UDI-DI: 10889942279777(each), 40889942279778(case), Lot Number: 25FMA232; 10) DYNJ53369C, UDI-DI: 10193489651331(each), 40193489651332(case), Lot Number: 25ILA917; 11) DYNJ53369C, UDI-DI: 10193489651331(each), 40193489651332(case), Lot Number: 25FLA554; 12) DYNJ53591A, UDI-DI: 10889942592371(each), 40889942592372(case), Lot Number: 25FBA222; 13) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 21JBN533; 14) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 21KBM563; 15) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 21KBQ110; 16) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 21LBI454; 17) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 23DMF559; 18) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 23EMB053; 19) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 23FME913; 20) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 23JME012; 21) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 24BMK272; 22) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 24CMK043; 23) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 24CMK043Z; 24) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 24DMJ156; 25) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 24FMI064; 26) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 24HMB643; 27) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 24JME212; 28) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 23HME551; 29) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 25DMB495; 30) DYNJ58722A, UDI-DI: 10193489329698(each), 40193489329699(case), Lot Number: 25GBS720; 31) DYNJ62742, UDI-DI: 10193489685923(each), 40193489685924(case), Lot Number: 24KBE607; 32) DYNJ67876, UDI-DI: 10193489449198(each), 40193489449199(case), Lot Number: 25KBP615; 33) VASC1170A, UDI-DI: 10193489774863(each), 40193489774864(case), Lot Number: 23GMC436
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

Medline Kits: 1) PICC TRAY, Model Number: DYNJ41648A

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98599
Lot/product code:
1) DYNJ41648A, UDI-DI: 10198459062834(each), 40198459062835(case), Lot Number: 25CLA242; 2) DYNJ41648A, UDI-DI: 10198459062834(each), 40198459062835(case), Lot Number: 24LLA758
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

Medline Kits: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB; 2) MANIFOLD KIT LOW PRESSURE OFF, Model Number: VASCSLPOFF1; 3) EP MANIFOLD KIT, Model Number: VASC1018A

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98599
Lot/product code:
1) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 22IBH073; 2) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 22IBH620; 3) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 22KBU236; 4) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 22LBB186; 5) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 23BBE163; 6) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 23BBQ244; 7) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 23BBT094; 8) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 23CBN156; 9) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 23DBO047; 10) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 23EBN965; 11) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 23FBG730; 12) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 23HBL275; 13) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 24BBT133; 14) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 24DBC913; 15) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 24DBM253; 16) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 24EBD055; 17) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 24EBM619; 18) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 24FBC811; 19) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 24GBO792; 20) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 24HBQ429; 21) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 24KBO162; 22) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 25ABL984; 23) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 25ABV250; 24) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 25BBC496; 25) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 25BBS716; 26) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 25BBU979; 27) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 25CBB632; 28) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 25CBC880; 29) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 25CBN329; 30) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 22JBU981; 31) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 23FBP998; 32) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 24JBO656; 33) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 25DBR721; 34) VASCSLPOFF1, UDI-DI: 10889942405527(each), 40889942405528(case), Lot Number: 24KBI875; 35) VASCSLPOFF1, UDI-DI: 10889942405527(each), 40889942405528(case), Lot Number: 23KBD992; 36) VASC1018A, UDI-DI: 10889942337033(each), 40889942337034(case), Lot Number: 25BBG137; 37) VASC1018A, UDI-DI: 10889942337033(each), 40889942337034(case), Lot Number: 25BBI161; 38) VASC1018A, UDI-DI: 10889942337033(each), 40889942337034(case), Lot Number: 25ABG686
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)