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Recalls affecting Wyoming

Data last updated: September 9, 2026 at 1:18 PM UTC

16,268 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 Men — dietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

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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/virusAnnounced September 4, 2026

Foods Alive — Moringa 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. Braun — 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

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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/virusAnnounced September 3, 2026

Great Value — Organic 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)
UnclassifiedUndeclaredAnnounced August 31, 2026

Lipofit — Lipofit 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

Kofinas — Garlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

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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)
UnclassifiedAllergenUndeclaredAnnounced August 31, 2026

Little Temptations — Chocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

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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)
UnclassifiedBacteria/virusAnnounced August 29, 2026

Everything Sprouts — Robust 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/virusAnnounced August 29, 2026

Martina — Mangoes

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)
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UnclassifiedRisk not yet known
Medical deviceRecalled April 27, 2026

MINOR CATH LAB PACK DYNJ84775A OR VASCULAR ANGIO PACK DYNJ47269D PORT-A-CATH DYNJ63276G

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

ALL 50 STATES
▸Full report

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

Recall #:
98951
Lot/product code:
DYNJ84775A UDI-DI 10195327606527 lot 25LMH070 DYNJ47269D UDI-DI 10195327674786 lot 25LMJ234 DYNJ63276G UDI-DI 10198459458835 lot 26BBC598
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 27, 2026

PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050

The recall is being conducted due to corrosion of the internal metallic spring within the sprayer component. This condition is caused by material incompatibility between the product solution and the stainless steel spring and may result in visible discoloration and the presence of trace levels of metallic elements (including iron, chromium, and nickel) in the solution during use.

ALL 50 STATES
▸Full report

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

Recall #:
98959
Lot/product code:
UDI:00860009268616 Lot: 25G263
Recalling firm:
Oculus Technologies of Mexico, S.A. de C.V.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 27, 2026

Medline convenience kits: BASIC EYE DYNJ905154I TUBAL LIGATION CDS CDS760053K

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

ALL 50 STATES
▸Full report

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

Recall #:
98951
Lot/product code:
DYNJ905154I UDI-DI 10198459549977 lots 26ABB308 26BBA671 CDS760053K UDI-DI 10195327182977 lot 25KBP010
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 27, 2026

Medline convenience kits: ACD DYNJ904999J ACDF DYNJ907336B DYNJ910821A ACDF PACK DYNJ81098C ACL DYNJ911996 ACL ACCESSORY PACK DYNJ86584B ACL- LF DYNJ905281B ACL PACK DYNJ67271A ALIF DYNJ904848L ANTERIOR CERVICAL DYNJ901355J ARTHROSCOPY DYNJ908193B ARTHROSCOPY PACK-LF DYNJ42963M DYNJ52268B ARTHROSCOPY SHOULDER DYNJ908684A BACK CDS-LF CDS983364G BACK PACK DYNJT4339 CDH SPINE PACK DYNJ908828D CERVICAL CDS DYNJ903477J CMC ORTHO BACK TRAY SYNJ10272B CRANIOTOMY DYNJ911853 CRANIOTOMY ROOSEVELT PACK DYNJ58358F CUSTOM HAND PACK-LF DYNJ0537135V CUSTOM SPINAL PACK DYNJT7544 DISCECTOMY PACK DYNJ86770 DJ ORTHO SPINE DYNJ48980M EXTREMITY PACK-LF DYNJT4161 FOOT PACK DYNJ53179D GENERAL ORTHO-ACNW DYNJ84891 GILMORE SHOULDER SCOPE PACK DYNJ58002 GV LUMBAR LAMINECTOMY PK DYNJ46938L HAND PACK DYNJ63113B DYNJ69662A DYNJT5855 HAND-LF DYNJ903263B KIT LAMINECTOMY DYNJ908806C KNEE ARTHROSCOPY DYNJ902056C DYNJ904846I KNEE ARTHROSCOPY-LF DYNJ905871F KNEE SCOPE DYNJ906986G LAMINECTOMY DYNJ904847K DYNJ909505D LAMINECTOMY CDS CDS983115K LAMINECTOMY CERVICAL DISC-LF DYNJ905286G LAMINECTOMY NEURO PACK DYNJ58356F LAMINECTOMY SPINE DYNJ904139L LOWER EXTREMITY PACK DYNJ63114C LUMBAR CERVICAL PACK-LF DYNJ0101088G LUMBAR LAMI DYNJ905020J LUMBAR LAMINECTOMY DYNJ53707 LUMBAR LAMINECTOMY PACK DYNJT4386 MAIN/LAMINECTOMY PACK-LF DYNJ0565499AN NJ SPINE SPECIALIST PACK DYNJ58706F OHOW SPINE-BACK PACK DYNJ910097A ORTHO NECK CDS-LF CDS983134C ORTHO PACK-LF DYNJ37202G ORTHO SPINE DYNJ40221G OSC BEACH CHAIR SHOULDER-LF DYNJ905282C PACC PETRIE ACL ADD ON PACK-LF DYNJ58290D PACK,ARTHROSCOPY ASC DYNJ65484A PACK,POSTERIOR SPINAL FUSION DYNJ906892B PAD LATERAL SPINE DYNJ902158L DYNJ902158M PAD POSTERIOR SPINE DYNJ902142L PK-SPINE DYNJ58259A PODIATRY PACK DYNJ62288D POST SPINE PACK DYNJ20509R POSTERIOR SPINAL FUSION DYNJ903250B RFT ARTHROSCOPY PACK DYNJ43956C RFT SHOULDER PACK-NOBLE DYNJ36331D SA SHOULDER #2 BORDEN DYNJ56501A SHOULDER DYNJ900893M DYNJ904184I SHOULDER ARTHROSCOPY DYNJ904842G SHOULDER PACK DYNJ83483 SHOULDER PACK-LF DYNJ42973N SHOULDER SCOPE PACK NTX DYNJ68399C SPINAL PACK DYNJ49692G SPINE DYNJ910451A SPINE PACK DYNJ20147O DYNJ84971 DYNJ86044A DYNJ86308C DYNJ88917 DYNJS3069 DYNJT4163 DYNJT8396 ST CHARLES TOTAL HIP DYNJ909593C TOTAL HIP DYNJ910906D TOTAL HIP PACK DYNJ64156B TOTAL JOINT DYNJ904186G TOTAL KNEE PACK DYNJ60967 DYNJ61409A WMC ORTHO SPINE WMC-LF DYNJ902528M XLIF DYNJ910795B

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

ALL 50 STATES
▸Full report

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

Recall #:
98951
Lot/product code:
DYNJ904999J UDI-DI 10195327305024 lot 26DBJ301 DYNJ907336B UDI-DI 10198459084300 lot 26DBF966 DYNJ910821A UDI-DI 10198459453359 lots 25KBH623 26BBL877 26BBM089 DYNJ81098C UDI-DI 10198459357107 lots 25JBR783 25KBD860 DYNJ911996 UDI-DI 10198459596230 lots 25LBI311 25LBV123 26ABN955 DYNJ86584B UDI-DI 10198459410604 lot 25LMH561 DYNJ905281B UDI-DI 10195327063191 lot 25KBD109 DYNJ67271A UDI-DI 10195327626822 lot 25JBV609 DYNJ904848L UDI-DI 10198459217500 lot 26DBK390 DYNJ901355J UDI-DI 10198459224775 lot 25LBK865 DYNJ908193B UDI-DI 10198459521720 lot 25LBD958 DYNJ42963M UDI-DI 10198459611834 lot 26AMB027 DYNJ52268B UDI-DI 10195327432423 lots 25LBC027 26CBA143 DYNJ908684A UDI-DI 10198459500510 lot 26AMH337 CDS983364G UDI-DI 10195327432508 lot 26BBR233 DYNJT4339 UDI-DI 10198459448720 lot 26CBC179 DYNJ908828D UDI-DI 10198459512919 lots 25KMC466 26AMG065 DYNJ903477J UDI-DI 10195327565206 lots 26AMG182 26AMG272 SYNJ10272B UDI-DI 10195327006532 lot 25LBO306 DYNJ911853 UDI-DI 10198459559372 lot 25KBI658 DYNJ58358F UDI-DI 10198459105029 lots 25JBX146 25LBP519 DYNJ0537135V UDI-DI 10195327556389 lots 25KBG081 25LBP178 26BBC915 DYNJT7544 UDI-DI 10198459631399 lots 25LBN779 DYNJ86770 UDI-DI 10195327674229 lot 25KBJ623 DYNJ48980M UDI-DI 10195327533694 lot 25LMK166 DYNJT4161 UDI-DI 10198459410741 lot 25JBA211 DYNJ53179D UDI-DI 10198459574658 lot 25LMH296 DYNJ84891 UDI-DI 10195327434151 lot 25JBT703 DYNJ58002 UDI-DI 10889942807383 lot 25LBO695 DYNJ46938L UDI-DI 10198459090103 lot 25JBS479 DYNJ63113B UDI-DI 10195327131449 lot 25KBJ559 DYNJ69662A UDI-DI 10198459132360 lot 25JBX052 DYNJT5855 UDI-DI 10198459515057 lots 25JBV938 25LBO691 DYNJ903263B UDI-DI 10889942754014 lot 26CBQ083 DYNJ908806C UDI-DI 10198459285868 lot 25LMJ639 DYNJ902056C UDI-DI 10195327422103 lots 25JBU940 25LBR965 DYNJ904846I UDI-DI 10198459217579 lot 26CBS964 DYNJ905871F UDI-DI 10198459206252 lot 25LBA302 DYNJ906986G UDI-DI 10198459610226 lot 26AMJ169 DYNJ904847K UDI-DI 10198459217586 lot 25KBR022 DYNJ909505D UDI-DI 10198459594229 lot 25LMJ127 CDS983115K UDI-DI 10198459579608 lot 25LBE987 DYNJ905286G UDI-DI 10198459248184 lots 26AMA067 26AMH307 DYNJ58356F UDI-DI 10198459104923 lot 25LBR764 DYNJ904139L UDI-DI 10198459528583 lot 25JBT916 DYNJ63114C UDI-DI 10193489870206 lot 25JBX122 DYNJ0101088G UDI-DI 10198459619960 lot 25LBQ608 DYNJ905020J UDI-DI 10198459548314 lot 25KBJ908 DYNJ53707 UDI-DI 10889942441082 lots 25LBP985 26CBR371 DYNJT4386 UDI-DI 10198459457609 lot 25KBK189 DYNJ0565499AN UDI-DI 10195327318352 lot 25JMF339 DYNJ58706F UDI-DI 10198459124877 lot 26CBC852 DYNJ910097A UDI-DI 10198459504785 lot 26AMD592 CDS983134C UDI-DI 10195327147655 lot 25KBT474 DYNJ37202G UDI-DI 10195327685393 lots 25JBS464 25LBR525 DYNJ40221G UDI-DI 10198459448515 lot 25LMJ294 DYNJ905282C UDI-DI 10195327393069 lot 25KBM844 DYNJ58290D UDI-DI 10195327513467 lot 25LBQ039 DYNJ65484A UDI-DI 10195327303501 lot 25LMB980 DYNJ906892B UDI-DI 10198459168611 lots 25KBG661 26BBC906 DYNJ902158L UDI-DI 10198459453021 lot 25LBD928 DYNJ902158M UDI-DI 10198459681721 lot 26DBK385 DYNJ902142L UDI-DI 10198459452970 lot 25LBA949 DYNJ58259A UDI-DI 10193489734034 lots 25JBY406 25LBM865 DYNJ62288D UDI-DI 10195327605827 lots 25JBA294 25KBB258 DYNJ20509R UDI-DI 10198459277849 lots 25LMH654 26AMB105 DYNJ903250B UDI-DI 10889942755288 lot 25KBM855 DYNJ43956C UDI-DI 10193489970708 lot 25KBL821 DYNJ36331D UDI-DI 10198459416446 lot 25LMH136 DYNJ56501A UDI-DI 10195327310752 lot 25LMI162 DYNJ900893M UDI-DI 10198459408632 lots 25KMB298 26AMB284 DYNJ904184I UDI-DI 10198459640704 lot 26CBO500 DYNJ904842G UDI-DI 10198459217753 lot 25LBC835 DYNJ83483 UDI-DI 10195327268916 lot 25KBH325 DYNJ42973N UDI-DI 10198459621178 lot 26AMA642 DYNJ68399C UDI-DI 10195327341763 lot 26BBD183 DYNJ49692G UDI-DI 10195327347352 lot 26AMA587 DYNJ910451A UDI-DI 10198459365560 lot 25KBG700 26ABF330 DYNJ20147O UDI-DI 10198459377617 lot 25JBA158 DYNJ84971 UDI-DI 10195327442620 lot 26BBC185 DYNJ86044A UDI-DI 10198459404351 lot 25LBQ169 DYNJ86308C UDI-DI 10198459425233 lot 25LBQ110 DYNJ88917 UDI-DI 10198459215926 lot 25LMF333 DYNJS3069 UDI-DI 10888277058286 lot 25LBC215 DYNJT4163 UDI-DI 10198459410758 lot 26BBC139 DYNJT8396 UDI-DI 10198459704871 lot 26CBE087 DYNJ909593C UDI-DI 10198459523816 lot 25LBB787 DYNJ910906D UDI-DI 10198459472626 lot 25KBJ090 DYNJ64156B UDI-DI 10195327678746 lots 25KBC275 25LBC916 26CBC871 DYNJ904186G UDI-DI 10198459002922 lots 25KBG639 25LBB568 DYNJ60967 UDI-DI 10193489537918 lot 25LMJ893 DYNJ61409A UDI-DI 10193489778595 lots 25LMH863 26AMC051 DYNJ902528M UDI-DI 10198459445873 lot 25KBU092 DYNJ910795B UDI-DI 10198459594205 lot 25LMH707
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 27, 2026

Medline convenience kits: WT LAVH PACK DYNJ46609F

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

ALL 50 STATES
▸Full report

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

Recall #:
98951
Lot/product code:
DYNJ46609F UDI-DI 10198459403989 lot 25JBS436
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 27, 2026

BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 405637, 405707.

This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.

ALL 50 STATES
▸Full report

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

Recall #:
98842
Lot/product code:
1. Catalog Number: 405637. UDI Numbers: (01)00382904056377(17)260628(10)B01V160D, (01)00382904056377(17)270101(10)B01V241D, (01)00382904056377(17)270101(10)B01V265D, (01)00382904056377(17)261001(10)B02V183D. Lot Numbers (Expiration Date): B01V160D (2026-06-28), B01V241D (2027-01-01), B01V265D (2027-01-01), B02V183D (2026-10-01). 2. Catalog Number: 405707. UDI Number: (01)00382904057077(17)270101(10)B02V230D. Lot Number (Expiration Date): B02V230D (2027-01-01).
Recalling firm:
Becton Dickinson & Company
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 27, 2026

Medline convenience kit: (82)LABOR & DELIVERY C-SECTION DYNJ907895F

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

ALL 50 STATES
▸Full report

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

Recall #:
98951
Lot/product code:
UDI-DI 10198459366390 Lot 25KBL873
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 27, 2026

Medline convenience kits: CMH CENTRAL LINE DRESSING CHANGE KIT EBSI1705A CVC/PICC/MIDLINE DRESSING CHANGE KIT EBSI1057A DIALYSIS DRESSING CHANGE EBSI1498 EBSI CVC DRESSING CHANGE KIT EBSI1585 PICC DRESSING CHANGE TRAY EBSI1621 PORT ACCESS KIT EBSI1837

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

ALL 50 STATES
▸Full report

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

Recall #:
98951
Lot/product code:
EBSI1705A UDI-DI 10653160382850 Lot 2025103090 EBSI1057A UDI-DI 10653160356875 Lot 2025120890 EBSI1498 UDI-DI 10193489111538 Lot 2025110690 EBSI1585 UDI-DI 10653160354796 Lot 2025102190 EBSI1621 UDI-DI 10653160358336 Lot 2025110390 EBSI1837 UDI-DI 10653160388555 Lot 2025102990
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 27, 2026

Medline EBSI Kit EBSI1534

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

ALL 50 STATES
▸Full report

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

Recall #:
98951
Lot/product code:
UDI-DI 10653160350507 Lot 2025110490
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 27, 2026

Medline convenience kits: BREAST-HERNIA-PORT CDS-LF CDS984853L

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

ALL 50 STATES
▸Full report

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

Recall #:
98951
Lot/product code:
UDI-DI 10198459293535 Lots 26AME511 26AMG737
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 27, 2026

Medline convenience kits: 20CM CVC INSERTION KIT ECVC6805B 2L 8.5FR 16CM CVC INSERTION KIT ECVC8055A VANTEX PI CVC 7F, 3L, 20CM BUNDLE ECVC6915A ECVC6985B

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

ALL 50 STATES
▸Full report

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

Recall #:
98951
Lot/product code:
ECVC6805B UDI-DI 10653160387428 Lot 2025120890 ECVC8055A UDI-DI 10653160387848 Lot 2025112690 ECVC6915A UDI-DI 10653160389439 Lot 2025102790 ECVC6985B UDI-DI 10653160388272 Lot 2025103190
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 27, 2026

BDSpinal Tray with BDWhitacre Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405645.

This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.

ALL 50 STATES
▸Full report

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

Recall #:
98842
Lot/product code:
Catalog Number: 405645. UDI Numbers: (01)00382904056452(17)261001(10)B01V223D. Lot Number (Expiration Date): B01V223D (2026-10-01).
Recalling firm:
Becton Dickinson & Company
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 27, 2026

BDSpinal Tray with BDWhitacre Needle 24 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 400868, 405652.

This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.

ALL 50 STATES
▸Full report

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

Recall #:
98842
Lot/product code:
1. Catalog Numbers: 400868. UDI Numbers: (01)10885403469510(17)261001(10)B01V206D, (01)10885403469510(17)261001(10)B01V220D, (01)10885403469510(17)270101(10)B02V266D. Lot Number (Expiration Date): B01V206D (2026-10-01), B01V220D (2026-10-01), B02V266D (2027-01-01). 2. Catalog Number: 405652. UDI Numbers: (01)00382904056520(17)270130(10)B01V353D, (01)00382904056520(17)270101(10)B02V267D. Lot Numbers (Expiration Date): B01V353D (2027-01-30), B02V267D (2027-01-01).
Recalling firm:
Becton Dickinson & Company
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 27, 2026

BDSpinal Tray with BDQuincke Needle 26 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405632.

This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.

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

Recall #:
98842
Lot/product code:
Catalog Number: 405632. UDI Number: (01)00382904056322(17)270101(10)B01V231D; Lot Number (Expiration Date): B01V231D (2027-01-01). ***Expansion 07/08/2026 UDI Number: (01)00382904056322(17)270101(10)B02V248D; Lot Number (Expiration Date): B02V248D (2027-01-01).
Recalling firm:
Becton Dickinson & Company
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 27, 2026

BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 2 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405658.

This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.

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

Recall #:
98842
Lot/product code:
Catalog Number: 405658. UDI Number: (01)00382904056582(17)261001(10)B01V217D. Lot Number (Expiration Date): B01V217D (2026-10-01).
Recalling firm:
Becton Dickinson & Company
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 27, 2026

Medline convenience kit: BHS NEURO DYNJ904900N MEDTRX NEURO PACK DYNJ67267B MRI DBS PACK DYNJ9814630O NEURO CDS-LF CDS983383L NEURO PACK DYNJ59397Q DYNJT7315 NEURO PACK-LF DYNJ25097I NEURO VP SHUNT/VAGAL NERVE-RF DYNJ21925S PK NEURO SHUNT BUMC DYNJT6428 RR-NEURO DBS HEAD PACK-LF DYNJ0785736M VP SHUNT SYNJ10307B

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

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

Recall #:
98951
Lot/product code:
DYNJ904900N UDI-DI 10198459504273 Lot 25LBB457 DYNJ67267B UDI-DI 10198459084331 Lot 25LBQ732 DYNJ9814630O UDI-DI 10195327587291 Lot 25LBD665 CDS983383L UDI-DI 10198459224577 Lot 25LBC092 DYNJ59397Q UDI-DI 10198459495427 Lot 25LMG049 DYNJT7315 UDI-DI 10198459620225 Lot 25LBO095 DYNJ25097I UDI-DI 10198459449550 Lot 25KBC747 DYNJ21925S UDI-DI 10195327105020 Lots 25KBD835 25LBR371 DYNJT6428 UDI-DI 10198459553660 Lot 26AMA602 DYNJ0785736M UDI-DI 10198459487149 Lot 25LMI831 SYNJ10307B UDI-DI 10195327007249 Lot 25LBE309
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 27, 2026

BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 400866, 405672, 405673, 405674, 405675, 405709, 405721, 405723, 406704.

This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.

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

Recall #:
98842
Lot/product code:
1. Catalog Number: 400866. UDI Number: (01)10885403469497(17)270101(10)B01V232D. Lot Number (Expiration Date): B01V232D (2027-01-01). 2. Catalog Number: 405672. UDI Number: (01)00382904056728(17)270101(10)B03V267D. Lot Number (Expiration Date): B03V267D (2027-01-01). 3. Catalog Number: 405673. UDI Numbers: (01)00382904056735(17)261001(10)B01V225D, (01)00382904056735(17)270101(10)B01V281D, (01)00382904056735(17)261001(10)B02V211D, (01)00382904056735(17)261001(10)B02V217D. Lot Numbers (Expiration Date): B01V225D (2026-10-01), B01V281D (2027-01-01), B02V211D (2026-10-01), B02V217D (2026-10-01). 4. Catalog Number: 405674. UDI Number: (01)00382904056742(17)261001(10)B01V218D. Lot Number (Expiration Date): B01V218D (2026-10-01). 5. Catalog Number: 405675. UDI Numbers: (01)00382904056759(17)261001(10)B01V183D, (01)00382904056759(17)260901(10)B01V198D. Lot Numbers (Expiration Date): B01V183D (2026-10-01), B01V198D (2026-09-01). 6. Catalog Number: 405709. UDI Numbers: (01)00382904057091(17)261001(10)B02V202D, (01)00382904057091(17)260628(10)B02V174D. Lot Numbers (Expiration Date): B02V202D (2026-10-01), B02V174D (2026-06-28). 7. Catalog Number: 405721. UDI Number: (01)00382904057213(17)270101(10)B02V227D. Lot Number (Expiration Date): B02V227D (2027-01-01). 8. Catalog Number: 405723. UDI Number: (01)00382904057237(17)260628(10)B01V174D, (01)00382904057237(17)270101(10)B02V254D, (01)00382904057237(17)261001(10)B01V189D. Lot Numbers (Expiration Date): B01V174D (2026-06-28), B02V254D (2027-01-01), B01V189D (2026-10-01). 9. Catalog Number: 406704. UDI Number: (01)00382904067045(17)270101(10)B02V246D. Lot Number (Expiration Date): B02V246D (2027-01-01).
Recalling firm:
Becton Dickinson & Company
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 27, 2026

Medline convenience kits: BIB AV FISTULA PACK DYNJ58304B CARDIAC MINOR SURGICOUNT PACK DYNJ56573B ENDOVASCULAR PACK DYNJ29135N EP DEVICE DYNJ65916B FULL LINE ANEURYSM CDS CDS983672P GEN FEM POP #14-RF DYNJ21877W IMPLANT PACK DYNJ39316D OPEN HEART MRNGSD DYNJ58354F PACEMAKER PACK-LF DYNJ0618174N PACEMAKER SETUP PACK DYNJ35761D PACER / CATH LAB PACK-LF DYNJ0972604A PACER CDS CDS983686I PACER PACK DYNJ52059D PK, EP LAB PACEMAKER DYNJ43663A VENOUS ACCESS PACK DYNJ45640B

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

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

Recall #:
98951
Lot/product code:
DYNJ58304B UDI-DI 10195327512699 Lot 25LBP470 DYNJ56573B UDI-DI 10193489903669 Lot 25KBK220 DYNJ29135N UDI-DI 10195327674755 Lot 25LMG563 DYNJ65916B UDI-DI 10193489902044 Lots 25KBG852 25LBB895 CDS983672P UDI-DI 10198459149139 Lots 25LBO027 26BBB852 DYNJ21877W UDI-DI 10195327104542 Lot 25JBW040 DYNJ39316D UDI-DI 10198459224447 Lot 25KBH774 DYNJ58354F UDI-DI 10195327515232 Lot 25KBI240 DYNJ0618174N UDI-DI 10195327227340 Lot 25KBC715 DYNJ35761D UDI-DI 10195327565374 Lot 26CBC772 DYNJ0972604A UDI-DI 10889942403905 Lot 25LMF965 CDS983686I UDI-DI 10193489852981 Lot 26ABE755 DYNJ52059D UDI-DI 10195327361785 Lots 25LBQ917 26CBE736 DYNJ43663A UDI-DI 10193489793680 Lot 26CBB662 DYNJ45640B UDI-DI 10193489494983 Lot 25LMJ305
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 27, 2026

Medline convenience kits: DAVINCI MAIN DYNJ908031D

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

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

Recall #:
98951
Lot/product code:
DYNJ908031D UDI-DI 10198459632297 lot 26AMB067
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 27, 2026

BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405671.

This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.

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▸Full report

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

Recall #:
98842
Lot/product code:
Catalog Number: 405671. UDI Number: (01)00382904056711(17)270101(10)B01V275D. Lot Number (Expiration Date): B01V275D (2027-01-01). ***Expansion 07/08/2026 UDI Number: (01)00382904056711(17)270101(10)B01V294D; Lot Number (Expiration Date): B01V294D (2027-01-01).
Recalling firm:
Becton Dickinson & Company
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 27, 2026

Medline convenience kits: DISCECTOMY PACK DYNJ86476B EAR DYNJ81460C DYNJ900004J DYNJ901779J DYNJ902900F EAR PACK DYNJ81419D ENT PACK DYNJ40498B HEAD & NECK CDS DYNJ901246J JEWISH DR SEVERTSON EAR DYNJ909252C JEWISH HEAD&NECK DYNJ909255C KIT HEAD AND NECK MHS DYNJ905364B MAJOR EAR CDS983347S MAJOR EAR FMOL LADY OF THE LAK DYNJ89581 MAJOR EAR PACK DYNJT4872 MAJOR HEAD AND NECK PACK DYNJ38985G MAJOR HEAD NECK PACK DYNJ45706B MZ EAR CDS DYNJ905642F PARATHYROID PACK DYNJ81389F PK,ENT-EAR DYNJ43700B SM-HEAD AND NECK PACK-LF DYNJ0780036W THYROID CDS CDS983693I TYMPANOPLASTY CDS982720S TYMPANOPLASTY MASTOIDECTOM DYNJ66231B TYMPANOPLASTY PACK-LF DYNJ62820D WH FACIAL HEAD AND NECK PACK DYNJ89028A WMC COCHLEAR IMPLANT ADD ON DYNJ907206G

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

ALL 50 STATES
▸Full report

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

Recall #:
98951
Lot/product code:
DYNJ86476B UDI-DI 10198459440366 Lot 25KBL478 DYNJ81460C UDI-DI 10198459434679 Lot 25KBE552 DYNJ900004J UDI-DI 10198459560354 Lot 26AMA112 DYNJ901779J UDI-DI 10193489979749 Lot 25LMI890 DYNJ902900F UDI-DI 10198459496936 Lot 25KBA607 DYNJ81419D UDI-DI 10198459113444 Lot 25KBM670 DYNJ40498B UDI-DI 10193489806779 Lots 25KBC776 25LBO494 DYNJ901246J UDI-DI 10198459447310 Lots 25KBQ989 26ABI798 26DBH373 DYNJ909252C UDI-DI 10198459318726 Lots 25JBS227 25KBC598 25LBR040 DYNJ909255C UDI-DI 10198459210167 Lot 25LBH411 DYNJ905364B UDI-DI 10198459346255 Lots 25LBM363 26BBO336 CDS983347S UDI-DI 10198459397370 Lots 26BBC029 26CBR342 DYNJ89581 UDI-DI 10198459278594 Lot 25LBP819 DYNJT4872 UDI-DI 10198459459672 Lot 25KBA908 DYNJ38985G UDI-DI 10195327385682 Lots 25JBA164 25KBG575 DYNJ45706B UDI-DI 10193489856293 Lot 25KBK200 DYNJ905642F UDI-DI 10195327587277 Lot 26AME607 DYNJ81389F UDI-DI 10198459394775 Lot 26BBC753 DYNJ43700B UDI-DI 10195327523039 Lot 25LBD750 DYNJ0780036W UDI-DI 10198459036972 Lot 25LMJ600 CDS983693I UDI-DI 10193489953848 Lot 25KBQ399 CDS982720S UDI-DI 10198459530258 Lots 25KBU081 25LBT481 26ABC446 DYNJ66231B UDI-DI 10195327341640 Lots 25JBY408 25KBK197 DYNJ62820D UDI-DI 10198459105463 Lot 25LMH554 DYNJ89028A UDI-DI 10198459472565 Lot 25KBI158 DYNJ907206G UDI-DI 10198459368028 Lot 25LBM564
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 24, 2026

EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01

Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.

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

Recall #:
98797
Lot/product code:
REF/UDI-DI/serial number: P10P-001/04260090040102/2230714, 2230709; P30P-001x01/04260090040126/2230254
Recalling firm:
BERLIN HEART GMBH
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 24, 2026

Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad Avanta Injection System; Catalog number: AVA 500 MPAT (Part 2 of 2); Affected material numbers: 87629007, 60729458, 86566648;

Supplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on the Avanta Injector System. Multiple customer reports indicate that the stopcock cannot be reliably engaged with the CFCV snap interface. In instances where engagement is achieved through applied force, the connection is unstable, and the stopcock may disengage before or during contrast injection, leading to procedure interruption.

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

Recall #:
98881
Lot/product code:
Catalog number: AVA 500 MPAT (Part 2 of 2) Affected material numbers: 87629007, 60729458, 86566648; Affected batch numbers: 251702, 252302, 252502, 252602, 252702, 252802, 253304, 253702, 253704, 253804, 254202, 254304, 254704, 254802;
Recalling firm:
Bayer Medical Care, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 24, 2026

Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV5 system. The affected component of the dV5 system tower is the NIR handheld camera, and is supplied by Schoelly as the manufacturer. Therefore, the product description in this report references the NIR handheld camera system. Product Description: The NIR handheld camera system is compatible for use with the da Vinci 5 system to aid in surgery. The components of the NIR handheld camera system include a camera control unit and a light source, NIR handheld camera, and additional components that together, connect to the Tower of the da Vinci 5 system. When setting up the da Vinci 5 system, the image from the NIR handheld camera system is displayed on the Tower monitor. Component: Yes, the SOCK is the component and integrated into the dV5 system

Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic endoscope.

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

Recall #:
98569
Lot/product code:
Lot Code: Part Number: 380746 UDI: 00886874119662 FDA Medical Device Listing Number: D531324 (U.S.) Part Number: 470653-01 Serial Numbers: 1008007 1008008 1008009 1008010 1008011 1008012 1008013 1008015 1008016 1008017 1008020 1008021 1008022 1008024 1008100 1008101 1008102 1008104 1008105 1008107 1008108 1008109 1008112 1008113 1008114 1008115 1008116 1008117 1008997 1008998 1009902 1010029 1010033 1010034 1010036 1010272 1010296 1010297 1010318 1010319 1010449 1010450 1010451 1010496 1010497 1010498 1010499 1010501 1010581 1010618 1010619 1010620 1010621 1010633 1010634 1010635 1010636 1010638 1010640 1010642 1010643 1010644 1010645 1010646 1011333 1011334 1011335 1011336 1011337 1011338 1011340 1011362 1011363 1011364 1011366 1011370 1011371 1011372 1011374 1011377 1011378 1011379 1011380 1011381 1011382 1011383 1011384 1011386 1011388 1011389 1011390 1011391 1011392 1011393 1011394 1011395 1011396 1012056 1012057 1012058 1012059 1012060 1012062 1012063 1012064 1012065 1012066 1012068 1012069 1012070 1012071 1012073 1012075 1012076 1012078 1012079 1012080 1012081 1012082 1012084 1012085 1012284 1012998 1012999 1013001 1013002 1013003 1013004 1013005 1013007 1013008 1013009 1013010 1013011 1013012 1013013 1013015 1013017 1013019 1013108 1013109 1013110 1013111 1013112 1013113 1013114 1013115 1013116 1013117 1013118 1013119 1013120 1013121 1013122 1013124 1013125 1013126 1013127 1013129 1013130 1013132 1013491 1013492 1013493 1013494 1013496 1013497 1014027 1014028 1014029 1014030 1014031 1014032 1014034 1014036 1014037 1014038 1014039 1014140 1014143 1014146 1014147 1014149 1014150 1014151 1014152 1014153 1014154 1014155 1014156 1014158 1014159 1014160 1014163 1014164 1014165 1014166 1014167 1014168 1014169 1014170 1014171 1014173 1014174 1014175 1014177 1014178 1014574 1014575 1014576 1014577 1014578 1014580 1014581 1014582 1014583 1014584 1014585 1014586 1014587 1014589 1014590 1014591 1014592 1014594 1014595 1014596 1014597 1014598 1014599 1014600 1014601 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1017552 1017553 1017555 1017556 1017557 1017558 1017560 1017561 1017562 1017565 1017566 1017569 1017570 1017571 1017572 1017573 1017867 1017871 1017873 1017874 1017875 1017878 1017879 1017880 1017882 1017884 1017887 1017888 1017890 1017891 1017893 1017894 1017895 1017896 1017898 1017899 1017900 1017902 1017903 1017904 1018075 1018076 1018108 1018109 1018110 1018111 1018112 1018114 1018146 1018148 1018150 1018151 1018152 1018153 1018194 1018195 1018196 1018197 1018198 1018199 1018256 1025415 1025416 1025417 1025418 1025419 1025420 1025421 1025427 1025433 1025434 1025435 1025436 1025437 1025438 1025439 1025440 1025442 1025443 1025444 1025716 1025717 1025718 1025719 1025720 1025721 1025722 1025723 1025724 1025725 1025726 1025727 1025728 1025729 1025730 1025731 1025732 1025733 1025734 1026046 1026047 1026048 1026049 1026051 1026052 1026770 1026771 1026772 1026773 1026774 1026775 1026776 1026779 1026780 1026781 1026782 1026783 1026784 1026786 1026787 1026788 1027960 1027961 1027962 1027963 1027964 1027965 1027966 1027967 1028043 1028044 1028045 1028046 1028047 1028048 1028049 1028050 1028051 1028052 1028053 1028054 1028057 1028078 1028080 1030040 1030042 1030043 1030044 1030045 1030046 1030048 1030069 1030090 1030091 1030092 1030093 1030095 1030096 1030098 1030099 1030102 1030103 1030104 1030105 1030106 1030108 1031386 1031387 1031388 1031389 1031390 1031391 1031392 1031393 1031394 1031395 1031396 1031397 1031398 1031399 1031400 1031401 1031402 1031403 1031404 1031406 1033055 1033056 1033057 1033058 1033059 1033060 1033061 1033062 1033063 1033064 1033066 1033067 1033068 1033069 1033070 1033071 1033072 1033073 1033074 1033075 1033076 1033077 1033078 1033079 1033080 1033081 1033083 1033084 1033085 1033086 1033087 1033088 1033089 1033090 1034577 1034578 1034579 1034580 1034581 1034582 1034583 1034585 1034586 1034587 1034588 1034589 1034590 1034593 1034594 1034595 1034596 1036621 1036622 1036625 1036626 1036630 1036631 1036632 1036633 1036634 1036635 1036636 1036637 1036638 10366… (truncated, 11123 characters total — see the official FDA record for the full value)
Recalling firm:
Intuitive Surgical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 24, 2026

GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER, REF #2108729-901, Product Code SS9; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).

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

Recall #:
98938
Lot/product code:
Serial #/Sales Order #: SS920500004SA, SS920500005SA, SS920500003SA, SS920500006SA, SS921120011SA, SS921120019SA, SS921120015SA.
Recalling firm:
GE Medical Systems Information Technologies Inc
View official FDA record (opens in a new tab)