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Recalls affecting Louisiana

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

16,881 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
Class IHigh risk
FoodBacteria/virusSalmonellaRecalled January 9, 2026

Spring & Mulberry Coffee Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), individually packaged in a light brown box, UPC 850055470224, Dist. By Spring & Mulberry Raleigh, NC 27606. Wholesale product packed 48 bars (caddied)/56 bars (uncaddied) per case. Retail product sold individually or as a 3-pk, 6-pk, or 12-pk (Amazon only).

Potential Salmonella contamination

ALL 50 STATES
Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
H-1105-2026
Lot/product code:
Product Number SMBARCO20001 Batch/Lot 025226 and Use By 02/28/2027 Batch/Lot 025274 and Use By 04/30/2027 Batch/Lot 025344 and Use By 06/30/2027
Recalling firm:
Spring & Mulberry Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
FoodBacteria/virusSalmonellaRecalled January 9, 2026

Spring & Mulberry Pecan Date Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), individually packaged in a yellow box, UPC 850055470040, Dist. By Spring & Mulberry Raleigh, NC 27606. Wholesale product packed 48 bars (caddied)/56 bars (uncaddied) per case. Retail product sold individually or as a 3-pk, 6-pk, or 12-pk (Amazon only).

Potential Salmonella contamination.

ALL 50 STATES
Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
H-1102-2026
Lot/product code:
Product Number SMBARPD20001 Batch/Lot 025233 and Use By 08/31/2026 Batch/Lot 025237 and Use By 08/31/2026 Batch/Lot 025238 and Use By 08/31/2026 Batch/Lot 025239 and Use By 08/31/2026 Batch/Lot 025240 and Use By 08/31/2026 Batch/Lot 025241 and Use By 08/31/2026 Batch/Lot 025261 and Use By 09/30/2026 Batch/Lot 025265 and Use By 09/30/2026 Batch/Lot 025267 and Use By 09/30/2026 Batch/Lot 025268 and Use By 09/30/2026 Batch/Lot 025290 and Use By 10/31/2026 Batch/Lot 025294 and Use By 10/31/2026 Batch/Lot 025329 and Use By 11/30/2026 Batch/Lot 025330 and Use By 11/30/2026 Batch/Lot 025339 and Use By 12/31/2026 Batch/Lot 025343 and Use By 12/31/2026
Recalling firm:
Spring & Mulberry Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
FoodBacteria/virusSalmonellaRecalled January 9, 2026

Spring & Mulberry Mixed Berry Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), individually packaged in a purple box, UPC 850055470026, Dist. By Spring & Mulberry Raleigh, NC 27606. Wholesale product packed 48 bars (caddied)/56 bars (uncaddied) per case. Retail product sold individually or as a 3-pk, 6-pk, or 12-pk (Amazon only).

Potential Salmonella contamination

ALL 50 STATES
Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
H-1097-2026
Lot/product code:
Product Number SMBARMB20001 Batch/Lot 025220 and Use By 08/31/2026 Batch/Lot 025223 and Use By 08/31/2026 Batch/Lot 025247 and Use By 09/30/2026 Batch/Lot 025248 and Use By 09/30/2026 Batch/Lot 025251 and Use By 09/30/2026 Batch/Lot 025253 and Use By 09/30/2026 Batch/Lot 025275 and Use By 10/31/2026 Batch/Lot 025281 and Use By 10/31/2026 Batch/Lot 025288 and Use By 10/31/2026 Batch/Lot 025296 and Use By 10/31/2026 Batch/Lot 025335 and Use By 12/31/2026 Batch/Lot 025337 and Use By 12/31/2026 Batch/Lot 026008 and Use By 01/31/2027
Recalling firm:
Spring & Mulberry Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
FoodBacteria/virusSalmonellaRecalled January 9, 2026

1) Spring & Mulberry Pure Dark Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), individually packaged in a navy blue box, UPC 850055470002, Dist. By Spring & Mulberry Raleigh, NC 27606. Wholesale product packed 48 bars (caddied)/56 bars (uncaddied) per case. Retail product sold individually or as a 3-pk, 6-pk, or 12-pk (Amazon only). 2) Spring & Mulberry Pure Dark Minis Date-Sweetened Chocolate, Net Wt. 0.75 oz. (22g), individually packaged in a navy blue box, UPC 850055470132, Dist. By Spring & Mulberry Raleigh, NC 27606. Wholesale product packed 64 bars (caddied)/204 bars (uncaddied) per case. Retail product sold individually or as a 3-pk, 6-pk, or 12-pk (Amazon only).

Potential Salmonella contamination

ALL 50 STATES
Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
H-1103-2026
Lot/product code:
1) Pure Dark: Product Number SMBARPC20001 Batch/Lot 025217 and Use By 02/28/2027 Batch/Lot 025218 and Use By 02/28/2027 Batch/Lot 025219 and Use By 02/28/2027 Batch/Lot 025254 and Use By 03/31/2027 Batch/Lot 025266 and Use By 03/31/2027 Batch/Lot 025269 and Use By 03/31/2027 Batch/Lot 025324 and Use By 05/31/2027 Batch/Lot 025338 and Use By 06/30/2027 Batch/Lot 025350 and Use By 06/30/2027 2) Pure Dark Minis: Product Number SMBARPC30001 Batch/Lot 025273 and Use By 03/31/2027 Batch/Lot 025302 and Use By 04/30/2027 Batch/Lot 025303 and Use By 04/30/2027 Batch/Lot 026009 and Use By 07/31/2027
Recalling firm:
Spring & Mulberry Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
FoodRecalled January 9, 2026

Modern Warrior Ready, Dietary Supplement, 60 CAPSULES

FDA analysis revealed the presence of unapproved ingredients including tianeptine, 1,4 DMAA, and aniracetam.

ALL 50 STATES
Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
H-1178-2026
Lot/product code:
Product distributed between April of 2022 until December 8th of 2025.
Recalling firm:
Modern Warrior Life, LLC
View official FDA record (opens in a new tab)
Class IHigh risk
FoodBacteria/virusSalmonellaRecalled January 9, 2026

Spring & Mulberry Mulberry Fennel Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), individually packaged in a burgundy box, UPC 850055470149, Dist. By Spring & Mulberry Raleigh, NC 27606. Wholesale product packed 48 bars (caddied)/56 bars (uncaddied) per case. Retail product sold individually or as a 3-pk, 6-pk, or 12-pk (Amazon only).

Potential Salmonella contamination.

ALL 50 STATES
Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
H-1101-2026
Lot/product code:
Product Number SMBARMF20001 Batch/Lot 025230 and Use By 02/28/2027 Batch/Lot 025287 and Use By 04/30/2027 Batch/Lot 025345 and Use By 06/30/2027
Recalling firm:
Spring & Mulberry Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 8, 2026

Medline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Medline NO CATHETER DIALYSIS INSERTION, SKU CVI5200

Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.

ALL 50 STATES
Full report

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

Recall #:
98333
Lot/product code:
IR PACK UDI-DI (ea) 10195327621780 UDI-DI (case) 40195327621781 Kit lots 24BBP627 24DBO029 24FBI148 24JBA858 24KBD925 24LBG978 25ABQ002 25EBV162; NO CATHETER DIALYSIS INSERTION UDI-DI (ea) 10195327675219 UDI-DI (case) 40195327675210 Kit Lots 24EBM915 24GBC287
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 8, 2026

Medline kits containing Tego Connectors Medline APHERESIS SUBQPORT ACCESS KIT SKU DYNDA2705 Medline CENTRAL LINE INSERTION SKU DYNJ63347A

Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.

ALL 50 STATES
Full report

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

Recall #:
98333
Lot/product code:
SKU DYNDA2705 UDI-DI (ea) 10193489468632 UDI-DI (case) 40193489468633 Kit lots 24DBL787 24HBR630 25ABH699 25DBV209 25GBQ405 SKU DYNJ63347A UDI-DI (ea) 10193489278064 UDI-DI (case) 40193489278065 Kit lots 24AMC874 24AME139 24AMH820 24BMF097 24CMF691 24GMB769 24GMK036 24IMC124 24LMA110 25AMJ634 25GMD386 25IMB510 25JMI708
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 8, 2026

Convenience kits used for dialysis maintenance Medline ADD A CATH DIALYSIS KIT SKU ECVC8415A Centurion CENTRAL LINE INSERTION TRAY SKU DT19810 Centurion DIALYSIS BUNDLE WITH NO CATHETTER SKU CVI4310A Medline DIALYSIS CAP CHANGE KIT SKU DYNDC2425 Medline DIALYSIS CHANGE KIT SKU EBSI1453A Centurion HEMODIALYSIS ACCESS KIT SKU DT12970 Medline LARGE BORE, DIALYSIS, ENHANCED SECUREMENT SKU EBSI1741

Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.

ALL 50 STATES
Full report

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

Recall #:
98333
Lot/product code:
Medline ADD A CATH DIALYSIS KIT SKU ECVC8415A UDI-DI (ea) 10653160383628 UDI-DI (case) 00653160383621 Kit lots 2024121390 2025033190 Centurion CENTRAL LINE INSERTION TRAY SKU DT19810 UDI-DI (ea) 10653160368755 UDI-DI (case) 00653160368758 Kit lot 2025041090 Centurion DIALYSIS BUNDLE WITH NO CATHETTER SKU CVI4310A UDI-DI (ea) 10653160374978 UDI-DI (case) 00653160374971 Kit lots 2024051490 2025021290 2025051390 2025091090 Medline DIALYSIS CAP CHANGE KIT SKU DYNDC2425 UDI-DI (ea) 10653160375845 UDI-DI (case) 00653160375848 Kit lots 2024060690 2024101690 2024103190 2025010890 2025040190 Medline DIALYSIS CHANGE KIT SKU EBSI1453A UDI-DI (ea) 10653160383475 UDI-DI (case) 00653160383478 Kit lots 2024050790 2024051390 2024082290 2024111990 2025013090 2025032090 2025050190 2025062790 Centurion HEMODIALYSIS ACCESS KIT SKU DT12970 UDI-DI (ea) 10653160368922 UDI-DI (case) 00653160368925 Kit lots 2025040401 2025081401 Medline LARGE BORE, DIALYSIS, ENHANCED SECUREMENT SKU EBSI1741 UDI-DI (ea) 10653160374527 UDI-DI (case) 00653160374520 Kit lots 2024061780 2024070180 2024081280 2024111290 2025012490 2025032690 2025051390 2025061790 2025071490 2025072190
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 8, 2026

Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System - Reuseable Probes Model/Catalog Number: SPL-SR, contains generator SPL-G Product Description: An assembly of devices that uses a combination of, or individually applied, pneumatically-created ballistic shock waves and ultrasonic waves for the intracorporeal fragmentation of stones (calculi) in the urinary tract (i.e., kidney, ureter, and bladder) for their removal. It typically includes a pressure and power regulator/control unit, handpieces, and two types of probes of various sizes. The probes are attached to the two handpieces which are connected to the control unit that supplies the energy for both the pneumatic and ultrasonic functions. Energy is applied to a calculus which is fragmented in situ and removed via a suction system facilitated by the lithotripsy system.

Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility (EMC) standards and may decrease the overall reliability of the system and result in delay of treatment. It was discovered that additional serial numbers of ShockPulse generators may also have the mis-wired component. As a result, this is expanding the action to the additional impacted devices.

ALL 50 STATES
Full report

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

Recall #:
98360
Lot/product code:
Model/Catalog Number: SPL-SR, contains generator SPL-G; UDI: SPL-SR 00821925043824, SPL-G 00821925044203; Serial Numbers: CG5026, CG5027, CG5028, CG5029, CG5030, CG5031, CG5032, CG5033, CG5034, CG5035, CG5036, CG5037, CG5039, CG5040, CG5041, CG5042, CG5043, CG5045, CG5046, CG5047, CG5048, CG5049, CG5050, CG5051, CG5052, CG5053, CG5054, CG5055, CG5056, CG5057, CG5058, CG5059, CG5060, CG5061, CG5062, CG5063, CG5065, CG5066, CG5067, CG6037, CG6061, CG6069, CG6070, CG6071, CG6088, CG6094, CG6095, CG6096, CG6097, CG6098, CG6099, CG7000, CG7001, CG7002, CG7003;
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 8, 2026

Convenience kits containing Tego Connectors: Medline DIALYSIS DRESSING CHANGE SKU EBSI1498 Medline DIALYSIS DRESSING CHANGE KIT SKU EBSI1107 EBSI1596 EBSI1781 EBSI1812 Centurion DIALYSIS/PHERESUS CVC DRSG CHANGE KIT SKU DT22630 Medline DIALYSIS/PHERESIS DRESSING CHANGE KIT SKU EBSI1470 Centurion VASCATH DRESSING CHANGE TRAY SKU DT22845

Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.

ALL 50 STATES
Full report

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

Recall #:
98333
Lot/product code:
Medline DIALYSIS DRESSING CHANGE SKU EBSI1498 UDI-DI (ea) 10193489111538 UDI-DI (case) 20193489111535 Kit lots 2024052090 2024072690 2024100390 2024121290 2025020490 2025041590 2025062790 2025090890 Medline DIALYSIS DRESSING CHANGE KIT SKU EBSI1107 UDI-DI (ea) 10889942723508 UDI-DI (case) 40889942723509 Kit lots 2024051690 2024073190 2024092490 2024121190 2025020790 2025032790 2025052990 EBSI1596 UDI-DI (ea) 10653160357162 UDI-DI (case) 00653160357165 Kit lots 2024070190 2024082390 2024102390 2024121790 2025031090 2025040190 2025052790 2025072890 EBSI1781 UDI-DI (ea) 10653160379638 UDI-DI (case) 00653160379631 Kit lots 2024100490 2024123090 EBSI1812 UDI-DI (ea) 10653160386735 UDI-DI (case) 00653160386738 Kit lots 2025032190 2025052990 Centurion DIALYSIS/PHERESUS CVC DRSG CHANGE KIT SKU DT22630 UDI-DI (ea) 10653160345343 UDI-DI (case) 00653160345346 Kit lots 2024050680 2024072980 2024090380 2024111290 2024121190 2025032890 2025061790 2025072390 Medline DIALYSIS/PHERESIS DRESSING CHANGE KIT SKU EBSI1470 UDI-DI (ea) 10193489199307 UDI-DI (case) 20193489199304 Kit lots 2024052080 2024070880 2024110490 2025010290 2025022090 2025030390 2025040990 2025072990 Centurion VASCATH DRESSING CHANGE TRAY SKU DT22845 UDI-DI (ea) 10653160355151 UDI-DI (case) 00653160355154 Kit lots 2024060790 2024080790 2024100990 2024112590 2025042490 2025082090
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 8, 2026

Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167

Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.

ALL 50 STATES
Full report

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

Recall #:
98333
Lot/product code:
UDI-DI (ea) 10195327015954 UDI-DI (case) 40195327015955 Kit lots 24IME953 25CMA708
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 8, 2026

Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746

Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.

ALL 50 STATES
Full report

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

Recall #:
98333
Lot/product code:
UDI-DI (ea) 10653160373582 UDI-DI (case) 00653160373585 Kit lots 2024051380 2024052080 2024052180 2024052280 2024071580 2025061790 2025072990
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBNDL165; 3) KIT LABOR & DELIVERY D&C/D&E, Model Number: DYKMBNDL31; 4) KIT LABOR & DELIVERY CERCLAGE, Model Number: DYKMBNDL38; 5) L & D PACK-LF, Model Number: DYNJ0456816O; 6) L & D PACK-LF, Model Number: DYNJ0456816P; 7) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ04692S; 8) VAGINAL DELIVERY PACK, Model Number: DYNJ16621B; 9) VAGINAL DELIVERY PACK, Model Number: DYNJ16621C; 10) DELIVERY PACK-LF, Model Number: DYNJ20546F; 11) VAGINAL DELIVERY PK, Model Number: DYNJ20979I; 12) VAGINAL DELIVERY PK, Model Number: DYNJ20979J; 13) VAGINAL DELIVERY PACK, Model Number: DYNJ24108D; 14) OB PACK-LF, Model Number: DYNJ26121I; 15) OB DELIVERY PACK, Model Number: DYNJ31024J; 16) OB DELIVERY PACK-LF, Model Number: DYNJ32139C; 17) DB VAG HYSTERECTOMY-LF, Model Number: DYNJ33590F; 18) MAJOR VAGINAL PACK, Model Number: DYNJ35488F; 19) ENS. ACCOUCHEMENT VAGINAL-LF, Model Number: DYNJ37331C; 20) VAG DELIVERY PACK, Model Number: DYNJ38481G; 21) VAG DELIVERY PACK, Model Number: DYNJ38481I; 22) VAG DELIVERY PACK, Model Number: DYNJ38481K; 23) OB PACK 2, Model Number: DYNJ39000D; 24) GYNECOLOGY VAGINAL KIT, Model Number: DYNJ40203A; 25) LABOR DELIVERY POUCH SCREEN, Model Number: DYNJ40918A; 26) L & D PACK WITHOUT INSTRUMENTS, Model Number: DYNJ44720B; 27) VAGINAL DELIVERY PACK, Model Number: DYNJ51377G; 28) FH VAG DELIVERY PK-LF, Model Number: DYNJ51794B; 29) VAGINAL DELIVERY PACK, Model Number: DYNJ55363A; 30) VAGINAL DELIVERY PACK, Model Number: DYNJ55363B; 31) MINOR VAGINAL PACK, Model Number: DYNJ61269B; 32) OB VAG DELIVERY PACK, Model Number: DYNJ61574; 33) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ61650; 34) OB-VAG PACK 9128190, Model Number: DYNJ62341; 35) HP VAGINAL DELIVERY PACK-LF, Model Number: DYNJ62402A; 36) L & D PACK, Model Number: DYNJ63216A; 37) L&D PACK, Model Number: DYNJ63757A; 38) GYN PACK DYNJ55833A, Model Number: DYNJ65145; 39) MINOR VAG PACK, Model Number: DYNJ68663; 40) UTHET TYLER OB PACK, Model Number: DYNJ68673A; 41) GYN VAGINAL PACK, Model Number: DYNJ68681; 42) VAGINAL DELIVERY PACK, Model Number: DYNJ69544A; 43) VAGINAL PACK, Model Number: DYNJ69774A; 44) LABOR & DELIVERY PACK-LF, Model Number: DYNJ84393; 45) DELIVERY PACK, Model Number: DYNJ87469A; 46) VAGINAL DELIVERY, Model Number: DYNJ901387A; 47) FLOYD DELIVERY, Model Number: DYNJ906937D; 48) OB VAGINAL MEDSTAR PACK-LF, Model Number: DYNJT3445; 49) OB PACK, Model Number: DYNJT5186; 50) VAGINAL DELIVERY KIT, Model Number: MNS13550A; 51) VAGINAL DELIVERY TRAY, Model Number: MNS7460A; 52) LABOR AND DELIVERY KIT, Model Number: MNS8950A

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

ALL 50 STATES
Full report

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

Recall #:
98329
Lot/product code:
1) DYKM2326, UDI-DI: 10198459565748(each), 40198459565749(case), Lot Number: 25KMF765; 2) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 24ABK386; 3) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 23KBV905; 4) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 23KBA329; 5) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 23HBR548; 6) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 23EBP170; 7) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 23BBT994; 8) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 22LBB693; 9) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 22KBS631; 10) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 22IBB499; 11) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21LBX453; 12) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21KBM483; 13) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21JBQ910; 14) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21IBO498; 15) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21IBE978; 16) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21GBN267; 17) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21FBP760; 18) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21EBE875; 19) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21DBA335; 20) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21ABT654; 21) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21ABI982; 22) DYKMBNDL31, UDI-DI: 10193489478716(each), 40193489478717(case), Lot Number: 21ABC201; 23) DYKMBNDL38, UDI-DI: 10193489477757(each), 40193489477758(case), Lot Number: 21ABM087; 24) DYNJ0456816O, UDI-DI: 10195327435219(each), 40195327435210(case), Lot Number: 23JME434; 25) DYNJ0456816O, UDI-DI: 10195327435219(each), 40195327435210(case), Lot Number: 23JMC541; 26) DYNJ0456816P, UDI-DI: 10195327570545(each), 40195327570546(case), Lot Number: 24HMK119; 27) DYNJ04692S, UDI-DI: 10193489338454(each), 40193489338455(case), Lot Number: 21ADB239; 28) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 25DMH878; 29) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 25CME932; 30) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 25AME014; 31) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24JMB353; 32) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24IMF157; 33) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24GMJ484; 34) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24FMF250; 35) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24DMI443; 36) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24CMB999; 37) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24BMA554; 38) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 23KMJ818; 39) DYNJ16621C, UDI-DI: 10198459421297(each), 40198459421298(case), Lot Number: 25GMD428; 40) DYNJ20546F, UDI-DI: 10193489346084(each), 40193489346085(case), Lot Number: 22IMG976; 41) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 22FMB686; 42) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 22EMF465; 43) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 22DMB332; 44) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 22CME094; 45) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 22AMA608; 46) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21KMB071; 47) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21JMA483; 48) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21IMD851; 49) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21HMD738; 50) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21GMB531; 51) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21DMD921; 52) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21CME149; 53) DYNJ20979J, UDI-DI: 10195327191733(each), 40195327191734(case), Lot Number: 23AMJ134; 54) DYNJ20979J, UDI-DI: 10195327191733(each), 40195327191734(case), Lot Number: 22LMA315; 55) DYNJ20979J, UDI-DI: 10195327191733(each), 40195327191734(case), Lot Number: 22IMH408; 56) DYNJ20979J, UDI-DI: 10195327191… (truncated, 17242 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 January 7, 2026

Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN, Model Number: PAIN0150C

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

ALL 50 STATES
Full report

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

Recall #:
98329
Lot/product code:
1) PAIN0150C, UDI-DI: 10193489819571(each), 21JBV886(case), Lot Number: 21JBV886
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Brilliance iCT; Product Code (REF): 728306;

As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.

ALL 50 STATES
Full report

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

Recall #:
98248
Lot/product code:
Product Code (REF): 728306; UDI-DI: 00884838059474; Serial Numbers: 87064, 87120, 87121, 87122, 87125, 87126, 87127, 87128, 87129, 87130, 87135, 87143, 87148, 87152, 87153, 87157, 87160, 87162, 87167, 87173, 87174, 87176, 87181, 87197, 87198, 87199, 87200 , 87202, 87203, 87204, 87205, 87206, 87207, 87208, 87209, 87210, 87211, 87212, 87213 , 87214, 87215, 87216, 87217, 87218, 87219, 87220, 87221;
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number: DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number: DYNJ56436B; 3) CPNB SETUP TRAY, Model Number: DYNJRA1979; 4) CPNB SETUP TRAY, Model Number: DYNJRA1979A; 5) CPNB SETUP TRAY, Model Number: SAMPA0108

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

ALL 50 STATES
Full report

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

Recall #:
98329
Lot/product code:
1) DYNJ56436A, UDI-DI: 10889942749874(each), 40889942749875(case), Lot Number: 21BMC737; 2) DYNJ56436A, UDI-DI: 10889942749874(each), 40889942749875(case), Lot Number: 21AMB799; 3) DYNJ56436B, UDI-DI: 10193489869569(each), 40193489869560(case), Lot Number: 21DME244; 4) DYNJRA1979, UDI-DI: 10195327186852(each), 40195327186853(case), Lot Number: 22IBU628; 5) DYNJRA1979, UDI-DI: 10195327186852(each), 40195327186853(case), Lot Number: 22GBV936; 6) DYNJRA1979A, UDI-DI: 10195327649258(each), 40195327649259(case), Lot Number: 25DME153; 7) DYNJRA1979A, UDI-DI: 10195327649258(each), 40195327649259(case), Lot Number: 24KMA261; 8) DYNJRA1979A, UDI-DI: 10195327649258(each), 40195327649259(case), Lot Number: 24JMA460; 9) SAMPA0108, UDI-DI: 10195327096861(each), 40195327096862(case), Lot Number: 22NBG086; 10) SAMPA0108, UDI-DI: 10195327096861(each), 40195327096862(case), Lot Number: 22BBD381
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

IQon Spectral CT; Product Code (REF): 728332;

As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.

ALL 50 STATES
Full report

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

Recall #:
98248
Lot/product code:
Product Code (REF): 728332; UDI-DI: 00884838059542; Serial Numbers: 60128, 60141, 60151, 60161, 60171, 60181, 60129, 60142, 60152, 60162, 60172, 60182, 60130, 60143, 60153, 60163, 60173, 60132, 60144, 60154, 60164, 60174, 60133, 60145, 60155, 60165, 60175, 60134, 60146, 60156, 60166, 60176, 60136, 60147, 60157, 60167, 60177, 60137, 60148, 60158, 60168, 60178, 60138, 60149, 60159, 60169, 60179, 60139, 60150, 60160, 60170, 60180.
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Medline Convenience Kits: 1) TOTE ABRAMS KNEE ARTHROSCOPY, Model Number: DYKM1801B; 2) TOTE SEN OSC HAND REPAIR, Model Number: DYKM1776; 3) TOTE MOMENI SB CAPSULOTOMY REC, Model Number: DYKM1765A; 4) TOTE YAO OSC HAND REPAIR, Model Number: DYKM1796A; 5) TOTE SB NGUYEN CAPSULOTOMY, Model Number: DYKM1756A; 6) TOTE FOX OSC HAND REPAIR, Model Number: DYKM1783A; 7) TOTE KAMAL OSC HAND REPAIR, Model Number: DYKM1730A; 8) TOTE SB NGUYEN LIPOSUCTION, Model Number: DYKM1927A; 9) TOTE YAO OSC WRIST ARTHROSCOPY, Model Number: DYKM1807; 10) TOTE CURTIN OSC HAND REPAIR, Model Number: DYKM1781A; 11) OSC SHERMAN KNEE ARTHRO BASIC, Model Number: DYKM1977B; 12) TOTE CHANGE OSC HAND REPAIR, Model Number: DYKM1751A; 13) TOTE CARROLL BLOCK BLOOD PATCH, Model Number: DYKM1864; 14) TOTE SB STONE JWIRE LUMPECTOMY/SEN NODE, Model Number: DYKM1925; 15) TOTE SAFRAN OSC HIP ARTHRSCPY, Model Number: DYKM1767B; 16) CVC PACK, Model Number: CVI4500A

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

ALL 50 STATES
Full report

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

Recall #:
98329
Lot/product code:
1) DYKM1801B, UDI-DI: 10653160360421(each), 00653160360424(case), Lot Number: 2024100790; 2) DYKM1776, UDI-DI: 10888277733794(each), 20888277733791(case), Lot Number: 2025013190; 3) DYKM1765A, UDI-DI: 10193489190236(each), 20193489190233(case), Lot Number: 2024071790; 4) DYKM1796A, UDI-DI: 10653160354888(each), 00653160354881(case), Lot Number: 2024072390; 5) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2024080190; 6) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2024101490; 7) DYKM1796A, UDI-DI: 10653160354888(each), 00653160354881(case), Lot Number: 2025010890; 8) DYKM1783A, UDI-DI: 10193489111330(each), 20193489111337(case), Lot Number: 2025011090; 9) DYKM1730A, UDI-DI: 10193489111019(each), 20193489111016(case), Lot Number: 2025012890; 10) DYKM1796A, UDI-DI: 10653160354888(each), 00653160354881(case), Lot Number: 2025020690; 11) DYKM1927A, UDI-DI: 10193489199901(each), 20193489199908(case), Lot Number: 2024012590; 12) DYKM1730A, UDI-DI: 10193489111019(each), 20193489111016(case), Lot Number: 2024030690; 13) DYKM1796A, UDI-DI: 10653160354888(each), 00653160354881(case), Lot Number: 2024041790; 14) DYKM1730A, UDI-DI: 10193489111019(each), 20193489111016(case), Lot Number: 2024052290; 15) DYKM1783A, UDI-DI: 10193489111330(each), 20193489111337(case), Lot Number: 2024053190; 16) DYKM1730A, UDI-DI: 10193489111019(each), 20193489111016(case), Lot Number: 2024060590; 17) DYKM1796A, UDI-DI: 10653160354888(each), 00653160354881(case), Lot Number: 2024061890; 18) DYKM1783A, UDI-DI: 10193489111330(each), 20193489111337(case), Lot Number: 2024062890; 19) DYKM1807, UDI-DI: 10193489191219(each), 20193489191216(case), Lot Number: 2024071990; 20) DYKM1781A, UDI-DI: 10653160352730(each), 00653160352733(case), Lot Number: 2024092390; 21) DYKM1796A, UDI-DI: 10653160354888(each), 00653160354881(case), Lot Number: 2024093090; 22) DYKM1977B, UDI-DI: 10653160360797(each), 00653160360790(case), Lot Number: 2024091290; 23) DYKM1765A, UDI-DI: 10193489190236(each), 20193489190233(case), Lot Number: 2024012490; 24) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2024022190; 25) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2023120590; 26) DYKM1751A, UDI-DI: 10193489111002(each), 20193489111009(case), Lot Number: 2023121190; 27) DYKM1927A, UDI-DI: 10193489199901(each), 20193489199908(case), Lot Number: 2023121490; 28) DYKM1776, UDI-DI: 10888277733794(each), 20888277733791(case), Lot Number: 2024031590; 29) DYKM1864, UDI-DI: 10193489191257(each), 20193489191254(case), Lot Number: 2024010880; 30) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2023070590; 31) DYKM1765A, UDI-DI: 10193489190236(each), 20193489190233(case), Lot Number: 2023071290; 32) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2023111590; 33) DYKM1977B, UDI-DI: 10653160360797(each), 00653160360790(case), Lot Number: 2023120890; 34) DYKM1801B, UDI-DI: 10653160360421(each), 00653160360424(case), Lot Number: 2024011790; 35) DYKM1801B, UDI-DI: 10653160360421(each), 00653160360424(case), Lot Number: 2024062890; 36) DYKM1925, UDI-DI: 10193489190311(each), 20193489190318(case), Lot Number: 2024040180; 37) DYKM1927A, UDI-DI: 10193489199901(each), 20193489199908(case), Lot Number: 2023072590; 38) DYKM1927A, UDI-DI: 10193489199901(each), 20193489199908(case), Lot Number: 2023080190; 39) DYKM1927A, UDI-DI: 10193489199901(each), 20193489199908(case), Lot Number: 2023081490; 40) DYKM1767B, UDI-DI: 10193489112368(each), 20193489112365(case), Lot Number: 2023102790; 41) DYKM1864, UDI-DI: 10193489191257(each), 20193489191254(case), Lot Number: 2023101680; 42) DYKM1977B, UDI-DI: 10653160360797(each), 00653160360790(case), Lot Number: 2023063090; 43) DYKM1925, UDI-DI: 10193489190311(each), 20193489190318(case), Lot Number: 2023112780; 44) DYKM1765A, UDI-DI: 10193489190236(each), 20193489190233(case), Lot Number: 2023050490; 45) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2023060290; 46) DYKM1807, UDI-DI: 10193489191219(each), 20193489191216(case), Lot Number: 2024032990; 47) CVI4500A, UDI-DI: 10653160327646(each), 00653160327649(case), Lot Number: 2020121550
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Spectral CT; Product Code (REF): 728333;

As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.

ALL 50 STATES
Full report

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

Recall #:
98248
Lot/product code:
Product Code (REF): 728333; UDI-DI: 00884838101111; Serial Numbers: 10055, 10075, 10086, 10096, 10106, 10116, 10126, 10136, 10146, 10156, 10166, 10176, 10186, 10196, 10206, 10217, 10227, 10237, 10247, 10257, 10267, 10277, 10289, 10302, 10314, 12009, 12019, 12029, 396013, 10056, 10076, 10087, 10097, 10107, 10117, 10127, 10137, 10147, 10157, 10167, 10177, 10187, 10197, 10207, 10218, 10228, 10238, 10248, 10258, 10268, 10278, 10290, 10303, 12000, 12010, 12020, 12030, 398003, 10057, 10077, 10088, 10098, 10108, 10118, 10128, 10138, 10148, 10158, 10168, 10178, 10188, 10198, 10208, 10219, 10229, 10239, 10249, 10259, 10269, 10279, 10291, 10304, 12001, 12011, 12021, 12031, 398004, 10058, 10078, 10089, 10099, 10109, 10119, 10129, 10139, 10149, 10159, 10169, 10179, 10189, 10199, 10209, 10220, 10230, 10240, 10250, 10260, 10270, 10280, 10292, 10305, 12002, 12012, 12022, 396005, 10059, 10079, 10090, 10100, 10110, 10120, 10130, 10140, 10150, 10160, 10170, 10180, 10190, 10200, 10210, 10221, 10231, 10241, 10251, 10261, 10271, 10281, 10293, 10306, 12003, 12013, 12023, 396006, 10060, 10080, 10091, 10101, 10111, 10121, 10131, 10141, 10151, 10161, 10171, 10181, 10191, 10201, 10211, 10222, 10232, 10242, 10252, 10262, 10272, 10284, 10294, 10307, 12004, 12014, 12024, 396008, 10061, 10081, 10092, 10102, 10112, 10122, 10132, 10142, 10152, 10162, 10172, 10182, 10192, 10202, 10212, 10223, 10233, 10243, 10253, 10263, 10273, 10285, 10298, 10308, 12005, 12015, 12025, 396009, 10062, 10082, 10093, 10103, 10113, 10123, 10133, 10143, 10153, 10163, 10173, 10183, 10193, 10203, 10213, 10224, 10234, 10244, 10254, 10264, 10274, 10286, 10299, 10310, 12006, 12016, 12026, 396010, 10070, 10083, 10094, 10104, 10114, 10124, 10134, 10144, 10154, 10164, 10174, 10184, 10194, 10204, 10214, 10225, 10235, 10245, 10255, 10265, 10275, 10287, 10300, 10311, 12007, 12017, 12027, 396011, 10074, 10085, 10095, 10105, 10115, 10125, 10135, 10145, 10155, 10165, 10175, 10185, 10195, 10205, 10215, 10226, 10236, 10246, 10256, 10266, 10276, 10288, 10301, 10312, 12008, 12018, 12028, 396012.
Recalling firm:
Philips North America Llc
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UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0725; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Devices which did not undergo thermoforming could deform and lose performance.

ALL 50 STATES
Full report

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

Recall #:
98252
Lot/product code:
Model/Catalog Number: KD-VC411Q-0725; Material REF: N5424710; UDI-DI: N/A; All Lots with a valid expiration date
Recalling firm:
Olympus Corporation of the Americas
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UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Spectral CT 7500 on Rails; Product Code (REF): 728334;

As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.

ALL 50 STATES
Full report

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

Recall #:
98248
Lot/product code:
Product Code (REF): 728334; UDI-DI: 00884838103627; Serial Numbers: 1005, 1007, 1008;
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Medline Convenience Kits: 1) KIT ACES INSERT PEG, Model Number: DYKMBNDL130; 2) KIT ACES INSERT PEG, Model Number: DYKMBNDL130A; 3) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4; 4) NICU LINE CHANGE TRAY, Model Number: LC295; 5) OSC SHERMAN KNEE ARTHRO BASIC, Model Number: DYKM1977C; 6) PICC CATHETER INSERTION TRAY, Model Number: CVI4300

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

ALL 50 STATES
Full report

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

Recall #:
98329
Lot/product code:
1) DYKMBNDL130, UDI-DI: 10193489479027(each), 40193489479028(case), Lot Number: 21BBB580; 2) DYKMBNDL130, UDI-DI: 10193489479027(each), 40193489479028(case), Lot Number: 21ABJ543; 3) DYKMBNDL130, UDI-DI: 10193489479027(each), 40193489479028(case), Lot Number: 21ABC197; 4) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22GLB021; 5) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22GLA694; 6) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22FLA745; 7) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22ELA008; 8) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22DLA407; 9) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22CLA448; 10) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22BLA721; 11) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22ALA593; 12) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21JLA910; 13) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21ILA163; 14) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21HLA740; 15) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21GLA677; 16) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21FLA214; 17) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21ELA080; 18) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21DLA326; 19) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21CLA621; 20) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21CLA391Z; 21) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21CLA391; 22) DYKMBNDL4, UDI-DI: 10193489477627(each), 40193489477628(case), Lot Number: 21DLA343; 23) DYKMBNDL4, UDI-DI: 10193489477627(each), 40193489477628(case), Lot Number: 21ALA631; 24) DYKMBNDL4, UDI-DI: 10193489477627(each), 40193489477628(case), Lot Number: 21ALA056; 25) LC295, UDI-DI: 10653160322702(each), 00653160322705(case), Lot Number: 2025110490; 26) DYKM1977C, UDI-DI: 10653160381105(each), 00653160381108(case), Lot Number: 2024110190; 27) CVI4300, UDI-DI: 10653160294313(each), 00653160294316(case), Lot Number: 2020120950
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3020 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Devices which did not undergo thermoforming could deform and lose performance.

ALL 50 STATES
Full report

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

Recall #:
98252
Lot/product code:
Model/Catalog Number: KD-V411M-3020; Material REF: N1090110; UDI-DI: N/A; All Lots with a valid expiration date
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55; 2) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55A; 3) TRACH TOTE, Model Number: DYNJ85691

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

ALL 50 STATES
Full report

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

Recall #:
98329
Lot/product code:
1) DYKMBNDL55, UDI-DI: 10193489478839(each), 40193489478830(case), Lot Number: 21FBA766; 2) DYKMBNDL55, UDI-DI: 10193489478839(each), 40193489478830(case), Lot Number: 21DBB713; 3) DYKMBNDL55, UDI-DI: 10193489478839(each), 40193489478830(case), Lot Number: 21CBH955; 4) DYKMBNDL55, UDI-DI: 10193489478839(each), 40193489478830(case), Lot Number: 21ABX057; 5) DYKMBNDL55, UDI-DI: 10193489478839(each), 40193489478830(case), Lot Number: 21ABK325; 6) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 23CBN841; 7) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22LBK911; 8) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22KBH787; 9) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22HBQ099; 10) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22FBX191; 11) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22FBF305; 12) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22DBR042; 13) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22DBM224; 14) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22BBM867; 15) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22BBL555; 16) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22ABM691; 17) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22ABD970; 18) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 21WBA902; 19) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 21JBJ227; 20) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 21IBU128; 21) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 21GBR277; 22) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 21GBR275; 23) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 21FBS122; 24) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 21FBE305; 25) DYNJ85691, UDI-DI: 10195327534141(each), 40195327534142(case), Lot Number: 24ABR853
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)