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Recalls affecting U.S. Virgin Islands

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

15,933 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

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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

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UnclassifiedBacteria/virusAnnounced September 3, 2026

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

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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

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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

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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.

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UnclassifiedUndeclaredAnnounced August 31, 2026

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

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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

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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.

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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

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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 May 20, 2026

Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242

Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

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

Recall #:
99045
Lot/product code:
Lot Code: Model No. 110040242 ; UDI-DI (01)00889024681989(17)350601(10)099471 ; Lot Number 099471 Model No. 110040242 ; UDI-DI (01)00889024681989(17)350614(10)099473 ; Lot Number 099473 Model No. 110040242 ; UDI-DI (01)00889024681989(17)350804(10)099474 ; Lot Number 099474 Model No. 110040242 ; UDI-DI (01)00889024681989(17)350806(10)099475 ; Lot Number 099475
Recalling firm:
Zimmer, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 20, 2026

Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240

Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

ALL 50 STATES
▸Full report

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

Recall #:
99045
Lot/product code:
Lot Code: Model No. 110040240 ; UDI-DI (01)00889024681965(17)350601(10)099457 ; Lot Number 099457 Model No. 110040240 ; UDI-DI (01)00889024681965(17)350712(10)099458 ; Lot Number 099458
Recalling firm:
Zimmer, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 20, 2026

RayCare 2024A SP4. Oncology Information Systems.

Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change.

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

Recall #:
99141
Lot/product code:
Software Version 8.0.4.60077, UDI 0735000201089120241218, Expiration Date: 2030-01-24.
Recalling firm:
RAYSEARCH LABORATORIES AB
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 20, 2026

RayCare 2024A SP1. Oncology Information Systems.

Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change.

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

Recall #:
99141
Lot/product code:
Software Version 8.0.1.60193, UDI 0735000201083920240906, Expiration Date: 2030-01-24
Recalling firm:
RAYSEARCH LABORATORIES AB
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 20, 2026

ARTIS icono ceiling. Model Number: 11328100.

Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.

ALL 50 STATES
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FDA has not published a risk classification for this recall yet.

Recall #:
99079
Lot/product code:
Model Number: 11328100. UDI-DI: 4056869295923. Serial Numbers: 194180, 194184, 194169, 194101, 194131, 194223, 194193, 194216, 194215, 194080, 194186, 194164, 194102, 194054, 194181, 194185, 194194, 194188, 194095, 194094, 194093, 194090, 194086, 194203, 194037, 194116, 194114, 194207, 194209, 194120, 194177, 194036, 194038, 194213, 194103, 194190, 194096, 194139, 194165, 194066, 194210, 194098, 194221, 194072, 194047, 194212, 194226, 194197, 194141, 194039, 194088, 194204, 194113, 194222, 194083, 194128, 194219, 194146, 194145, 194099, 194205, 194200, 194081, 194082, 194218, 194147, 194189, 194109, 194183, 194187, 194105, 194119, 194201, 194050, 194049, 194174, 194199, 194079, 194135, 194085, 194125, 194034, 194121, 194111, 194158, 194092, 194133, 194220, 194192, 194071, 194136, 194182, 194161, 194162, 194211, 194127, 194126, 194124, 194123, 194122, 194108, 194175, 194035, 194225, 194149, 194107, 194208, 194104, 194089, 194227, 194041, 194040, 194173, 194179, 194163, 194172, 194143, 194117, 194144.
Recalling firm:
Siemens Medical Solutions USA, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 20, 2026

Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444

Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

ALL 50 STATES
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FDA has not published a risk classification for this recall yet.

Recall #:
99045
Lot/product code:
Lot Code: 110040444 ; UDI-DI (01)00889024681903(17)350531(10)097487 ; Lot Number 097487
Recalling firm:
Zimmer, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 20, 2026

Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number: 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/A

Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.

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

Recall #:
99026
Lot/product code:
Product Number; UDI-DI Code; Lot Code: Product Number 9323-5511; UDI-DI 04719886906929; Lot number 25FB54 Product Number 9323-5512; UDI-DI 04719886906936; Lot number 25FB55 Product Number 9323-5513; UDI-DI 04719886906943; Lot number 25FB56 Product Number 9323-5514; UDI-DI 04719886906950; Lot number 25FB57 Product Number 9323-5515; UDI-DI 04719886906967; Lot number 25FB58 Product Number 9323-5516; UDI-DI 04719886906424; Lot number 25FB59 Product Number 9323-5521; UDI-DI 04719886906974; Lot number 25FB29 Product Number 9323-5522; UDI-DI 04719886906981; Lot number 25FB30 Product Number 9323-5523; UDI-DI 04719886906998; Lot number 25FB31 Product Number 9323-5524; UDI-DI 04719886907001; Lot number 25FB32 Product Number 9323-5525; UDI-DI 04719886907018; Lot number 25FB33 Product Number 9323-5526; UDI-DI 04719886907025; Lot number 25FB34
Recalling firm:
United Orthopedic Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 20, 2026

Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241

Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

ALL 50 STATES
▸Full report

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

Recall #:
99045
Lot/product code:
Lot Code: Model No. 110040241 ; UDI-DI (01)00889024681941(17)350602(10)099463 ; Lot Number 099463 Model No. 110040241 ; UDI-DI (01)00889024681941(17)350531(10)099464 ; Lot Number 099464 Model No. 110040241 ; UDI-DI (01)00889024681941(17)350812(10)099465 ; Lot Number 099465 Model No. 110040241 ; UDI-DI (01)00889024681941(17)350707(10)099467 ; Lot Number 099467
Recalling firm:
Zimmer, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 20, 2026

Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476

Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

ALL 50 STATES
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FDA has not published a risk classification for this recall yet.

Recall #:
99045
Lot/product code:
Lot Code: Model No. 110040476 ; UDI-DI (01)00889024682047(17)350531(10)097492 ; Lot Number 097492
Recalling firm:
Zimmer, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 20, 2026

ARTIS icono biplane. Model Number: 11327600.

Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.

ALL 50 STATES
▸Full report

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

Recall #:
99079
Lot/product code:
Model Number: 11327600. UDI-DI: 4056869063317. Serial Numbers: 184246, 184241, 184086, 184178, 184108, 184099, 184070, 184127, 184095, 184167, 184184, 184205, 184199, 184221, 184126, 184047, 184093, 184044, 184096, 184214, 184100, 184119, 184073, 184188, 184134, 184150, 184081, 184153, 184085, 184243, 184117, 184045, 184159, 184151, 184177, 184079, 184087, 184169, 184116, 184157, 184163, 184123, 184090, 184118, 184140, 184230, 184224, 184195, 184248, 184225, 184190, 184106, 184046, 184078, 184200, 184142, 184138, 184166, 184152, 184113, 184186, 184196, 184105, 184102, 184147, 184120, 184121, 184124, 184211, 184233, 184216, 184050, 184067, 184112, 184122, 184220, 184089, 184097, 184234, 184103, 184098, 184084, 184183, 184179, 184109
Recalling firm:
Siemens Medical Solutions USA, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 20, 2026

Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242

Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

ALL 50 STATES
▸Full report

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

Recall #:
99045
Lot/product code:
Lot Code: Model No. 110040242 ; UDI-DI (01)00889024681989(17)350601(10)099471 ; Lot Number 099471 Model No. 110040242 ; UDI-DI (01)00889024681989(17)350614(10)099473 ; Lot Number 099473 Model No. 110040242 ; UDI-DI (01)00889024681989(17)350804(10)099474 ; Lot Number 099474 Model No. 110040242 ; UDI-DI (01)00889024681989(17)350806(10)099475 ; Lot Number 099475
Recalling firm:
Zimmer, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 20, 2026

Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241

Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

ALL 50 STATES
▸Full report

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

Recall #:
99045
Lot/product code:
Lot Code: Model No. 110040241 ; UDI-DI (01)00889024681941(17)350602(10)099463 ; Lot Number 099463 Model No. 110040241 ; UDI-DI (01)00889024681941(17)350531(10)099464 ; Lot Number 099464 Model No. 110040241 ; UDI-DI (01)00889024681941(17)350812(10)099465 ; Lot Number 099465 Model No. 110040241 ; UDI-DI (01)00889024681941(17)350707(10)099467 ; Lot Number 099467
Recalling firm:
Zimmer, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 19, 2026

Halyard medical convenience kits labeled as: 1) ENT, Model/Item Number (kit) ACEN89-01; 2) ENT, Model/Item Number (kit) ACEN89-02; 3) BACK PACK, Model/Item Number (kit) ALBK51-01; 4) DR DERIAN SPINE PACK SNEDHCPDH, Model/Item Number (kit) DGSP71; 5) BASIC PACK DR BROWN SBADHBPR16, Model/Item Number (kit) DRBS37; 6) BASIC PACK DR BROWN SBADHBPR16, Model/Item Number (kit) DRBS37-01; 7) NASAL PACK SEN23SNRC3, Model/Item Number (kit) DRNS92; 8) NASAL PACK SEN23SNRC3, Model/Item Number (kit) DRNS92-01; 9) NASAL PACK SEN23SNRC3, Model/Item Number (kit) DRNS92-02; 10) SPINE PACK DR BROWN SNEDHSPR14, Model/Item Number (kit) DRSP26; 11) SPINE PACK DR BROWN SNEDHSPR14, Model/Item Number (kit) DRSP26-01; 12) SPINE PACK DR BROWN SNEDHSPR14, Model/Item Number (kit) DRSP26-02; 13) SPINE DR HEYS PACK SNE23SSRCT, Model/Item Number (kit) DRSP52; 14) SPINE DR HEYS PACK SNE23SSRCT, Model/Item Number (kit) DRSP52-01; 15) OHN LARYNGOSCOPY PACK SEN23BRD, Model/Item Number (kit) DULY32; 16) OHN LARYNGOSCOPY PACK SEN23BRD, Model/Item Number (kit) DULY32-01; 17) MICRO FLAP PK SEN23EN14T, Model/Item Number (kit) DUMF13-01; 18) MICRO FLAP PK SEN23EN14T, Model/Item Number (kit) DUMF13-02; 19) OHN NASAL PROCEDURE PACK SEN23, Model/Item Number (kit) DUNS94; 20) OHN NASAL PROCEDURE PACK SEN23, Model/Item Number (kit) DUNS94-01; 21) ORTHO POSTERIOR SPINE PK SOP23, Model/Item Number (kit) DUPS11-01; 22) ORTHO POSTERIOR SPINE PK, Model/Item Number (kit) DUPS11-02; 23) TRAM PACK SBA95TPDU6, Model/Item Number (kit) DUTM67-01; 24) SPINE PACK 176537, Model/Item Number (kit) DVSP33J; 25) LAMINECTOMY PACK, Model/Item Number (kit) EAMC108-03; 26) OMFS PACK, Model/Item Number (kit) EAMC124; 27) SINUS PACK 711866, Model/Item Number (kit) EFSN20-01; 28) KIT,SPINE, Model/Item Number (kit) EUOR004-04; 29) SPINE PACK 176556, Model/Item Number (kit) HOSP20I; 30) LAMINECTOMY PACK, Model/Item Number (kit) JACK401-07; 31) LAMINECTOMY PACK, Model/Item Number (kit) JACK401-08; 32) LAMINECTOMY PACK, Model/Item Number (kit) JACK401-09; 33) SPINE PACK 176476, Model/Item Number (kit) JCSP60F; 34) BACK PACK, Model/Item Number (kit) JEBK01-01; 35) PEDS SINUS PACK, Model/Item Number (kit) LBPS18-01; 36) SINUS PACK, Model/Item Number (kit) LBSN49-01; 37) ORAL SURGERY MAJOR PACK, Model/Item Number (kit) MAMC251-09; 38) SPINE PACK, Model/Item Number (kit) NAFB071-10; 39) SPINE PACK 176524, Model/Item Number (kit) OSSP27-01; 40) ORAL SURGERY HEAD, Model/Item Number (kit) SAMM029-17; 41) LAMINECTOMY PACK, Model/Item Number (kit) SELF112-03; 42) CPT FSC SINUS PACK, Model/Item Number (kit) SHAN415-01; 43) DR. DELASOTTA PLIF, Model/Item Number (kit) SHOR001-15; 44) DELASOTTA MINOR BACK, Model/Item Number (kit) SHOR005-12; 45) SPINE PACK, Model/Item Number (kit) SLCR80-01; 46) DIEP PACK, Model/Item Number (kit) SLDP19-01; 47) SPINE PACK - MAJOR, Model/Item Number (kit) SPST001-06; 48) ESS TRAY, Model/Item Number (kit) SWMR011-02; 49) SPINE PACK 176547, Model/Item Number (kit) TPSP14-01; 50) LAMINECTOMY PACK, Model/Item Number (kit) VALD009-08; 51) EENT PACK, Model/Item Number (kit) VALV225-02; 52) NEURO PACK, Model/Item Number (kit) VAST008-10; 53) SPINAL FUSION, Model/Item Number (kit) WRNM033-22.

The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.

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

Recall #:
99469
Lot/product code:
Model/Item Number (kit) ACEN89-01, UDI/DI 10809160459447, Kit Lot Number 1650691; Model/Item Number (kit) ACEN89-01, UDI/DI 10809160496411, Kit Lot Number 1675577; Model/Item Number (kit) ACEN89-01, UDI/DI 10809160459447, Kit Lot Number 1666553; Model/Item Number (kit) ACEN89-02, UDI/DI 10809160505304, Kit Lot Number 1683926; Model/Item Number (kit) ACEN89-02, UDI/DI 10809160505304, Kit Lot Number 1683927; Model/Item Number (kit) ALBK51-01, UDI/DI 10809160458587, Kit Lot Number 1649240; Model/Item Number (kit) ALBK51-01, UDI/DI 10809160458587, Kit Lot Number 1649721; Model/Item Number (kit) ALBK51-01, UDI/DI 10809160496374, Kit Lot Number 1675589; Model/Item Number (kit) DGSP71, UDI/DI 10809160468036, Kit Lot Number 1659332; Model/Item Number (kit) DRBS37, UDI/DI 10809160466858, Kit Lot Number 1658530; Model/Item Number (kit) DRBS37-01, UDI/DI 10809160503829, Kit Lot Number 1681363; Model/Item Number (kit) DRBS37-01, UDI/DI 10809160503829, Kit Lot Number 1681470; Model/Item Number (kit) DRBS37-01, UDI/DI 10809160503829, Kit Lot Number 1691461; Model/Item Number (kit) DRNS92, UDI/DI 10809160466346, Kit Lot Number 1658536; Model/Item Number (kit) DRNS92-01, UDI/DI 10809160503942, Kit Lot Number 1681504; Model/Item Number (kit) DRNS92-02, UDI/DI 10809160509463, Kit Lot Number 1696890; Model/Item Number (kit) DRSP26, UDI/DI 10809160466384, Kit Lot Number 1659340; Model/Item Number (kit) DRSP26-01, UDI/DI 10809160505113, Kit Lot Number 1683469; Model/Item Number (kit) DRSP26-02, UDI/DI 10809160509470, Kit Lot Number 1691780; Model/Item Number (kit) DRSP52, UDI/DI 10809160466391, Kit Lot Number 1658538; Model/Item Number (kit) DRSP52-01, UDI/DI 10809160503928, Kit Lot Number 1681522; Model/Item Number (kit) DRSP52-01, UDI/DI 10809160503928, Kit Lot Number 1690963; Model/Item Number (kit) DULY32, UDI/DI 10809160491713, Kit Lot Number 1672111; Model/Item Number (kit) DULY32-01, UDI/DI 10809160506752, Kit Lot Number 1684863; Model/Item Number (kit) DUMF13-01, UDI/DI 10809160498194, Kit Lot Number 1675866; Model/Item Number (kit) DUMF13-02, UDI/DI 10809160513668, Kit Lot Number 1696000; Model/Item Number (kit) DUNS94, UDI/DI 10809160493380, Kit Lot Number 1672112; Model/Item Number (kit) DUNS94-01, UDI/DI 10809160513309, Kit Lot Number 1696906; Model/Item Number (kit) DUPS11-01, UDI/DI 10809160497654, Kit Lot Number 1675527; Model/Item Number (kit) DUPS11-02, UDI/DI 10809160514245, Kit Lot Number 1696671; Model/Item Number (kit) DUTM67-01, UDI/DI 10809160498255, Kit Lot Number 1675954; Model/Item Number (kit) DVSP33J, UDI/DI 10809160488256, Kit Lot Number 1663944; Model/Item Number (kit) DVSP33J, UDI/DI 10809160422601, Kit Lot Number 1630941; Model/Item Number (kit) DVSP33J, UDI/DI 10809160488256, Kit Lot Number 1668872; Model/Item Number (kit) DVSP33J, UDI/DI 10809160488256, Kit Lot Number 1668873; Model/Item Number (kit) DVSP33J, UDI/DI 10809160488256, Kit Lot Number 1663942; Model/Item Number (kit) DVSP33J, UDI/DI 10809160488256, Kit Lot Number 1663941; Model/Item Number (kit) DVSP33J, UDI/DI 10809160488256, Kit Lot Number 1693905; Model/Item Number (kit) EAMC108-03, UDI/DI 10809160308332, Kit Lot Number 1648525; Model/Item Number (kit) EAMC108-03, UDI/DI 10809160308332, Kit Lot Number 1657459; Model/Item Number (kit) EAMC124, UDI/DI 10809160404799, Kit Lot Number 1647073; Model/Item Number (kit) EAMC124, UDI/DI 10809160404799, Kit Lot Number 1652746; Model/Item Number (kit) EAMC124, UDI/DI 10809160404799, Kit Lot Number 1653958; Model/Item Number (kit) EAMC124, UDI/DI 10809160404799, Kit Lot Number 1663289; Model/Item Number (kit) EAMC124, UDI/DI 10809160404799, Kit Lot Number 1668701; Model/Item Number (kit) EAMC124, UDI/DI 10809160404799, Kit Lot Number 1702932; Model/Item Number (kit) EFSN20-01, UDI/DI 10809160442104, Kit Lot Number 1633240; Model/Item Number (kit) EFSN20-01, UDI/DI 10809160456132, Kit Lot Number 1646885; Model/Item Number (kit) EFSN20-01, UDI/DI 10809160456132, Kit Lot Number 1679527; Model/Item Number (kit) EFSN20-01, UDI/DI 10809160456132, Kit Lot Number 1666246; Model/Item Number (kit) EFSN20-01, UDI/DI 10809160456132, Kit Lot Number 1666500; Model/Item Number (kit) EFSN20-01, UDI/DI 10809160456132, Kit Lot Number 1667490; Model/Item Number (kit) EFSN20-01, UDI/DI 10809160456132, Kit Lot Number 1696290; Model/Item Number (kit) EFSN20-01, UDI/DI 10809160456132, Kit Lot Number 1697819; Model/Item Number (kit) EUOR004-04, UDI/DI 10809160436172, Kit Lot Number 1627776; Model/Item Number (kit) EUOR004-04, UDI/DI 10809160457252, Kit Lot Number 1668123; Model/Item Number (kit) HOSP20I, UDI/DI 10809160488133, Kit Lot Number 1665330; Model/Item Number (kit) HOSP20I, UDI/DI 10809160488133, Kit Lot Number 1669003; Model/Item Number (kit) HOSP20I, UDI/DI 10809160488133, Kit Lot Number 1671045; Model/Item Number (kit) HOSP20I, UDI/DI 10809160488133, Kit Lot Number 1693989; Model/Item Number (kit) HOSP20I, UDI/DI 10809160488133, Kit Lot Number … (truncated, 13907 characters total — see the official FDA record for the full value)
Recalling firm:
AVID Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 19, 2026

TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300.

Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB).

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

Recall #:
99080
Lot/product code:
Part Number: 5521-B-300. UDI: (01)07613327026313(17)260921(10) UZD9IB. Lot Number: UZD9IB.
Recalling firm:
Howmedica Osteonics Corp.
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UnclassifiedRisk not yet known
Medical deviceRecalled May 19, 2026

Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.

Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper sealing, potentially leading to fluid occlusion or leakage.

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

Recall #:
99250
Lot/product code:
Model/Catalog Number: PVHM234-01. UDI-DI: 10809160416761. Lot Numbers (Expiration date): 1597314 (8/31/2026), 1599022 (5/31/2026).
Recalling firm:
AVID Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 19, 2026

GORE TAG Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region) United States (includes Puerto Rico) and Canada: TSB080806A, TSB081006A, TSB081206A, TSB081506A, TSB081706A, TSB121506A, TSB121706A, TSB122006A EMEA Countries, Australia, New Zealand: TSB080806E, TSB081006E, TSB081206E, TSB081506E, TSB081706E, TSB121506E, TSB121706E, TSB122006E Japan: TSB080806J, TSB081006J, TSB081206J, TSB081506J, TSB081706J, TSB121506J, TSB121706J, TSB122006J China and Taiwan: TSB080806W, TSB081006W, TSB081206W, TSB081506W, TSB081706W, TSB121506W, TSB121706W, TSB122006W The GORE TAG Thoracic Branch Endoprosthesis is indicated for endovascular repair of lesions of the aortic arch and descending thoracic aorta, while maintaining flow into a single aortic arch branch vessel The GORE TAG Thoracic Branch Endoprosthesis is a modular device consisting of the Aortic Component (AC), the Side Branch (SB) Component, and an optional Aortic Extender (AE), and their respective delivery systems. These components may be used together as a stand-alone device or in conjunction with the GORE TAG Conformable Thoracic Endoprosthesis to accommodate the intended treatment site.

Due to catheter separation

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

Recall #:
99140
Lot/product code:
Catalog Number / UDI-DI Code: TSB081006A (00733132654369) Serial Numbers: 31602664 Catalog Number / UDI-DI Code: TSB081006J (00733132662630) Serial Numbers: 31421864 31421865 31421870 31432339 31432340 31440637 31440638 31440639 31440640 31440641 31440642 31462061 31462062 31462063 31462064 Catalog Number / UDI-DI Code: TSB081006W (00733132650866) Serial Numbers: 31530086 Catalog Number / UDI-DI Code: TSB081206A (00733132654376) Serial Numbers: 31251480 31251481 31251482 31251484 31256961 31256963 31272521 31272522 31272523 31272525 31272526 31272527 31272528 31272529 31272530 31272531 31272533 31272534 31277206 31277207 31277208 31277209 31277210 31280248 31280249 31280250 31280251 31280252 31280254 31280255 31280256 31280257 31289924 31289925 31289926 31289928 31289929 31290547 31290548 31290549 31290550 31301117 31301118 31307814 31312365 31312366 31312367 31319612 31319613 31332034 31332036 31342363 31342364 31345617 31366643 31387545 31395549 31395550 31397877 31397878 31407669 31407670 31407674 31407675 31407676 31407677 31407678 31410726 31416877 31430425 31430426 31430428 31432234 31432235 31432236 31432239 31432240 31432241 31435513 31435514 31440731 31440734 31462230 31465437 31465438 31465440 31472456 31472457 31472459 31479940 31493741 31493742 31499222 31499223 31499226 31563552 31563560 31572876 31572880 31572882 31572891 31572892 31581245 31581253 31581254 31611436 31611437 31611441 31642687 31642688 31642689 Catalog Number / UDI-DI Code: TSB081206E (00733132640485) Serial Numbers: 31253984 31253985 31253986 31253987 31253988 31253989 31253990 31290053 31293373 31293374 Catalog Number / UDI-DI Code: TSB081206J (00733132662647) Serial Numbers: 31271809 31271810 31271811 31275136 31275137 31275138 31275139 31275140 31277767 31277768 31277769 31277770 31277771 31285319 31285320 31285321 31289881 31289882 31289883 31301127 31301128 31301129 31311216 31311217 31311218 31315622 31315623 31315624 31315625 31371534 31371535 31371536 31371537 31390397 31390398 31390399 31397568 31397569 31397570 31411861 31411862 31411863 31411864 31411865 31411866 31421871 31421872 31421873 31421874 31421875 31421876 31421877 31421878 31421879 31421880 31438746 31438747 31438748 31438749 31438750 31440643 31440644 31440645 31453248 31453249 31453250 31453251 31462065 31462066 31462067 31462068 31472889 31472890 31474581 31474582 31482166 31482167 31571943 31571944 31571945 31571946 31571947 31582095 31582096 Catalog Number / UDI-DI Code: TSB081206W (00733132650873) Serial Numbers: 31249440 31249441 31249442 31256132 31256133 31256134 31256135 31256136 31256137 31256138 31256139 31256140 31256141 31258012 31258013 31258014 31258015 31258016 31266804 31266805 31266806 31277725 31277726 31277727 31277728 31277729 31276236 31276237 31276238 31276239 31276240 31276241 31285066 31285067 31285068 31289757 31289758 31289759 31289760 31289761 31293955 31293956 31293957 31293958 31293959 31293960 31293961 31293962 31293963 31293964 31365908 31408580 31408581 Catalog Number / UDI-DI Code: TSB081506A (00733132654383) Serial Numbers: 31272538 31272540 31272542 31272543 31272544 31272545 31272546 31272547 31272548 31272549 31272552 31272553 31268417 31268418 31268423 31268426 31280282 31280284 31280285 31280290 31280291 31280292 31280293 31280295 31289931 31289932 31289934 31289935 31299696 31299697 31299699 31309365 31309366 31312893 31312894 31312895 31312896 31319619 31319620 31319624 31319625 31325034 31325036 31325037 31332048 31332049 31332050 31335377 31335378 31335379 31335380 31335381 31335382 31335383 31335385 31363232 31363236 31366645 31366646 31388732 31388734 31401068 31401069 31401070 31425503 31425504 31425505 31425506 31425507 31425509 31425510 31425511 31430434 31430435 31435520 31435524 31342367 31345621 31345623 31345624 31456133 31456134 31462236 31484441 31484442 31484446 31484448 31493794 31493795 31493797 31499229 31499230 31499231 31499234 31499238 31506698 31506699 31506700 31510601 31510606 31595556 31595557 31595562 31602670 31602675 31607624 31616508 31622720 31622721 Catalog Number / UDI-DI Code: TSB081506W (00733132644414) Serial Numbers: 31274125 31274126 31274127 31319417 31319418 31319419 31367372 Catalog Number / UDI-DI Code: TSB121506A (00733132654406) Serial Numbers: 31320042 31320043 31320044 31332059 31332060 31342369 31342371 31412313 31412314 31412316 31412317 31412320 31416880 31416881 31416882 31416883 31416885 31420186 31420187 31420188 31420189 31420190 31445434 31445435 31445437 31445438 31462238 31462239 31462241 31465442 31465446 31472477 31472478 31484427 31484429 31484431 31484432 31484433 31493782 31493783 31506692 31506693 31506695 31534695 31534698 31534699 31536819 31586919 31586921 31586922 31586925 31586928 Catalog Number / UDI-DI Code: TSB121506W (00733132650897) Serial Numbers: 31380152 Catalog Number / UDI-DI Code: TSB121706A (00733132654413) Serial Numbers: 31541449 Catalog Number / UDI-DI Code: TSB122006A (00733132654420) Serial Numbers: 31299708 31299710 312… (truncated, 5251 characters total — see the official FDA record for the full value)
Recalling firm:
W L Gore & Associates, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 19, 2026

Halyard medical convenience kits labeled as: 1) A-P PACK - 205936, Model/Item Number (kit) ANAP22-01; 2) POSTERIOR PACK - 205960, Model/Item Number (kit) ANPP15-01; 3) ANEURYSM PACK, Model/Item Number (kit) BPAY14-01; 4) SPINE PACK, Model/Item Number (kit) HSLM53-01; 5) ANTERIOR CERVICAL PACK - 205988, Model/Item Number (kit) MHAC65-01; 6) SPINE PACK - 206013, Model/Item Number (kit) MHSP99-01; 7) CRANI PACK, Model/Item Number (kit) WECR41-01.

The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.

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

Recall #:
99469
Lot/product code:
Model/Item Number (kit) ANAP22-01, UDI/DI 10809160473146, Kit Lot Number 346967; Model/Item Number (kit) ANAP22-01, UDI/DI 10809160473146, Kit Lot Number 346982; Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343413; Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343414; Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343713; Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343715; Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343716; Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343412; Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343416; Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343714; Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343717; Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343718; Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343719; Model/Item Number (kit) ANPP15-01, UDI/DI 10809160473573, Kit Lot Number 343723; Model/Item Number (kit) BPAY14-01, UDI/DI 10809160473979, Kit Lot Number 343746; Model/Item Number (kit) BPAY14-01, UDI/DI 10809160473979, Kit Lot Number 343747; Model/Item Number (kit) BPAY14-01, UDI/DI 10809160473979, Kit Lot Number 343771; Model/Item Number (kit) BPAY14-01, UDI/DI 10809160473979, Kit Lot Number 374128; Model/Item Number (kit) BPAY14-01, UDI/DI 10809160473979, Kit Lot Number 374129; Model/Item Number (kit) BPAY14-01, UDI/DI 10809160473979, Kit Lot Number 374296; Model/Item Number (kit) HSLM53-01, UDI/DI 10809160476888, Kit Lot Number 342005; Model/Item Number (kit) HSLM53-01, UDI/DI 10809160476888, Kit Lot Number 344071; Model/Item Number (kit) HSLM53-01, UDI/DI 10809160476888, Kit Lot Number 347906; Model/Item Number (kit) HSLM53-01, UDI/DI 10809160476888, Kit Lot Number 341835; Model/Item Number (kit) HSLM53-01, UDI/DI 10809160476888, Kit Lot Number 343206; Model/Item Number (kit) HSLM53-01, UDI/DI 10809160476888, Kit Lot Number 343208; Model/Item Number (kit) MHAC65-01, UDI/DI 10809160479537, Kit Lot Number 345289; Model/Item Number (kit) MHSP99-01, UDI/DI 10809160479797, Kit Lot Number 345694; Model/Item Number (kit) MHSP99-01, UDI/DI 10809160479797, Kit Lot Number 341654; Model/Item Number (kit) WECR41-01, UDI/DI 10809160485392, Kit Lot Number 344464.
Recalling firm:
AVID Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 19, 2026

1) NEURO, (kit) ACNE73-01; 2) NEURO, (kit) ACNE73-03; 3) CRANI, (kit) AKCR19-01; 4) ORTHO SPINE PACK, (kit) ARMC017; 5) BMHM NEURO PACK, (kit) BMHT016-05; 6) LUMBAR PACK, (kit) BMHT112-03; 7) NEURO LAMINECTOMY PACK, (kit) DGNE75; 8) NEURO LAMINECTOMY PACK, (kit) DGNE75-02; 9) DRAH NEURO LAMINECTOMY SNEDHDN,(kit) DRNE75; 10) DRAH NEURO LAMINECTOMY SNEDHDN, (kit) DRNE75-01; 11) CRANIOSYNOSTOSIS CUSTOM SNE23C, (kit) DUCR36-01; 12) CRANIOSYNOSTOSIS CUSTOM SNE23C, (kit) DUCR36-02; 13) NEURO CRANIOTOMY PK SNE23C1116, (kit) DUNC42-01; 14) PEDS NEURO PACK SNE2301147, (kit) DUNE88-01; 15) NEURO SPINE PACK SNE23LM110, (kit) DUSP98-01; 16) NEURO SPINE PACK SNE23LM110, (kit) DUSP98-02; 17) CRANI PACK 712638, (kit) EFCR86-01; 18) SPINE PACK 712040, (kit) EFSP30-01; 19) SPINE PACK 712040, (kit) EFSP30-02; 20) CRANIOTOMY TRAY, (kit) EURO009-09; 21) CRANI PACK, (kit) IHCR36-01; 22) NEURO PACK, (kit) IHNE35-01; 23) CRANIOTOMY PACK, (kit) JACK410-11; 24) BASIC NEURO PACK, (kit) MAMC275-06; 25) BASIC NEURO PACK, (kit) MAMC275-07; 26) SPINE CRANI PACK, (kit) MCSP92-01; 27) CRANIOTOMY PACK, (kit) MECP05R; 28) SPINE TRAY GLOBALMICROSURG, (kit) MEDF217-02; 29) NEURO BASIC PACK, (kit) MENE06T; 30) CRANIAL PACK - 205992, (kit) MHCP75-01; 31) NEURO PACK, (kit) MMOK007-03; 32) NEURO PACK, (kit) MMTN012-04; 33) CRANIOTOMY PACK SNECGCRM11, (kit) MSMC108-01; 34) NEURO ANT CERV LAMI ADD A PACK, (kit) NAMC413-07; 35) STRL NEURO LUMB LAMI ADD A PK, (kit) NAMC433-05; 36) NEURO CRANI ADD A PACK, (kit) NAMC434-08; 37) NEURO PACK, (kit) NWHR010-03; 38) CRANIOTOMY PACK OSBORN 176518, (kit) OSCR20-01; 39) NEURO PACK, (kit) RDLD001-14; 40) CRANI PACK, (kit) RDLD008-14; 41) NEURO LUMBAR CERVICAL PACK,(kit) SAMM031-18; 42) CRANIOTOMY PACK, (kit) SELF111-02; 43) PELHAM ACDF, (kit) SGAC31-02; 44) PELHAM ACDF, (kit) SGAC31-03; 45) PELHAM MINA SPINE, (kit) SGSP11; 46) PELHAM MINA SPINE, (kit) SGSP11-03; 47) PELHAM SPINE, (kit) SGSP44-02; 48) PELHAM SPINE, (kit) SGSP44-03; 49) SPINE, (kit) SGSP91; 50) SPINE, (kit) SGSP91-02; 51) SPINE, (kit) SGSP91-03; 52) NEURO SPINAL TRAY SHANDS JACKS, (kit) SHND416-02; 53) DR. DELASOTTA NEURO NECK, (kit) SHOR003-15; 54) CRANI PACK, (kit) SLCN72-01; 55) CRANI PACK, (kit) SLCN72-02; 56) CRANI PACK, (kit) SLCN72-03; 57) CRANI PACK - 208400, (kit) UDCP57-01; 58) NEURO TRAY-LF, (kit) UMIA104-11; 59) CRANIOTOMY PACK, (kit) USMA005; 60) CERVICAL NEURO PACK PGYBK, (kit) VAML012-07; 61) LUMBAR NEURO PACK PGYBK, (kit) VAML028-06; 62) NASAL SINUS, (kit) VAPX009-02; 63) LUMBAR LAMINECTOMY TRAY, (kit) VMCC024-14; 64) VA LUMBAR LAMINECTOMY, (kit) VMED009-05; 65) ANTERIOR CERVICAL PACK, (kit) WEAC53-01; 66) CRANI PACK, (kit) WECR41-01; 67) LUMBAR LAMINECTOMY PACK,67) LUMBAR LAMINECTOMY PACK, Model/Item Number (kit) WELL73-01; 68) LUMBAR LAMINECTOMY, (kit) WKMC114-03; 69) CRANIOTOMY PK, (kit) WKMC125-03; 70) DISKECTOMY PACK, (kit) WRNM030-21.

The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.

ALL 50 STATES
▸Full report

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

Recall #:
99469
Lot/product code:
Model/Item Number (kit) ACNE73-01, UDI/DI 10809160458532, Kit Lot Number 1649716; Model/Item Number (kit) ACNE73-01, UDI/DI 10809160458532, Kit Lot Number 1666559; Model/Item Number (kit) ACNE73-01, UDI/DI 10809160458532, Kit Lot Number 1649717; Model/Item Number (kit) ACNE73-03, UDI/DI 10809160513996, Kit Lot Number 1696563; Model/Item Number (kit) AKCR19-01, UDI/DI 10809160459515, Kit Lot Number 1650945; Model/Item Number (kit) AKCR19-01, UDI/DI 10809160459515, Kit Lot Number 1666564; Model/Item Number (kit) AKCR19-01, UDI/DI 10809160459515, Kit Lot Number 1664544; Model/Item Number (kit) AKCR19-01, UDI/DI 10809160459515, Kit Lot Number 1666978; Model/Item Number (kit) ARMC017, UDI/DI 10809160506455, Kit Lot Number 1685117; Model/Item Number (kit) ARMC017, UDI/DI 10809160506455, Kit Lot Number 1688043; Model/Item Number (kit) ARMC017, UDI/DI 10809160506455, Kit Lot Number 1688044; Model/Item Number (kit) BMHT016-05, UDI/DI 10809160468821, Kit Lot Number 1666733; Model/Item Number (kit) BMHT016-05, UDI/DI 10809160468821, Kit Lot Number 1659950; Model/Item Number (kit) BMHT112-03, UDI/DI 10809160457634, Kit Lot Number 1649141; Model/Item Number (kit) BMHT112-03, UDI/DI 10809160404430, Kit Lot Number 1606455; Model/Item Number (kit) DGNE75, UDI/DI 10809160468104, Kit Lot Number 1659330; Model/Item Number (kit) DGNE75-02, UDI/DI 10809160510001, Kit Lot Number 1688056; Model/Item Number (kit) DRNE75, UDI/DI 10809160467190, Kit Lot Number 1658535; Model/Item Number (kit) DRNE75-01, UDI/DI 10809160503843, Kit Lot Number 1681499; Model/Item Number (kit) DRNE75-01, UDI/DI 10809160503843, Kit Lot Number 1691081; Model/Item Number (kit) DUCR36-01, UDI/DI 10809160497388, Kit Lot Number 1675499; Model/Item Number (kit) DUCR36-02, UDI/DI 10809160513538, Kit Lot Number 1691089; Model/Item Number (kit) DUNC42-01, UDI/DI 10809160497524, Kit Lot Number 1675518; Model/Item Number (kit) DUNC42-01, UDI/DI 10809160497524, Kit Lot Number 1686203; Model/Item Number (kit) DUNC42-01, UDI/DI 10809160497524, Kit Lot Number 1686204; Model/Item Number (kit) DUNE88-01, UDI/DI 10809160498217, Kit Lot Number 1675520; Model/Item Number (kit) DUSP98-01, UDI/DI 10809160497708, Kit Lot Number 1680111; Model/Item Number (kit) DUSP98-02, UDI/DI 10809160513392, Kit Lot Number 1691105; Model/Item Number (kit) EFCR86-01, UDI/DI 10809160442210, Kit Lot Number 1633353; Model/Item Number (kit) EFCR86-01, UDI/DI 10809160456026, Kit Lot Number 1694281; Model/Item Number (kit) EFCR86-01, UDI/DI 10809160456026, Kit Lot Number 1691158; Model/Item Number (kit) EFCR86-01, UDI/DI 10809160442210, Kit Lot Number 374076; Model/Item Number (kit) EFSP30-01, UDI/DI 10809160456187, Kit Lot Number 1648983; Model/Item Number (kit) EFSP30-01, UDI/DI 10809160456187, Kit Lot Number 1646886; Model/Item Number (kit) EFSP30-01, UDI/DI 10809160456187, Kit Lot Number 1649731; Model/Item Number (kit) EFSP30-01, UDI/DI 10809160456187, Kit Lot Number 1633403; Model/Item Number (kit) EFSP30-02, UDI/DI 10809160492024, Kit Lot Number 1669417; Model/Item Number (kit) EFSP30-02, UDI/DI 10809160492024, Kit Lot Number 1678530; Model/Item Number (kit) EFSP30-02, UDI/DI 10809160492024, Kit Lot Number 1670304; Model/Item Number (kit) EFSP30-02, UDI/DI 10809160492024, Kit Lot Number 1691551; Model/Item Number (kit) EFSP30-02, UDI/DI 10809160492024, Kit Lot Number 1669415; Model/Item Number (kit) EFSP30-02, UDI/DI 10809160492024, Kit Lot Number 1680385; Model/Item Number (kit) EURO009-09, UDI/DI 10809160414217, Kit Lot Number 1649363; Model/Item Number (kit) IHCR36-01, UDI/DI 10809160477557, Kit Lot Number 344863; Model/Item Number (kit) IHNE35-01, UDI/DI 10809160477724, Kit Lot Number 343178; Model/Item Number (kit) IHNE35-01, UDI/DI 10809160477724, Kit Lot Number 343377; Model/Item Number (kit) IHNE35-01, UDI/DI 10809160477724, Kit Lot Number 343179; Model/Item Number (kit) IHNE35-01, UDI/DI 10809160477724, Kit Lot Number 348826; Model/Item Number (kit) IHNE35-01, UDI/DI 10809160477724, Kit Lot Number 348828; Model/Item Number (kit) IHNE35-01, UDI/DI 10809160477724, Kit Lot Number 348829; Model/Item Number (kit) IHNE35-01, UDI/DI 10809160477724, Kit Lot Number 348830; Model/Item Number (kit) IHNE35-01, UDI/DI 10809160477724, Kit Lot Number 348834; Model/Item Number (kit) IHNE35-01, UDI/DI 10809160477724, Kit Lot Number 348835; Model/Item Number (kit) JACK410-11, UDI/DI 10809160464991, Kit Lot Number 1664733; Model/Item Number (kit) JACK410-11, UDI/DI 10809160464991, Kit Lot Number 1656356; Model/Item Number (kit) JACK410-11, UDI/DI 10809160464991, Kit Lot Number 1667191; Model/Item Number (kit) JACK410-11, UDI/DI 10809160464991, Kit Lot Number 838447; Model/Item Number (kit) JACK410-11, UDI/DI 10809160464991, Kit Lot Number 1664206; Model/Item Number (kit) JACK410-11, UDI/DI 10809160464991, Kit Lot Number 1664732; Model/Item Number (kit) MAMC275-06, UDI/DI 10809160421666, Kit Lot Number 1644895; Model/Item Number (kit) MAMC275-… (truncated, 16695 characters total — see the official FDA record for the full value)
Recalling firm:
AVID Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 19, 2026

TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400.

Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB).

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

Recall #:
99080
Lot/product code:
Part Number: 5521-B-400. UDI: (01)07613327026061(17)260921(10) TYX7OB. Lot Number: TYX7OB.
Recalling firm:
Howmedica Osteonics Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 19, 2026

Medtronic O-arm O2 Imaging System. Model Number: BI70002000.

Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.

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

Recall #:
99041
Lot/product code:
Model Number: BI70002000. GTIN (Serial Numbers): 00643169639683 (C1640), 00643169651814 (C3815, C3816, C3817, C3818, C3891, C3898, C3899, C3900, C3901, C3902, C3903, C3905, C3990, C3997, C3998, C3999, C4001, C4002, C4003, C4004, C4059, C4060, C4061, C4062, C4063, C4064, C4065, C4066, C4067, C4068, C4116, C4117, C4118, C4119, C4120, C4121, C4122, C4123, C4130, C4201, C4202, C4203, C4356, C4357, C4360, C4361), 00763000132378 (C2096, C2187), 00763000355555 (C2768), 00763000481599 (C3895, C3996), 00763000496586 (C3794, C3896, C4023, C4031, C4032, C4043, C4088, C4092), 00763000496593 (C3887, C3889, C3978, C3988, C3991, C3994, C4041, C4109, C4110, C4111, C4161), 00763000496609 (C3802), 00763000496630 (C4035), 00763000496647 (C4012, C4126, C4129), 00763000496661 (C3824, C3987, C4071, C4072), 00763000496678 (C3879), 00763000496692 (C3799, C3823, C3897, C3979, C4027, C4037, C4044, C4125), 00763000496708 (C3825), 00763000496715 (C4074, C4128), 00763000496722 (C3812, C3822, C3828, C3881, C4034, C4036, C4038, C4039, C4160), 00763000616304 (C3795), 00763000616397 (C3800), 00763000616441 (C3811), 00763000616458 (C3783, C3784), 00763000616564 (C3316, C3735, C3777, C3778, C3779, C3780, C3781, C3786, C3787, C3790, C3791, C3792, C3793, C3796, C3797, C3798), 00763000709365 (C4307), 00763000709372 (C4221, C4284, C4294, C4301, C4354, C4370, C4399), 00763000709389 (C4166, C4295, C4402), 00763000709396 (C4394), 00763000709402 (C4149, C4150), 00763000709419 (C4395), 00763000709426 (C4115, C4248, C4304), 00763000709457 (C4293, C4298,C4403), 00763000709464 (C4368), 00763000709488 (C4204, C4205, C4302, C4363, C4366), 00763000709518 (C4148, C4167, C4222, C4223, C4224, C4225, C4285, C4292, C4303, C4309, C4362, C4369, C4374, C4375), 00763000709532 (C4206, C4208, C4209, C4236, C4245, C4283, C4286, C4287, C4288, C4289, C4290, C4308, C4310, C4372, C4373, C4377, C4378), 00763000709556 (C4390), 00763000709570 (C4249, C4250), 00763000709594 (C4396), 00763000709631 (C3883, C3884, C3885, C3907, C3908, C3909, C3910, C3911, C3912, C3913, C3914, C3915, C3916, C3918, C3919, C3920, C3921, C3922, C3923, C3924, C3925, C3926, C3927, C3928, C3929, C3930, C3931, C3932, C3933, C3934, C3935, C3936, C3937, C3938, C3939, C3940, C3941, C3942, C3943, C3944, C3945, C3946, C3947, C3948, C3949, C3950, C3951, C3953, C3954, C3955, C3956, C3957, C3958, C3959, C3960, C3961, C3962, C3963, C3964, C3965, C3966, C3967, C3968, C3969, C3970, C3971, C3972, C3973, C3974, C3975, C3976, C3977, C3982, C3983, C3984, C4014, C4015, C4016, C4017, C4018, C4019, C4020, C4021, C4022, C4028, C4045, C4046, C4047, C4048, C4049, C4050, C4051, C4052, C4053, C4075, C4076, C4077, C4078, C4079, C4080, C4081, C4082, C4083, C4084, C4085, C4086, C4087, C4089, C4090, C4093, C4094, C4095, C4096, C4097, C4098, C4100, C4101, C4102, C4103, C4104, C4105, C4106, C4107, C4108, C4131, C4132, C4133, C4134, C4135, C4136, C4137, C4138, C4139, C4140, C4141, C4142, C4143, C4144, C4145, C4146, C4151, C4152, C4153, C4154, C4155, C4156, C4157, C4158, C4162, C4163, C4168, C4169, C4170, C4171, C4172, C4173, C4174, C4175, C4176, C4177, C4178, C4179, C4180, C4181, C4182, C4183, C4184, C4185, C4186, C4187, C4188, C4190, C4191, C4193, C4194, C4195, C4196, C4197, C4198, C4199, C4200, C4210, C4211, C4212, C4213, C4214, C4215, C4217, C4218, C4219, C4220, C4226, C4227, C4228, C4229, C4230, C4231, C4232, C4233, C4234, C4235, C4237, C4238, C4239, C4240, C4241, C4242, C4243, C4244, C4246, C4247, C4251, C4252, C4253, C4254, C4256, C4257, C4258, C4259, C4260, C4261, C4263, C4264, C4265, C4266, C4267, C4268, C4269, C4270, C4271, C4272, C4273, C4274, C4278, C4279, C4281, C4311, C4312, C4313, C4314, C4315, C4316, C4318, C4319, C4320, C4321, C4322, C4323, C4324, C4325, C4326, C4328, C4329, C4330, C4331, C4332, C4333, C4334, C4335, C4336, C4337, C4339, C4340, C4341, C4342, C4343, C4344, C4345, C4346, C4347, C4348, C4349, C4350, C4351, C4382, C4383, C4384, C4385, C4386, C4388, C4405, C4406, C4407, C4414, C4415, C4416, C4418, C4421, C4422, C4280), 00763000709648 (C4282, C4300), 00763000709662 (C4306, C4353), 00763000709686 (C4352), 00763000709693 (C4299, C4397), 00763000745462 (C4040), 00763000745486 (C3863, C4069, C4070), 00763000863203 (C4033), 00763000863210 (C3789, C3801, C3804, C3805, C3806, C3807, C3808, C3809, C3878, C3985, C4005, C4006, C4007, C4008, C4009, C4010, C4011), 00763000863241 (C3833, C3890, C3892, C3894, C3980, C3995, C4013, C4029), 00763000863265 (C3826, C4164, C4165), 00763000863272 (C3813, C3814, C3820, C3821, C3827, C3888, C3904, C3906, C3992, C4024, C4026, C4054, C4055, C4056, C4057, C4073, C4112, C4113, C4124, C4147, C4159), 00763000863302 (C3829, C3830, C3831, C3832, C3835, C3837, C3838, C3839, C3840, C3841, C3842, C3843, C3844, C3845, C3848, C3849, C3850, C3851, C3852, C3853, C3854, C3855, C3856, C3857, C3858, C3859, C3860, C3861, C3862, C3864, C3865, C3866, C3867, C3868, C3869, C3870, C3871, C3872, C3873, C3874, C3875, C3876), 00763000871109 (C4127), 00763000871116 (C3989), 00763000871123 (C3986, C3993, C… (truncated, 5140 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic Navigation, Inc.-Boxborough
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 18, 2026

Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride, syringe, IntegraDose Compounding Services, LLC. 3650 Victoria St N, Suite 900, Shoreview, MN, NDC 71139-0190-1.

Weaker than it should be Drug

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

Recall #:
D-0593-2026
Lot/product code:
Lot#: 20260327VAS-3, BUD: 05/26/2026; 20260320VAS-3, BUD: 05/19/2026.
Recalling firm:
IntegraDose Compounding Services LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 18, 2026

Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper FD10C; Model # 722002 for Allura Xper FD10F; Model # 722003 for Allura Xper FD10; Model # 722005 for Allura Xper FD10/10; Model # 722006 for Allura Xper FD20; Model # 722008 for Allura Xper FD20 Biplane; Model # 722010 for Allura Xper FD10; Model # 722011 for Allura Xper FD10/10; Model # 722012 for Allura Xper FD20; Model # 722013 for Allura Xper FD20 Biplane; Model # 722015 for Allura Xper FD20 OR Table; Model # 722019 for Allura Xper FD10/10 OR Table; Model # 722020 for Allura Xper FD20 Biplane OR Table; Model # 722022 for Allura Xper FD10 OR Table; Model # 722023 for Allura Xper FD20 OR Table; Model # 722025 for Allura Xper FD20 Biplane OR Table; Model # 722026 for Allura Xper FD10; Model # 722027 for Allura Xper FD10/10; Model # 722028 for Allura Xper FD20; Model # 722029 for Allura Xper FD20/10; Model #722033 for Allura Xper FD10 OR Table; Model #722035 for Allura Xper FD20 OR Table; Model #722038 for Allura Xper FD20/20; Model #722039 for Allura Xper FD20/20 OR Table; Model #722058 for Allura Xper FD20/15; Model #722059 for Allura Xper FD20/15 OR Table.

Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended radiation exposure and additional contrast injection

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

Recall #:
99223
Lot/product code:
All codes
Recalling firm:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 18, 2026

GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in FLUORESCENT PROC. (QUAL), GALACTOSE-1-PHOSPHATE URIDYL TRANSFERASE.

Reduction in the on-board stability of the GSP GALT assay. This may increase the likelihood of run-QC failures and consequently delay the reporting of patient results.

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

Recall #:
99065
Lot/product code:
1. Product Code: 3303-001U. UDI-DI: 06438147321704. UDI-PI (PACKING LOT): (01)06438147321704(17)260531(10)763638 (1076363801); (01)06438147321704(17)260531(10)764085 (1076408501); (01)06438147321704(17)260531(10)765033 (1076503301); (01)06438147321704(17)260731(10)765231 (1076523101); (01)06438147321704(17)260731(10)765316 (1076531601); (01)06438147321704(17)261031(10)766420 (1076642001); (01)06438147321704(17)261031(10)766894 (1076689401); (01)06438147321704(17)261130(10)767873 (1076763801); (01)06438147321704(17)261130(10)768361 (1076836101); (01)06438147321704(17)261130(10)768703 (1076870301); (01)06438147321704(17)270228(10)769355 (1076935501); (01)06438147321704(17)270228(10)769542 (1076954201); (01)06438147321704(17)270228(10)769632 (1076963201); (01)06438147321704(17)270228(10)769671 (1076967101); (01)06438147321704(17)270228(10)769782 (1076978201); (01)06438147321704(17)270228(10)769871 (1076987101); (01)06438147321704(17)270228(10)769975 (1076997501); (01)06438147321704(17)270228(10)770078 (1077007801); (01)06438147321704(17)270228(10)770086 (1077008601); (01)06438147321704(17)270228(10)770351 (1077035101). 2. Product Code: 3303-0010. UDI-DI: 06438147311347. UDI-PI (PACKING LOT): (01)06438147311347(17)260531(10)763396 (1076339601); (01)06438147311347(17)260531(10)763396 (1076339602); (01)06438147311347(17)260531(10)764209 (1076420901); (01)06438147311347(17)260531(10)764209 (1076420902); (01)06438147311347(17)260731(10)765317 (1076531702); (01)06438147311347(17)260731(10)7653177 (1076531703); (01)06438147311347(17)261031(10)766378 (1076637801); (01)06438147311347(17)261031(10)766943 (1076694301); (01)06438147311347(17)261031(10)767323 (1076732301); (01)06438147311347(17)261130(10)767955 (1076795501); (01)06438147311347(17)261031(10)767956 (1076795601); (01)06438147311347(17)261130(10)769214 (1076921401); (01)06438147311347(17)261231(10)769967 (1076996701).
Recalling firm:
WALLAC OY
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 18, 2026

DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)

Sterile wound dressing, lacks sterility assurance

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

Recall #:
99044
Lot/product code:
Lot: 63295141/UDI: None
Recalling firm:
DeRoyal Industries Inc
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled May 18, 2026

Lidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL), 2 mL per Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520. NDC: 55150-164-02

Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan

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A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0552-2026
Lot/product code:
Lot, expiry: Lot 3LC26029A, exp Feb-2029; Lot 3LC26031A, exp Mar-2029
Recalling firm:
Eugia US LLC
View official FDA record (opens in a new tab)