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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

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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

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

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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.

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

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

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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

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

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

Contains garlic essential oil not approved for culinary use

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Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

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

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

Undeclared milk

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Food & BeveragesAllergens

Recalling firm: Crystal Temptations

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

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

Everything Sprouts — Robust Radish Mix, 5oz Cups

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

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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)
NewestOldest
High riskLow riskAll
Wording
Class IIModerate risk
DrugRecalled May 22, 2026

Xyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Fort Bio-Pharma, LLC., Las Vegas, NV 89113, NDC 72245-058-10

Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona

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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-0599-2026
Lot/product code:
Lot #: AE11393, Exp Date: 10/2027.
Recalling firm:
SUN PHARMACEUTICAL INDUSTRIES INC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 22, 2026

Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System

Pedicle screw system intended to provide immobilization/stabilization of spinal segments as adjunct to thoracic/lumbar/sacral spine fusion may have anti-torque instrument with undersized condition which could prevent mating tip from engaging with the pedicle screw tulip and rod during tightening, which may lead to surgical delay, intervention/alternative methods to perform final tightening step.

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

Recall #:
99188
Lot/product code:
LS-749: UDI-DI: M711BTA2020, M711LS7490, Serial Numbers: 002, 003, 007, 012, 014
Recalling firm:
Innovasis, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 22, 2026

GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed.

10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).

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

Recall #:
99143
Lot/product code:
Incorrect Catalogue Number/UDI: VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796; Lot Serial No. 30970948, 30970949, 30970950, 30970951, 30970952, 30970953, 30970954, 30970955, 30970956, 30970957, 30970958, 30970959, 30970960.
Recalling firm:
W L Gore & Associates, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2026

Medline Convenience Kits: 1) ARTERIAL LINE KIT, Model Number: ART890B; 2) ULTRASOUND GUIDED IV SECUREMENT SET, Model Number: IVS3350

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.

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

Recall #:
99162
Lot/product code:
1) ART890B, UDI-DI: 10653160360834(each), 00653160360837(case), Lot Number: 2025102390; 2) IVS3350, UDI-DI: 10653160313045(each), 00653160313048(case), Lot Number: 2025102490
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2026

CRE Wireguided 8-10mm 240cm

Potential sterile breach of the pouches in which devices are packaged.

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

Recall #:
99067
Lot/product code:
UPN: M00558460; GTIN: 8714729339397; Lot No. 38064055, 38099717, 38100033, 38100034, 38164759, 38165000, 38165003, 38293337, 38293338, 38293339, 38333957, 38347335, 38347336, 38398764, 38398765, 38398766, 38529517, 38552112, 38552113, 38596880, 38680056, 38680057, 38739675; Exp. October 27, 2028 January 31, 2029.
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2026

CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 The Poly Per-Q-Cath Midline catheters are indicated for short or long term peripheral access to the peripheral venous system for selected intravenous therapies and blood sarnpling.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

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

Recall #:
99096
Lot/product code:
CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609 Lot Number: REKV1588 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 Lot Number: REKX0938 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 Lot Number: REKY1965
Recalling firm:
Bard Access Systems, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2026

Medline Convenience Kits: 1) L&D CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1699A

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.

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

Recall #:
99162
Lot/product code:
1) PAIN1699A, UDI-DI: 10195327411107(each), 40195327411108(case), Lot Number: 25JLA719
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2026

Papablic Replacement Brush Heads. Model Number: PAPA317AA.

Potential for brush heads to break.

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

Recall #:
98898
Lot/product code:
Model Number: PAPA317AA; Amazon FNSKU: X0040USQ0N; Lot Numbers: PS2509A01, PS2511A01, PS2512A01; Date Codes: 2509, 2511, 2512. The recalled product is limited to PAPA317AA replacement brush head packs bearing the above lot numbers/date codes. Products with other lot numbers/date codes are not included in this recall.
Recalling firm:
Papablic Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2026

Medline Convenience Kits: 1) SUTURE TRAY, Model Number: SUT12260; 2) CHEST TUBE INSERTION TRAY, Model Number: MNS3390; 3) CONTRACEPTIVE IMPLANT INSERTION KIT, Model Number: MNS9715; 4) 20GX3" RADIAL ART LINE KIT, Model Number: ART351; 5) MYELOGRAM PACK, Model Number: P155615A; 6) CHEST TUBE INSERTION TRAY, Model Number: MNS3390; 7) LACERATION TRAY, Model Number: SUT18660A; 8) GENERAL BIOPSY TRAY, Model Number: MNS5985; 9) LACERATION TRAY, Model Number: DYNDL1351; 10) 20GX3" RADIAL ART LINE KIT, Model Number: ART351; 11) ARTERIAL LINE TRAY, Model Number: ART600; 12) SUTURE TRAY, Model Number: SUT12260; 13) ER SUTURING TRAY, Model Number: SUT9710C; 14) INCISION & DRAINAGE TRAY, Model Number: ID2060; 15) LACERATION TRAY - SNAG FREE, Model Number: SUT12265; 16) BIOPSY TRAY, Model Number: DYNDH1466; 17) GENERAL BIOPSY TRAY, Model Number: MNS5985; 18) SUTURE SET, Model Number: SUT19665; 19) MYELOGRAM-LF SAFE PACK, Model Number: P124863; 20) 20GX3" RADIAL ART LINE KIT, Model Number: ART351; 21) LACERATION TRAY, Model Number: SUT18660A; 22) 20GX6" FEMORAL ART LINE KIT, Model Number: ART352; 23) BIOPSY PACK, Model Number: DYNDH1699; 24) SUTURE TRAY, Model Number: SUT12260; 25) CHEST TUBE INSERTION TRAY, Model Number: MNS3390; 26) ARTHROGRAM TRAY, Model Number: SPEC0070B; 27) SUTURING SET, Model Number: SUT4155; 28) SUTURE TRAY, Model Number: SUT16080; 30) MYELOGRAM TRAY CHOICE, Model Number: DYNDH1213; 31) MYELOGRAM PACK, Model Number: P155615A; 32) LACERATION TRAY - SNAG FREE, Model Number: SUT12265

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.

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

Recall #:
99162
Lot/product code:
1) SUT12260, UDI-DI: 00653160130942(each), 10653160130949(case), Lot Number: 2026031190; 2) MNS3390, UDI-DI: 00653160100433(each), 10653160100430(case), Lot Number: 2025120590; 3) MNS9715, UDI-DI: 10653160292029(each), 00653160292022(case), Lot Number: 2025120890; 4) ART351, UDI-DI: 10653160323754(each), 00653160323757(case), Lot Number: 2025120990; 5) P155615A, UDI-DI: 10889942219889(each), 40889942219880(case), Lot Number: 2025120890; 6) MNS3390, UDI-DI: 00653160100433(each), 10653160100430(case), Lot Number: 2025102790; 7) SUT18660A, UDI-DI: 10653160359302(each), 00653160359305(case), Lot Number: 2025120890; 8) MNS5985, UDI-DI: 00653160204407(each), 10653160204404(case), Lot Number: 2025120590; 9) DYNDL1351, UDI-DI: 10884389278352(each), 40884389278353(case), Lot Number: 2025120190; 10) ART351, UDI-DI: 10653160323754(each), 00653160323757(case), Lot Number: 2025112690; 11) ART600, UDI-DI: 10653160312727(each), 00653160312720(case), Lot Number: 2025112690; 12) SUT12260, UDI-DI: 00653160130942(each), 10653160130949(case), Lot Number: 2025112690; 13) SUT9710C, UDI-DI: 10653160331254(each), 00653160331257(case), Lot Number: 2025103090; 14) ID2060, UDI-DI: 10653160310006(each), 00653160310009(case), Lot Number: 2025101790; 15) SUT12265, UDI-DI: 00653160130898(each), 10653160130895(case), Lot Number: 2025102390; 16) DYNDH1466, UDI-DI: 10193489193756(each), 20193489193753(case), Lot Number: 2025102190; 17) MNS5985, UDI-DI: 00653160204407(each), 10653160204404(case), Lot Number: 2025101690; 18) SUT19665, UDI-DI: 10653160288572(each), 00653160288575(case), Lot Number: 2025102490; 19) P124863, UDI-DI: 10889942140787(each), 40889942140788(case), Lot Number: 2025102090; 20) ART351, UDI-DI: 10653160323754(each), 00653160323757(case), Lot Number: 2025101090; 21) SUT18660A, UDI-DI: 10653160359302(each), 00653160359305(case), Lot Number: 2025092690; 22) ART352, UDI-DI: 10653160323747(each), 00653160323740(case), Lot Number: 2025100790; 23) DYNDH1699, UDI-DI: 10653160349914(each), 00653160349917(case), Lot Number: 2025092590; 24) SUT12260, UDI-DI: 00653160130942(each), 10653160130949(case), Lot Number: 2025092690; 25) MNS3390, UDI-DI: 00653160100433(each), 10653160100430(case), Lot Number: 2025091590; 26) SPEC0070B, UDI-DI: 10193489196627(each), 20193489196624(case), Lot Number: 2025100890; 27) SUT4155, UDI-DI: 00653160008760(each), 50653160008765(case), Lot Number: 2025100990; 28) SUT16080, UDI-DI: 00653160225051(each), 10653160225058(case), Lot Number: 2025092690; 29) DYNDH1213, UDI-DI: 10653160383864(each), 00653160383867(case), Lot Number: 2025091990; 30) P155615A, UDI-DI: 10889942219889(each), 40889942219880(case), Lot Number: 2025090490; 31) SUT12265, UDI-DI: 00653160130898(each), 10653160130895(case), Lot Number: 2025090590
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2026

Medline Convenience Kits: 1) PAIN MGMT/ PREF W. MED NDL, Model Number: PAIN0072L; 2) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1317; 3) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1579A; 4) CSE TRAY, Model Number: PAIN1885A; 5) REINFORCED CATH EPIDURAL TRAY, Model Number: PAIN1967A; 6) TRAY,CON EPID,19G REINF OPNTIP, Model Number: PAIN2269; 7) EPIDURAL TRAY, Model Number: PAIN2278; 8) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN2305; 9) CSE TRAY MEDLINE, Model Number: PAIN2334; 10) PNBT TRAY, Model Number: SAMPA0147

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.

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

Recall #:
99162
Lot/product code:
1) PAIN0072L, UDI-DI: 10198459544163(each), 40198459544164(case), Lot Number: 25JDB100; 2) PAIN1317, UDI-DI: 10888277797109(each), 40888277797100(case), Lot Number: 25JLA788; 3) PAIN1579A, UDI-DI: 10193489422443(each), 40193489422444(case), Lot Number: 25JLA779; 4) PAIN1885A, UDI-DI: 10195327486310(each), 40195327486311(case), Lot Number: 25JLA861; 5) PAIN1967A, UDI-DI: 10198459241215(each), 40198459241216(case), Lot Number: 25JLA659; 6) PAIN2269, UDI-DI: 10198459342004(each), 40198459342005(case), Lot Number: 25JLA781; 7) PAIN2278, UDI-DI: 10198459376177(each), 40198459376178(case), Lot Number: 25JLA886; 8) PAIN2305, UDI-DI: 10198459478819(each), 40198459478810(case), Lot Number: 25JLA601; 9) PAIN2334, UDI-DI: 10198459540639(each), 40198459540630(case), Lot Number: 25JLA942; 10) SAMPA0147, UDI-DI: 10198459552809(each), 40198459552800(case), Lot Number: 25JLA928;
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2026

MOSAIQ Oncology Information System

Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.

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

Recall #:
98980
Lot/product code:
Software Version: MOSAIQ 3.2/UDI: 07340201500071
Recalling firm:
Elekta, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2026

5625240 DuoGlide Short-Term Straight Dialysis Catheter 13 Fr Dual-Lumen UDI-DI Code: 00801741042119 The intended use of the Short-Term Dialysis Catheter is attaining temporary/short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, or apheresis therapy via the jugular, subclavian, or femoral vein.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

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

Recall #:
99096
Lot/product code:
5625240 DuoGlide Short-Term Straight Dialysis Catheter 13 Fr Dual-Lumen UDI-DI Code: 00801741042119 Lot Number: REKY0255
Recalling firm:
Bard Access Systems, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2026

Brand Name: Medical Action Industries Product Name: Dialysis Change Tray Clear Sequence Model/Catalog Number: 78791

Convenience kits contain needle free access device that has an improper seal which may result in doming or tearing of the silicone seal.

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

Recall #:
99338
Lot/product code:
Lot Code: Lot No.: 327075 328690 319980 320965 318461 322375 325653 330775 331356 336680 UDI: 20809160242558
Recalling firm:
Medical Action Industries, Inc. 306
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2026

Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474; Oscillation Lung Expansion Therapy, positive pressure breathing device

There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.

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

Recall #:
99119
Lot/product code:
UDI: 10887761981499; Lot Numbers: All lot numbers distributed beginning on 4/28/2025
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2026

CRE Pro Wireguided 18-20mm 240cm

Potential sterile breach of the pouches in which devices are packaged.

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

Recall #:
99067
Lot/product code:
UPN: M00558710; GTIN: 8714729797593; Lot No. 38031485, 38031486, 38031487, 38031488, 38031489, 38031490, 38031642, 38031643, 38031644, 38031645, 38043600, 38043601, 38043602, 38043603, 38043604, 38055580, 38055581, 38055582, 38099704, 38099705, 38099706, 38099707, 38099709, 38099710, 38099711, 38099712, 38099713, 38099714, 38099715, 38110376, 38110377, 38110378, 38110379, 38131547, 38131548, 38150880, 38150881, 38150882, 38150883, 38162872, 38162873, 38162874, 38162875, 38169202, 38169203, 3818825438188255, 38193520, 38241877, 38241878, 38258885, 38258886, 38258887, 38258888, 38258889, 38278151, 38285220, 38285221, 38306689, 38306692, 38338285, 38338288, 38338290, 38338292, 38338294, 38338296, 38338297, 38338299, 38338301, 38347330, 38462126, 38462127, 38462128, 38462129, 38479753, 38479754, 38553523, 38553524, 38553525, 38608098, 38608099, 38612875, 38612876, 38612877, 38612878, 38622479, 38622600, 38622601, 38622602, 38622603, 38642700, 38642701, 38642702, 38642722, 38650472, 38665039, 38665260, 38665261, 38665262, 38665263, 38678316, 38678317, 38678318, 38678319, 38678760, 38702327, 38702328, 38702329, 38702330, 38702331, 38702332, 38709525, 38709526, 38709527, 38709528, 38734736, 38742717, 38742718, 38745588, 38745589, 38745590, 38748246, 38748247, 38748248, 38808893, 38808894, 38808897, 38808899, 38809140, 38823455, 38823456, 38823457, 38874308, 38874309, 38874310, 38874311, 38877005, 38877006, 38886252, 38886253, 38886254, 38886255, 38946205, 38946207, 38946209, 38959786, 38964092, 38964093; Exp. November 23, 2028 March 29, 2029.
Recalling firm:
Boston Scientific Corporation
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Class IIModerate risk
DrugRecalled May 21, 2026

safco SensiCaine-Ultra (20% Benzocaine), Topical Anesthetic Gel, Strawberry Flavor, 1 oz. (29.6mL), Distributed by: Safco Dental Supply Co., Buffalo Grove, IL 60099, Made in USA, NDC 67239-0223-1.

Defective container:may contain bottles with incomplete seals

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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-0606-2026
Lot/product code:
BNZ-001921, Exp 04/15/2029
Recalling firm:
Keystone Industries
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 21, 2026

Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor, 1 oz (30 mL), Manufactured for Burkhart Dental Supply, Tacoma, Washington, 98409. NDC: 43498-310-30

Defective container:may contain bottles with incomplete seals

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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-0603-2026
Lot/product code:
BNZ-001917, Exp 04/15/2029
Recalling firm:
Keystone Industries
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 21, 2026

DHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor, 1 oz. (30 g), Manufactured for and Distributed by Dental Health Products, Inc, 2614 North Sugar Bush Road, New Franken, WI 54229. NDC 69634-020-30

Defective container:may contain bottles with incomplete seals

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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-0602-2026
Lot/product code:
BNZ-001921, EXP 04/15/2029
Recalling firm:
Keystone Industries
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UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2026

4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108563 4382A SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108501 The Soft Tissue Biopsy devices are indicated for use in the collection of aspirate tissue (e.g. liver, kidney, etc.).

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

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

Recall #:
99096
Lot/product code:
4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108563 Lot Number: REKY3390 4382A SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108501 Lot Numbers: REKY3393 REJZ0942 REJZ0943
Recalling firm:
Bard Access Systems, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 21, 2026

Dental City TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, Strawberry Flavor, 1 OZ (30 g), Distributed by Dental City, 3205 Yeager Dr., Green Bay, WI 54311. NDC 69483-001-30

Defective container:may contain bottles with incomplete seals

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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-0604-2026
Lot/product code:
BNZ-001921, Exp 04/15/2029
Recalling firm:
Keystone Industries
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2026

CRE Wireguided 6-8mm 240cm

Potential sterile breach of the pouches in which devices are packaged.

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

Recall #:
99067
Lot/product code:
UPN: M00558450; GTIN: 8714729339380; Lot No. 38064056, 38064057, 38200574, 38200575, 38204501, 38204504, 38204506, 38204508, 38628161, 38640993, 38767490, 38904960, 38904961, 38946757, 38946758, 38946759; Exp. October 27, 2028 February 24, 2029.
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2026

CRE Pro Wireguided 12-15mm 240cm

Potential sterile breach of the pouches in which devices are packaged.

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

Recall #:
99067
Lot/product code:
UPN: M00558690; GTIN: 8714729797579; Lot No. 38031635, 38031636, 38031637, 38031638, 38031639, 38031640, 38031641, 38043114, 38043115, 38053614, 38053615, 38053616, 38078354, 38188253, 38200578, 38211780, 38214898, 38214899, 38222485, 38222487, 38241871, 38241872, 38267022, 38267023, 38267024, 38267025, 38267026, 38267027, 38267028, 38269136, 38269137, 38269138, 38277754, 38277755, 38278152, 38278153, 38278154, 38285222, 38285223, 38293322, 38293324, 38293325, 38293326, 38293327, 38293328, 38293329, 38303877, 38303878, 38320463, 38346663, 38346664, 38346681, 38347329, 38378376, 38379273, 38379917, 38379918, 38379919, 38380040, 38380041, 38380042, 38383937, 38383938, 38383939, 38383980, 38383981, 38383982, 38383983, 38383984, 38398522, 38414085, 38414086, 38414087, 38414088, 38414089, 38414090, 38414091, 38414092, 38445939, 38446200, 38446201, 38446202, 38446203, 38446216, 38479982, 38479983, 38479984, 38479985, 38479986, 38507316, 38507317, 38507318, 38507319, 38507560, 38529186, 38529188, 38529189, 38529191, 38529193, 38529194, 38529195, 38529197, 38529198, 38529199, 38529380, 38529381, 38529383, 38529384, 38570828, 38570829, 38570830, 38589819, 38672653, 38672654, 38672655, 38726668, 38726669, 38726670, 38726671, 38726672, 38726673, 38726674, 38726675, 38734732, 38734733, 38734735, 38748256, 38748257, 38748258, 38748259, 38748401, 38800521, 38800522, 38800523, 38827801, 38827802, 38827803, 38827804, 38827805, 38827806, 38831789, 38831790, 38831791, 38831792, 38847493, 38847494, 38847495, 38847496, 38847497, 38847498, 38847499, 38847680, 38847681, 38878813, 38878814, 38878815, 38878816, 38878817, 38878818, 38886480, 38886481, 38916787, 38916788, 38916789, 38916790, 38933953, 38933954, 38933955, 38933956; Exp. November 23, 2028 March 25, 2029.
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2026

Medline Convenience Kits: 1) IMAGING BIOPSY TRAY, Model Number: DYNDH1068; 2) BREAST BIOPSY PACK, Model Number: PHS234706I

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.

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

Recall #:
99162
Lot/product code:
1) DYNDH1068, UDI-DI: 10889942172122(each), 40889942172123(case), Lot Number: 2025101090; 2) PHS234706I, UDI-DI: 10198459330278(each), 40198459330279(case), Lot Number: 25JLB029
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2026

Medline Convenience Kits: 1) ARTERIAL ACCESS TRAY W/LIDOCAINE, Model Number: ART1145; 2) Universal Central/Art Line Insertion Kit, Model Number: ART155A; 3) ARTERIAL LINE INSERTION TRAY, Model Number: ART1010B

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.

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

Recall #:
99162
Lot/product code:
1) ART1145, UDI-DI: 10653160349259(each), 00653160349252(case), Lot Number: 2025120590; 2) ART1145, UDI-DI: 10653160349259(each), 00653160349252(case), Lot Number: 2025101490; 3) ART155A, UDI-DI: 10653160316459(each), 00653160316452(case), Lot Number: 2025100890; 4) ART1010B, UDI-DI: 10653160353577(each), 00653160353570(case), Lot Number: 2025091590
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2026

CK000727 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138478 CK000729 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138713 P4153108D PowerMidline Catheter 3 Fr Single-lumen UDI-DI Code: 00801741108747 P4154108 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108754 P4154108D PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108761 The PowerMidline" Catheter is intended for short term peripheral access for selected intravenous therapies, blood sampling, and power injection of contrast media.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

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

Recall #:
99096
Lot/product code:
CK000727 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138478 Lot Numbers: REKP2822 REKW2840 REKX3882 CK000729 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138713 Lot Number: REKW2434 P4153108D PowerMidline Catheter 3 Fr Single-lumen UDI-DI Code: 00801741108747 Lot Number: REKW0907 P4154108 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108754 Lot Numbers: REKW2479 REKX3439 P4154108D PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108761 Lot Numbers: REKP0895 REKX0665 REKX2216 REKY1281
Recalling firm:
Bard Access Systems, Inc.
View official FDA record (opens in a new tab)