BIGNOPE
Ko-fi

Recalls affecting Virginia

Data last updated: September 8, 2026 at 1:13 PM UTC

17,028 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

▸Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

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

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

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

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

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

Presence of particulate matter identified as iron oxide

▸Full report
Drugs

Recalling firm: B. Braun Medical Inc.

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

Company contact: recalls@bbraunusa.com

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

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

▸Full report
Food & BeveragesFoodborne Illness

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

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

Company contact: Info.foodsafety@comfrut.com

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

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

Presence of particulate matter and lack of sterility assurance

▸Full report
Food & Beverages

Recalling firm: American Regent, Inc.

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

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

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

▸Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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

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

Contains garlic essential oil not approved for culinary use

▸Full report
Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

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

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

Undeclared milk

▸Full report
Food & BeveragesAllergens

Recalling firm: Crystal Temptations

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

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

Everything Sprouts — Robust Radish Mix, 5oz Cups

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

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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

Martina — Mangoes

Potential contamination with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

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

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
NewestOldest
High riskLow riskAll
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2026

GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010 00055445011 00055360010.A

The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae.

ALL 50 STATES
▸Full report

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

Recall #:
99128
Lot/product code:
Part No. 00055360010 UDI-DI 08426950807599 Lots 260505K, 260504AG, 260505F; Part No. 00055360011 UDI-DI 08426950807605 Lots 260505F and 260505J; Part No. 00055407504 UDI-DI 08426950807537 Lot 260505R; Part No. 00055415010 UDI-DI 08426950807698 Lots 260505H and 260505K; Part No. 00055430010 UDI-DI 08426950807759 Lots 260505H, 260505K and 260505F; Part No. 00055430011 UDI-DI 08426950807766 Lot 260505K; Product No. 00055445010 UDI-DI 08426950807810 Lots 260504AA and 260505K; Product No. 00055445011 UDI-DI 08426950807827 Lots 260505F and 260505J; Product No. 00055360010.A UDI-DI 08426950807599 Lot 260504AF;
Recalling firm:
Instrumentation Laboratory
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.

ALL 50 STATES
▸Full report

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

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.

ALL 50 STATES
▸Full report

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

CRE Pro Wireguided 10-12mm 240cm

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

ALL 50 STATES
▸Full report

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

Recall #:
99067
Lot/product code:
UPN: M00558680; GTIN: 8714729797562; Lot No. 38031620, 38031621, 38031622, 38031623, 38031624, 38031625, 38031626, 38031627, 38031628, 38031629, 38031631, 38075353, 38078357, 38078358, 38078359, 38078740, 38078741, 38078742, 38078743, 38078744, 38078745, 38078747, 38100058, 38100717, 38100718, 38118422, 38118423, 38118424, 38118425, 38118426, 38118427, 38139132, 38139133, 38162877, 38164341, 38169205, 38169206, 38172338, 38176726, 38176727, 38187282, 38187283, 38193521, 38238865, 38304060, 38304061, 38304062, 38304063, 38304064, 38306688, 38334070, 38334071, 38334072, 38334073, 38383986, 38398490, 38398491, 38398492, 38402798, 38402799, 38403020, 38403021, 38421915, 38421916, 38421917, 38421918, 38421919, 38450264, 38450265, 38450266, 38450267, 38450268, 38450269, 38450270, 38468759, 38507309, 38507310, 38507311, 38507312, 38507313, 38507314, 38515209, 38515210, 38552614, 38552615, 38552616, 38552617, 38552618, 38552619, 38553520, 38553521, 38553522, 38578999, 38579280, 38579284, 38579285, 38608100, 38612264, 38612265, 38612266, 38622468, 38622469, 38622470, 38622471, 38622472, 38622473, 38650479, 38650820, 38650821, 38666087, 38668807, 38678761, 38678762, 38689027, 38689034, 38690516, 38745675, 38745676, 38769693, 38769694, 38769695, 38800516, 38800517, 38800518, 38800519, 38864609, 38864610, 38864611, 38864720, 38886482, 38886483, 38886484, 38906032, 38906033, 38906034, 38906035, 38916791, 38916792, 38933950, 38933951, 38933952, 38958793, 38959787, 38959788; Exp. November 23, 2028 March 29, 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) PI CVC KIT 3L 7 FR 16 CM, Model Number: ECVC8520; 2) NO CATH CENTRAL LINE KIT, Model Number: CVI4880B; 3) 20G x 6" ARTERIAL CATHETER KIT, Model Number: ART356; 4) MULTIMED 7FR, 16CM, 3L CVC BUNDLE, Model Number: STCVC03; 5) A-LINE KIT, NO CATH, Model Number: ARTNC217; 6) PRESSURE INJ. CVC INSERTION BUNDLE, Model Number: ECVC1720; 7) DIALYSIS CATHETER INSERTION KIT, Model Number: CVI4815; 8) MULTIMED 7FR, 20CM, 3L CVC BUNDLE, Model Number: STCVC04; 9) PI CVC KIT 3L 7 FR 16 CM, Model Number: ECVC8520; 10) ARTERIAL LINE TRAY, Model Number: ART350; 11) CVC INSERTION BUNDLE 8.5FR 4L 16CM, Model Number: ECVC6355; 12) UMBILICAL VESSEL INSERTION TRAY, Model Number: UVT980; 13) 7F, 16cm, 3L MAX BARRIER CVC BUNDLE, Model Number: ECVC5480; 14) UCLA - FINE NEEDLE BIOPSY, Model Number: P972300A; 15) TRIPLE LUMEN COMPLETE CATH KIT 16CM, Model Number: ECVC825A; 16) 8.5F 4L 20CM CVC + BUNDLE, Model Number: ECVC8640; 17) ULTRA CORE BIOPSY KIT, Model Number: SPEC0291B; 18) 3L 7FR 16CM CVC INSERTION BUNDLE, Model Number: ECVC7605; 19) WATERBURY 3L CVC BUNDLE, Model Number: ECVC7330; 20) 3L 7FR 20CM CVC INSERTION BUNDLE, Model Number: ECVC7600; 21) VANTEX 8.5FR 2L 16CM CVC BUNDLE-US, Model Number: ECVC8110; 22) FEMORAL ARTERIAL LINE TRAY, Model Number: ART660A; 23) VANTEX 3L, 7FR, 16CM CVC INSERTION BNDL, Model Number: ECVC5370B; 24) STD, VAN, 3L, 7F, 20CM, KIC, Model Number: A3720KIC; 25) PICC KIT 5F DL PL MB, Model Number: DYNJ70152MB; 26) VANTEX 7FR 3L 20CM CVC BUNDLE W/US, Model Number: ECVC8180; 27) NO CATH DIALYSIS KIT, Model Number: ECVC8595; 28) SOFT TISSUE TRAY, Model Number: DYNDA1954A; 30) LACERATION TRAY WITH LIDOCAINE, Model Number: SUT10830A; 31) LACERATION TRAY, Model Number: SUT10520; 32) VANTEX 7F 20CM 3L CVC BUNDLE, Model Number: CMPV7203LBB; 33) VANTEX 7F 16CM TRIPLE LUMEN CVC KIT, Model Number: ECVC8380B; 34) BIOPSY TRAY, Model Number: MNS7065A; 35) STD, INTRO-FLEX INTRODUCER 8.5F, Model Number: I500BF85; 36) A LINE TRAY, Model Number: ART690; 37) 8.5F 16cm DOUBLE LUMEN CVC BUNDLE, Model Number: ECVC5490; 38) VANTEX 8.5FR 16CM 4L CVC BUNDLE, Model Number: ECVC8633; 39) VANTEX PI CVC 7F, 3L, 16CM BUNDLE, Model Number: ECVC6920A; 40) BIOPSY PACK, Model Number: DYNDH1135B; 41) PERCUTANEOUS CHEST TUBE KIT, Model Number: CHT1825; 42) VANTEX 7F 16CM 3L PI CVC BUNDLE, Model Number: ECVC7485; 43) ULTRA SOUND TRAY, Model Number: CVI190; 44) BASIC BIOPSY TRAY, Model Number: SPEC0051; 45) MULTIMED 7F 20CM 3L CVC BUNDLE, Model Number: CMPM7203LBB; 46) TRIPLE LUMEN CVC INSERTION TRAY, Model Number: ECVC1490A; 47) 20CM, 3L INSERT BUNDLE-CINCINNATI VA, Model Number: ECVC3505; 48) LOCAL INFILTRATION TRAY, Model Number: DYNDH1406; 49) VANTEX 7FR 20CM 3L CVC BUNDLE, Model Number: ECVC8632; 50) I & D KIT, Model Number: ID1135A; 51) VANTEX 7FR 3L 20CM CVC BUNDLE, Model Number: ECVC8637; 52) VANTEX CVC BUNDLE, 7 FR 3L 16CM, Model Number: ECVC5080; 53) 20CM 7F 3L CVC MAX BARRIER INSERTION, Model Number: ECVC1970B; 54) VASCULAR ACCESS INSERTION KIT, Model Number: CVI5331; 55) VANTEX 7F 20CM 3L CVC BUNDLE PLUS, Model Number: CMPV7203LBPA; 56) VANTEX 7FR 3L 20CM BUNDLE, Model Number: ECVC6110B; 57) A LINE KIT, 20G, Model Number: ART1303; 58) DIALYSIS ACCESSORY PACK W/O CATHETER, Model Number: MNS10750A; 59) 7FR 3L 20CM CVC INSERTION BNDL, Model Number: ECVC7830C; 60) CVC INSERTION KIT 3L-16CM, Model Number: ECVC8616; 61) VANTEX 7FR 3L 20CM CVC BUNDLE US, Model Number: ECVC8320A; 62) VANTEX 7F 20CM TRIPLE LUMEN CVC KIT, Model Number: ECVC8385B; 63) TRIPLE LUMEN BUNDLE, Model Number: ECVC5475; 64) CVC BUNDLE KIT, Model Number: ECVC1700; 65) 3" 20G RADIAL ARTERIAL LINE KIT-ICU, Model Number: ART240C; 66) MAXIMUM PROTECTION CVC INSERTION KIT, Model Number: ECVC1950; 67) CVC TRIPLE LUMEN 7FR PI 16CM BUNDLE, Model Number: ECVC8360; 68) PLASTICS SUTURING SET, Model Number: SUT4065; 69) 3L 7F 20CM CVC INSERTION KIT, Model Number: ECVC8465; 70) ARTHROGRAM TRAY, M

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.

ALL 50 STATES
▸Full report

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

Recall #:
99162
Lot/product code:
1) ECVC8520, UDI-DI: 10653160375104(each), 00653160375107(case), Lot Number: 2026031790; 2) CVI4880B, UDI-DI: 10653160377191(each), 00653160377194(case), Lot Number: 2026021190; 3) ART356, UDI-DI: 10653160375371(each), 00653160375374(case), Lot Number: 2026011990; 4) STCVC03, UDI-DI: 10653160365235(each), 00653160365238(case), Lot Number: 2026011990; 5) ARTNC217, UDI-DI: 10653160383352(each), 00653160383355(case), Lot Number: 2025121190; 6) ECVC1720, UDI-DI: 10653160365761(each), 00653160365764(case), Lot Number: 2025121990; 7) CVI4815, UDI-DI: 10653160386049(each), 00653160386042(case), Lot Number: 2025121890; 8) STCVC04, UDI-DI: 10653160339342(each), 00653160339345(case), Lot Number: 2025121890; 9) ECVC8520, UDI-DI: 10653160375104(each), 00653160375107(case), Lot Number: 2025122290; 10) ART350, UDI-DI: 10653160362050(each), 00653160362053(case), Lot Number: 2025120890; 11) ECVC6355, UDI-DI: 10653160336396(each), 00653160336399(case), Lot Number: 2025120890; 12) UVT980, UDI-DI: 10653160376705(each), 00653160376708(case), Lot Number: 2025120990; 13) ECVC5480, UDI-DI: 10653160380368(each), 00653160380361(case), Lot Number: 2025122290; 14) P972300A, UDI-DI: 10653160377467(each), 00653160377460(case), Lot Number: 2025120490; 15) ECVC825A, UDI-DI: 10653160387596(each), 00653160387599(case), Lot Number: 2025120490; 16) ECVC8640, UDI-DI: 10653160390848(each), 00653160390841(case), Lot Number: 2025122390; 17) SPEC0291B, UDI-DI: 10653160382003(each), 00653160382006(case), Lot Number: 2026010790; 18) ECVC7605, UDI-DI: 10653160364498(each), 00653160364491(case), Lot Number: 2026010890; 19) ECVC7330, UDI-DI: 10653160364566(each), 00653160364569(case), Lot Number: 2026010790; 20) ECVC7600, UDI-DI: 10653160364443(each), 00653160364446(case), Lot Number: 2026010790; 21) ECVC8110, UDI-DI: 10653160377207(each), 00653160377200(case), Lot Number: 2025120890; 22) ART660A, UDI-DI: 10653160366096(each), 00653160366099(case), Lot Number: 2025120990; 23) ECVC5370B, UDI-DI: 10653160385905(each), 00653160385908(case), Lot Number: 2025120990; 24) A3720KIC, UDI-DI: 10653160376354(each), 00653160376357(case), Lot Number: 2025121090; 25) DYNJ70152MB, UDI-DI: 10653160366157(each), 00653160366150(case), Lot Number: 2025121290; 26) ECVC8180, UDI-DI: 10653160378235(each), 00653160378238(case), Lot Number: 2025121290; 27) ECVC8595, UDI-DI: 10653160378822(each), 00653160378825(case), Lot Number: 2025091890; 28) DYNDA1954A, UDI-DI: 10653160387060(each), 00653160387063(case), Lot Number: 2025102390; 29) ECVC7040A, UDI-DI: 10653160369165(each), 00653160369168(case), Lot Number: 2025102390; 30) SUT10830A, UDI-DI: 10653160386902(each), 00653160386905(case), Lot Number: 2025102390; 31) SUT10520, UDI-DI: 10653160364672(each), 00653160364675(case), Lot Number: 2025102790; 32) CMPV7203LBB, UDI-DI: 10653160360025(each), 00653160360028(case), Lot Number: 2025120190; 33) ECVC8380B, UDI-DI: 10653160382409(each), 00653160382402(case), Lot Number: 2025112590; 34) MNS7065A, UDI-DI: 10193489196566(each), 20193489196563(case), Lot Number: 2025120190; 35) I500BF85, UDI-DI: 10653160378785(each), 00653160378788(case), Lot Number: 2025120290; 36) ART690, UDI-DI: 10653160318019(each), 00653160318012(case), Lot Number: 2025120390; 37) ECVC5490, UDI-DI: 10653160363309(each), 00653160363302(case), Lot Number: 2025120390; 38) ECVC8633, UDI-DI: 10653160390428(each), 00653160390421(case), Lot Number: 2025120490; 39) ECVC6920A, UDI-DI: 10653160389392(each), 00653160389395(case), Lot Number: 2025120890; 40) DYNDH1135B, UDI-DI: 10653160387459(each), 00653160387452(case), Lot Number: 2025120390; 41) CHT1825, UDI-DI: 10653160385660(each), 00653160385663(case), Lot Number: 2025120490; 42) ECVC7485, UDI-DI: 10653160372738(each), 00653160372731(case), Lot Number: 2025120490; 43) CVI190, UDI-DI: 00653160001372(each), 50653160001377(case), Lot Number: 2025120590; 44) SPEC0051, UDI-DI: 10653160387503(each), 00653160387506(case), Lot Number: 2025120290; 45) CMPM7203LBB, UDI-DI: 10653160363798(each), 00653160363791(case), Lot Number: 2025120290; 46) ECVC1490A, UDI-DI: 10653160367147(each), 00653160367140(case), Lot Number: 2025120590; 47) ECVC3505, UDI-DI: 10653160364467(each), 00653160364460(case), Lot Number: 2025120590; 48) DYNDH1406, UDI-DI: 10653160375739(each), 00653160375732(case), Lot Number: 2025121090; 49) ECVC8632, UDI-DI: 10653160390442(each), 00653160390445(case), Lot Number: 2025121290; 50) ID1135A, UDI-DI: 00653160204056(each), 10653160204053(case), Lot Number: 2025120490; 51) ECVC8637, UDI-DI: 10653160389538(each), 00653160389531(case), Lot Number: 2025112690; 52) ECVC5080, UDI-DI: 10653160363194(each), 00653160363197(case), Lot Number: 2025120190; 53) ECVC1970B, UDI-DI: 10653160362975(each), 00653160362978(case), Lot Number: 2025120490; 54) ECVC7675, UDI-DI: 10653160348122(each), 00653160348125(case), Lot Number: 2025112090; 55) CVI5331, UDI-DI: 10653160383017(each), 00653160383010(case), Lot Number: 2025120390; 56) CMPV7203LBPA, UDI-DI: 10653160367529(each), 006531… (truncated, 31025 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2026

Medline Convenience Kits: 1) STD, INTRO-FLEX INTRODUCER 6F, C, Model Number: I550BF6C; 2) STD, INTRO-FLEX INTRODUCER 9F, C, Model Number: I505BF9C

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.

ALL 50 STATES
▸Full report

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

Recall #:
99162
Lot/product code:
1) I550BF6C, UDI-DI: 10653160339748(each), 00653160339741(case), Lot Number: 2025102290; 2) I505BF9C, UDI-DI: 10653160339687(each), 00653160339680(case), Lot Number: 2025093090
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 21, 2026

Quala Dental Products, Topical Anesthetic Gel, 20 % Benzocaine, Strawberry Flavor Net Contents: 1 oz (30 g), Quala Dental Products, Made in USA for NDC Inc., 407 Sanford Road, Le Vergne, TN 37086, NDC 43128-034-30.

Defective container:may contain bottles with incomplete seals

ALL 50 STATES
▸Full report

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

Recall #:
D-0601-2026
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 Pro Wireguided 12-15mm 240cm

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

ALL 50 STATES
▸Full report

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

GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008 00077415010 00077430010 Product Description: The GEM Premier 7000 with iQM3 is a portable critical care system for use by health care professionals to rapidly analyze lithium heparinized whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory.

The active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with iQM3 PAK lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae.

ALL 50 STATES
▸Full report

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

Recall #:
99128
Lot/product code:
Part No.00077407508 UDI-DI 00195226000764 Lot 260504E; Part No. 00077407510 UDI-DI 00195226000665 Lot 260505B; Part No. 00077415004 UDI-DI 00195226000856 Lot 260505A; Part No. 00077415008 UDI-DI 00195226000757 Lot No.260505A; Part No. 00077415010 UDI-DI 00195226000658 Lot 260505C; Part No. 00077430010 UDI-DI 00195226000641 Lot 260505B
Recalling firm:
Instrumentation Laboratory
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2026

CRE Pro Wireguided 15-18mm 240cm

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

ALL 50 STATES
▸Full report

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

Recall #:
99067
Lot/product code:
UPN: M00558700; GTIN: 8714729797586; Lot No. 38043116, 38192116, 38192117, 38192118, 38192119, 38192960, 38192961, 38214896, 38214897, 38222153, 38222496, 38222497, 38222498, 38222499, 38222660, 38222661, 38222662, 38222663, 38222664, 38222665, 38238864, 38239084, 38239085, 38239086, 38239087, 38239088, 38239089, 38241874, 38241875, 38241876, 38242679, 38242820, 38242821, 38242822, 38242824, 38269134, 38269135, 38274558, 38274559, 38282412, 38324631, 38324632, 38324633 ,38324634, 38324636, 38324637, 38324638, 38347325, 38347326, 38347327, 38347328, 38364300, 38381887, 38421906, 38421907, 38421908, 38421909, 38421910, 38421911, 38421912, 38421913, 38421914, 38441933, 38441934, 38441935, 38441936, 38450077, 38450078, 38450079, 38450260, 38450261, 38450262, 38450263, 38462131, 38462132, 38462133, 38468755, 38468756, 38472371, 38472372, 38472373, 38479757, 38479758, 38503030, 38507563, 38507564, 38507565, 38507566, 38507567, 38507568, 38507569, 38568778, 38568779, 38568860, 38585010, 38585011, 38585012, 38585013, 38621957, 38621958, 38642724, 38642725, 38642726, 38642727, 38665032, 38665033, 38665034, 38665035, 38665036, 38665038, 38678315, 38688161, 38726662, 38726663, 38726664, 38734730, 38734731, 38745591, 38748249, 38748250, 38748251, 38748253, 38762224, 38762225, 38762226, 38762227, 38762228, 38769690, 38769691, 38769692, 38800533, 38800534, 38800535, 38800536, 38831782, 38831783, 38831784, 38831785, 38831786, 38831787, 38831788, 38877007, 38877008, 38877009, 38878807, 38878808, 38878809, 38878810, 38878811, 38878812, 38886257, 38886258, 38886259, 38916782, 38916783, 38916784, 38916785, 38933957, 38933958, 38933959, 38935360, 38945672; Exp. November 24, 2028 March 26, 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) BLOCK TRAY, Model Number: DYNJRA1590

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.

ALL 50 STATES
▸Full report

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

Recall #:
99162
Lot/product code:
1) DYNJRA1590, UDI-DI: 10193489284829(each), 40193489284820(case), Lot Number: 25JLA522
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) 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.

ALL 50 STATES
▸Full report

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)
Class IIModerate risk
DrugRecalled May 21, 2026

PureLife, TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, 1 oz (30mL), Strawberry Flavor, Manufactured for Pure Life, LLC, Manufactured for PureLife LLC., Carson, CA 90810. NDC 68987-001-30

Defective container:may contain bottles with incomplete seals

ALL 50 STATES
▸Full report

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

Recall #:
D-0605-2026
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

1274108D PowerPICC SV Catheter 4 Fr Dual-Lumen REKW2449 00801741087110 3173108D PowerPICC SV Catheter 3 Fr Single-Lumen REKV2227 00801741027536 The PowerPlCC SV catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.

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

ALL 50 STATES
▸Full report

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

Recall #:
99096
Lot/product code:
1274108D PowerPICC SV Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741087110 Lot Number: REKW2449 3173108D PowerPICC SV Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741027536 Lot Number: REKV2227
Recalling firm:
Bard Access Systems, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2026

7617408 Groshong NXT ClearVue Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741035258 The Groshong NXT PICC provides short (less than 30 days) or long (greater than 30 days) term peripheral access to the central venous system for intravenous therapy or blood sampling.

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

ALL 50 STATES
▸Full report

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

Recall #:
99096
Lot/product code:
7617408 Groshong NXT ClearVue Catheter 4 Fr Single-Lumen UDI-DI Code: 008017410352 Lot Number: REKY1686
Recalling firm:
Bard Access Systems, Inc.
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.

ALL 50 STATES
▸Full report

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

Solar GI System (Water Perfusion); Product Name (Catalog Number): Solar GI LGI H2O, 12p, Trolley system (G3-6), Solar GI HRM H2O, 24p, Compact Pole system (G3-7), Solar GI HRM H2O, 24p, Trolley system (G3-8), Solar GI HRM H2O, 36p, Trolley system (G3-12), Solar GI HRAM H2O, 24p, Trolley system (G3-14);

Under extended clinical use conditions (e.g., long duration studies), moisture generated within the pneumatic circuit may accumulate inside the system's internal tubing or at the hydrophobic filter and waterproof pressure sensors. Accumulated moisture may affect airflow or pressure measurement performance if not properly removed.

ALL 50 STATES
▸Full report

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

Recall #:
98876
Lot/product code:
1. Catalog Number: G3-6; UDI-DI: Primary UDI-DI: 08717775955047; Basic UDI-DI: 87177759500G3G8; All serial numbers; 2. Catalog Number: G3-7; UDI-DI: Primary UDI-DI: 08717775955054; Basic UDI-DI: 87177759500G3G8; All serial numbers; 3. Catalog Number: G3-8; UDI-DI: Primary UDI-DI: 08717775955061; Basic UDI-DI: 87177759500G3G8; All serial numbers; 4. Catalog Number: G3-12; UDI-DI: Primary UDI-DI: 08717775955078; Basic UDI-DI: 87177759500G3G8; All serial numbers; 5. Catalog Number: G3-14; UDI-DI: Primary UDI-DI: 08717775955085; Basic UDI-DI: 87177759500G3G8; All serial numbers;
Recalling firm:
Laborie Medical Technologies Corp
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2026

Papablic Replacement Brush Heads. Model Number: Papablic18B

Potential for brush heads to break.

ALL 50 STATES
▸Full report

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

Recall #:
98898
Lot/product code:
Model Number: Papablic18B; Amazon FNSKU: X004LOZKE3; Lot Numbers: PS2509A01, PS2511A01, PS2512A01; Date Codes: 2509, 2511, 2512. The recalled product is limited to Papablic18B 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

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.

ALL 50 STATES
▸Full report

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)
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

ALL 50 STATES
▸Full report

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

Recall #:
D-0603-2026
Lot/product code:
BNZ-001917, 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

OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 0110885403284748 PIG1260T SAFE-T-CENTESIS TRAY 6FR X 16CM UDI-DI Code: 0110885403108365 TPT1000 THORACENTESIS/PARACENTESIS TRAY UDI-DI Code: 0110885403108488 The Acute Drainage devices are indicated for use in removing fluid from either the pleural or peritoneal spaces during an acute drainage / aspiration procedure.

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

ALL 50 STATES
▸Full report

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

Recall #:
99096
Lot/product code:
OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 0110885403284748 Lot Number: REKY3402 PIG1260T SAFE-T-CENTESIS TRAY 6FR X 16CM UDI-DI Code: 0110885403108365 Lot Number: REKY3397 TPT1000 THORACENTESIS/PARACENTESIS TRAY UDI-DI Code: 0110885403108488 Lot Number: REKY3386
Recalling firm:
Bard Access Systems, Inc.
View official FDA record (opens in a new tab)
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

ALL 50 STATES
▸Full report

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

Recall #:
D-0606-2026
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

5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107177 5855300 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107184 5865120 Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107191 5865200 Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI_DI Code: 00801741107214 5865240 Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107221 The Power-Trialysis Slim-Cath Short-Term Dialysis Catheter, with a third internal lumen for intravenous therapy, power injection of contrast media, and central venous pressure monitoring, is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, and apheresis treatments. The catheter is intended to be inserted in the jugular, femoral, or subclavian vein as required. The maximum recommended infusion rate is 5 mL/sec for 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.

ALL 50 STATES
▸Full report

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

Recall #:
99096
Lot/product code:
5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107177 Lot Number: REKY2412 5855300 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107184 Lot Number: REKY1364 5865120 Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107191 Lot Number: RELN0881 5865200 Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI_DI Code: 00801741107214 Lot Number: REKY1381 5865240 Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107221 Lot Number: REJZ0927
Recalling firm:
Bard Access Systems, Inc.
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

ALL 50 STATES
▸Full report

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

Recall #:
D-0602-2026
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

Medline Convenience Kits: 1) MULTIMED, 7FR, 20CM, 3L, CVC BUNDLE, Model Number: ECVC5995; 2) TRIPLE LUMEN CENTRAL LINE BUNDLE, Model Number: ECVC2625; 3) INTROFLEX 6F, 1L, TB, US, Model Number: STCVC26US; 4) AVA HIGH FLOW, Model Number: ECVC3720; 5) CDP, MM, 3L, 7F, 16CM, H, Model Number: 3K16H1838; 6) CVC Insertion Bundle 3L 7FR 20CM, Model Number: ECVC5610; 7) TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number: ECVC3810; 8) 16CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number: ECVC2555; 9) CENTRAL LINE BUNDLE W/7F, 20CM, 3L, Model Number: ECVC2750; 10) TRIPLE LUMEN COMPLETE CATH KIT, Model Number: ECVC5200; 11) TRIPLE LUMEN CVC 20CM BUNDLE W/O SUTURE, Model Number: ECVC7290; 12) AVA HIGH FLOW, Model Number: ECVC3720; 13) 7FR 3L 16CM CVC INSERTION BUNDLE, Model Number: ECVC8215; 14) CENTRAL LINE INSERTION BUNDLE, Model Number: ECVC2080; 15) 3L 7FR 16 CM CVC INSERTION TRAY, Model Number: ECVC8165; 16) VANTEX 7FR 3L 20CM CVC BUNDLE, Model Number: ECVC6505; 17) VANTEX 7FR, 16CM, 3L CVC BUNDLE, Model Number: STCVC02; 18) O.R. CVC TRIPLE LUMEN BUNDLE, Model Number: ECVC1377; 19) INTROFLEX 8.5FR. 1L CVC BUNDLE, Model Number: CMPI851LBA; 20) INTROFLEX 5F, 1L, TB, US, BAS, Model Number: STCVC49US; 21) CVC BUNDLE, Model Number: ECVC8090; 22) TRIPLE LUMEN INSERTION KIT W/CATHETER, Model Number: ECVC2885; 23) O.R. CVC TRIPLE LUMEN BUNDLE, Model Number: ECVC1377; 24) MULTIMED, 7FR, 20CM, 3L, CVC BUNDLE, Model Number: ECVC5995; 25) 3L 7FR 20CM CVC INSERTION BUNDLE, Model Number: ECVC6845; 26) CVC BUNDLE TRIPLE LUMEN 16CM, Model Number: ECVC5540A; 27) CDP, MM, 3L, 7F, 16CM, H, Model Number: 3K16H1838; 28) CVC INSERTION BUNDLE, Model Number: ECVC1120; 29) TRIPLE LUMEN CENTRAL LINE BUNDLE, Model Number: ECVC2625; 30) TRIPLE LUMEN COMPLETE CATH KIT, Model Number: ECVC5200; 31) VANTEX 7FR 3L 16CM CVC BUNDLE W/US, Model Number: ECVC8075; 32) CENTRAL LINE BUNDLE W/7F, 16CM, 3L, Model Number: ECVC2745; 33) VANTEX 7FR 3L 16CM CVC BUNDLE W/US, Model Number: ECVC7945; 34) CENTRAL LINE BUNDLE W/7F, 20CM, 3L, Model Number: ECVC2750

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.

ALL 50 STATES
▸Full report

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

Recall #:
99162
Lot/product code:
1) ECVC5995, UDI-DI: 10653160338970(each), 00653160338973(case), Lot Number: 2026011990; 2) ECVC2625, UDI-DI: 10653160334255(each), 00653160334258(case), Lot Number: 2025121990; 3) STCVC26US, UDI-DI: 10653160343424(each), 00653160343427(case), Lot Number: 2026010290; 4) ECVC3720, UDI-DI: 10653160341499(each), 00653160341492(case), Lot Number: 2025123090; 5) 3K16H1838, UDI-DI: 10653160341260(each), 00653160341263(case), Lot Number: 2025120590; 6) ECVC5610, UDI-DI: 10653160335047(each), 00653160335040(case), Lot Number: 2025122290; 7) ECVC3810, UDI-DI: 10653160336013(each), 00653160336016(case), Lot Number: 2025102390; 8) ECVC2555, UDI-DI: 10653160336570(each), 00653160336573(case), Lot Number: 2025121190; 9) ECVC2750, UDI-DI: 10653160334217(each), 00653160334210(case), Lot Number: 2025102490; 10) ECVC5200, UDI-DI: 10653160336150(each), 00653160336153(case), Lot Number: 2025101490; 11) ECVC7290, UDI-DI: 10653160344933(each), 00653160344936(case), Lot Number: 2025101490; 12) ECVC3720, UDI-DI: 10653160341499(each), 00653160341492(case), Lot Number: 2025101690; 13) ECVC8215, UDI-DI: 10653160358992(each), 00653160358995(case), Lot Number: 2025101790; 14) ECVC2080, UDI-DI: 10653160334408(each), 00653160334401(case), Lot Number: 2025101690; 15) ECVC8165, UDI-DI: 10653160358749(each), 00653160358742(case), Lot Number: 2025101390; 16) ECVC6505, UDI-DI: 10653160336327(each), 00653160336320(case), Lot Number: 2025101490; 17) STCVC02, UDI-DI: 10653160336822(each), 00653160336825(case), Lot Number: 2025101690; 18) ECVC1377, UDI-DI: 10653160332152(each), 00653160332155(case), Lot Number: 2025101690; 19) CMPI851LBA, UDI-DI: 10653160347453(each), 00653160347456(case), Lot Number: 2025090290; 20) STCVC49US, UDI-DI: 10653160347972(each), 00653160347975(case), Lot Number: 2025092390; 21) ECVC8090, UDI-DI: 10653160357667(each), 00653160357660(case), Lot Number: 2025091990; 22) ECVC2885, UDI-DI: 10653160335405(each), 00653160335408(case), Lot Number: 2025092490; 23) ECVC1377, UDI-DI: 10653160332152(each), 00653160332155(case), Lot Number: 2025092290; 24) ECVC5995, UDI-DI: 10653160338970(each), 00653160338973(case), Lot Number: 2025100790; 25) ECVC6845, UDI-DI: 10653160339366(each), 00653160339369(case), Lot Number: 2025091590; 26) ECVC5540A, UDI-DI: 10653160335009(each), 00653160335002(case), Lot Number: 2025092990; 27) 3K16H1838, UDI-DI: 10653160341260(each), 00653160341263(case), Lot Number: 2025092490; 28) ECVC1120, UDI-DI: 10653160334644(each), 00653160334647(case), Lot Number: 2025091990; 29) ECVC2625, UDI-DI: 10653160334255(each), 00653160334258(case), Lot Number: 2025091990; 30) ECVC5200, UDI-DI: 10653160336150(each), 00653160336153(case), Lot Number: 2025090390; 31) ECVC8075, UDI-DI: 10653160357124(each), 00653160357127(case), Lot Number: 2025091090; 32) ECVC2745, UDI-DI: 10653160334224(each), 00653160334227(case), Lot Number: 2025091190; 33) ECVC7945, UDI-DI: 10653160353966(each), 00653160353969(case), Lot Number: 2025091190; 34) ECVC2750, UDI-DI: 10653160334217(each), 00653160334210(case), Lot Number: 2025091090
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)