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Recalls affecting Alabama

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

16,873 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

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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.

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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.

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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

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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

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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

CK000980A PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236150 P4254108 PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741129278 P4254108D PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741129353 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:
CK000980A PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236150 Lot Number: REKX0112 P4254108 PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741129278 Lot Number: REKW0949 P4254108D PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741129353 Lot Number: REJZ1337
Recalling firm:
Bard Access Systems, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2026

Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; 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: 00887761985018, 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

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.

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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

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.

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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)
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.

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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

CRE Wireguided 10-12mm 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: M00558470; GTIN: 8714729339403; Lot No. 38099718, 38165001, 38165002, 38196568, 38196569, 38196570, 38204511, 38204512, 38204513, 38285933, 38397792, 38398767, 38398768, 38507308, 38552115, 38596881, 38596882, 38612829, 38612830, 38680058, 38683384, 38683385, 38689434, 38690171, 38707829, 38707830, 38710480, 38769697, 38800182, 38800183, 38871161, 38871162, 38871163, 38937571 ; Exp. November 2, 2028 February 23, 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 Wireguided 15-18mm 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: M00558490; GTIN: 8714729339427; Lot No. 38033568, 38033569, 38033570, 38033571, 38047498, 38047722, 38047731, 38200167, 38239090, 38325015, 38325016, 38325017, 38413205, 38413206, 38413207, 38413208, 38413214, 38422540, 38422541, 38422542, 38422543, 38479759, 38507303, 38507304, 38519497, 38519498, 38529540, 38529541, 38529542, 38529543, 38529544, 38585005, 38585006, 38647771, 38790079, 38817673, 38817674, 38817675, 38817676, 38817677, 38817678, 38817679; Exp. October 24, 2028 February 9, 2029.
Recalling firm:
Boston Scientific Corporation
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

Medline Convenience Kits: 1) DYNJ0621189X, Model Number: SM RADIOLOGY-ANGIO PACK-LF; 2) PAIN1470A, Model Number: CONT. 20G EPI MRI COMPATIBLE; 3) TVS4000L, Model Number: TVS4000 ENDOVENOUS PACK

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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▸Full report

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

Recall #:
99162
Lot/product code:
1) DYNJ0621189X, UDI-DI: 10195327638566(each), 40195327638567(case), Lot Number: 25ILA890; 2) PAIN1470A, UDI-DI: 10193489957365(each), 40193489957366(case), Lot Number: 25JLA514; 3) TVS4000L, UDI-DI: 10195327223540(each), 40195327223541(case), Lot Number: 25JDB583; 4) TVS4000L, UDI-DI: 10195327223540(each), 40195327223541(case), Lot Number: 25KDA180; 5) TVS4000L, UDI-DI: 10195327223540(each), 40195327223541(case), Lot Number: 25KDB274
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2026

BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta" Stopcocks are used to administer fluids or medication through one or two different ports via an IV cannula or extension tube. The ports can be used to sample blood or for hemodynamic monitoring. When used with IV lipid nutritional products, the stopcock device can be used for up to 24 hours.

Due to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread or continue to spin rather than tightening securely. This behavior has led some clinical users to perceive the connection as unstable.

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

Recall #:
98855
Lot/product code:
Catalog/Model Number: 394910 UDI-DI code: 00382903949106 Lot Numbers: 4277968 4277973 4282451 4282461 4289801 4290582 4292904 4295848 4299949 4303841 4305108 4306700 5129635 5129642 5129649 5129650 5129651 5139250 5139251 5139252 5150181 5153940 5164061 5164062 5178078 5181442 5183810 5183816 5183824 5183828 5218287 5218291 5218293 5218299 5218302 5241476 5247729 5247731 5251098 5275601 5275602
Recalling firm:
BD SWITZERLAND SARL
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2026

A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical convenience kit

Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.

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

Recall #:
99189
Lot/product code:
UDI/DI none, Lot Codes: 237663, 237901, 237957, 238041, 238084, 238085, 238146, 238197, 238589, 239157, 239216, 239286, 239337, 239386, 239943, 240269, 240633, 240705, 240903, 240904, 241034, 241223, 241224, 241313.
Recalling firm:
Windstone Medical Packaging, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2026

A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit

Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.

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

Recall #:
99189
Lot/product code:
UDI/DI none, Lot Codes: 237663, 237901, 237957, 238041, 238084, 238085, 238146, 238197, 238589, 239157, 239216, 239286, 239337, 239386, 239943, 240269, 240633, 240705, 240903, 240904, 241034, 241223, 241224, 241313.
Recalling firm:
Windstone Medical Packaging, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2026

Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; 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: 10887761985015; 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)
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)
UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2026

Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473; 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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▸Full report

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

Recall #:
99119
Lot/product code:
UDI: 00887761981492; 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 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 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: M00558500; GTIN: 8714729339434; Lot No. 38033572, 38063250, 38063251, 38063252, 38211783, 38211784, 38215261, 38215262, 38215263, 38222236, 38222237, 38222238, 38222239, 38241879, 38242360, 38242361, 38334062, 38334063, 38347338, 38468864, 38472364, 38472365, 38479755, 38596733, 38596734, 38596735, 38596736, 38596883, 38596884, 38692526, 38707831, 38709738, 38709739, 38748244, 38808896, 38874312, 38874313, 38874314, 38886248, 38886249; Exp. October 24, 2028 February 17, 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) LUMBAR PUNCTURE CHOICE, Model Number: DYNDH1215

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) DYNDH1215, UDI-DI: 10889942550876(each), 40889942550877(case), Lot Number: 2025092390
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2026

A M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS, Pack Number AMS18227, surgical convenience kit

Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.

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▸Full report

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

Recall #:
99189
Lot/product code:
UDI/DI none, Lot Codes: 237663, 237901, 237957, 238041, 238084, 238085, 238146, 238197, 238589, 239157, 239216, 239286, 239337, 239386, 239943, 240269, 240633, 240705, 240903, 240904, 241034, 241223, 241224, 241313.
Recalling firm:
Windstone Medical Packaging, Inc.
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

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)
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
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2026

CK000662 PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741129674 Catheter stylets provide internal reinforcement to aid in catheter placement.

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:
CK000662 PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741129674 Lot Number: REKT1554
Recalling firm:
Bard Access Systems, Inc.
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.

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▸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)