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Recalls affecting Connecticut

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

16,745 recalls found

Just announced

Straight from FDA press releases — not yet formally classified or risk-graded
UnclassifiedUndeclaredAnnounced September 4, 2026

Business Pill, Branch Manager for Men — dietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

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Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

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

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

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

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

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

Presence of particulate matter identified as iron oxide

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Drugs

Recalling firm: B. Braun Medical Inc.

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

Company contact: recalls@bbraunusa.com

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UnclassifiedBacteria/virusAnnounced September 3, 2026

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

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Food & BeveragesFoodborne Illness

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

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

Company contact: Info.foodsafety@comfrut.com

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UnclassifiedAnnounced September 3, 2026

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

Presence of particulate matter and lack of sterility assurance

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Food & Beverages

Recalling firm: American Regent, Inc.

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

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UnclassifiedUndeclaredAnnounced August 31, 2026

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

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Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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UnclassifiedAnnounced August 31, 2026

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

Contains garlic essential oil not approved for culinary use

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Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

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

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

Undeclared milk

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Food & BeveragesAllergens

Recalling firm: Crystal Temptations

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

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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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Wording
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.

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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)
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

CK000880 Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188770 S4153108BDP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154003 S4153108BP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741153990 S4153108D Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741153952 S4153108DCP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741233258 S4153108DGP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154027 S4254108BD Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154140 S4254108BDP Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154164 S4254108D Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154119 S4254108DCP Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741233234 S4254108DGP Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154188 SP4153108D Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741185052 SP4153108DG Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741185069 The Provena" Midline Catheters are 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:
CK000880 Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188770 Lot Number: REKN2105 S4153108BDP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154003 Lot Numbers: REKW2429 REKX1484 S4153108BP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741153990 Lot Number: REKW2494 S4153108D Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741153952 Lot Numbers: REKP0118 REKX2225 S4153108DCP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741233258 Lot Number: REKX3430 S4153108DGP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154027 Lot Numbers: REKQ0118 REKW1477 S4254108BD Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154140 Lot Number: REKY0144 S4254108BDP Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154164 Lot Numbers: REKW0447 REKW0953 REKX2214 S4254108D Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154119 Lot Number: REKX3445 S4254108DCP Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741233234 Lot Number: REKW2430 S4254108DGP Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154188 Lot Numbers: REKV3192 REKX3437 SP4153108D Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741185052 Lot Number: REKW2448 SP4153108DG Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741185069 Lot Number: REKW0959
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) 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)
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

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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-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

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.

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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)
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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▸Full report

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)
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.

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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) MERCY MEDICAL CIRCUMCISION TRAY, Model Number: CIT6780; 2) CIRCUMCISION TRAY W/1.1CM CIRCLAMP, Model Number: CIT3225A; 3) CIRCUMCISION TRAY, Model Number: CIT6325

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) CIT6780, UDI-DI: 10653160324232(each), 00653160324235(case), Lot Number: 2025102790; 2) CIT3225A, UDI-DI: 00653160165142(each), 10653160165149(case), Lot Number: 2025102190; 3) CIT6325, UDI-DI: 10653160294160(each), 00653160294163(case), Lot Number: 2025102390
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2026

Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1.

Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal for gynecology use, which could impact the assurance of sterility.

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

Recall #:
99027
Lot/product code:
Kit UDI-DI: 04048551226087. Kit Serial Numbers: 2274269, 2273282, 2276217, 2276216, 2264656, 2275787, 2279756, 2280154, 2280379, 2275789, 2283453, 2277877, 2280204, 2273324, 2275986, 2283483, 2229591, 2273599, 2215800, 2274197, 2280156, 2275483, 2083136, 2275790, 2275482, 2274271, 2248338, 2283444, 2188673, 2276221, 2276217, 2275788, 2274199, 2283445, 2274198, 2274041, 2283716, 2274049, 2236228, 2279757, 2274267, 2275785, 2277894, 2230599, 2267785. 26153EAU/1 seals with expiration date: January 23, 2023.
Recalling firm:
Karl Storz Endoscopy
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

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.

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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

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)
UnclassifiedRisk not yet known
Medical deviceRecalled May 20, 2026

Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525 (5-Pack), POD-BLE-I1-520 (Single Pod). 2. POD-BLE-I1-529 (10-Pack), POD-BLE-I1-520 (Single Pod). 3. BLE-I1-529 (10-Pack), BLE-I1-520 (Single Pod). 4. BLE-C1-529 (10-Pack), BLE-C1-520 (Single Pod).

External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of insulin to an external leak. If insulin is not delivered properly, users may experience high blood glucose levels due to under-delivery of insulin. In the most severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), or even death.

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

Recall #:
99034
Lot/product code:
1. Model/REF Number: POD-BLE-I1-525 (5-Pack), POD-BLE-I1-520 (Single Pod). Pack UDI-DI: 20385082000051. Single Pod UDI-DI: 10385082000023. Lot Numbers: PD1U11052421, PD1U11012421, PD1U11022421, PD1U02152521, PD1U02192521, PD1U04242522, PD1U10282522, PD1U10292521, PD1U10302521, PD1U10312521, PD1U11032521, PD1U11042521, PD1U01082621. 2. Model/REF Number: POD-BLE-I1-529 (10-Pack), POD-BLE-I1-520 (Single Pod). Pack UDI-DI: 20385082000020. Single Pod UDI-DI: 10385082000023. Lot Numbers: PD1U11192421, PD1U09102421, PD1U09092421, PD1U09062421, PD1U10242421, PD1U10252421, PD1U10282421, PD1U10292421, PD1U10312421, PD1U11042421. 3. Model/REF Number: BLE-I1-529 (10-Pack), BLE-I1-520 (Single Pod). Pack UDI-DI: 20385082000020. Single Pod UDI-DI: 10385082000023. Lot Numbers: PD1U11152421, PD1U11182421, PD1U11202421, PD1U09042421, PD1U11132421, PD1U11122421, PD1U11142421, PD1U11152411, PD1U11162421, PD1U04292521, PD1U09032421, PD1U11112421, PD1U04262521. 4. Model/REF Number: BLE-C1-529 (10-Pack), BLE-C1-520 (Single Pod). Pack UDI-DI: 20385082000112. Single Pod UDI-DI: 10385082000115. Lot Numbers: PD1U03042521, PD1U09052421, PD1U11072421, PD1U11082421, PD1U03062521, PD1U03032521, PD1U03072521, PD1U02282525, PD1U02282526, PD1U04252521, PD1U11062521, PD1U11072521, PD1U11102521, PD1U11112511, PD1U11112522, PD1U11122521.
Recalling firm:
Insulet Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 20, 2026

Omnipod (Eros) Pod. Includes the below Model/REF Numbers: 1. POD-ZXP425 (10 Pack), POD- ZXP420 (Single Pod). 2. ZXR425 (10-Pack), ZXR420 (Single Pod). 3. ZXP425 (10 Pack), ZXP420 (Single Pod).

External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of insulin to an external leak. If insulin is not delivered properly, users may experience high blood glucose levels due to under-delivery of insulin. In the most severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), or even death.

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

Recall #:
99034
Lot/product code:
1. Model/REF Number: POD-ZXP425 (10 Pack), POD- ZXP420 (Single Pod). Pack UDI-DI: 20385081120033. Single Pod UDI-DI: 10385081120036. Lot Numbers: L72514. 2. Model/REF Number: ZXR425 (10-Pack), ZXR420 (Single Pod). Pack UDI-DI: N/A. Single Pod UDI-DI: N/A. Lot Numbers: L72516, L72521. 3. Model/REF Number: ZXP425 (10 Pack), ZXP420 (Single Pod). Pack UDI-DI: 20385081120033. Single Pod UDI-DI: 10385081120036. Lot Numbers: L72515, L72509, L72513, L72511, L72510, L71480, L72514.
Recalling firm:
Insulet Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 20, 2026

ARTIS icono biplane. Model Number: 11327600.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

ARTIS icono ceiling. Model Number: 11328100.

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

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

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

ARTIS icono floor. Model Number: 11327700.

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

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

Recall #:
99079
Lot/product code:
Model Number: 11327700. UDI-DI: 4056869149325. Serial Numbers: 174132, 174128, 174085, 174152, 174056, 174055, 174083, 174121, 174122, 174087, 174044, 174061, 174099, 174058, 174063, 174150, 174126, 174125, 174096, 174145, 174101, 174065, 174076, 174078, 174091, 174149, 174059, 174073, 174081, 174067.
Recalling firm:
Siemens Medical Solutions USA, Inc
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UnclassifiedRisk not yet known
Medical deviceRecalled May 20, 2026

Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalog Number: 9323-5333 and 9323-5334 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No

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

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

Recall #:
99026
Lot/product code:
Product Number; UDI-DI Code; Lot Code: Product number 9323-5333; UDI-DI 04719886908084; Lot number 25FB50 Product number 9323-5334; UDI-DI 04719886908091; Lot number 25FB51
Recalling firm:
United Orthopedic Corp.
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UnclassifiedRisk not yet known
Medical deviceRecalled May 20, 2026

Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left and Femoral valgus offset adaptor, 2mm, 4mm, 6mm, right Model/Catalog Number: 9323-5335, 9323-5337, 9323-5339 and 9323-5336, 9323-5338, 9323-5340 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No

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

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

Recall #:
99026
Lot/product code:
Product Number; UDI-DI Code; Lot Code: Product number 9323-5335; UDI-DI 04719886906554; Lot number 25FB64 Product number 9323-5337; UDI-DI 04719886906578; Lot number 25FB48 Product number 9323-5339; UDI-DI 04719886906592; Lot number 25FB52 Product number 9323-5336; UDI-DI 04719886906561; Lot number 25FB65 Product number 9323-5338; UDI-DI 04719886906585; Lot number 25FB49 Product number 9323-5340; UDI-DI 04719886906608; Lot number 25FB53
Recalling firm:
United Orthopedic Corp.
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UnclassifiedRisk not yet known
Medical deviceRecalled May 20, 2026

RayCare 2024A SP4. Oncology Information Systems.

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

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

Recall #:
99141
Lot/product code:
Software Version 8.0.4.60077, UDI 0735000201089120241218, Expiration Date: 2030-01-24.
Recalling firm:
RAYSEARCH LABORATORIES AB
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