BIGNOPE
Ko-fi

Recalls affecting Kentucky

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

16,694 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

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.

ALL 50 STATES
▸Full report

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

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.

ALL 50 STATES
▸Full report

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

CRE Wireguided 8-10mm 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: 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

Papablic Replacement Brush Heads. Model Number: PAPA317AA.

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

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

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.

ALL 50 STATES
▸Full report

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

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

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

ALL 50 STATES
▸Full report

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

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

Medline Convenience Kits: 1) 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

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.

ALL 50 STATES
▸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

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

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

ALL 50 STATES
▸Full report

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

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

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.

ALL 50 STATES
▸Full report

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)
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

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

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

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

CRE Wireguided 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: 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 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: M00558480; GTIN: 8714729339410; Lot No. 38033567, 38056239, 38056940, 38056941, 38215260, 38266854, 38266855, 38293330, 38391881, 38413876, 38413877, 38413878, 38413879, 38414080, 38422547, 38446204, 38466097, 38468862, 38468863, 38529518, 38529519, 38585004, 38622477, 38622478, 38640994, 38670501, 38670502, 38670504, 38686282, 38686283, 38693725, 38726666, 38726667, 38748254, 38767487, 38789996, 38800181, 38879160, 38879163, 38879164, 38911928, 38911929, 38911930, 38944841; Exp. October 24, 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 20, 2026

Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2. POD-OMNI-I1-6220. 3. OMNI-I1-6729 (10-Pack), OMNI-I1-6720 (Single Pod). 4. OMNI-I1-6220. 5. OMNI-I1-6720. 6. BLE-H1-529 (10-Pack), BLE-H1-520 (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.

ALL 50 STATES
▸Full report

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

Recall #:
99034
Lot/product code:
1. Model/REF Number: POD-OMNI-I1-6720. Pack UDI-DI: 20385083000579. Single Pod UDI-DI: 10385083000527. Lot Numbers: PH1U01032521, PH1U01102521, PH1U12102421, PH1U12172421, PH1U11212421, PH1U11252421, PH1U11222421, PH1U12092421, PH1U09112421, PH1U11262421, PH1U04032521, PH1U12022421, PH1U12182421, PH1U04302524, PH1U05022521, PH1U01222521, PR1U11202533, PH1U09122421, PH1U10102421, PH1U12122421, PH1U01302522, PH1U02222521, PH1U05052521, PH1U10042421, PH1U12102412, PH1U01312521, PH1U03312521, PH1U05012521, PH1U09122422, PH1U09162421, PH1U09192421, PH1U09212421, PH1U09262411, PH1U09262421, PH1U10112422, PH1U10122421, PH1U10172421, PH1U12132422, PH1U01132521, PH1U01172521, PH1U02132511, PH1U03202521, PH1U03262521, PH1U04042521, PR1U11192531, PH1U11192511, PR1U01162621, PH1U09172421, PH1U09182421, PH1U09202421, PH1U10142421, PH1U10152421, PH1U10162421, PH1U01232522, PH1U01312511, PH1U02032521, PH1U02042521, PH1U02212521, PH1U03282521, PH1U04092521, PH1U04102521, PH1U04112521, PH1U10172522, PH1U10182521, PH1U10202521, PH1U10212521, PH1U10222521, PH1U10232521, PH1U10242521, PH1U10252521, PH1U11152521, PH1U11172511, PH1U11172521, PH1U11182521, PR1U11182531, PR1U11182541, PR1U11192541, PH1U11192521, PR1U11192532, PR1U11192542, PR1U11202521, PR1U11202532, PR1U11202541, PR1U11202542, PR1U11212521, PR1U11222531, PR1U11222541, PR1U11222521, PR1U11232541, PR1U11242521, PR1U11242531, PR1U11252541, PR1U11252512, PR1U11252521, PR1U11262521, PR1U12012521, PR1U12022521, PR1U12032521, PR1U12102522, PR1U12112521, PR1U12122521, PR1U12132511, PR1U12132521, PR1U12152521, PR1U12162521, PR1U12172521, PR1U01132621, PR1U01152621, PR1U01172621, PR1U01202621, PR1U01212621, PR1U01222621, PR1U01232621, PR1U01272621, PR1U01302641, PR1U01312631, PR1U02022641, PR1U02032631, PR1U02032641, PR1U02042641, PR1U02052631, PR1U02052641, PR1U02062631, PR1U02112641, PR1U02132611, PR1U02132641, PR1U11252531, PR1U11262541, PH1U06282422. 2. Model/REF Number: POD-OMNI-I1-6220. Pack UDI-DI: 20385083000425. Single Pod UDI-DI: 10385083000411. Lot Numbers: PH1U10182422, PH1U02202521, PH1U04222521, PH1U04232511, PH1U04232521, PH1U11142521, PH1U12042521, PH1U12052521, PH1U01092621. 3. Model/REF Number: OMNI-I1-6729 (10-Pack), OMNI-I1-6720 (Single Pod). Pack UDI-DI: N/A. Single Pod UDI-DI: N/A. Lot Numbers: PH1U01222522. 4. Model/REF Number: OMNI-I1-6220. Pack UDI-DI: 2038508300043. Single Pod UDI-DI: 10385083000411. Lot Numbers: PH1U04182521, PH1U04212521, PH1U12192411. 5. Model/REF Number: OMNI-I1-6720. Pack UDI-DI: 20385083000548. Single Pod UDI-DI: 10385083000527. Lot Numbers: PH1U01022521, PH1U12202421, PH1U12192421, PH1U10212421, PH1U10232421. 6. Model/REF Number: BLE-H1-529 (10-Pack), BLE-H1-520 (Single Pod). Pack UDI-DI: 20385083000135. Single Pod UDI-DI: 10385083000114. Lot Numbers: PH1U01072521, PH1U01242521, PH1U03082521, PH1U04172521, PH1U01272513.
Recalling firm:
Insulet Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 20, 2026

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

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

ALL 50 STATES
▸Full report

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

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

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.

ALL 50 STATES
▸Full report

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.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 20, 2026

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

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

ALL 50 STATES
▸Full report

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

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

Brand Name: USTAR II Knee System Product Name: Hinge Box Trial, L, #1-6 and Hinge Box Trial, R, #1-6 Model/Catalog Number: 9325-5711 thru 9325-5716 and 9325-5721 thru 9325-5726 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.

ALL 50 STATES
▸Full report

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 9325-5711; UDI-DI 04719886907032; Lot number 25FB41 Product number 9325-5712; UDI-DI 04719886907049; Lot number 25FB42 Product number 9325-5713; UDI-DI 04719886907056; Lot number 25FB43 Product number 9325-5714; UDI-DI 04719886907063; Lot number 25FB44 Product number 9325-5715; UDI-DI 04719886907070; Lot number 25FB45 Product number 9325-5716; UDI-DI 04719886907087; Lot number 25FB46 Product number 9325-5721; UDI-DI 04719886907094; Lot number 25FB35 Product number 9325-5722; UDI-DI 04719886907100; Lot number 25FB36 Product number 9325-5723; UDI-DI 04719886907117; Lot number 25FB37 Product number 9325-5724; UDI-DI 04719886907124; Lot number 25FB38 Product number 9325-5725; UDI-DI 04719886907131; Lot number 25FB39 Product number 9325-5726; UDI-DI 04719886907148; Lot number 25FB40
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.

ALL 50 STATES
▸Full report

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

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

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

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

ALL 50 STATES
▸Full report

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

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

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

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

ALL 50 STATES
▸Full report

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

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

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.

ALL 50 STATES
▸Full report

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

Recall #:
99141
Lot/product code:
Software Version 8.0.4.60077, UDI 0735000201089120241218, Expiration Date: 2030-01-24.
Recalling firm:
RAYSEARCH LABORATORIES AB
View official FDA record (opens in a new tab)