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Recalls affecting Oregon

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

16,587 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

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

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

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Food & BeveragesFoodborne Illness

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

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

Company contact: Info.foodsafety@comfrut.com

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

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

Presence of particulate matter and lack of sterility assurance

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Food & Beverages

Recalling firm: American Regent, Inc.

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

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

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

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Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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

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

Contains garlic essential oil not approved for culinary use

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Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

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

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

Undeclared milk

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Food & BeveragesAllergens

Recalling firm: Crystal Temptations

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

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

Everything Sprouts — Robust Radish Mix, 5oz Cups

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

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Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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

Martina — Mangoes

Potential contamination with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

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

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
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Wording
UnclassifiedRisk not yet known
Medical deviceRecalled June 26, 2026

Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dilator , Stiffen Dilator, Nitinol Mandrel Wire w/ Radiopaque Tip [Au}, Needle, Extension Tube with Stopcock

Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.

ALL 50 STATES
▸Full report

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

Recall #:
99369
Lot/product code:
UDI:00841268107250/Lot: G22171212 G22201213 G22201214 G22201215 G22201216 G22201217 G22201218 G22234219 G22234220 G22262227 G22234221 G22234222 G22234223 G22262225 G22234224 G22262226 G22262228 G22262229 G22262230 G22292231 G22292232 G22292233 G22292234 G22292235 G22292236 G22292237 G22320238 G22320239 G22320240 G22320241 G22320242 G22320243 G22320244 G22354191 G22362192 G22362194 G22362195 R23083454 G23076104 G23076105 G23083106 G23083107 G23083108 G23083109 G23111110 G23111111 G23111112 G23111113 G23111114 G23111115 G23146116 G23146117 G23146118 G23146119 G23146121 G23146120 G23174122 G23174123 G23174124 G23174125 G23174126 G23174127 G23202128 G23202129 G23202130 G23202131 G23202132 G23202133 G23237134 G23237135 G23094468 G23237136 G23237137 G23237138 G23237139 G23237159 G23265140 G23265141 G23265142 G23265143 G23265144 G23265145 G23293146 G23293147 G23293148 G23293149 G23293150 G23293151 G23328152 G23328153 G23328154 G23328156 G24110621 G24110621 G24113622 G24113623 G24113625 G24113626 G24113624 G24036110 G24036113 G24036111 G24036111 G24036112 G24064115 G24064118 G24064118 G24064116 G24064116 G24064117 G24064119 G24064119 G24064120 G24064121 G24064122 G24092123 G24178931 G24092126 G24092127 G24092128 G24092129 G24127485 G24092125 G24092124 G24127486 G24127487 G24127488 G24127489 G24127490 G24127491 G24155492 G24155493 G24155494 G24155494 G24155495 G24155496 G24155497 G24155498 G24190499 G24190500 G24190501 G24190502 G24190503 G24190504 G24190505 G24190506 G24218507 G24218512 G24218509 G24218510 G24337696 G24337697 G24218508 G24337698 G24218511 G24246514 G24246515 G24246513 G24246517 G24246518 G24281519 G24281521 G24281520 G24281522 G24281523 G24246516 G24337699 G24281524 G24281525 G24281526 G24281527 G24309528 G24309529 G24309530 G24309532 G24309531 G24309533 G24309534 G24309535 G24337700 G24337701 G24337702 G24337703 G24337704 G25001012 G25008017 G25008013 G25008014 G25008015 G25008018 G25008016 G25008019 G25252905 G25252907 G25252906 G25273965 G25252910 G25294007 G25317082 G25318095 G25318096 G25318097 G25318094 G25318098 G25350169 G25350167 G25350170 G25353258 G25353259 G25350164 G22362193 G25350165 G25350171 G26016028 G26016029 G26016030 G26016031 G26016032 G26016033 G26016034 G26016035 G26044036 G26044039 G26044040 G26044041 G26044042 G26044043 G26044037 G26044038 G26099125 G26099126 G26099127 G26099128 G26099129 G26128429 G25252908 G25252909
Recalling firm:
Galt Medical Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 26, 2026

Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL

Not meeting quality requirements sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no serious harm anticipated.

ALL 50 STATES
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FDA has not published a risk classification for this recall yet.

Recall #:
99381
Lot/product code:
UDI-DI 00842768014321 Lot U2
Recalling firm:
Siemens Healthcare Diagnostics, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 26, 2026

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules, 5 mg, Rx Only, 100 capsules, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC: 0527-0790-37.

Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.

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-0660-2026
Lot/product code:
Lot#: 25285401A, Exp. Date: 04/2027
Recalling firm:
Lannett Company Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 26, 2026

ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000

A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short circuit between he gas inlet and the connector resulting in CO2 leaking into the return path, leading to excessive pressure causing the cryoprobe to rupture.

ALL 50 STATES
▸Full report

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

Recall #:
99341
Lot/product code:
UDI-DI 04050147013797/ Serial Numbers: All serial numbers up to 11608268 Software Version: 1.0.3
Recalling firm:
Erbe USA Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 25, 2026

Brand Name: Quantum Rehab Product Name: Quantum Outback Model/Catalog Number: Quantum Outback Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller

If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.

ALL 50 STATES
▸Full report

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

Recall #:
99286
Lot/product code:
Lot Code: Quantum Outback 0060650920024*0 K112815 D143578 41875 ITI
Recalling firm:
Pride Mobility Products Corp.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 25, 2026

CVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316-822-00.); b) Kit (1 BULB, Syringe & Drops- NDC 51316-823-00.), Distributed by: CVS Pharmacy., Inc. One CVS Drive, Woonsocket, RI 02895,

Weaker than it should be Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

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-0678-2026
Lot/product code:
Lot: a) 1505121, 1504242, exp 2027-03; 1505132, 1505182, 1505191, 1505291, 1505331, exp 2027-04; b) 1504231, 1504311, exp 2027-03; 1505312, 1505321, exp 2027-04.
Recalling firm:
Bell Pharmaceuticals, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 25, 2026

Brand Name: Quantum Rehab Product Name: Q6 Edge 3 Stretto Model/Catalog Number: Q6 Edge 3 Stretto Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller

If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.

ALL 50 STATES
▸Full report

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

Recall #:
99286
Lot/product code:
Lot Code: Q6 Edge 3 Stretto 0060650920018*9 K143383 D246699 41875 ITI
Recalling firm:
Pride Mobility Products Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 25, 2026

Products that contain the Pericare Wipes: SureStep" Foley Tray System Add-A-Foley Catheter REF: A153200 UDI code: 00801741121067 10801741121064 SureStep" Foley Tray System Complete Care Add-A-Foley Catheter REF: A304400A UDI code: 00801741073847 10801741073844 SureStep" Foley Tray System Add-A-Foley Catheter REF: A399400 UDI code: 00801741100369 10801741100366 SureStep" Foley Tray System Complete Care Add-A-Foley Catheter REF: A399400A UDI code: 00801741073915 10801741073912 SureStep" Foley Tray System Complete Care Add-A-Foley Catheter REF: A904400A UDI code: 00801741074097 10801741074094 SureStep Intermittent Catheter Tray REF: INTAAI UDI code: 00801741183317 10801741183314 For urological use only, Intended for use in the drainage and/or collection and/or measurement of urine.

Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.

ALL 50 STATES
▸Full report

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

Recall #:
98840
Lot/product code:
SureStep" Foley Tray System Add-A-Foley Catheter A153200 / 00801741121067¿ 10801741121064 Lot Number: NGKS2397 SureStep" Foley Tray System Complete Care¿ Add-A-Foley Catheter A304400A / 00801741073847¿ 10801741073844 Lot Numbers: NGKU1023 NGKU3043 SureStep" Foley Tray System Add-A-Foley Catheter A399400 / 00801741100369¿ 10801741100366 Lot Number: NGKU2042 SureStep" Foley Tray System Complete Care¿ Add-A-Foley Catheter A399400A / 00801741073915¿ 10801741073912 Lot Numbers: NGKT2456 NGKT3292 NGKU0999 NGKU1026 SureStep" Foley Tray System Complete Care¿ Add-A-Foley Catheter A904400A / 00801741074097¿ 10801741074094 Lot Numbers: NGKT3231 NGKU2051 SureStep Intermittent Catheter Tray INTAAI / 00801741183317 10801741183314 Lot Number: NGKU1409
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 25, 2026

meijer, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Washer Bulb included, NDC 41250-835-33, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544.

Weaker than it should be Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

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-0687-2026
Lot/product code:
Lot:1505344, exp 2027-04.
Recalling firm:
Bell Pharmaceuticals, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 25, 2026

Brand Name: Quantum Rehab Product Name: Q6 Edge 2.0 (ilevel) Model/Catalog Number: Q6 Edge 2.0 (ilevel) Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller

If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.

ALL 50 STATES
▸Full report

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

Recall #:
99286
Lot/product code:
Lot Code: Q6 Edge 2.0 (ilevel) 0060650920004*2 K143383 D246699 41875 ITI
Recalling firm:
Pride Mobility Products Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 25, 2026

Products that contain the Pericare Wipes: SureStep Intermittent Catheter Tray REF: INTP16 INTS14 INTS14C INTS16 INTS16C PEDINTS06 PEDINTS08 PEDINTS10 UDI code: 00801741183300 10801741183307 00801741183218 10801741183215 00801741183232 10801741183239 00801741183225 10801741183222 00801741183249 10801741183246 00801741183263 10801741183260 00801741183270 10801741183277 00801741183287 10801741183284 Preamendment REF: INTL14 INTL15 INTL16 INTP14 UDI code: 00801741183164 10801741183161 00801741183171 10801741183178 00801741183188 10801741183185 00801741183294 10801741183291 For urological use only, Intended for use in the drainage and/or collection and/or measurement of urine.

Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.

ALL 50 STATES
▸Full report

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

Recall #:
98840
Lot/product code:
SureStep Intermittent Catheter Tray INTP16 / 00801741183300¿ 10801741183307 Lot Numbers: NGKT3672 NGKU1467 NGKU3559 INTS14 / 00801741183218 10801741183215 Lot Numbers: NGKT2630 NGKT2687 NGKT3636 NGKT3673 NGKU0119 NGKU0134 NGKU1412 NGKU1439 NGKU1494 NGKU2451 NGKU2487 NGKU2510 INTS14C / 00801741183232 10801741183239 Lot Numbers: NGKT2660 NGKU0149 NGKU1468 INTS16 / 00801741183225 10801741183222 Lot Numbers: NGKT2688 NGKT3587 NGKU0135 NGKU2423 INTS16C / 00801741183249 10801741183246 Lot Numbers: NGKT2631 NGKU0120 NGKU1413 PEDINTS06 / 00801741183263¿ 10801741183260 Lot Number: NGKU2452 PEDINTS08 / 00801741183270 10801741183277 Lot Numbers: NGKT3637 NGKU0166 NGKU1495 PEDINTS10 / 00801741183287¿ 10801741183284 Lot Number: NGKT3674 Pre-amendment INTL14 / 00801741183164 10801741183161 Lot Numbers: NGKT3670 NGKU0132 NGKU1491 INTL15 / 00801741183171 10801741183178 Lot Numbers: NGKT2658 NGKT3584 NGKT3609 NGKU0116 NGKU0118 NGKU0133 NGKU0147 NGKU0163 NGKU1411 NGKU1436 NGKU1437 NGKU1465 NGKU1466 NGKU1492 NGKU2421 NGKU2449 NGKU2450 NGKU2485 NGKU2486 NGKU2508 NGKU2509 NGKU4598 NGKU4601 INTL16 / 00801741183188 10801741183185 Lot Number: NGKU3558 INTP14 / 00801741183294 10801741183291 Lot Numbers: NGKT2659 NGKT3585 NGKT3610 NGKT3635 NGKU0148 NGKU1438 NGKU3567
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 25, 2026

Foster & Thrive, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), NDC 70677-1154-01, Distributed by: McKesson Corp., via SSSL, Memphis, TN 38141.

Weaker than it should be Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

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-0686-2026
Lot/product code:
Lot:1505161, 1505181, 1505301, 1505382, exp 2027-04.
Recalling firm:
Bell Pharmaceuticals, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 25, 2026

Products that contain the Pericare Wipes: Bardex Lubricath Foley Catheter Tray REF: 899914 899916 899918 UDI codes: 00801741024801 10801741024808 00801741024818 10801741024815 00801741024825 10801741024822 SureStep" Foley Tray System with Bardex Lubricath Temp Sensing Foley Catheter REF: A119416M UDI code: 00801741073700 10801741073707 SureStep" Foley Tray System Bard Lubricath Foley REF: A800361 UDI code: 00801741073939 10801741073936 SureStep" Foley Tray System Bard Lubricath Foley Catheter Tray REF: A899616 UDI code: 00801741104534 10801741104531 SureStep" Foley Tray System Bardex Lubricath Foley Catheter REF: A899914 UDI code: 00801741074004 10801741074001 SureStep" Foley Tray System Bardex Lubricath Foley Catheter REF: A899916 UDI code: 00801741074011 10801741074018 SureStep" Foley Tray System Bardex Lubricath Temperature Sensing Catheter REF: A900216 UDI code: 00801741120978 10801741120975 SureStep" Foley Tray System BardLubricath Foley Catheter REF: A902914 A902916 A902918 UDI code: 0080174107406610801741074063 00801741074073 10801741074070 0080174107408010801741074087 Bard Urine Meter Foley Catheter Tray With Bardex Lubricath Foley Catheter REF: 304916 UDI code: 00801741019736 01801741019739 Bard Urine Meter Foley Catheter Tray With Bardex Lubricath Foley Catheter REF: 902916 UDI codes: 00801741024863 10801741024860 (416A) SureStep Foley Tray System Bardex IC Complete Care (714A/716A/718A)SureStep Foley Tray System Bardex IC Complete REF: A304914 A304916 A304918 UDI codes: 00801741104350 10801741104357 00801741104367 10801741104364 00801741100499 10801741100496 SureStep" Foley Tray System Bard Lubricath Foley REF: A800365 UDI codes: 00801741073960 10801741073967 SureStep" Foley Tray System Bardex Lubricath Foley Catheter REF: A899918 UDI codes: 00801741074028 10801741074025 SureStep" Foley Tray System BardLubricath Foley Catheter REF: A902618 UDI codes: 00801741104640 10801741104647 SureStep" Foley Tray System BardLubricath Foley Catheter REF: A902616 UDI codes: 00801741104633 10801741104630 SureStep Intermittent Catheter Tray REF: INTL16C UDI codes: 00801741183195 10801741183192 For urological use only, Intended for use in the drainage and/or collection and/or measurement of urine.

Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.

ALL 50 STATES
▸Full report

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

Recall #:
98840
Lot/product code:
Catalog Numbers / UDI codes: 899914 / 00801741024801¿ 10801741024808 Lot Number: NGKU4611 899916 / 00801741024818¿ 10801741024815 Lot Numbers: NGKU2448 NGKU4610 899918 / 00801741024825¿ 10801741024822 Lot Number: NGKU3555 ***** SureStep" Foley Tray System with Bardex¿ Lubricath Temp Sensing Foley Catheter REF: A119416M UDI code: 00801741073700 10801741073707 SureStep" Foley Tray System Bard¿ Lubricath Foley REF: A800361 UDI code: 00801741073939 10801741073936 SureStep" Foley Tray System Bard¿ Lubricath¿ Foley Catheter Tray REF: A899616 UDI code: 00801741104534¿ 10801741104531 SureStep" Foley Tray System Bardex¿ Lubricath¿ Foley Catheter REF: A899914 UDI code: 00801741074004 10801741074001 SureStep" Foley Tray System Bardex¿ Lubricath¿ Foley Catheter REF: A899916 UDI code: 00801741074011¿ 10801741074018 SureStep" Foley Tray System Bardex¿ Lubricath¿ Temperature Sensing Catheter REF: A900216 UDI code: 00801741120978¿ 10801741120975 SureStep" Foley Tray System Bard¿Lubricath¿ Foley Catheter REF: A902914 A902916 A902918 UDI code: 00801741074066¿10801741074063 00801741074073 10801741074070 00801741074080¿10801741074087 Bard¿ Urine Meter Foley Catheter Tray With Bardex¿ Lubricath¿ Foley Catheter REF: 304916 UDI code: 00801741019736 01801741019739 Bard¿ Urine Meter Foley Catheter Tray With Bardex¿ Lubricath¿ Foley Catheter REF: 902916 UDI codes: 00801741024863 10801741024860 (416A) SureStep Foley Tray System Bardex IC Complete Care (714A/716A/718A)SureStep Foley Tray System Bardex IC Complete REF: A304914 A304916 A304918 UDI codes: 00801741104350¿ 10801741104357 00801741104367¿ 10801741104364 00801741100499¿ 10801741100496 SureStep" Foley Tray System Bard¿ Lubricath Foley REF: A800365 UDI codes: 00801741073960 10801741073967 SureStep" Foley Tray System Bardex¿ Lubricath¿ Foley Catheter REF: A899918 UDI codes: 00801741074028 10801741074025 SureStep" Foley Tray System Bard¿Lubricath¿ Foley Catheter REF: A902618 UDI codes: 00801741104640 10801741104647 SureStep" Foley Tray System Bard¿Lubricath¿ Foley Catheter REF: A902616 UDI codes: 00801741104633¿ 10801741104630 SureStep Intermittent Catheter Tray REF: INTL16C UDI codes: 00801741183195¿ 10801741183192
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 25, 2026

Products that contain the Pericare Wipes: (Canada Only) SureStep" Foley Tray System Bardex IC Complete Care REF: A300314AC UDI-DI code: 00801741143243 SureStep" Foley Tray System Bardex IC Complete Care REF: A300316AC UDI-DI code: 00801741143250 SureStep" Foley Tray System Lubri-Sil IC Complete Care REF: A319516AMC UDI-DI code: 00801741143472 SureStep" Foley Tray System Bard Lubricath Foley REF: A800366C UDI-DI code: 00801741143571 SureStep" Foley Tray System Bard Silicone Foley Catheter Tray REF: A897514C UDI-DI code: 00801741074011 SureStep" Foley Tray System Bard Silicone Foley Catheter Tray REF: A897516C UDI-DI code: 00801741143595 SureStep" Foley Tray System Bard Silicone Foley Catheter Tray REF: A902114C UDI-DI code: 00801741144325 ***** SureStep" Foley Tray System Lubri-Sil IC Complete Care REF: A300416AC UDI code: 00801741143281 10801741143288 SureStep" Foley Tray System Bardex IC Complete Care REF: A303314AC UDI code: 00801741143304 10801741143301 SureStep" Foley Tray System Lubri-Sil IC Complete Care REF: A319514AMC UDI code: 00801741143465 10801741143462 SureStep" Foley Tray System Bard Lubricath Foley Catheter Tray REF: A800061C UDI code: 00801741144172 10801741144179 SureStep" Foley Tray System Bard Lubricath Foley Catheter Tray REF: A800065C UDI code: 00801741144202 10801741144209 SureStep" Foley Tray System Bard Lubricath Foley Catheter Tray REF: A800360C UDI code: 00801741143519 10801741143516 SureStep" Foley Tray System Bard Lubricath Foley Catheter Tray REF:A800361C UDI code: 00801741143526 10801741143523 SureStep" Foley Tray System Bard Lubricath Foley Catheter Tray REF: A800362C UDI code: 00801741143540 10801741143547 SureStep" Foley Tray System Bard Lubricath Foley REF: A800365C UDI code: 00801741143564 10801741143561 For urological use only, Intended for use in the drainage and/or collection and/or measurement of urine.

Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.

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

Recall #:
98840
Lot/product code:
(Canada Only) SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300314AC UDI-DI code: 00801741143243 Lot Number: NGKT2492 SureStep" Foley Tray System Bardex¿ IC Complete Care¿ A300316AC / 00801741143250 Lot Number: NGKU2005 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ A319516AMC / 00801741143472 Lot Number: NGKT2392 SureStep" Foley Tray System Bard¿ Lubricath Foley A800366C / 00801741143571 Lot Number: NGKT2413 SureStep" Foley Tray System Bard¿ Silicone Foley Catheter Tray A897514C / 00801741074011¿ Lot Number: NGKU0852 SureStep" Foley Tray System Bard¿ Silicone Foley Catheter Tray A897516C / 00801741143595 Lot Number: NGKT2393 SureStep" Foley Tray System Bard¿ Silicone Foley Catheter Tray A902114C / 00801741144325 Lot Number: NGKU0854 **** SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care A300416AC / 00801741143281 10801741143288 Lot Number: NGKX2635 SureStep" Foley Tray System Bardex¿ IC Complete Care A303314AC / 00801741143304 10801741143301 Lot Number: NGKW2895 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care A319514AMC / 00801741143465 10801741143462 Lot Number: NGKV2284 SureStep" Foley Tray System Bard¿ Lubricath¿ Foley Catheter Tray A800061C / 00801741144172 10801741144179 Lot Number: NGKV1388 SureStep" Foley Tray System Bard¿ Lubricath¿ Foley Catheter Tray A800065C / 00801741144202 10801741144209 Lot Number: NGKW1905 SureStep" Foley Tray System Bard¿ Lubricath¿ Foley Catheter Tray A800360C / 00801741143519 10801741143516 Lot Number: NGKV5086 SureStep" Foley Tray System Bard¿ Lubricath¿ Foley Catheter Tray A800361C / 00801741143526 10801741143523 Lot Number: NGKX4683 SureStep" Foley Tray System Bard¿ Lubricath¿ Foley Catheter Tray A800362C / 00801741143540 10801741143547 Lot Number: NGKW2771 SureStep" Foley Tray System Bard¿ Lubricath Foley A800365C / 00801741143564 10801741143561 Lot Number: NGKW1853
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 25, 2026

AUDIOLOGIST'S CHOICE, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) a) Kit - Washer Bulb Included (NDC 59256-001-02); b) 1 bottle (NDC 59256-836-34), Distributed By: Oaktree Products Inc., St. Louis. MO 63005.

Weaker than it should be Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

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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-0682-2026
Lot/product code:
Lot: a)1505123, expires: 2027-04; b) 1505131, expires: 2027-04.
Recalling firm:
Bell Pharmaceuticals, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 25, 2026

Brand Name: Quantum Rehab Product Name: Q6 Edge 3 Model/Catalog Number: Q6 Edge 3 Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller

If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.

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▸Full report

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

Recall #:
99286
Lot/product code:
Lot Code: Q6 Edge 3 0060650920015*8 K143383 D246699 41875 ITI
Recalling firm:
Pride Mobility Products Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 25, 2026

Brand Name: Quantum Rehab Product Name: Q6 Edge 4 Model/Catalog Number: Q6 Edge 4 Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller

If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.

ALL 50 STATES
▸Full report

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

Recall #:
99286
Lot/product code:
Lot Code: Q6 Edge 4 0060650920028*8 K143383 D246699 41875 ITI
Recalling firm:
Pride Mobility Products Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 25, 2026

Brand Name: Quantum Rehab Product Name: Quantum 4Front 2HD Model/Catalog Number: Quantum 4Front 2HD Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller

If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.

ALL 50 STATES
▸Full report

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

Recall #:
99286
Lot/product code:
Lot Code: Quantum 4Front 2HD 0060650920020*2 K143383 D246699 41875 ITI
Recalling firm:
Pride Mobility Products Corp.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 25, 2026

Clinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x 0.50 mL) 6.5%, 0.5 fl. oz. (15 mL); b) 1 bottle of Clinere Carbamide Peroxide (0,50 fl. oz. (15 mL), Dist. by: Quest Products LLC, Pleasant Prairie, WI 53158, NDC 68229-102-01.

Weaker than it should be Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

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-0679-2026
Lot/product code:
Lot: a) 1504241, exp 2027-03; b) 1504291, 1504301, exp 2027-03.
Recalling firm:
Bell Pharmaceuticals, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 25, 2026

Brand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Number: R-TRAK Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller

If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.

ALL 50 STATES
▸Full report

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

Recall #:
99286
Lot/product code:
Lot Code: R-TRAK 0060650920022*6 K011993 D049085 41875 ITI
Recalling firm:
Pride Mobility Products Corp.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 25, 2026

CAREone, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Bottle, NDC 72476-838-34, DISTRIBUTED BY: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785.

Weaker than it should be Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

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-0688-2026
Lot/product code:
Lot:1505141, exp 2027-04.
Recalling firm:
Bell Pharmaceuticals, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 25, 2026

Brand Name: Quantum Rehab Product Name: Quantum 1450 Model/Catalog Number: Quantum 1450 Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller

If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.

ALL 50 STATES
▸Full report

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

Recall #:
99286
Lot/product code:
Lot Code: Quantum 1450 0060650920009*7 K112815 D143578 41875 ITI
Recalling firm:
Pride Mobility Products Corp.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 25, 2026

QC Quality Choice, Carbamide Peroxide, 6.5%, 0.5 FL. OZ. (15 mL) a) Washer Bulb included (NDC 63868-026-15); b) 1 bottle (NDC 63868-027-16), Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376.

Weaker than it should be Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

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-0680-2026
Lot/product code:
Lot: a) 1505121, 1505342, exp 2027-04; b) 1505381, exp 2027-04.
Recalling firm:
Bell Pharmaceuticals, Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 25, 2026

FAMILY Wellness, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), Kit - Washer Bulb Included, (NDC 55319-835-01), DISTRIBUTED BY: MIDWOOD BRANDS LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320.

Weaker than it should be Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

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-0683-2026
Lot/product code:
Lot: 1505124, 1505311, 1505332, expires: 2027-04.
Recalling firm:
Bell Pharmaceuticals, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 25, 2026

Brand Name: Quantum Rehab Product Name: Quantum 4Front 2 Model/Catalog Number: Quantum 4Front 2 Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller

If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.

ALL 50 STATES
▸Full report

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

Recall #:
99286
Lot/product code:
Lot Code: Quantum 4Front 2 0060650920019*6 K143383 D246699 41875 ITI
Recalling firm:
Pride Mobility Products Corp.
View official FDA record (opens in a new tab)