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FDA food · drug · device recalls, merged

Before you eat it, take it, or plug it in — check.

Big Nope pulls three separate FDA recall feeds into one list per state, so you’re not searching three government databases to get one answer.

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)

Recalls nationwide

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

19,424 recalls found
NewestOldest
High riskLow riskAll
Wording
Class IHigh risk
FoodBacteria/virusRecalled June 25, 2026

Organic Whole Blueberries, Net Wt. 48 oz (3Lb) plastic bag, packed in 6 bags per case of 10 oz each. Keep Frozen. UPC 41415-12053

Due to potential E. coli O145:H28 contamination

ALFLGAKYNCSCTNVA
▸Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
H-1239-2026
Lot/product code:
all product with an expiration date prior to Feb 9, 2028 (Best by Date Feb 09, 2028)
Recalling firm:
Publix Super Markets, Inc.
Resolved:
September 4, 2026
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 25, 2026

GOOD NEIGHBOR PHARMACY, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit - Washer Bulb Included, (NDC 46122-556-05); b) 1 bottle (NDC 46122-557-05), Distributed by: AmerisourceBergen, 1 West First Avenue, Conshohocken, PA 19428.

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-0684-2026
Lot/product code:
Lot: a) 1505334, expires: 2027-04; b) 1505143, 1505151, expires: 2027-04
Recalling firm:
Bell Pharmaceuticals, 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%).

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-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)
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: 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)
UnclassifiedRisk not yet known
Medical deviceRecalled June 25, 2026

Brand Name: Quantum Rehab Product Name: 4Front Model/Catalog Number: 4Front 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: 4Front 0060650920003*5 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

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

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)
UnclassifiedRisk not yet known
Medical deviceRecalled June 25, 2026

Brand Name: Quantum Rehab Product Name: Q6 Edge HD Model/Catalog Number: Q6 Edge HD 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 HD 0060650920005*9 K042612 D049086 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 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

Brand Name: Quantum rehab Product Name: Q6 Edge 2.0 Model/Catalog Number: Q6 Edge 2.0 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 0060650920004*2 K042612 D049086 41875 ITI
Recalling firm:
Pride Mobility Products Corp.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 25, 2026

LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRINGE, 0.5 FL OZ DROPS, (NDC 70000-0689-1); b) 1 bottle (NDC 70000-0688-1), DIST. BY CARDINAL HEALTH, DUBLIN, OH 43017.

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-0685-2026
Lot/product code:
Lot: a) 1505333, expires: 2027-04; b) 1505144, 1505302, expires: 2027-04.
Recalling firm:
Bell Pharmaceuticals, Inc
View official FDA record (opens in a new tab)
Class IHigh risk
FoodBacteria/virusRecalled June 25, 2026

Organic Whole Mixed Berries, Net Wt. 48 oz (3Lb) plastic bag. packed in 6 bags per case of 10 oz each. Keep Frozen. UPC 41415-12153

Due to potential E. coli O145:H28 contamination

ALFLGAKYNCSCTNVA
▸Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
H-1241-2026
Lot/product code:
all product with an expiration date prior to Feb 9, 2028 (Best by Date Feb 09, 2028)
Recalling firm:
Publix Super Markets, Inc.
Resolved:
September 4, 2026
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 25, 2026

Products that contain the Pericare Wipes: Bard Foley Tray With Lubri-Sil All-Silicone Foley Catheter REF: 947314 947316 947318 UDI codes: 00801741024924 10801741024921 00801741024931 10801741024938 00801741024948 10801741024945 Lubri-Sil I.C. Complete Care All-Silicone Foley Catheter Tray REF: 300416A UDI code: 00801741024580 10801741024587 SureStep" Foley Tray System Lubri-Sil IC Complete Care REF: A300416A UDI code: 00801741073762 10801741073769 SureStep" Foley Tray System Lubri-Sil IC Complete Care REF: A303416A UDI code: 00801741073823 10801741073820 SureStep" Foley Tray System Lubri-Sil IC Complete Care REF: A307416A A307418A UDI codes: 00801741104381 10801741104388 00801741100505 10801741100502 SureStep" Foley Tray System Bard Silicone Foley Catheter Tray REF: A897516 UDI code: 00801741073984 10801741073981 SureStep" Foley Tray System Bardex All- Silicone Foley Catheter Tray REF: A902416 UDI code: 00801741074042 10801741074049 SureStep" Foley Tray System Bardex All- Silicone Foley Catheter Tray REF: A902418 UDI code: 00801741074059 10801741074056 SureStep" Foley Tray System Bard Lubri-Sil Foley Catheter REF: A907316 UDI code: 00801741104749 10801741104746 SureStep" Foley Tray System with Bard Lubri-Sil Catheter REF: A942210 UDI code: 00801741100567 10801741100564 SureStep" Foley Tray System with Bard Lubri-Sil Catheter REF: A942212 UDI code: 00801741100536 10801741100533 SureStep" Foley Tray System Bard Lubri-Sil Foley Catheter Tray REF: A942214 UDI code: 00801741074103 10801741074100 SureStep" Foley Tray System Bard Lubri-Sil Foley Catheter Tray REF: A942216 UDI code: 00801741074110 10801741074117 SureStep" Foley Tray System Bard Lubri-Sil Foley Catheter REF: A947316 UDI code: 00801741074141 10801741074148 SureStep" Foley Tray System with Bard Lubri-Sil Catheter REF: A942206 UDI code: 00801741100543 10801741100540 **** Lubri-Sil I.C. Complete Care Temp-Sensing Foley Catheter Tray and Urine Meter REF: 319516AM UDI code: 00801741024696 10801741024693 SureStep" Foley Tray System with Bard Lubri-Sil Temp Sensing Foley Catheter REF: A119214M UDI code: 00801741073670 10801741073677 REF: A119216M UDI code: 00801741073687 10801741073684 SureStep" Foley Tray Lubri-Sil I.C. Complete Care Temp Sensing Catheter REF: A300916A UDI code: 00801741120862 10801741120869 SureStep" Foley Tray System Lubri-Sil IC Complete Care REF: A319516A UDI code: 00801741100338 10801741100335 SureStep" Foley Tray System Lubri-Sil IC Complete Care REF: A319516AM UDI code: 00801741073892 10801741073899 SureStep" Foley Tray Lubri-Sil I.C. Complete Care Temp Sensing Catheter REF: A900916A UDI code: 00801741121029 10801741121026 SureStep" Foley Tray System Lubri-Sil Temperature Sensing Foley Catheter REF: A909216M UDI code: 00801741104763 10801741104760 ***** Bard Urine Meter Foley Catheter Tray With Bard Lubri-Sil Catheter REF 942208 UDI code: 00801741029370 10801741029377 Bard Urine Meter Foley Tray With Lubri-Sil All-Silicone Foley Catheter REF: 942216 UDI code: 00801741024979 10801741024976 Lubri-Sil I.C. Complete Care All-Silicone Foley Catheter Tray and Urine Meter REF: 303416A UDI code: 00801741024726 10801741024723 SureStep" Foley Tray System with Bard Lubri-Sil Temp Sensing Foley Catheter REF: A119218M UDI code: 00801741073694 10801741073691 SureStep" Foley Tray System Lubri-Sil IC Complete Care REF: A300418A UDI code: 00801741073779 10801741073776 SureStep" Foley Tray System Lubri-Sil IC Complete Care REF: A303418A UDI code: 00801741073830 10801741073837 SureStep" Foley Tray System Lubri-Sil IC Complete Care REF: A319514AM UDI code: 00801741073885 10801741073882 SureStep" Foley Tray System with Bard Lubri-Sil Catheter REF: A942208 UDI code: 00801741100550 10801741100557 SureStep" Foley Tray System Bard Lubri-Sil Foley Catheter Tray REF: A942218 UDI code: 00801741074127 10801741074124 SureStep" Foley Tray System Bard Lubri-Sil Foley

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:
Bard¿ Foley Tray With Lubri-Sil¿ All-Silicone Foley Catheter Catalog Numbers / UDI codes: 947314 / 00801741024924¿ 10801741024921 Lot Numbers: NGKT2599 NGKU0115 947316 / 00801741024931¿ 10801741024938 Lot Numbers: NGKU0162 NGKU2507 947318 / 00801741024948¿ 10801741024945 Lot Numbers: NGKU2420 NGKU2865 Lubri-Sil¿ I.C. Complete Care¿ All-Silicone Foley Catheter Tray 300416A / 00801741024580 10801741024587 Lot Numbers: NGKT1464 NGKU0129 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ A300416A / 00801741073762¿ 10801741073769 Lot Numbers: NGKT3316 NGKU0946 NGKU0972 NGKU1747 NGKU1823 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care A303416A / 00801741073823 10801741073820 Lot Numbers: NGKT2388 NGKT2495 NGKT3290 NGKT3303 NGKT3318 NGKU0949 NGKU0974 NGKU1749 NGKU2011 NGKU2036 NGKU2922 NGKV0359 NGKV0360 NGKV1433 NGKV1454 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ A307416A / 00801741104381 10801741104388 Lot Number: NGKS3764 A307418A / 00801741100505 10801741100502 Lot Number: NGKT2453 SureStep" Foley Tray System Bard¿ Silicone Foley Catheter Tray A897516 / 00801741073984 10801741073981 Lot Numbers: NGKT3226 NGKU0841 NGKU0954 SureStep" Foley Tray System Bardex¿ All- Silicone Foley Catheter Tray A902416 / 00801741074042¿ 10801741074049 Lot Numbers: NGKU0843 NGKU2016 NGKU2049 NGKU2887 NGKU2929 NGKU3049 NGKU3975 NGKU4043 NGKU4716 SureStep" Foley Tray System Bardex¿ All- Silicone Foley Catheter Tray A902418 / 00801741074059¿ 10801741074056 Lot Number: NGKU0956 SureStep" Foley Tray System Bard¿ Lubri-Sil¿ Foley Catheter A907316 / 00801741104749¿ 10801741104746 Lot Number: NGKU0855 SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Catheter A942210 / 00801741100567¿ 10801741100564 Lot Number: NGKT2458 SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Catheter A942212 / 00801741100536¿ 10801741100533 Lot Number: NGKT3373 SureStep" Foley Tray System Bard¿ Lubri-Sil¿ Foley Catheter Tray A942214 / 00801741074103¿ 10801741074100 Lot Number: NGKT3232 SureStep" Foley Tray System Bard¿ Lubri-Sil¿ Foley Catheter Tray A942216 / 00801741074110 10801741074117 Lot Numbers: NGKT3366 NGKT3374 NGKT3375 NGKT3394 NGKT3395 NGKU0845 NGKU0856 NGKU0957 NGKU1003 NGKU1004 NGKU1757 NGKU1850 NGKU2021 NGKU2052 NGKU2890 SureStep" Foley Tray System Bard¿ Lubri-Sil¿ Foley Catheter A947316 / 00801741074141 10801741074148 Lot Numbers: NGKT2396 NGKT2416 NGKT2460 NGKT3368 NGKT3377 NGKU0846 NGKU0857 NGKU0958 NGKU1758 NGKU1851 NGKU2022 NGKU4047 SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Catheter A942206 / 00801741100543 10801741100540 Lot Number: NGKT3364 ***** Lubri-Sil¿ I.C. Complete Care¿ Temp-Sensing Foley Catheter Tray and Urine Meter 319516AM / 00801741024696¿ 10801741024693 Lot Number: NGKU1994 SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Temp Sensing Foley Catheter A119214M / 00801741073670¿ 10801741073677 Lot Number: NGKV0292 A119216M / 00801741073687 10801741073684 Lot Numbers: NGKS3759 NGKT1887 NGKT2383 NGKT2404 NGKT3314 NGKU0971 SureStep" Foley Tray Lubri-Sil¿ I.C. Complete Care¿ Temp Sensing Catheter A300916A / 00801741120862¿ 10801741120869 Lot Number: NGKS4948 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ A319516A / 00801741100338 10801741100335 Lot Number: NGKT1899 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ A319516AM / 00801741073892 10801741073899 Lot Numbers: NGKS4850 NGKT0702 NGKT0768 NGKT1863 NGKT2391 NGKT2412 NGKT2455 NGKT3305 NGKU0978 NGKU1025 NGKU2925 SureStep" Foley Tray Lubri-Sil¿ I.C. Complete Care¿ Temp Sensing Catheter A900916A / 00801741121029¿ 10801741121026 Lot Number: NGKS4959 SureStep" Foley Tray System Lubri-Sil¿ Temperature Sensing Foley Catheter A909216M / 00801741104763¿ 10801741104760 Lot Number: NGKT2394 ***** Bard¿ Urine Meter Foley Catheter Tray With Bard¿ Lubri-Sil¿ Catheter 942208 / 00801741029370 10801741029377 Lot Number: NGKW2677 Bard¿ Urine Meter Foley Tray With Lubri-Sil¿ All-Silicone Foley Catheter 942216 / 00801741024979 10801741024976 Lot Numbers: NGKW2822 NGKW2751 Lubri-Sil¿ I.C. Complete Care¿ All-Silicone Foley Catheter Tray and Urine Meter 303416A / 00801741024726 10801741024723 Lot Numbers: NGKW3769 NGKW0682 SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Temp Sensing Foley Catheter A119218M / 00801741073694 10801741073691 Lot Number: NGKW0605 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ A300418A / 00801741073779 10801741073776 Lot Number: NGKX3768 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ A303418A / 00801741073830 10801741073837 Lot Numbers: NGKW1796 NGKV1455 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ A319514AM / 00801741073885 10801741073882 Lot Numbers: NGKW2687 NGKV2393 SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Catheter A942208 / 00801741100550 10801741100557 Lot Number: NGKV3560 SureStep" Foley Tray System Bard¿ Lubri-Sil¿ Foley Catheter Tray A942218 / 00801741074127 10801741074124 Lot Number: NGKX4530 SureStep" Foley Tray System Bard¿ Lubr… (truncated, 5110 characters total — see the official FDA record for the full value)
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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▸Full report

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)
UnclassifiedRisk not yet known
Medical deviceRecalled June 25, 2026

Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory support for patients weighing more than 11lb (5kg) who require mechanical ventilation.

Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy.

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

Recall #:
99304
Lot/product code:
Catalog Number: Astral 100 UDI-DI code: 00619498003259 Serial Numbers: Astral Ventilators-Serial number < 22241890149 PCBA Spare Parts via physical PCBA or Ventilator UI - Characters 2 8 < 2707658 PCBA Spare Parts in Box - Box serial number < 22241978070 Catalog Number: Astral 150 UDI-DI code: 00619498270033 Serial Numbers: Astral Ventilator-Serial numbers < 22241440282 PCBA Spare Parts via physical PCBA or Ventilator UI - Characters 2 8 < 2707658 PCBA Spare Parts in Box - Box serial number < 22241978070
Recalling firm:
ResMed Ltd.
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: *Bardex I.C. Complete Care Foley Catheter Tray REF: 300316A UDI codes: 00801741024344 10801741024341 *Bardex I.C. Complete Care Foley Catheter Tray and Urine Meter REF: 303314A 303316A 303318A UDI code: 00801741024252 10801741024259 00801741024269 10801741024266 00801741024276 10801741024273 *SureStep" Foley Tray System Bardex IC Complete Care REF: A300314A UDI codes: 00801741073724 10801741073721 REF: A300314AC (Canada Only) UDI-DI code: 00801741143243 *SureStep" Foley Tray System Bardex IC Complete Care REF: A300316A UDI code: 00801741073731 10801741073738 *SureStep" Foley Tray System Bardex IC Complete Care REF: A300318A UDI code: 00801741073748 10801741073745 *SureStep" Foley Tray System Bardex IC Complete Care REF: A303314A A303316A A303318A UDI code: 00801741073786 10801741073783 00801741073793 10801741073790 00801741073809 10801741073806 *SureStep" Foley Tray System Lubri-Sil IC Complete Care REF: A303414A UDI code: 00801741073816 10801741073813 *(416A)SureStep" Foley Tray System Bardex IC Complete Care (714A/716A/718A)SureStep" Foley Tray System Bardex IC Complete Care (914)SureStep" Foley Tray System REF: A304716A A304714A A304716A A304718A UDI code: 00801741104206 10801741104203 00801741104268 10801741104265 00801741104299 10801741104296 00801741100376 10801741100373 *SureStep" Foley Tray System Bardex IC Complete Care REF: A319416A UDI code: 00801741100307 10801741100304 *SureStep" Foley Tray System Bardex I.C. Complete Care Foley Catheter REF: A319416AM UDI code: 00801741073861 10801741073868 *SureStep" Foley Tray System Bardex IC Complete Care REF: A319418A UDI code: 00801741100314 10801741100311 SureStep" Foley Tray System Bardex IC Complete Care REF: A903316A UDI code: 00801741096600 10801741096607 ***** SureStep" Foley Tray System Lubri-Sil IC Complete Care REF: A300414A UDI code: 00801741073755 10801741073752 SureStep" Foley Tray System Bardex I.C. Complete Care Foley Catheter REF: A319414AM UDI code: 00801741073854 10801741073851 SureStep" Foley Tray System Bardex I.C. Complete Care Foley Catheter REF: A319418AM UDI code: 00801741073878 10801741073875 SureStep" Foley Tray System Bardex IC Complete Care REF: A903318A UDI code: 00801741104657 10801741104654 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:
Bardex¿ I.C. Complete Care¿ Foley Catheter Tray 300316A / 00801741024344¿ 10801741024341 Lot Number: NGKT3657 Bardex¿ I.C. Complete Care¿ Foley Catheter Tray and Urine Meter 303314A / 00801741024252¿ 10801741024259 Lot Number: NGKU4153 303316A / 00801741024269 10801741024266 Lot Number: NGKW2883 303318A / 00801741024276¿ 10801741024273 Lot Number: NGKU0966 *SureStep" Foley Tray System Bardex¿ IC Complete Care¿ A300314A / 00801741073724¿ 10801741073721 Lot Number: NGKU1020 A300314AC (Canada Only) / 00801741143243 Lot Number: **** SureStep" Foley Tray System Bardex¿ IC Complete Care¿ A300316A / 00801741073731 10801741073738 Lot Numbers: NGKT2448 NGKT3221 NGKT3288 NGKT3301 NGKT3315 NGKU2921 NGKV0293 SureStep" Foley Tray System Bardex¿ IC Complete Care¿ A300318A / 00801741073748¿ 10801741073745 Lot Number: NGKT2493 SureStep" Foley Tray System Bardex¿ IC Complete Care¿ A303314A / 00801741073786¿ 10801741073783 Lot Numbers: NGKT3222 NGKV0249 A303316A / 00801741073793¿ 10801741073790 Lot Numbers: NGKU0894 NGKU0947 NGKU0973 NGKU1021 NGKU1748 NGKU1826 NGKU1830 NGKU2034 NGKU2035 NGKU2996 NGKU3042 NGKU3969 NGKU4037 NGKU4077 NGKU4078 NGKU4135 NGKU4713 NGKU4714 NGKU4720 NGKU4721 NGKU4722 NGKU4727 NGKV2390 NGKV3390 A303318A / 00801741073809¿ 10801741073806 Lot Numbers: NGKT3223 NGKU4136 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ A303414A / 00801741073816¿ 10801741073813 Lot Number: NGKU1022 (416A)SureStep" Foley Tray System Bardex¿ IC Complete Care¿ (714A/716A/718A)SureStep" Foley Tray System Bardex¿ IC Complete Care¿ (914)SureStep" Foley Tray System A304716A / 00801741104206 10801741104203 Lot Number: NGKT2496 A304714A / 00801741104268 10801741104265 Lot Number: NGKU2923 A304716A / 00801741104299 10801741104296 Lot Numbers: NGKU1833 NGKU4729 A304718A / 00801741100376¿ 10801741100373 Lot Numbers: NGKT3224 NGKU3971 SureStep" Foley Tray System Bardex¿ IC Complete Care¿ A319416A / 00801741100307¿ 10801741100304 Lot Number: NGKS1605 SureStep" Foley Tray System Bardex¿ I.C. Complete Care Foley Catheter A319416AM / 00801741073861¿ 10801741073868 Lot Numbers: NGKT2390 NGKT2410 NGKT3225 NGKT3319 NGKU0951 NGKU0977 SureStep" Foley Tray System Bardex¿ IC Complete Care¿ A319418A / 00801741100314¿ 10801741100311 Lot Number: NGKT2411 SureStep" Foley Tray System Bardex¿ IC Complete Care¿ A903316A / 00801741096600¿ 10801741096607 Lot Numbers: NGKT3392 NGKU2020 **** SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care A300414A / 00801741073755 10801741073752 Lot Number: NGKV3524 SureStep" Foley Tray System Bardex¿ I.C. Complete Care Foley Catheter A319414AM / 00801741073854 10801741073851 Lot Number: NGKV3487 SureStep" Foley Tray System Bardex¿ I.C. Complete Care Foley Catheter A319418AM / 00801741073878 10801741073875 Lot Number: NGKV4983 SureStep" Foley Tray System Bardex¿ IC Complete Care A903318A / 00801741104657 10801741104654 Lot Number: NGKV2397
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 25, 2026

TopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit - WASHER BULB & DROPS INCLUDED (NDC 36800-835-33); b) 1 bottle (NDC 36800-835-34), DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007.

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-0681-2026
Lot/product code:
Lot: a) 1505122, 1505343, expires: 2027-04; b) 1505142, 1505341, expires: 2027-04.
Recalling firm:
Bell Pharmaceuticals, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 24, 2026

BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic

Due to increase in false negative results

ALL 50 STATES
▸Full report

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

Recall #:
99261
Lot/product code:
Part Number: 423742 UDI-DI code: 00815381020529 Pouch Lot: 3VLB25 Kit Lot: 1872125
Recalling firm:
BioFire Diagnostics, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 24, 2026

Azacitidine for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For Subcutaneous and Intravenous Use, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0857-01

Lack of Sterility Assurance

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▸Full report

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

Recall #:
D-0674-2026
Lot/product code:
Lot, expiry: RAZM0425A Jun 30, 2027; RAZM0525A Jun 30, 2027; RAZM0725A Jun 30, 2027; RAZM0825A Jun 30, 2027; RAZM0925A Jul 31, 2027; RAZM1125A Jul 31, 2027; RAZM1225A Jul 31, 2027; RAZM1425A Jul 31, 2027; RAZM1525A Jul 31, 2027; RAZM1625A Aug 31, 2027; RAZM1725A Aug 31, 2027; RAZM2025A Sep 30, 2027
Recalling firm:
Reliance Life Sciences Private Limited
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 24, 2026

Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX

Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.

ALL 50 STATES
▸Full report

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

Recall #:
99390
Lot/product code:
S8698GX UDI-DI 20612479214716 Lot D5M3438FY
Recalling firm:
Covidien, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 24, 2026

EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77622

Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.

ALL 50 STATES
▸Full report

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

Recall #:
99320
Lot/product code:
UDI-DI: 20763000135670, Lot Numbers: 0232601501 0232601510 0232601549 0232601550 0232602178 0232602290 0232602302 0232910952 0232910953 0232910954 0232910955 0233244075 0233244301 0233244531 0233286362 0233286374 0233286390 0233409034 0233416071 0233528731
Recalling firm:
Medtronic Perfusion Systems
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 24, 2026

EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77522

Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.

ALL 50 STATES
▸Full report

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

Recall #:
99320
Lot/product code:
UDI-DI: 00199150023288, Lot Numbers: 0233286436; UDI-DI: 20199150023282, Lot Numbers: 0232709428 0232744924 0232745061 0232745092 0232798556 0232862763 0232862778 0232862794 0232862798 0232903216 0232903291 0232903383 0232990983 0233286318 0233286414 0233286436 0233427120 0233528730 0233553623 0233556386 0233585113 0233585114 0232670802
Recalling firm:
Medtronic Perfusion Systems
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 24, 2026

EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77422

Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.

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▸Full report

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

Recall #:
99320
Lot/product code:
UDI-DI: 20763000135632, Lot Numbers: 0232446429 0232446444 0232486752 0232601515 0232601516 0232601522 0232601586 0232601591 0232601593 0232602180 0232798265 0232798353 0232849583 0232894981 0232895082 0232902694 0232902697 0232902698 0232902700 0232902803 0232902805 0232902846 0232985469 0233009922 0233108251 0233116991 0233127352 0233334923 0233334966 0233426694 0233426695 0233528727; UDI-DI: 00763000135638, Lot Numbers: 0232446444 0232798353 0232895082 0232902697 0232902803 0232902846 0232985469 0233127352 0233334923
Recalling firm:
Medtronic Perfusion Systems
View official FDA record (opens in a new tab)