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Recalls affecting Puerto Rico

Data last updated: September 10, 2026 at 1:16 PM UTC

16,244 recalls found
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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/virusSalmonellaAnnounced 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

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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/virusE. coliAnnounced 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)
UnclassifiedAllergenMilkUndeclaredAnnounced 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)
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

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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)
UnclassifiedBacteria/virusSalmonellaE. coliAnnounced 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/virusSalmonellaAnnounced 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)
Wording
Class IIModerate risk
DrugRecalled December 26, 2025

DAYQUIL COLD & FLU, 32CT/2PK

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

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-0267-2026
Lot/product code:
All lots within expiry distributed by Gold Star Distribution.
Recalling firm:
GOLD STAR DISTRIBUTION INC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 26, 2025

Petroleum jelly: a) Vaseline Petroleum Jelly, 1.75, 12CT, UPC: 6001085120946; b) Vaseline Men Cooling Petroleum Jelly, 100ML, 12CT, UPC: 60022141; c) Vaseline Vitamin E, Petroleum Jelly, 100ML, 12CT, UPC: 6001085121028; MEN FRESH PETROLEUM JELLY, 100ML, 12CT, UPC: 60022127; d) Lucky Petroleum Jelly, 6 OZ, 12 PK, UPC: 808829081466;048155903562; e) Lucky Petroleum Jelly, COCOA, 6oz, 12ct, UPC: 808829081572, 048155922150; f) Personal Care, CREAMY PETROLEUM JELLY, 4.5oz, 12CT, UPC: 048155908642; g) Personal Care, CREAMY COCOA PETROLEUM JELLY, 4.5oz, 12CT, UPC: 048155922242; h) SOFTEE, PETROLEUM JELLY, 5oz, 12CT, UPC: 096002007208

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

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-0285-2026
Lot/product code:
All lots within expiry distributed by Gold Star Distribution.
Recalling firm:
GOLD STAR DISTRIBUTION INC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 26, 2025

MOTRIN 2'S DISP.- 50CT

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

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-0271-2026
Lot/product code:
All lots within expiry distributed by Gold Star Distribution.
Recalling firm:
GOLD STAR DISTRIBUTION INC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 26, 2025

PEPTO BISMOL 32CT

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

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-0275-2026
Lot/product code:
All lots within expiry distributed by Gold Star Distribution.
Recalling firm:
GOLD STAR DISTRIBUTION INC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 26, 2025

Bayer 2Pk- 25 CT

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

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-0265-2026
Lot/product code:
All lots within expiry distributed by Gold Star Distribution.
Recalling firm:
GOLD STAR DISTRIBUTION INC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 26, 2025

Aleve 1's, 60 CT

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

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-0262-2026
Lot/product code:
All lots within expiry distributed by Gold Star Distribution.
Recalling firm:
GOLD STAR DISTRIBUTION INC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 26, 2025

Toothpaste: a) COLGATE, TOOTHPASTE, WHITENING, 2.5oz, 24ct; UPC: 035000511065; b) COLGATE, TOOTHPASTE, Regular, 2.5oz, 24ct, UPC: 035000511058; c) COLGATE, TOOTHPASTE, TRIPLE, 2.5oz, 24ct, UPC: 035000512109; d) COLGATE, TOOTHPASTE, MINT ZING, 24CT, 2.5oz, UPC: 035000744609; COLGATE, MAXFRESH, SPICY FRESH, RED TOOTH PASTE, 72CT, 150G; e) CREST, TOOTHPASTE, 40CT, 8.2OZ, UPC: 037000247081

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

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-0287-2026
Lot/product code:
All lots within expiry distributed by Gold Star Distribution.
Recalling firm:
GOLD STAR DISTRIBUTION INC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 26, 2025

LIQUID NYQUIL a) regular, 12/8oz; b) cherry, 12/8oz

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

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-0272-2026
Lot/product code:
All lots within expiry distributed by Gold Star Distribution.
Recalling firm:
GOLD STAR DISTRIBUTION INC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 26, 2025

LIQUID DAYQUIL 12/8oz

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

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-0268-2026
Lot/product code:
All lots within expiry distributed by Gold Star Distribution.
Recalling firm:
GOLD STAR DISTRIBUTION INC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 26, 2025

Claritin, 20 Count, UPC: 655708016305

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

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-0266-2026
Lot/product code:
All lots within expiry distributed by Gold Star Distribution.
Recalling firm:
GOLD STAR DISTRIBUTION INC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 26, 2025

Condoms, labeled as: TROJAN MAGNUM CONDOMS 6/DSP BLACK, TROJAN LUBRICATED CONDOMS 6/DSP LITE BLUE, TROJAN SPERMICIDE CONDOMS 6/DSP DARK BLUE, TROJAN ULTRA THIN CONDOMS 6/DSP GREY, TROJAN RIBBED CONDOMS 6/DSP GOLD/BROWN, TROJAN NONLUBRICATED CONDOMS 6/DSP RED, TROJAN ULTRA HER PLEASURE CONDOMS 6/DSP, TROJAN CONDOMS MAGNUM 48 CT DISP, *BOX TROJAN CONDOMS MAGNUM 50CT .

Potential exposure of rodents and rodent activity in the distribution center.

ALL 50 STATES
▸Full report

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

Recall #:
98234
Lot/product code:
TROJAN MAGNUM CONDOMS 6/DSP BLACK, UPC 022600642039; TROJAN LUBRICATED CONDOMS 6/DSP LITE BLUE, UPC 022600930501; TROJAN SPERMICIDE CONDOMS 6/DSP DARK BLUE, UPC 022600931508; TROJAN ULTRA THIN CONDOMS 6/DSP GREY, UPC 022600926207; TROJAN RIBBED CONDOMS 6/DSP GOLD/BROWN, UPC 022600940500; TROJAN NONLUBRICATED CONDOMS 6/DSP RED, UPC 22600920502; TROJAN ULTRA HER PLEASURE CONDOMS 6/DSP, UPC 022600973201; TROJAN CONDOMS MAGNUM 48 CT DISP, UPC 815556020125; *BOX TROJAN CONDOMS MAGNUM 50Ct, UPC none All codes purchased from this firm
Recalling firm:
GOLD STAR DISTRIBUTION INC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 24, 2025

Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S. 3200TS Tourniquet Systems Model/Catalog Number: 60320010100 Software Version: Software version v2.06 or prior are within scope of the recall for A.T.S. 3200TS Product Description: A.T.S 3200TS Tourniquet Systems Component: N/A

Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings. Issue may cause delay or extension while alternate device is located.

ALL 50 STATES
▸Full report

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

Recall #:
98235
Lot/product code:
Lot Code: Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67505739(21)32067505739001" ; Lot No. 67505739 ; Serial No. 32067505739001 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67505739(21)32067505739003" ; Lot No. 67505739 ; Serial No. 32067505739003 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67505739(21)32067505739004" ; Lot No. 67505739 ; Serial No. 32067505739004 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67505739(21)32067505739005" ; Lot No. 67505739 ; Serial No. 32067505739005 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67505739(21)32067505739006" ; Lot No. 67505739 ; Serial No. 32067505739006 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67505739(21)32067505739007" ; Lot No. 67505739 ; Serial No. 32067505739007 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67505739(21)32067505739008" ; Lot No. 67505739 ; Serial No. 32067505739008 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67505739(21)32067505739010" ; Lot No. 67505739 ; Serial No. 32067505739010 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67505739(21)32067505739013" ; Lot No. 67505739 ; Serial No. 32067505739013 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67505739(21)32067505739014" ; Lot No. 67505739 ; Serial No. 32067505739014 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67505739(21)32067505739015" ; Lot No. 67505739 ; Serial No. 32067505739015 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67505739(21)32067505739017" ; Lot No. 67505739 ; Serial No. 32067505739017 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67505739(21)32067505739019" ; Lot No. 67505739 ; Serial No. 32067505739019 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67505739(21)32067505739020" ; Lot No. 67505739 ; Serial No. 32067505739020 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67508816(21)32067508816001" ; Lot No. 67508816 ; Serial No. 32067508816001 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67508816(21)32067508816002" ; Lot No. 67508816 ; Serial No. 32067508816002 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67508816(21)32067508816003" ; Lot No. 67508816 ; Serial No. 32067508816003 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67508816(21)32067508816004" ; Lot No. 67508816 ; Serial No. 32067508816004 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67508816(21)32067508816005" ; Lot No. 67508816 ; Serial No. 32067508816005 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67508816(21)32067508816006" ; Lot No. 67508816 ; Serial No. 32067508816006 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67508816(21)32067508816007" ; Lot No. 67508816 ; Serial No. 32067508816007 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67508816(21)32067508816008" ; Lot No. 67508816 ; Serial No. 32067508816008 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67508816(21)32067508816009" ; Lot No. 67508816 ; Serial No. 32067508816009 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67508816(21)32067508816010" ; Lot No. 67508816 ; Serial No. 32067508816010 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67508816(21)32067508816012" ; Lot No. 67508816 ; Serial No. 32067508816012 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67508816(21)32067508816013" ; Lot No. 67508816 ; Serial No. 32067508816013 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67508816(21)32067508816014" ; Lot No. 67508816 ; Serial No. 32067508816014 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67508816(21)32067508816016" ; Lot No. 67508816 ; Serial No. 32067508816016 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67508816(21)32067508816017" ; Lot No. 67508816 ; Serial No. 32067508816017 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67508816(21)32067508816019" ; Lot No. 67508816 ; Serial No. 32067508816019 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67508816(21)32067508816020" ; Lot No. 67508816 ; Serial No. 32067508816020 Model No. 60320010100 ; UDI "(01)00889024626447(11)250730(10)67508820(21)32067508820001" ; Lot No. 67508820 ; Serial No. 32067508820001 Model No. 60320010100 ; UDI "(01)00889024626447(11)250730(10)67508820(21)32067508820002" ; Lot No. 67508820 ; Serial No. 32067508820002 Model No. 60320010100 ; UDI "(01)00889024626447(11)250730(10)67508820(21)32067508820003" ; Lot No. 67508820 ; Serial No. 32067508820003 Model No. 60320010100 ; UDI "(01)00889024626447(11)250730(10)67508820(21)32067508820004" ; Lot No. 67508820 ; Serial No. 32067508820004 Model No. 60320010100 ; UDI "(01)00889024626447(11)250730(10)67508820(21)32067508820005" ; Lot No. 67508820 ; Serial No. 32067508820005 Model No. 60320010100 ; UDI "(01)00889024626447(11)250730(10)67508820(21)32067508820006" ; Lot… (truncated, 6945 characters total — see the official FDA record for the full value)
Recalling firm:
Zimmer Surgical Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 24, 2025

GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm - MEA, Omni Legend PET Gantry 16cm Haifa LM, Omni Legend PET Gantry 16cm Mobile, Omni Legend PET Gantry 21cm - BJ for Global, Omni Legend PET Gantry 21cm - Global Haifa LM, Omni Legend PET Gantry 21cm - Mobile, Omni Legend PET Gantry 21cm WSO LM, Omni Legend PET Gantry 32cm - MEA, Omni Legend PET Gantry 32cm Haifa LM, Omni Legend PET Gantry 32cm Mobile, OMNI PET Gantry 15cm, Omni PET Gantry 15cm - WSO, OMNI PET Gantry 15cm Cardiac- WSO, OMNI PET Gantry 15cm ES - WSO, Omni PET Gantry 15cm Mobile WSO, Omni PET Gantry 21cm - WSO, Omni PET Gantry 21cm Mobile - WSO, OMNI PET Gantry 30cm, Omni PET Gantry 30cm - WSO; System, Tomography, Computed, Emission

There is a potential intermittent issue on certain Omni Legend systems that can result in a streaking artifact in the PET clinical scan images. This streaking artifact is most easily identified in transaxial slices on the acquisition console (both corrected and non-corrected for attenuation).

ALL 50 STATES
▸Full report

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

Recall #:
98269
Lot/product code:
OMNI Legend 16: UDI (01)00195278454218(21)OM3D31087(11)240400, Manufacturing Lot/Serial Number OM3D31087; OMNI Legend 16: UDI (01)00195278454218(21)OM3D31071(11)240200, Manufacturing Lot/Serial Number OM3D31071; OMNI Legend 16: UDI (01)00195278454218(21)OM3D31100(11)240700, Manufacturing Lot/Serial Number OM3D31100; OMNI Legend 16: UDI (01)00195278454218(21)OM3E31115(11)250100, Manufacturing Lot/Serial Number OM3E31115; OMNI Legend 16: UDI (01)00195278592309(21)OH3D35001(11)240600, Manufacturing Lot/Serial Number OH3D35001; OMNI Legend 16: UDI (01)00195278592309(21)OH3E35003(11)250100, Manufacturing Lot/Serial Number OH3E35003; Omni Legend 21: UDI (01)00195278454218(21)OM4E44014(11)250400, Manufacturing Lot/Serial Number OM4E44014; Omni Legend 21: UDI (01)00195278454218(21)OM4E44012(11)250200, Manufacturing Lot/Serial Number OM4E44012; Omni Legend 21: UDI (01)00195278592309(21)OH4E43004(11)250400, Manufacturing Lot/Serial Number OH4E43004; Omni Legend 21: UDI (01)00195278592309(21)OH4E43001(11)250100, Manufacturing Lot/Serial Number OH4E43001; Omni Legend 21: UDI (01)00195278592309(21)OH4E43002(11)250100, Manufacturing Lot/Serial Number OH4E43002; OMNI Legend 32: UDI (01)00195278454218(21)OM6E61101(11)250400, Manufacturing Lot/Serial Number OM6E61101; OMNI Legend 32: UDI (01)00195278454218(21)OM6D61084(11)240900, Manufacturing Lot/Serial Number OM6D61084; OMNI Legend 32: UDI (01)00195278454218(21)OM6C61031(11)230700, Manufacturing Lot/Serial Number OM6C61031; OMNI Legend 32: UDI (01)00195278454218(21)OM6E61097(11)250200, Manufacturing Lot/Serial Number OM6E61097; OMNI Legend 32: UDI (01)00195278454218(21)OM6D61072(11)240600, Manufacturing Lot/Serial Number OM6D61072; Omni Legend PET Gantry 16cm - MEA: UDI (01)00195278792822(11)250623(21)NL1EG2500002BH, Manufacturing Lot/Serial Number NL1EG2500002BH/ CBDDG2500041HM/ C1PMT2500115HM; Omni Legend PET Gantry 16cm - MEA: UDI (01)00195278792822(11)240900(21)NL1EG2400002BH, Manufacturing Lot/Serial Number NL1EG2400002BH/ CBDDG2400112HM/ C1PMT2400271HM; Omni Legend PET Gantry 16cm - MEA: UDI (01)00195278792822(11)240600(21)NL1EG2400001BH, Manufacturing Lot/Serial Number NL1EG2400001BH /CBDDG2400079HM/C1PMT2400151HM; Omni Legend PET Gantry 16cm - MEA: UDI (01)00195278792822(11)250100(21)NL1EG2400003BH, Manufacturing Lot/Serial Number NL1EG2400003BH/ NL1EG2400003BH /CBDDG2400144HM/ C1PMT2400123HM; Omni Legend PET Gantry 16cm - MEA: UDI (01)00195278792822(11)250400(21)NL1EG2500001BH, Manufacturing Lot/Serial Number NL1EG2500001BH/ CBDDG2500026HM/ C1PMT2500074HM; Omni Legend PET Gantry 16cm Haifa LM: UDI (01)00195278592309(21)OH3D35002(11)241000, Manufacturing Lot/Serial Number OH3D35002; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32001(11)230600, Manufacturing Lot/Serial Number OW3C32001; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32002(11)230700, Manufacturing Lot/Serial Number OW3C32002; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32003(11)230900, Manufacturing Lot/Serial Number OW3C32003; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32006(11)231000, Manufacturing Lot/Serial Number OW3C32006; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32010(11)231100, Manufacturing Lot/Serial Number OW3C32010; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32018(11)240500, Manufacturing Lot/Serial Number OW3D32018; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32021(11)241000, Manufacturing Lot/Serial Number OW3D32021; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32013(11)240100, Manufacturing Lot/Serial Number OW3D32013; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32007(11)231000, Manufacturing Lot/Serial Number OW3C32007; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32020(11)240700, Manufacturing Lot/Serial Number OW3D32020; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32019(11)240500, Manufacturing Lot/Serial Number OW3D32019; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32014(11)240100, Manufacturing Lot/Serial Number OW3D32014; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32015(11)240100, Manufacturing Lot/Serial Number OW3D32015; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32004(11)230900, Manufacturing Lot/Serial Number OW3C32004; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32011(11)231200, Manufacturing Lot/Serial Number OW3C32011; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32005(11)231000, Manufacturing Lot/Serial Number OW3C32005; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32008(11)231000, Manufacturing Lot/Serial Number OW3C32008; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32016(11)240300, Manufacturing Lot/Seri… (truncated, 44945 characters total — see the official FDA record for the full value)
Recalling firm:
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 24, 2025

Medline medical convenience kits packaged as: 1) CANCER SERVICE PORT KIT, Kit SKU DT22710; 2) LINE KIT, Kit SKU DYNDA1857A; 3) PICC REMOVAL KIT, Kit SKU DYNDC1978A; 4) PORT ACCESS TRAY, Kit SKU DYNDC2367; 5) NICU CENTRAL LINE TRAY, Kit SKU DYNDC2407B; 6) CVC DRESSING CHANGE W/ TEG CHG, Kit SKU DYNDC3222A; 7) PICC PROCEDURE PACK, Kit SKU DYNJ59067A; 8) PICC PROCEDURE PACK, Kit SKU PHS950205004B.

Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.

ALL 50 STATES
▸Full report

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

Recall #:
98284
Lot/product code:
1) Kit SKU DT22710, Lot Numbers: 25EBC812; 2) Kit SKU DYNDA1857A, Lot Numbers: 25FBH991; 3) Kit SKU DYNDC1978A, Lot Numbers: 25EBC577; 4) Kit SKU DYNDC2367, Lot Numbers: 25EBS434; 5) Kit SKU DYNDC2407B, Lot Numbers: 25FMG170; 6) Kit SKU DYNDC3222A, Lot Numbers: 25EBK184; 7) Kit SKU DYNJ59067A, Lot Numbers: 25EBM461, 25EBD386; 8) Kit SKU PHS950205004B, Lot Numbers: 25FMD059.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 24, 2025

1) UNIVERSAL KIT, Kit SKU DT22010B; 2) VAD ACCESS KIT, Kit SKU DT22790C; 3) VAD ACCESS KIT, Kit SKU DT22790C; 4) PROCEDURE TRAY, Kit SKU DYNDA2966A; 5) PROCEDURE TRAY, Kit SKU DYNDA2966A; 6) PEDIATRIC CENTRAL LINE SMALL, Kit SKU DYNDC2208C; 7) PORT DRESSING KIT, Kit SKU DYNDC3107; 8) NON STERILE DIALYSIS KIT, Kit SKU DYNDH1029C; 9) UMBILICAL TRAY W/3.5&5FR CATH, Kit SKU UVT1250; 10) UMBILICAL VESSEL TRAY, Kit SKU UVT835; 11) HEMODIALYSIS TRAY, Kit SKU VAR101HVAA.

Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.

ALL 50 STATES
▸Full report

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

Recall #:
98284
Lot/product code:
1) Kit SKU DT22010B, UDI/DI 10653160351092, Lot number 25EBC888; 2) Kit SKU DT22790C, UDI/DI 10653160996965, Lot number 25EBO566; 3) Kit SKU DT22790C, UDI/DI 10653160996965, Lot number 25EBD964; 4) Kit SKU DYNDA2966A, UDI/DI 10198459005848, Lot number 25EBN178; 5) Kit SKU DYNDA2966A, UDI/DI 10198459005848, Lot number 25EBL624; 6) Kit SKU DYNDC2208C, UDI/DI 10889942815333, Lot number 25EBC706; 7) Kit SKU DYNDC3107, UDI/DI 10193489917628, Lot number 25EBN742; 8) Kit SKU DYNDH1029C, UDI/DI 10889942816453, Lot number 25EBC778; 9) Kit SKU UVT1250, UDI/DI 10653160995340, Lot number 25EBO757; 10) Kit SKU UVT835, UDI/DI 10653160289180, Lot number 25FMI300; 11) Kit SKU VAR101HVAA, UDI/DI 10193489388145, Lot number 25EBE079.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 24, 2025

Medline medical convenience kits packaged as: BLOOD CULTURE KIT NS, Kit SKU DYNDH2088

Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.

ALL 50 STATES
▸Full report

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

Recall #:
98284
Lot/product code:
UDI/DI 10198459230363, Lot Numbers: 25EBU508, 25EBE330.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 24, 2025

Intubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B

A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may result in hypoxia and/or respiratory failure related to partial or full airway obstruction. Airway obstruction may require immediate emergent medical intervention to prevent respiratory failure or death. Other potential outcomes include prolonged procedure, airway irritation, or prolonged dyspnea.

ALL 50 STATES
▸Full report

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

Recall #:
98285
Lot/product code:
Kit lots 25IBC172 25HBJ413 UDI (ea) 10198459480317 UDI (case) 40198459480318
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 24, 2025

Medline medical convenience kits packaged as: MERCY CIRCUMCISION TRAY, Kit SKU CIT6135B

Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.

ALL 50 STATES
▸Full report

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

Recall #:
98284
Lot/product code:
UDI/DI 10653160990666, Lot Number 25EBC648
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 24, 2025

Medline medical convenience kits packaged as: PEDIATRIC CATH SECUREMENT DRSG, Kit SKU DYNDC3108

Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.

ALL 50 STATES
▸Full report

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

Recall #:
98284
Lot/product code:
UDI/DI 10193489918007, Lot Number 25EBD612
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 24, 2025

Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S. 5000TS Tourniquet Systems Model/Catalog Number: 60500010100 Software Version: Software version v2.04 or prior are within scope of the recall for A.T.S. 5000TS Product Description: A.T.S 5000TS Tourniquet Systems Component: N/A

Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings. Issue may cause delay or extension while alternate device is located.

ALL 50 STATES
▸Full report

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

Recall #:
98235
Lot/product code:
Lot Code: Model No. 60500010100 ; UDI (01)00889024626454(11)240410(10)66722609(21)50066722609001; Lot No. 66722609 ; Serial No. 50066722609001 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722609(21)50066722609002; Lot No. 66722609 ; Serial No. 50066722609002 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722609(21)50066722609003" ; Lot No. 66722609 ; Serial No. 50066722609003 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722609(21)50066722609004" ; Lot No. 66722609 ; Serial No. 50066722609004 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722609(21)50066722609005" ; Lot No. 66722609 ; Serial No. 50066722609005 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722610(21)50066722610001" ; Lot No. 66722610 ; Serial No. 50066722610001 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722610(21)50066722610002" ; Lot No. 66722610 ; Serial No. 50066722610002 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722610(21)50066722610003" ; Lot No. 66722610 ; Serial No. 50066722610003 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722610(21)50066722610004" ; Lot No. 66722610 ; Serial No. 50066722610004 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722610(21)50066722610005" ; Lot No. 66722610 ; Serial No. 50066722610005 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722611(21)50066722611001" ; Lot No. 66722611 ; Serial No. 50066722611001 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722611(21)50066722611002" ; Lot No. 66722611 ; Serial No. 50066722611002 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722611(21)50066722611003" ; Lot No. 66722611 ; Serial No. 50066722611003 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722611(21)50066722611004" ; Lot No. 66722611 ; Serial No. 50066722611004 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722611(21)50066722611005" ; Lot No. 66722611 ; Serial No. 50066722611005 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722611(21)50066722611006" ; Lot No. 66722611 ; Serial No. 50066722611006 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722611(21)50066722611007" ; Lot No. 66722611 ; Serial No. 50066722611007 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722611(21)50066722611008" ; Lot No. 66722611 ; Serial No. 50066722611008 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722611(21)50066722611009" ; Lot No. 66722611 ; Serial No. 50066722611009 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722611(21)50066722611010" ; Lot No. 66722611 ; Serial No. 50066722611010 Model No. 60500010100 ; UDI "(01)00889024626454(11)240422(10)66742892(21)50066742892001" ; Lot No. 66742892 ; Serial No. 50066742892001 Model No. 60500010100 ; UDI "(01)00889024626454(11)240422(10)66742892(21)50066742892002" ; Lot No. 66742892 ; Serial No. 50066742892002 Model No. 60500010100 ; UDI "(01)00889024626454(11)240422(10)66742892(21)50066742892003" ; Lot No. 66742892 ; Serial No. 50066742892003 Model No. 60500010100 ; UDI "(01)00889024626454(11)240422(10)66742892(21)50066742892004" ; Lot No. 66742892 ; Serial No. 50066742892004 Model No. 60500010100 ; UDI "(01)00889024626454(11)240422(10)66742892(21)50066742892005" ; Lot No. 66742892 ; Serial No. 50066742892005 Model No. 60500010100 ; UDI "(01)00889024626454(11)240422(10)66742892(21)50066742892006" ; Lot No. 66742892 ; Serial No. 50066742892006 Model No. 60500010100 ; UDI "(01)00889024626454(11)240422(10)66742892(21)50066742892007" ; Lot No. 66742892 ; Serial No. 50066742892007 Model No. 60500010100 ; UDI "(01)00889024626454(11)240422(10)66742892(21)50066742892008" ; Lot No. 66742892 ; Serial No. 50066742892008 Model No. 60500010100 ; UDI "(01)00889024626454(11)240422(10)66742892(21)50066742892009" ; Lot No. 66742892 ; Serial No. 50066742892009 Model No. 60500010100 ; UDI "(01)00889024626454(11)240422(10)66742892(21)50066742892010" ; Lot No. 66742892 ; Serial No. 50066742892010 Model No. 60500010100 ; UDI "(01)00889024626454(11)240422(10)66742892(21)50066742892016" ; Lot No. 66742892 ; Serial No. 50066742892016 Model No. 60500010100 ; UDI "(01)00889024626454(11)240423(10)66742893(21)50066742893001" ; Lot No. 66742893 ; Serial No. 50066742893001 Model No. 60500010100 ; UDI "(01)00889024626454(11)240423(10)66742893(21)50066742893002" ; Lot No. 66742893 ; Serial No. 50066742893002 Model No. 60500010100 ; UDI "(01)00889024626454(11)240423(10)66742893(21)50066742893003" ; Lot No. 66742893 ; Serial No. 50066742893003 Model No. 60500010100 ; UDI "(01)00889024626454(11)240423(10)66742893(21)50066742893004" ; Lot No. 66742893 ; Serial No. 50066742893004 Model No. 60500010100 ; UDI "(01)00889024626454(11)240423(10)66742893(21)50066742893005" ; Lot No. 66742893 ; Serial No. 50066742893005 Model No. 60500010100 ; UDI "(01)00889024626454(11)240423(10)66742893(21)50066742893006" ; Lot No. … (truncated, 28020 characters total — see the official FDA record for the full value)
Recalling firm:
Zimmer Surgical Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 24, 2025

Medline medical convenience kits packaged as: SUTURE REMOVAL TRAY, Kit SKU DYNDR1277A

Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.

ALL 50 STATES
▸Full report

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

Recall #:
98284
Lot/product code:
UDI/DI 10195327379308, Lot Number 25EBO576
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 24, 2025

Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit

A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may result in hypoxia and/or respiratory failure related to partial or full airway obstruction. Airway obstruction may require immediate emergent medical intervention to prevent respiratory failure or death. Other potential outcomes include prolonged procedure, airway irritation, or prolonged dyspnea.

ALL 50 STATES
▸Full report

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

Recall #:
98285
Lot/product code:
Kit lot 48625040001 UDI (ea) 10080196033317 UDI (case) 40080196033318¿
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 24, 2025

Medline medical convenience kits packaged as: STERILE RESUTURE PACK, Kit SKU DYNDL1980A

Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.

ALL 50 STATES
▸Full report

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

Recall #:
98284
Lot/product code:
UDI/DI 10195327379292, Lot Number 25EBJ785
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 24, 2025

Medline medical convenience kits packaged as: ADULT CATH SECUREMENT DRSG, Kit SKU DYNDC3109

Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.

ALL 50 STATES
▸Full report

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

Recall #:
98284
Lot/product code:
UDI/DI 10193489918113, Lot Number 25EBD613
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 24, 2025

Medline medical convenience kits packaged as: ANESTHESIA ARTLINE PACK, Kit SKU DYNJ47387B

Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.

ALL 50 STATES
▸Full report

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

Recall #:
98284
Lot/product code:
UDI/DI 10193489217070, Lot Number 25EBJ414
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)