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Recalls affecting Hawaii

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

16,268 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 Mendietary 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 AliveMoringa 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. Braun0.9% 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/virusE. coliAnnounced September 3, 2026

Great ValueOrganic 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)
UnclassifiedAllergenMilkUndeclaredAnnounced August 31, 2026

Little TemptationsChocolatey 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)
UnclassifiedUndeclaredAnnounced August 31, 2026

LipofitLipofit 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

KofinasGarlic 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)
UnclassifiedBacteria/virusSalmonellaE. coliAnnounced August 29, 2026

Everything SproutsRobust 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

MartinaMangoes

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 January 20, 2026

Dynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%), 100 packets, 5" x 7", Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, USA Made in USA, NDC 67777-244-02

CGMP Deviations

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-0369-2026
Lot/product code:
Lot #: 52347-R, 52348-R, 52349-R, 52350-R, 52351-R, 52352-R, 53518, 53519, Exp. Date Mar 2027.
Recalling firm:
ACME UNITED CORPORATION
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 20, 2026

First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 50 Wipes, NDC 0924-7116-03.

CGMP Deviations

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-0359-2026
Lot/product code:
Lot #: MN34722, MN34722, Exp. Date Nov 2027; MN34722B, Exp. Date Aug 2027.
Recalling firm:
ACME UNITED CORPORATION
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 20, 2026

1) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5"x7" Piedmont Sanitizing Hand Wipes, 1,000 ea Bulk, Made in USA for: Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00. 2) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x 7" Touchpoint, 1000 ea Bulk, Made in USA for : Food Service Resources, Flowery Branch, GA 30542. NDC 0924-7130-00. 3) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x 7" Wellstar Cobb Hand Wipes, 1000 ea Bulk, Made in the USA for Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00. 4) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x 7" FSR Sanitizing Hand Wipes, 1000 ea Bulk, Made in USA for Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00. Inner Packaging - Instant Hand Sanitizing Wipes 5) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x7" Children's 1000 ea Bulk, Made in USA for: Food Service Resources, Flowery Branch, GA 30542 NDC 0924-713-00. Inner packaging -Children's Healthcare of Atlanta

CGMP Deviations

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-0362-2026
Lot/product code:
1) Lot #: MN22222, Exp. Date Jul 2027; MN05523, Exp. Date Jan 2028; MN32023, Exp. Date Oct 2028; MN15523, Exp. Date May 2028. 2) Lots MN11422B, MN11422, Exp. Date Mar 2027; MN03823, Exp. Date Jan 2028; MN09223 Exp. Date Mar 2028; MN32123, Exp. Date Oct 2028; MN20323, Exp. Date Jun 2028; MN30822 Exp. Date Oct 2027; MN304024, Exp. Date Dec 2028; MN13023, Exp. Date Apr 2028; MN12222 Exp. Date Apr 2027-Apr; MN16023, Exp. Date May 2028; MN27423, Exp. Date Aug 2028. 3) Lot #: MN304024, Exp. Date Dec 2028; MN13023, Exp. Date Apr 2028; MN12222, Exp. Date Apr 2027; MN16023, Exp. Date May 2028; MN27423, Exp. Date Aug2028. 4) Lot#: MN04423, Exp. Date Jan 2028; MN10022, Exp. Date Jul 2027; MN30722, Exp. Date Oct 2027; MN03523, Exp. Date Jan 2028; MN09323, Exp. Date Mar 2028; MN20223, Exp. Date July 2028; MN32223, Exp. Date Oct 2028 5) Lots MN12122 2027-Apr, MN27523 2028-Aug & MN30922 2027-Oct.
Recalling firm:
ACME UNITED CORPORATION
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 20, 2026

Dukal BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%) 1000 Packs per case, Manufactured For: Dukal, LLC, Ronkonkoma, NY 11779, Made in USA, NDC 65517-0004-1

CGMP Deviations

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-0360-2026
Lot/product code:
Lot #: MN31621, Exp. Date Oct 2026; MN14522, MN15522, Exp. Date Apr 2027; MN28122, MN31522, Exp. Date Sept 2027; MN04223, MN06023, Exp. Date Feb 2028; MN17223, Exp. Date May 2028; MN25123, Exp Date Aug 2028; MN33123, MN33523, Exp. Date Nov 2028.
Recalling firm:
ACME UNITED CORPORATION
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 20, 2026

GEM Premier 5000; Part No. 00055445010 & 00055445011.

Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.

ALL 50 STATES
Full report

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

Recall #:
98349
Lot/product code:
Part number: 00055445010; UDI: 08426950807810; Lots No.: 251023N, 251024J, 251114K, 251117A, 251117AC, 251117AE, 251117F, 251117I, 251117J, 251117Y, 251118A, 251119A, 251120U, 251121Q, 251121S, 251121T, 251121W, 251121X, 251124K, 251124O, 251124U, 251125I, 251126C, 251126D, 251202H, 251203L, 251203M, 251204R, 251204S, 251205K, 251205L, 251208J, 251208L, 251215D, 251215W, 251215X, 251216S, 251216V, 251217W, 251217X, 251218R, 251218Y, 251219B, 251219C, 251219E, 251219H, 251219I, 251219P, 251219Q, 251223B, 251223D, 251223F, 251223K, 251229AL, 251229D, 251229E, 251229F, 251229S, 251229U, 251230R, 251231B, 251231D, 251231E, 251231H, 251231M. Part number: 00055445011 UDI: 08426950807827 Kits distributed in US: 96 Lots No.: 251117L, 251118O, 251124K, 251125I, 251201X, 251202G, 251203M, 251204O, 251223K, 251229W, 251230A.
Recalling firm:
Instrumentation Laboratory
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 20, 2026

GEM Premier 5000; Model No. 00055430010.

Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.

ALL 50 STATES
Full report

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

Recall #:
98349
Lot/product code:
Part number: 00055430010; UDI: 08426950807759; Lots No.: 251021K, 251027AA, 251110AH, 251114K, 251114O, 251114P, 251114Y, 251117AA, 251117AC, 251117AG, 251117AM, 251117AN, 251117P, 251117T, 251117V, 251117Y, 251118A, 251118B, 251118R, 251118X, 251119A, 251120R, 251120U, 251121Q, 251124O, 251124Q, 251125I, 251126S, 251126T, 251126U, 251201W, 251201X, 251202G, 251202H, 251203L, 251204R, 251205L, 251208N, 251211W, 251215D, 251215Z, 251216O, 251216S, 251217L, 251217V, 251218AB, 251218B, 251218X, 251218Y, 251219A, 251219O, 251222AE, 251222E, 251222F, 251222K, 251222M, 251222P, 251222Z, 251223A, 251223B, 251223C, 251223I, 251223M, 251223O, 251229D, 251229E, 251229I, 251229S, 251231B, 251231G.
Recalling firm:
Instrumentation Laboratory
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 20, 2026

GEM Premier 5000; Part No. 00055430008.

Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.

ALL 50 STATES
Full report

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

Recall #:
98349
Lot/product code:
Part number: 00055430008; UDI: 08426950807735; Lots No.: 251106X, 251110AF, 251202P, 251203Q, 251215J, 251229AG, 251229X, 251230P.
Recalling firm:
Instrumentation Laboratory
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 20, 2026

GEM Premier 5000; Part No. 00055430004.

Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.

ALL 50 STATES
Full report

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

Recall #:
98349
Lot/product code:
Part number: 00055430004; UDI: 08426950807711; Lots No.: 251111O, 251113U, 251117AD, 251118D, 251119D, 251120X, 251124Z, 251125S, 251201AI, 251201AJ, 251202P, 251203Q, 251208AA, 251212O, 251215J, 251216K, 251217I, 251217J, 251218V, 251219R, 251222T, 251222U, 251223E, 251223P, 251229AG, 251229X, 251230P.
Recalling firm:
Instrumentation Laboratory
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 20, 2026

GEM Premier 5000; Part No: 00055415011.

Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.

ALL 50 STATES
Full report

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

Recall #:
98349
Lot/product code:
Part number: 00055415011; UDI: 08426950807704; Lots No.: 251215D.
Recalling firm:
Instrumentation Laboratory
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 20, 2026

GEM Premier 5000; Part No. 00055415010.

Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.

ALL 50 STATES
Full report

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

Recall #:
98349
Lot/product code:
Part number: 00055415010; UDI: 08426950807698; Lots No.: 251114J, 251114K, 251114L, 251117AA, 251117F, 251117I, 251117L, 251117T, 251118A, 251118B, 251118C, 251119A, 251119B, 251124K, 251126D, 251126M, 251126N, 251126U, 251201V, 251202E, 251202F, 251203L, 251204N, 251204R, 251205L, 251208J, 251211V, 251211W, 251215D, 251215W, 251216O, 251216W, 251217V, 251219A, 251219B, 251219N, 251219O, 251219P, 251219Q, 251219S, 251222AD, 251222AF, 251223D, 251229AL, 251229I, 251229K, 251229U, 251230A, 251230S, 251231B, 251231E, 251231I, 260102D, 260105A.
Recalling firm:
Instrumentation Laboratory
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 20, 2026

Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 packets, 5x7, Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962,USA, NDC 67777-245-01

CGMP Deviations

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-0375-2026
Lot/product code:
Lot #: 52347-R, 52348-R, 52349-R, 52350, 52351-R, 52352, Exp. Date Mar 2027; 53518, Exp. Date Jun 2027.
Recalling firm:
ACME UNITED CORPORATION
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 20, 2026

GEM Premier 5000; Part No. 00055415008.

Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.

ALL 50 STATES
Full report

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

Recall #:
98349
Lot/product code:
Part number: 00055415008; UDI: 08426950807674; Lots No. 251021P, 251106X, 251110AF, 251111O, 251113J, 251113V, 251117AD, 251118D, 251124Z, 251126Q, 251201AJ, 251202P, 251204T, 251212N, 251215J, 251215K, 251223E, 251229AG, 251229X.
Recalling firm:
Instrumentation Laboratory
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 20, 2026

Max Packaging Antibacterial Towelette (Benzalkonium Chloride 0.13%), 1 towelette, 4x7, Max Packaging, Made in the USA, NDC 59647-750-01

CGMP Deviations

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-0363-2026
Lot/product code:
Lot #: MN24523, Exp. Date July 2028; MN27123, Exp. Date Aug 2028; MN28223, Exp. Date Sep 2028.
Recalling firm:
ACME UNITED CORPORATION
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 20, 2026

GEM Premier 5000; Part No. 00055415005.

Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.

ALL 50 STATES
Full report

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

Recall #:
98349
Lot/product code:
Part number: 00055415005; UDI: 08426950807667; Lots No. 251125S, 251201AJ, 251212O, 251218V, 251229X.
Recalling firm:
Instrumentation Laboratory
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 20, 2026

GEM Premier 5000 PAK; Part No. 00055415004.

Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.

ALL 50 STATES
Full report

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

Recall #:
98349
Lot/product code:
Part number: 00055415004; UDI: 08426950807650; Lots No.: 251111O, 251112P, 251113U, 251117AD, 251118D, 251119D, 251120X, 251124Z, 251125S, 251201AI, 251202Q, 251203Q, 251208AA, 251209T, 251212O, 251216K, 251217I, 251217J, 251219R, 251222U, 251223E, 251229AG, 251229X, 251230P, 260102F.
Recalling firm:
Instrumentation Laboratory
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 20, 2026

GEM Premier 5000 PAK; Part No. 00055407511.

Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.

ALL 50 STATES
Full report

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

Recall #:
98349
Lot/product code:
Part number: 00055407511; UDI: 08426950807643; Lots No. 251114K, 251201X, 251215D.
Recalling firm:
Instrumentation Laboratory
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 20, 2026

GEM Premier 5000 PAK; Part No. 00055407504.

Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.

ALL 50 STATES
Full report

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

Recall #:
98349
Lot/product code:
Lot Code: Part number: 00055407504; UDI: 08426950807537; Lots No.: 251111O, 251112P, 251113U, 251114T, 251117AD, 251118D, 251119D, 251120X, 251125S, 251126Q, 251201AI, 251202Q, 251203Q, 251204T, 251209T, 251212O, 251215K, 251216K, 251217I, 251218U, 251219R, 251222U, 251223E, 251223P, 251229AG, 251229X, 251230P, 251231F.
Recalling firm:
Instrumentation Laboratory
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 20, 2026

GEM Premier 5000 PAK; Part No. 00055360011.

Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.

ALL 50 STATES
Full report

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

Recall #:
98349
Lot/product code:
Part number: 00055360011; UDI: 08426950807605; Lots No.: 251119A.
Recalling firm:
Instrumentation Laboratory
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 20, 2026

Cleansing Towelette (Benzalkonium Chloride 0.13%), 5"x 7", 1,000 case/Bulk, Med-Nap, Brooksville, FL 34601, Made in USA, NDC 0924-0243-00.

CGMP Deviations

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-0370-2026
Lot/product code:
Lot #: MN15923, Exp. Date May 2028; MN25822, Exp. Date Aug 2027.
Recalling firm:
ACME UNITED CORPORATION
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 20, 2026

Children's Healthcare of Atlanta, Instant Hand Sanitizing Wipe(Benzalkonium Chloride 0.13%), 1000 per case, Made in USA for Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00

CGMP Deviations

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-0377-2026
Lot/product code:
Lot #: MN12122, Exp. Date Apr 2027; MN27523, Exp. Date Aug 2028; MN30922, Exp. Date Oct 2027.
Recalling firm:
ACME UNITED CORPORATION
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 20, 2026

Atellica CH Urine Albumin (UAlb). Material Number: 11537225

Falsely depressed UAlb patient results may occur. Affected samples with any urine albumin concentration above the UAlb measuring interval >40.0 mg/dL may report values between 6.2 mg/dL and 40.0 mg/dL.

ALL 50 STATES
Full report

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

Recall #:
98370
Lot/product code:
Material Number: 11537225. UDI-DI: 00630414611099. Lot Numbers: All lot numbers.
Recalling firm:
Siemens Healthcare Diagnostics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 20, 2026

GEM Premier 5000 PAK; Part No. 00055360010.

Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.

ALL 50 STATES
Full report

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

Recall #:
98349
Lot/product code:
Part number: 00055360010; UDI: 08426950807599; Lots No.: 251023N, 251024I, 251103I, 251117T, 251118B, 251120R, 251124O, 251126E, 251201X, 251202E, 251202G, 251203H, 251204O, 251205L, 251205N, 251208C, 251208G, 251209Q, 251209R, 251215Y, 251217V, 251218AA, 251218T, 251219M, 251222AE, 251222AF, 251222AG, 251222E, 251222F, 251223R, 251223S, 251229H, 251229J, 251229U, 251230A, 251231E, 251231K, 251231L.
Recalling firm:
Instrumentation Laboratory
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 20, 2026

GEM Premier 5000 PAK; Part No. 00055407508.

Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.

ALL 50 STATES
Full report

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

Recall #:
98349
Lot/product code:
Part number: 00055407508; UDI: 08426950807612; Lots No.: 251021P, 251106X, 251110AF, 251201AJ, 251202P, 251209S, 251212N, 251215J, 251218W, 251219A, 251223E, 251223M, 251223P, 251229X, 260102F.
Recalling firm:
Instrumentation Laboratory
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 20, 2026

cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464502001 cobas pro SSU, material number 09205632001 Affected Assays: (Product Name/ Catalog Number/ Application Code/ Application Short Name) 1. Cystatin C Gen.2 08105596190 20510 CYSC2 2. Ferritin Gen.4 08057648190 20571 FER4X 3. Lipoprotein (a) Gen.2 08106126190 20861 LPA2X 4. Lipoprotein (a) molarity 08106126160 20864 LPA2-X 5. Vancomycin Gen.3 08058849190 21211 VANC3O 6. Kappa Free Light Chains Partner Channel 08896640190 21421 KFLCX 7. Lambda Free Light Chains Partner Channel 08896631190 21430 LFLC 8. fCAL turbo Partner Channel 08910367190 21490 FCAL

Software defect, which allows the system to accept erroneous, non-monotonous calibrations for Spline-type assays. Cobas pro integrated solutions is an automated analyzer, intended for running qualitative, semi-quantitative and quantitative clinical chemistry and immunochemistry assays, as well as ion-selective measurements. When an erroneous calibration is active, the instrument fails to calculate new values and instead repeats the last successfully calculated result from any Spline-type assay for all subsequent measurements, leading to identical and erroneous patient and QC results. The defect could lead to patients receiving erroneous lab results, which could result in a remote risk of serious adverse health consequences. The following assays use spline type calibration and are affected by this issue: Cystatin C Gen.2, Ferritin Gen.4, Lipoprotein (a) Gen. 2, Lipoprotein (a) molarity, Vancomycin Gen.3, Kappa Free Light Chains Partner Channel, Lambda Free Light Chains Partner Channel, and fCAL turbo Partner Channel.

ALL 50 STATES
Full report

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

Recall #:
98347
Lot/product code:
cobas pro sample supply unit, UDI-DI 07613336158852 cobas pro SSU, UDI-DI 07613336179499 all software versions previous to 03-02
Recalling firm:
Roche Diagnostics Operations, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 20, 2026

Antimicrobial Alcohol Hand Wipe, Isopropyl Alcohol 70%, Manufactured for : Custom Packaging Co., Inc, Louisville, KY 4023, NDC 0924-251-00.

CGMP Deviations

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-0378-2026
Lot/product code:
Lot #: MN15423 , MN16422, Exp. Date Apr 2027-Apr; MN26322, MN26322, Exp. Date Aug 2027; MN03423, MN03423, Exp. Date Jan 2028; MN09722, Exp. Date Mar 2027; MN31722, Exp. Date Oct 2027; MN15722, MN13722 Exp. Date Apr 2027; MN31722, Exp. Date Oct 2027; MN09722, Exp. Date Mar 2027.
Recalling firm:
ACME UNITED CORPORATION
View official FDA record (opens in a new tab)