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Recalls affecting Alabama

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

16,859 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

▸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 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)
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

▸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 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
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; 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)
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. 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)
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; 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 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

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; Part No. 00055445008.

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: 00055445008; UDI: 08426950807797; Lots No.: 251103J, 251110AF, 251111O, 251117AD, 251201AJ, 251202P, 251202Q, 251215K.
Recalling firm:
Instrumentation Laboratory
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; Part No. 00055430011.

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: 00055430011; UDI: 08426950807766; Lots No.: 251114K, 251205K, 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. 00055445004.

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: 00055445004; UDI: 08426950807773; Lots No. 251111O, 251117AD, 251124Z, 251125S, 251202P, 251204T, 251208AA, 251212O, 251216K, 251217I, 251223E, 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 PAK, Part No. 00055360004.

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: 00055360004; UDI: 08426950899662; Lot No. 251113U, 251201AI, 251202Q, 251223E, 251223P, 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. 00055407510.

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: 00055407510; UDI: 08426950807636; Lots No.: 251114J, 251117AC, 251117T, 251118B, 251119B, 251121P, 251124O, 251124Q, 251126E, 251201U, 251201V, 251201W, 251202G, 251203H, 251203L, 251204N, 251204O, 251205L, 251208I, 251208J, 251215Y, 251215Z, 251216V, 251217L, 251217X, 251218AA, 251218Y, 251219G, 251219M, 251219N, 251219S, 251222E, 251223D, 251223I, 251223N, 251223O, 251229J, 251229L, 251229U, 251231E.
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. 00055360008.

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: 00055360008; UDI: 08426950807575; Lot No. 251021P, 251113U, 251117AD, 251204T, 251222U, 251223E, 251229AG, 251229X.
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.

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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

Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5x7, 1000 packets, 5x7, Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962,USA, NDC 67777-245-04.

CGMP Deviations

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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-0376-2026
Lot/product code:
Lot #: 53518, 53519, Exp. Date Jun 2027.
Recalling firm:
ACME UNITED CORPORATION
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 20, 2026

Med Nap BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, Manufactured by: Acme United Corporation, 1 Waterview Dr, Shelton, CT 06481, NDC 0924-0246-01.

CGMP Deviations

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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-0366-2026
Lot/product code:
Lot #: MN09322, Exp. Date Mar 2027; MN15222, Exp. Date May 2027; MN21622, Exp. Date Jul 2027; MN31822, Exp. Date Oct 2027; MN06223, MN06323, Exp. Date Feb 2028; MN12523, Exp. Date Apr 2028; MN16123, Exp. Date May 2028; MN20523, MN20623, MN20723, Exp. Date Jun 2028; MN23223, Exp. Date Jul 2028; MN31123, Exp. Date Oct 2028; MN300524, MN300624 MN302624, MN302724, MN303324, Exp. Date Dec 2028.
Recalling firm:
ACME UNITED CORPORATION
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodUndeclaredRecalled January 17, 2026

VEGETARIAN CHICKEN FLAVOR RAMEN Express Net wt 3oz (85g) Ingredients: Enriched unbleached flour (wheat flour***) Palm oil***" Contains: Wheat, Soy. UPC 8 10037 81004 2 Produced by PALMETTO GOURMET FOODS, INC SALUDA, SC 29138

Product contains not listed on the label Yellow #5

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

Recall #:
H-0548-2026
Lot/product code:
All products with Best By Date before 01/15/2027
Recalling firm:
Palmetto Gourmet Foods Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodUndeclaredRecalled January 17, 2026

VEGETARIAN CHICKEN FLAVOR RAMEN Express Net wt 3oz (85g) Ingredients: Enriched unbleached flour (wheat flour***) Vegetable oil***" Contains: Wheat, Soy. UPC 8 10037 81061 5 Produced by PALMETTO GOURMET FOODS, INC SALUDA, SC 29138

Product contains not listed on the label Yellow #5

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

Recall #:
H-0547-2026
Lot/product code:
All products with Best By Date before 01/15/2027
Recalling firm:
Palmetto Gourmet Foods Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 16, 2026

Thyroid, USP, Rx only, Net Wt: 0.50kg, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-100-02

Weaker than it should be Drug

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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-0294-2026
Lot/product code:
Lot #H22254-1XV; Exp. 01/31/2027
Recalling firm:
Specialty Process Labs LLC
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled January 16, 2026

UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, Manufactured by Accord BioPharma, Inc., 8041 Arco Corporate Drive, Suite 200, Raleigh, NC 27617, NDC 69448-025-63

Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the required refrigerated environment.

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

Recall #:
D-0353-2026
Lot/product code:
Subset of Lot 2199821, Expires: 05/31/2027 Specific Serial Numbers being Recalled: 160R694TT06X; 1C74A686RPPG; 1W6A2M777N3V; 20825394KR8P; 242E2RK3EA92; 2DG49VH89EPG; 2WEA2ADK1P4H; 3KR2TVAG3VDH; 42M0V0G9PM84; 46E9XKDPTH1R; 4AM12WEAE48H; 4FGHR096DMNV; 4MWGWM991XNA; 4NEW8XD9DNM2; 4Y2PYDFN9YA1; 61EPX42R4K2A; 63FN9VW5CAV7; 69TG160DW2CV; 69XFP3TMTP7X; 6AWVDCNHTV61; 6CEFY72W5GPA; 6FHF1A59X0X4; 6GA64FNDVGXY; 6NW5FACPPWDW; 75V19CF2A0PA; 7HK7155YNAK3; 7R51VVA1WX9T; 7XCKXMH2EERC; 85D8MFVM66D4; 8F3Y5NFFHC64; 8RDWKPM53N5R; 8W1PVXC5NAFW; 9338DPED7P3R; 9A4CXFTGCPYN; 9FKN5NRDX99A; 9G79AR0RGAY4; 9K28G80GGYXN; 9NN7NXE40M13; A48PXEPE77YE; A8M168K58G64; AMR0RNWHTWMW; AR145NW8WTVX; AY19W6DEGRX4; C276HMDGRE49; CAY0ARAEGMCF; CKT370X2G4NP; D0DFAXCN6G5W; D54TXR8AD9Y8; DAK3XP1P3DMP; DH44AGKTX27F; E69E9K6C29VD; EK1D8P703RCH; EX947FYVW7Y6; F2K148YVNRDD; F4EVX8573F1V; FEXA7MENKWF1; FNDNMPAFH89D; G2W3WTMP5HK9; G5MN0F418FFY; G6XECANG6P01; G7FNVGWW3D72; GAHFFNX336GA; GKNTDP4AV6AA; GVPN5C4D23H6; GVPPYARK1FCD; GVXDAAA87GA1; GX7AP73W4HMH; HDTFT2W59K52; HDVG3W6VW59Y; HP703MKWGGM7; K8CGDV1301TP; KN6Y35T0A198; KVGC92YVC6XF; KYCP1Y7CK4R4; MEY2VW5MC0N9; MGH40F2679X3; N11XGETGDAVM; N9DGTY65NFGN; NH9VM1K2ECGP; NNCFT59RD1KF; NVFCXRWHX93N; P3XY0RNV0VPY; P609NH6W670V; P9Y7926YN82A; PA88CCXMWCMG; PKADTN18YR1X; PM0YHNNK6P4T; R11TYM5VE9CK; R45AXAEK4TTN; R6C3533P943P; RMW35MXX4R4K; RX75F9DA58W4; RXRCRP9272DG; RXTH041DMT5D; T2FW4C24F364; T442NHDFD7H8; TC3443DCR4F8; TK8TRR8NT92A; TT8K21TGYFWY; V255NE533X59; V6MYKEA7HN7P; V764DEYM4RYP; VCPTYV1EF0R1; VECGDTDV1Y3A; VEE09A07R9X5; VEER64AW2C51; VRN2TE3HPK5N; WF14WA03FNT2; WTP5TKRGNFGW; WWPMXV50FRM4; X1DKP0T2AE1W; X59C5AV3VDTG; XKG3T7811TD2; Y0CYY950EYK8; YCRW0EPK620Y; YNYA64T18DPW.
Recalling firm:
McKesson
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 16, 2026

Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.

Issue with software algorithm which may lead to overpressure events.

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

Recall #:
98243
Lot/product code:
Model Number: UHI-2; UDI-DI: N/A; All Serial Numbers
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 16, 2026

MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE LEPTOSPERMUM HONEY supports and aids autolytic debridement and is indicated for the management of moderately to heavily exuding wounds

Potential packaging failures, which could lead to a breach in the sterile barrier.

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

Recall #:
98175
Lot/product code:
(1) Model Number: 31012; UDI-DI: 10381780486909; Lot numbers: A24008, A24057, B21123, B24075, C22159, C23177, C24148, D24190, E21365, E24254, E24255, G23393, H21523, H22452, H23443, I22512, I23464, J21693, L22706. (2) Model Number: 31022; UDI-DI: 10381780486916; Lot numbers: A23045, A23065, A25028, A25056, B23079, B25068, B25077, C21151, C21152, C21155, C21195, C22182, C22196, C23183, C23193, C25152, D23196, D23208, E21300, E22305, E22319, F21407, F21428, F21430, F22333, F24317, G23405, H21544, H22438, H23415, H23442, H23446, H24415, I21610, I21617, J22530 , J23551, J23560, J24622, K21723, K21739, K24625, K24646, L21838. (3) Model Number: 31045; UDI-DI: 10381780486923; Lot numbers: A21056, A22036, A22047, A24036, B21062, B21084, B21100, B21107, B21119, B25110, D21229, D21247, D22251, D22270, D22275, D23236, D23248, D24192, D24220, E21314, E21337, E21361, E22277, E23253, E23271, E24296, F21376, F22361, F22362, F22382, F23369, F23370, G21490, G21504, G22385, G23384, H21506, H21512, H21530, H23450, H23451, I22479, I22481, I22495, I23466, I23498, I24511, I24523, J21680, J21691, K21777, K21801, K21806, K22597, K22609, K22632, K22663, K24650, K24679, L21812, L21823, L22674, L22711, L23649.
Recalling firm:
Integra LifeSciences Corp. (NeuroSciences)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 16, 2026

GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047; System, Image Processing, Radiological

Under certain workflows, patient information shown in the viewer may not match the images displayed on Centricity Universal Viewer Zero Footprint Client (ZFP) with versions ZFP v6.0: SP11.6, SP11.6.0.1 and SP11.6.1 on systems with Patient Timeline installed,

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

Recall #:
98368
Lot/product code:
1) 2110344-039, UDI/DI 00840682102988, System ID Numbers: 105906-2-Centricity Universal Viewer Zero Footprint / ZFP-02312614, 4491-1-Centricity Universal Viewer Zero Footprint / ZFP-22180897, 10908-1-Centricity Universal Viewer Zero Footprint / ZFP-25199248, 10908-7-Centricity Universal Viewer Zero Footprint / ZFP-22203146, 10908-7-Centricity Universal Viewer Zero Footprint / ZFP-25188736, 4263-3-Centricity Universal Viewer Zero Footprint / ZFP-00106869, 4263-3-Centricity Universal Viewer Zero Footprint / ZFP-00106870, 4263-5-Centricity Universal Viewer Zero Footprint / ZFP-01300798, 3064-15-Centricity Universal Viewer Zero Footprint / ZFP-25222931, 3064-15-Centricity Universal Viewer Zero Footprint / ZFP-25248683, 3064-15-Centricity Universal Viewer Zero Footprint / ZFP-25248688, 3064-15-Centricity Universal Viewer Zero Footprint / ZFP-25248690, 3064-15-Centricity Universal Viewer Zero Footprint / ZFP-25248695, 3064-15-Centricity Universal Viewer Zero Footprint / ZFP-25248713, 3064-15-Centricity Universal Viewer Zero Footprint / ZFP-25248716, 3064-15-Centricity Universal Viewer Zero Footprint / ZFP-26608643, 10458-9-Centricity Universal Viewer Zero Footprint / ZFP-26580437, 10458-9-Centricity Universal Viewer Zero Footprint / ZFP-26694204, 10458-9-Centricity Universal Viewer Zero Footprint / ZFP-26694229, 105197-2-Centricity Universal Viewer Zero Footprint / ZFP-20813950, 4642-6-Centricity Universal Viewer Zero Footprint / ZFP-25210052, 4642-6-Centricity Universal Viewer Zero Footprint / ZFP-25210057, 4642-6-Centricity Universal Viewer Zero Footprint / ZFP-25210107, 103829-6-Centricity Universal Viewer Zero Footprint / ZFP-20900298, 103829-6-Centricity Universal Viewer Zero Footprint / ZFP-21180523, 103829-6-Centricity Universal Viewer Zero Footprint / ZFP-21180525, 3212-5-Centricity Universal Viewer Zero Footprint / ZFP-26390526, 3212-5-Centricity Universal Viewer Zero Footprint / ZFP-26694221, 3212-5-Centricity Universal Viewer Zero Footprint / ZFP-26694222, 10360-3-Centricity Universal Viewer Zero Footprint / ZFP-24463042, 10360-3-Centricity Universal Viewer Zero Footprint / ZFP-25239139, 10360-3-Centricity Universal Viewer Zero Footprint / ZFP-25239140, 10360-3-Centricity Universal Viewer Zero Footprint / ZFP-26714200, 10360-3-Centricity Universal Viewer Zero Footprint / ZFP-26714202, 3471-36-Centricity Universal Viewer Zero Footprint / ZFP-24399434, 3471-36-Centricity Universal Viewer Zero Footprint / ZFP-26295812, 1198-18-Centricity Universal Viewer Zero Footprint / ZFP-02348419, 1198-18-Centricity Universal Viewer Zero Footprint / ZFP-18990433, 1198-78-Centricity Universal Viewer Zero Footprint / ZFP-22223452, 100581-1-Centricity Universal Viewer Zero Footprint / ZFP-25168130, 8746-1-Centricity Universal Viewer Zero Footprint / ZFP-23900206, 8746-1-Centricity Universal Viewer Zero Footprint / ZFP-21318104, 1207-14-Centricity Universal Viewer Zero Footprint / ZFP-24836084, 2123-19-Centricity Universal Viewer Zero Footprint / ZFP-24836053, 102901-1-Centricity Universal Viewer Zero Footprint / ZFP-23251238, 3922-17-Centricity Universal Viewer Zero Footprint / ZFP-00098229, 3922-18-Centricity Universal Viewer Zero Footprint / ZFP-24466083, 3922-18-Centricity Universal Viewer Zero Footprint / ZFP-26132903, 3922-18-Centricity Universal Viewer Zero Footprint / ZFP-26132895, 3922-18-Centricity Universal Viewer Zero Footprint / ZFP-24466076, 3922-18-Centricity Universal Viewer Zero Footprint / ZFP-24466077, 3922-18-Centricity Universal Viewer Zero Footprint / ZFP-24466078, 3922-18-Centricity Universal Viewer Zero Footprint / ZFP-24466079, 3922-18-Centricity Universal Viewer Zero Footprint / ZFP-24466088, 3922-18-Centricity Universal Viewer Zero Footprint / ZFP-00098228, 103696-33-Centricity Universal Viewer Zero Footprint / ZFP-20098431, 103696-4-Centricity Universal Viewer Zero Footprint / ZFP-20036715, 4578-1-Centricity Universal Viewer Zero Footprint / ZFP-25014571, 100468-1-Centricity Universal Viewer Zero Footprint / ZFP-24480189, 2440-1-Centricity Universal Viewer Zero Footprint / ZFP-22206970, 613493-Centricity Universal Viewer Zero Footprint / ZFP-26356112, 672721-Centricity Universal Viewer Zero Footprint / ZFP-25151288, 313741-Centricity Universal Viewer Zero Footprint / ZFP-26548614, 101223-6-Centricity Universal Viewer Zero Footprint / ZFP-20569855, 101223-22-Centricity Universal Viewer Zero Footprint / ZFP-20575531, 101223-22-Centricity Universal Viewer Zero Footprint / ZFP-20575532, 101223-22-Centricity Universal Viewer Zero Footprint / ZFP-20575543, 101223-16-Centricity Universal Viewer Zero Footprint / ZFP-20575533, 101223-16-Centricity Universal Viewer Zero Footprint / ZFP-20575535, 283039-Centricity Universal Viewer Zero Footprint / ZFP-02283242, 283039-Centricity Universal Viewer Zero Footprint / ZFP-02170574, 283039-Centricity Universal Viewer Zero Footprint / ZFP-01819807, 104894-1-Centricity Universal Viewer Zero Footprint / ZFP-01225123, 104894-1-Centricity Universal Viewer Zero Footp… (truncated, 16946 characters total — see the official FDA record for the full value)
Recalling firm:
GE Healthcare
View official FDA record (opens in a new tab)