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Recalls affecting Oregon

Data last updated: September 11, 2026 at 1:08 PM UTC

16,620 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
UnclassifiedRisk not yet known
Medical deviceRecalled November 24, 2021

Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in preparation for sterilization of re-usable instruments required for implanting the Triathlon Globalization Implant System for individual patients receiving primary total knee arthroplasty (TKA). Catalog# 6541-9-109

Triathlon Pro Tibial Preparation Tray may have been kitted with the Triathlon Cemented #1-3 Keel Punch (P/N: 6541-2-013) instead of the Triathlon Pro #0-3 Cemented Keel Punch (P/N: 6541-2-013Y) instrument can lead to delay in surgery or if used could lead to unintended bone preparation

ALL 50 STATES
Full report

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

Recall #:
89190
Lot/product code:
Lots #: 0552101A596, 0552101A602 GTIN#: 07613327461503
Recalling firm:
Howmedica Osteonics Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 26, 2021

Infa-Therm Transport Mattress, Reference Number 989805616831 1015

After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance.

ALL 50 STATES
Full report

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

Recall #:
89173
Lot/product code:
All units are impacted
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 29, 2021

Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T

After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance.

ALL 50 STATES
Full report

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

Recall #:
89163
Lot/product code:
All units are impacted
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 29, 2021

Medichoice Infant Heel Warmer, Reference # 989805643721 1079906

After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance.

ALL 50 STATES
Full report

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

Recall #:
89163
Lot/product code:
All units are impacted
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 29, 2021

Infant Heel Warmers w/strap, Reference # 989805603201 1223

After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance.

ALL 50 STATES
Full report

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

Recall #:
89163
Lot/product code:
All units are impacted
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 29, 2021

Heel Snuggler, Reference # 989805603411 99047

After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance.

ALL 50 STATES
Full report

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

Recall #:
89163
Lot/product code:
All units are impacted
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 30, 2021

Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-997-64

Stronger than it should be Drug: Minimally stronger than it should be

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-0296-2022
Lot/product code:
Lot #: 15594, Exp Date 05/2023
Recalling firm:
Teligent Pharma, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 30, 2021

activforce 2 package labeling: Model: Activ5-M R 201-200563

Due to: 1) Manufacturing issue that result in inaccurate force measurement which may lead to may potential lead to incorrect treatment planning. 2) Firm failing to register and list its medical devices with U.S. Food and Drug Administration.

Full report

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

Recall #:
89070
Lot/product code:
Activforce 2 Serial Numbers: 5M1011012046AK7655 5M1011012046AK7556 5M1011012046AK7557 5M1011012046AK7559 5M1011012046AK7560 5M1011012046AK7561 5M1011012046AK7562 5M1011012046AK7563 5M1011012046AK7564 5M1011012046AK7565 5M1011012046AK7566 5M1011012046AK7567 5M1011012046AK7568 5M1011012046AK7569 5M1011012046AK7570 5M1011012046AK7571 5M1011012046AK7572 5M1011012046AK7573 5M1011012046AK7574 5M1011012046AK7575 5M1011012046AK7576 5M1011012046AK7577 5M1011012046AK7578 5M1011012046AK7579 5M1011012046AK7580 5M1011012046AK7581 5M1011012046AK7582 5M1011012046AK7583 5M1011012046AK7584 5M1011012046AK7585 5M1011012046AK7586 5M1011012046AK7587 5M1011012046AK7588 5M1011012046AK7589 5M1011012046AK7590 5M1011012046AK7591 5M1011012046AK7592 5M1011012046AK7593 5M1011012046AK7594 5M1011012046AK7595 5M1011012046AK7596 5M1011012046AK7597 5M1011012046AK7598 5M1011012046AK7599 5M1011012046AK7600 5M1011012046AK7601 5M1011012046AK7602 5M1011012046AK7603 5M1011012046AK7604 5M1011012046AK7605 5M1011012046AK7606 5M1011012046AK7607 5M1011012046AK7608 5M1011012046AK7609 5M1011012046AK7610 5M1011012046AK7611 5M1011012046AK7612 5M1011012046AK7613 5M1011012046AK7614 5M1011012046AK7615 5M1011012046AK7616 5M1011012046AK7617 5M1011012046AK7618 5M1011012046AK7619 5M1011012046AK7620 5M1011012046AK7621 5M1011012046AK7622 5M1011012046AK7623 5M1011012046AK7624 5M1011012046AK7625 5M1011012046AK7626 5M1011012046AK7627 5M1011012046AK7628 5M1011012046AK7629 5M1011012046AK7630 5M1011012046AK7631 5M1011012046AK7632 5M1011012046AK7633 5M1011012046AK7634 5M1011012046AK7635 5M1011012046AK7636 5M1011012046AK7637 5M1011012046AK7638 5M1011012046AK7639 5M1011012046AK7640 5M1011012046AK7641 5M1011012046AK7642 5M1011012046AK7643 5M1011012046AK7644 5M1011012046AK7645 5M1011012046AK7646 5M1011012046AK7647 5M1011012046AK7648 5M1011012046AK7649 5M1011012046AK7650 5M1011012046AK7651 5M1011012046AK7652 5M1011012046AK7653 5M1011012046AK7654 5M1011012102AL7776 5M1011012102AL7777 5M1011012102AL7778 5M1011012102AL7779 5M1011012102AL7780 5M1011012102AL7781 5M1011012102AL7783 5M1011012102AL7784 5M1011012102AL7785 5M1011012102AL7786 5M1011012102AL7787 5M1011012102AL7788 5M1011012102AL7789 5M1011012102AL7790 5M1011012102AL7791 5M1011012102AL7792 5M1011012102AL7793 5M1011012102AL7794 5M1011012102AL7795 5M1011012102AL7796 5M1011012102AL7797 5M1011012102AL7798 5M1011012102AL7799 5M1011012102AL7800 5M1011012102AL7801 5M1011012102AL7802 5M1011012102AL7803 5M1011012102AL7804 5M1011012102AL7805 5M1011012102AL7806 5M1011012102AL7807 5M1011012102AL7808 5M1011012102AL7809 5M1011012102AL7810 5M1011012102AL7811 5M1011012102AL7812 5M1011012102AL7813 5M1011012102AL7814 5M1011012102AL7815 5M1011012102AL7816 5M1011012102AL7817 5M1011012102AL7818 5M1011012102AL7819 5M1011012102AL7820 5M1011012102AL7821 5M1011012102AL7822 5M1011012102AL7823 5M1011012102AL7824 5M1011012102AL7825 5M1011012102AL7826 5M1011012102AL7827 5M1011012102AL7828 5M1011012102AL7829 5M1011012102AL7830 5M1011012102AL7831 5M1011012102AL7832 5M1011012102AL7833 5M1011012102AL7834 5M1011012102AL7835 5M1011012102AL7836 5M1011012102AL7837 5M1011012102AL7838 5M1011012102AL7839 5M1011012102AL7840 5M1011012102AL7841 5M1011012102AL7842 5M1011012102AL7843 5M1011012102AL7844 5M1011012102AL7845 5M1011012102AL7846 5M1011012102AL7847 5M1011012102AL7848 5M1011012102AL7849 5M1011012102AL7850 5M1011012102AL7851 5M1011012102AL7852 5M1011012102AL7853 5M1011012102AL7854 5M1011012102AL7855 5M1011012102AL7856 5M1011012102AL7857 5M1011012102AL7858 5M1011012102AL7859 5M1011012102AL7860 5M1011012102AL7861 5M1011012102AL7862 5M1011012102AL7863 5M1011012102AL7864 5M1011012102AL7865 5M1011012102AL7866 5M1011012102AL7867 5M1011012102AL7868 5M1011012102AL7869 5M1011012102AL7870 5M1011012102AL7871 5M1011012102AL7872 5M1011012102AL7873 5M1011012102AL7874 5M1011012102AL7875 5M1011012102AL7876 5M1011012102AL7877 5M1011012102AL7878 5M1011012102AL7879 5M1011012102AL7880 5M1011012102AL7881 5M1011012102AL7882 5M1011012102AL7883 5M1011012102AL7884 5M1011012102AL7885 5M1011012102AL7886 5M1011012102AL7887 5M1011012102AL7888 5M1011012102AL7889 5M1011012102AL7890 5M1011012102AL7891 5M1011012102AL7892 5M1011012102AL7893 5M1011012102AL7894 5M1011012102AL7895 5M1011012102AL7896 5M1011012102AL7897 5M1011012102AL7898 5M1011012102AL7899 5M1011012102AL7900 5M1011012102AL7901 5M1011012102AL7902 5M1011012102AL7903 5M1011012102AL7904 5M1011012102AL7905 5M1011012102AL7906 5M1011012102AL7907 5M1011012102AL7908 5M1011012102AL7909 5M1011012102AL7910 5M1011012102AL7911 5M1011012102AL7912 5M1011012102AL7913 5M1011012102AL7914 5M1011012102AL7915 5M1011012102AL7916 5M1011012102AL7917 5M1011012102AL7918 5M1011012102AL7919 5M1011012102AL7920 5M1011012102AL7921 5M1011012102AL7922 5M1011012102AL7923 5M1011012102AL7924 5M1011012102AL7925 5M1011012102AL7926 5M1011012102AL7927 5M1011012102AL7928 5M1011012102AL7929 5M1011012102AL7930 5M1011012102AL7931 5M1011012102AL7932 5M1011012102AL7933 5M1011012102AL7934 5M1011012102AL7935 5M1011012102AL7936 5M1011012102AL7937 5M1011012102AL7938 5M1011012102… (truncated, 150280 characters total — see the official FDA record for the full value)
Recalling firm:
Activbody, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 30, 2021

Box Label: activ5 TINY GYM IN YOUR POCKET activbody Model: Activ5 User Manual: ACTIV5 USER MANUAL Welcome to Activ5, the first isometrics-based smart strength training and rehabilitation device.

Due to: 1) Manufacturing issue that result in inaccurate force measurement which may lead to may potential lead to incorrect treatment planning. 2) Firm failing to register and list its medical devices with U.S. Food and Drug Administration.

Full report

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

Recall #:
89070
Lot/product code:
Activforce Kit Number: AB0000-AC5540 Serial Numbers: 5P1011011708AB0000 5P1011011708AB0001 5P1011011708AB0002 5P1011011708AB0003 5P1011011708AB0004 5P1011011708AB0005 5P1011011708AB0006 5P1011011708AB0007 5P1011011708AB0008 5P1011011708AB0009 5P1011011708AB0010 5P1011011708AB0011 5P1011011708AB0012 5P1011011708AB0013 5P1011011708AB0014 5P1011011708AB0015 5P1011011708AB0016 5P1011011708AB0017 5P1011011708AB0018 5P1011011708AB0019 5P1011011708AB0020 5P1011011708AB0021 5P1011011708AB0022 5P1011011708AB0023 5P1011011708AB0024 5P1011011708AB0025 5P1011011708AB0026 5P1011011708AB0027 5P1011011708AB0028 5P1011011708AB0029 5P1011011708AB0030 5P1011011708AB0031 5P1011011708AB0032 5P1011011708AB0033 5P1011011708AB0034 5P1011011708AB0035 5P1011011708AB0036 5P1011011708AB0037 5P1011011708AB0038 5P1011011708AB0039 5P1011011708AB0040 5P1011011708AB0041 5P1011011708AB0042 5P1011011708AB0043 5P1011011708AB0044 5P1011011708AB0045 5P1011011708AB0046 5P1011011708AB0047 5P1011011708AB0048 5P1011011708AB0049 5P1011011708AB0050 5P1011011708AB0051 5P1011011708AB0052 5P1011011708AB0053 5P1011011708AB0054 5P1011011708AB0055 5P1011011708AB0056 5P1011011708AB0057 5P1011011708AB0058 5P1011011708AB0059 5P1011011708AB0060 5P1011011708AB0061 5P1011011708AB0062 5P1011011708AB0063 5P1011011708AB0064 5P1011011708AB0065 5P1011011708AB0066 5P1011011708AB0067 5P1011011708AB0068 5P1011011708AB0069 5P1011011708AB0070 5P1011011708AB0071 5P1011011708AB0072 5P1011011708AB0073 5P1011011708AB0074 5P1011011708AB0075 5P1011011708AB0076 5P1011011708AB0077 5P1011011708AB0078 5P1011011708AB0079 5P1011011708AB0080 5P1011011708AB0081 5P1011011708AB0082 5P1011011708AB0083 5P1011011708AB0084 5P1011011708AB0085 5P1011011708AB0086 5P1011011708AB0087 5P1011011708AB0088 5P1011011708AB0089 5P1011011708AB0090 5P1011011708AB0091 5P1011011708AB0092 5P1011011708AB0093 5P1011011708AB0094 5P1011011708AB0095 5P1011011708AB0096 5P1011011708AB0097 5P1011011708AB0098 5P1011011708AB0099 5P1011011708AB0100 5P1011011708AB0101 5P1011011708AB0102 5P1011011708AB0103 5P1011011708AB0104 5P1011011708AB0105 5P1011011708AB0106 5P1011011708AB0107 5P1011011708AB0108 5P1011011708AB0109 5P1011011708AB0110 5P1011011708AB0111 5P1011011708AB0112 5P1011011708AB0113 5P1011011708AB0114 5P1011011708AB0115 5P1011011708AB0116 5P1011011708AB0117 5P1011011708AB0118 5P1011011708AB0119 5P1011011708AB0120 5P1011011708AB0121 5P1011011708AB0122 5P1011011708AB0123 5P1011011708AB0124 5P1011011708AB0125 5P1011011708AB0126 5P1011011708AB0127 5P1011011708AB0128 5P1011011708AB0129 5P1011011708AB0130 5P1011011708AB0131 5P1011011708AB0132 5P1011011708AB0133 5P1011011708AB0134 5P1011011708AB0135 5P1011011708AB0136 5P1011011708AB0137 5P1011011708AB0138 5P1011011708AB0139 5P1011011708AB0140 5P1011011708AB0141 5P1011011708AB0142 5P1011011708AB0143 5P1011011708AB0144 5P1011011708AB0145 5P1011011708AB0146 5P1011011708AB0147 5P1011011708AB0148 5P1011011708AB0149 5P1011011708AB0150 5P1011011708AB0151 5P1011011708AB0152 5P1011011708AB0153 5P1011011708AB0154 5P1011011708AB0155 5P1011011708AB0156 5P1011011708AB0157 5P1011011708AB0158 5P1011011708AB0159 5P1011011708AB0160 5P1011011708AB0161 5P1011011708AB0162 5P1011011708AB0163 5P1011011708AB0164 5P1011011708AB0165 5P1011011708AB0166 5P1011011708AB0167 5P1011011708AB0168 5P1011011708AB0169 5P1011011708AB0170 5P1011011708AB0171 5P1011011708AB0172 5P1011011708AB0173 5P1011011708AB0174 5P1011011708AB0175 5P1011011708AB0176 5P1011011708AB0177 5P1011011708AB0178 5P1011011708AB0179 5P1011011708AB0180 5P1011011708AB0181 5P1011011708AB0182 5P1011011708AB0183 5P1011011708AB0184 5P1011011708AB0185 5P1011011708AB0186 5P1011011708AB0187 5P1011011708AB0188 5P1011011708AB0189 5P1011011708AB0190 5P1011011708AB0191 5P1011011708AB0192 5P1011011708AB0193 5P1011011708AB0194 5P1011011708AB0195 5P1011011708AB0196 5P1011011708AB0197 5P1011011708AB0198 5P1011011708AB0199 5P1011011708AB0200 5P1011011708AB0201 5P1011011708AB0202 5P1011011708AB0203 5P1011011708AB0204 5P1011011708AB0205 5P1011011708AB0206 5P1011011708AB0207 5P1011011708AB0208 5P1011011708AB0209 5P1011011708AB0210 5P1011011708AB0211 5P1011011708AB0212 5P1011011708AB0213 5P1011011708AB0214 5P1011011708AB0215 5P1011011708AB0216 5P1011011708AB0217 5P1011011708AB0218 5P1011011708AB0219 5P1011011708AB0220 5P1011011708AB0221 5P1011011708AB0222 5P1011011708AB0223 5P1011011708AB0224 5P1011011708AB0225 5P1011011708AB0226 5P1011011708AB0227 5P1011011708AB0228 5P1011011708AB0229 5P1011011708AB0230 5P1011011708AB0231 5P1011011708AB0232 5P1011011708AB0233 5P1011011708AB0234 5P1011011708AB0235 5P1011011708AB0236 5P1011011708AB0237 5P1011011708AB0238 5P1011011708AB0239 5P1011011708AB0240 5P1011011708AB0241 5P1011011708AB0242 5P1011011708AB0243 5P1011011708AB0244 5P1011011708AB0245 5P1011011708AB0246 5P1011011708AB0247 5P1011011708AB0248 5P1011011708AB0249 5P1011011708AB0250 5P1011011708AB0251 5P1011011708AB0252 5P1011011708AB0253 5P1011011708AB0254 5P1011011708AB0255 5P1011011708AB0256 5P1011011708AB0257 5P1011011708AB0258 5P1011011708AB0259 5P10110… (truncated, 295331 characters total — see the official FDA record for the full value)
Recalling firm:
Activbody, Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled November 30, 2021

Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-997-64

Stronger than it should be Drug

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

Recall #:
D-0295-2022
Lot/product code:
Lot #: 16345, Exp. Date 01/2024
Recalling firm:
Teligent Pharma, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 2, 2021

Zenition 50, Model #718096

Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or interruption of procedure if the hand switch is not used or if the wired foot switch is not connected to the system.

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

Recall #:
89437
Lot/product code:
Wireless Foot switch 3P : 459801238191  Wireless Foot switch 3P: 459801238231
Recalling firm:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 2, 2021

Veradius Unity, Model #718132

Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or interruption of procedure if the hand switch is not used or if the wired foot switch is not connected to the system.

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

Recall #:
89437
Lot/product code:
Wireless Foot switch 3P : 459801238191  Wireless Foot switch 3P: 459801238231
Recalling firm:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 2, 2021

Zenition 70, Model #718133

Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or interruption of procedure if the hand switch is not used or if the wired foot switch is not connected to the system.

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

Recall #:
89437
Lot/product code:
Wireless Foot switch 3P : 459801238191  Wireless Foot switch 3P: 459801238231
Recalling firm:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 3, 2021

Stryker CLAW II ORTHOLOC 3DSi Plate, Hole Qty: 4, 30mm, REF 40240430.

The incorrect product is contained in the packaging.

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

Recall #:
89089
Lot/product code:
Lot #1642103
Recalling firm:
Wright Medical Technology Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 3, 2021

Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm.

The incorrect product is contained in the packaging.

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

Recall #:
89089
Lot/product code:
Lot #1643355
Recalling firm:
Wright Medical Technology Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 3, 2021

Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7mm x 18mm, a component of the CHARLOTTE Lisfranc Reconstruction System.

Incorrect product is contained in the packaging.

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

Recall #:
89086
Lot/product code:
Lot numbers 02010697711582590 and 02010697711582591, GTIN 00840420108340.
Recalling firm:
Wright Medical Technology, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 6, 2021

Alinity m System, Part No. 08N53-002

There is a potential for abnormal (non-sigmoidal) amplification curves.

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

Recall #:
89166
Lot/product code:
Model 08N53-002, all serial numbers
Recalling firm:
Abbott Molecular, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 6, 2021

Alinity m System, Part No. 08N53-002

There is a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high.

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

Recall #:
89168
Lot/product code:
Alinity m System, Model 08N53-002, all serial numbers
Recalling firm:
Abbott Molecular, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 6, 2021

Alinity m System, Part No. 08N53-002

There is a software issue associated with the ability to properly complete a Field Service Engineer Maintenance and Diagnostics procedure.

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

Recall #:
89167
Lot/product code:
Alinity m System, Model 08N53-002, all serial numbers
Recalling firm:
Abbott Molecular, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 7, 2021

Novalung Sensor Box (F30000163) a component of Novalung Console (F30000162)- Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO2 removal) of the patient's blood in adults with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed,

Error messages 206 (yellow) and 208 (red) technical failure, flow measurement during use of the Novalung System imply that the communication between flow sensor and sensor box is interrupted. An interrupted communication between flow sensor and sensor box might lead to a disabled flow measurement and air bubble detection.

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

Recall #:
89369
Lot/product code:
Serial Numbers: XCONUS0013 XCONUS0079 XCONUS0105 XCONUS0036 XCONUS0044 XCONUS0004 XCONUS0014 XCONUS0080 XCONUS0109 XCONUS0021 XCONUS0066 XCONUS0027 XCONUS0017 XCONUS0084 XCONUS0061 XCONUS0043 XCONUS0089 XCONUS0059 XCONUS0019 XCONUS0085 XCONUS0051 XCONUS0047 XCONUS0005 XCONUS0042 XCONUS0020 XCONUS0086 XCONUS0110 XCONUS0055 XCONUS0010 XCONUS0083 XCONUS0022 XCONUS0087 XCONUS0111 XCONUS0064 XCONUS0053 XCONUS0121 XCONUS0023 XCONUS0088 XCONUS0112 XCONUS0002 XCONUS0056 XCONUS0018 XCONUS0024 XCONUS0090 XCONUS0113 XCONUS0003 XCONUS0006 XCONUS0054 XCONUS0030 XCONUS0091 XCONUS0115 XCONUS0007 XCONUS0052 XCONUS0081 XCONUS0032 XCONUS0094 XCONUS0116 XCONUS0012 XCONUS0073 XCONUS0008 XCONUS0039 XCONUS0095 XCONUS0118 XCONUS0070 XCONUS0009 XCONUS0040 XCONUS0096 XCONUS0025 XCONUS0072 XCONUS0001 XCONUS0049 XCONUS0092 XCONUS0026 XCONUS0075 XCONUS0011 XCONUS0058 XCONUS0093 XCONUS0028 XCONUS0082 XCONUS0045 XCONUS0067 XCONUS0097 XCONUS0122 XCONUS0048 XCONUS0065 XCONUS0068 XCONUS0098 XCONUS0123 XCONUS0063 XCONUS0029 XCONUS0069 XCONUS0099 XCONUS0124 XCONUS0031 XCONUS0035 XCONUS0074 XCONUS0100 XCONUS0034 XCONUS0071 XCONUS0046 XCONUS0076 XCONUS0102 XCONUS0038 XCONUS0060 XCONUS0050 XCONUS0077 XCONUS0103 XCONUS0041 XCONUS0062 XCONUS0015 XCONUS0078 XCONUS0104 XCONUS0033 XCONUS0037 XCONUS0016 UDI: Prefix: 4057224 (+ serial number)
Recalling firm:
Fresenius Medical Care Holdings, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 9, 2021

Vaporizer Sevoflurane Maquet Filling, Part No. 6886601 Component of the following systems: Product Code(s) UPN/UDI: Flow-c Anesthesia System 6887700 07325710009765 Flow-e Anesthesia System 6887900 07325710010457 Flow-i Anesthesia System C20 6888520 07325710010617 Flow-i Anesthesia System C30 6888530 07325710010624 Flow-i Anesthesia System C40 6888540 07325710010631 Flow-i C20 Anesthesia System 6677200 07325710001349 Flow-i C30 Anesthesia System 6677300 07325710001349 Flow-i C40 Anesthesia System 6677400 07325710001318

A potential chemical degradation of Sevoflurane by Lewis acids (metal oxides and metal halides) has been discovered that may result in inhalation and/or skin exposure of hydrogen fluoride.

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

Recall #:
89125
Lot/product code:
UDI: 07325710008430 Serial Nos. 15580 15890 15924 16284 16637 16837 16970 15582 15891 15925 16285 16638 16840 16971 15721 15894 16268 16345 16639 16842 15722 15914 16269 16352 16640 16843 15725 15917 16270 16354 16690 16844 15726 15919 16271 16632 16828 16961 15728 15920 16272 16633 16832 16964 15729 15921 16273 16634 16833 16965 15731 15922 16276 16635 16834 16966 15732 15923 16283 16636 16836 16968
Recalling firm:
Getinge Usa Sales Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 10, 2021

THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA

This recall was initiated to recover a Dunnage Case, which is a case of three (3) CLXUSA kits. This Dunnage Case was shipped on 02-Dec-2021. Dunnage is used during the sterilization process and is not intended for customer use.

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

Recall #:
89383
Lot/product code:
Dunnage case consists of a random unknown lot, which may have been shipped in place of Kit lot K341
Recalling firm:
Mallinckrodt Pharmaceuticals Ireland Ltd
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 10, 2021

VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.

The lot has a shape deformity which may lead to a 16% reduction in the volume of the sample or reagent dispensed. In cases where the error is not detected and the affected results are not suppressed, clinical impact may include reduced drug dosage, or false positive or false negative results for bloodborne infectious disease assays when sample results are close to the cut-off value.

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

Recall #:
89362
Lot/product code:
UDI 10758750006786  Lot 1039734
Recalling firm:
Ortho-Clinical Diagnostics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 13, 2021

The EnPlace is a single use trans-vaginal pelvic floor repair system which enables delivery of a tissue anchor to the ligaments of the vaginal cavity. The anchors are pre-loaded inside the device shaft and are ready for use. A thimble is also supplied, as an accessory for the device, to be used as a guide channel for better handling of the EnPlace. Intended Use / Indications for Use: The EnPlace system is intended for attaching sutures to ligaments of the pelvic floor.

Certain lots may not have been packaged wth the Channel Tube Limiter.

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

Recall #:
89309
Lot/product code:
UDI (01)07290017 08201 1 (10) YYMMDDXX (11)YYMMDD (17)YYMMDD, Lot Numbers: 21072510 and 21072512.
Recalling firm:
FEMSelect Ltd
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 14, 2021

Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open and arthroscopic surgical procedures Product Number: 72205104

Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process

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

Recall #:
89443
Lot/product code:
Lot Numbers: 50971615, 50971617 & 50967788
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)