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Recalls affecting Pennsylvania

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

17,233 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

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Food & BeveragesIngredients

Recalling firm: LMSI LLC

Cincinnati, OH (Aug. 29, 2026) - LMSI LLC/ Kofinas Olive Oil is issuing a voluntary recall of its Garlic Mediterranean infused extra virgin olive oil for using a garlic essential oil not approved for culinary use. The flavored oil was bottled in glass bottles in 500 ml, 250 ml, and 100 ml sizes.

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaE. coliAnnounced August 29, 2026

Everything Sprouts — Robust Radish Mix, 5oz Cups

Potential to be contaminated with Shiga toxin-producing Escherichia coli (STEC) or Salmonella.

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

Everything Sprouts, LLC, based in Minneapolis, MN is expanding its voluntary recall of sprouts to include certain lots of Robust Radish Sprout Mix because it has the potential to be contaminated with Shiga toxin producing Escherichia coli (STEC) or Salmonella bacteria.

Company contact: everythingsproutsmn@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaAnnounced August 29, 2026

Martina — Mangoes

Potential contamination with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

MAMARONECK, NY, AUG. 28, 2026 - Panorama Produce is recalling 302 boxes of size 9 (nine) mangoes because they may be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled April 21, 2021

Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. KIM 22/05, Length 50 mm, diameter 22G/0,7 mm; Article no. KIM 22/07,Length 75 mm, diameter 22 G (0.7 mm); Article no. KIM 22/10, Length 100 mm, diameter 22 G (0.7 mm); Article no. KIM 20/15, Length 150 mm, diameter 20 G (0.9 mm); Article no. KIM 18/10, Length 100 mm, diameter 18 G (1.25 mm); Article no. KIM 18/10T, Length 100 mm, diameter 18 G (1.25 mm); Article no. KIM 18/15, Length 150 mm, diameter 18 G (1.25 mm); Article no. KIM 18/15T, Length 150 mm, diameter 18 G (1.25 mm); Article No. KIM 18/20, Length 200 mm, diameter 18G/1.27mm, Article no. KIM 13/04T, Length 44 mm, diameter 13 G (2.40 mm); Article no. KIM 13/09T, Length 94 mm , diameter 13 G (2.40 mm); Article no. KIM 13/14T, Length 144 mm, diameter 13 G (2.40 mm); Article no. KIM 15/04T, Length 44 mm, diameter 15 G (1.95 mm); Article no. KIM 15/09T, Length 94 mm, diameter 15 G (1.95 mm); Article no. KIM 15/14T, Length 144 mm, diameter 15 G (1.95 mm); Article no. KIM 16/04T,Length 44 mm, diameter 16 G (1.60 mm); Article no. KIM 16/09T, Length 94 mm, diameter 16 G (1.60 mm); Article no. KIM 16/14T, Length 144 mm, diameter 16 G (1.60 mm); Article no. KIM 14/20T, Length 200 mm, Diameter 14 G (2.1 mm)

Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized

ALL 50 STATES
▸Full report

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

Recall #:
88213
Lot/product code:
Affected Lot Numbers:  KIM 22/05: LOT: 3416, 5016, 0717, 1417, 4117, 4217, 0418, 2818, 2119, 4619A, 3819, 0220A, 0220B, 0220C, 2420, 3820;  KIM 22/07: LOT: 4216, 0717, 1417, 4918, 2119, 4619A, 4319, 0220A, 0220B, 3820;  KIM 22/10: LOT: 3616, 5016, 0717, 1417, 0418, 1118, 2818, 2119, 2419, 4619A, 0220A, 0220B, 0220C, 4319, 1220, 1020, 2720, 3520;  KIM 22/15: LOT: 1417, 2118,4319;  KIM 20/10: LOT: 4318;  KIM 20/15: LOT: 4318;  KIM 18/10: LOT: 0717, 4318;  KIM 18/10T: LOT: 0217;  KIM 18/15: LOT: 0717, 4318, 0920;  KIM 18/15T: LOT: 4318;  KIM 18/20: LOT: 4318;  KIM 13/04T: LOT: 0817, 4318;  KIM 13/09T: LOT: 0817, 4318;  KIM 13/14T: LOT: 0817, 4318;  KIM 15/04T: LOT: 2818;  KIM 15/09T: LOT: 2818;  KIM 15/14T: LOT: 2818;  KIM 16/04T: LOT: 2818, 4820;  KIM 16/09T: LOT: 2818, 4820, 5020;  KIM 16/14T: LOT: 2818, 4820;  KIM 14/20T: LOT: 2419;
Recalling firm:
INNOVATIVE TOMOGRAPHY PRODUCT GMBH
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 21, 2021

Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. BIM 18/10, Length 100 mm, Diameter 18 G (1.25 mm); Article no. BIM 18/15, Length 150 mm, Diameter 18 G (1.25 mm); Article no. BIM 18/20, Length 200 mm, Diameter 18 G (1.25 mm); Article no. BIM 16/10, Length 100 mm, Diameter 16 G (1.6 mm); Article no. BIM 16/15, Length 150 mm, Diameter 16 G (1.6 mm); Article no. BIM 16/20, Length 200 mm, Diameter 16 G (1.6 mm); Article no. BIM 14/10, Length 100 mm, Diameter 14 G (2.1 mm); Article no. BIM 14/15, Length 150 mm, Diameter 14 G (2.1 mm); Article no. BIM 14/20, Length 200 mm, Diameter 14 G (2.1 mm) *NOT DISTRIBUTED WITHIN THE US

Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized

ALL 50 STATES
▸Full report

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

Recall #:
88213
Lot/product code:
Affected Lot Numbers:  BIM 18/10: LOT: 4918;  BIM 18/15: LOT: 4017, 4918, 4719;  BIM 18/20: LOT: 4017, 4918;  BIM 16/10: LOT: 4918, 1119, 1219;  BIM 16/15: LOT: 4918, 1119;  BIM 16/20: LOT: 4918, 1119;  BIM 14/10: LOT: 4918, 3019;  BIM 14/15: LOT: 4918;  BIM 14/20: LOT: 4918
Recalling firm:
INNOVATIVE TOMOGRAPHY PRODUCT GMBH
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 21, 2021

Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. KIR 23/05, Length 50 mm, Diameter 23 G (0.6 mm); Article no. KIR 23/05N, Length 50 mm, Diameter 23 G (0.6 mm); Article no. KIR 23/07, Length 75 mm, Diameter 23 G (0.6 mm); Article no. KIR 23/07N, Length 70 mm, Diameter 23 G (0.6 mm); Article no. KIR 23/10, Length 100 mm, Diameter 23G (0,6mm); Article no. KIR 23/15, Length 150 mm, Diameter 23 G (0.6 mm); Article no. KIR 21/10, Length 100 mm, Diameter 21 G (0.8 mm); Article no. KIR 21/12, Length 120 mm, Diameter 21 G (0.8 mm); Article no. KIR 21/15, Length 150 mm, Diameter 21 G (0.8 mm); Article no. KIR 21/20, Length 200 mm, Diameter 21 G (0.8 mm); Article no. KIR 17/15, Length 150 mm, Diameter 17 G (1.40mm) Article no. KIR 17/15:45, Length 150 mm, Diameter 17 G (1.40mm) *NOT DISTRIBUTED WITHIN THE US

Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized

ALL 50 STATES
▸Full report

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

Recall #:
88213
Lot/product code:
Affected Lot Numbers:  KIR 23/05: LOT: 2516, 5016, 1417, 0718, 3318, 4318, 3819, 1520;  KIR 23/05N: LOT: 0717, 5117, 0518, 4318, 1520;  KIR 23/07: LOT: 2516, 4216, 3617, 0718, 3318, 4318, 2119, 3819, 1520, 3320, 4420;  KIR 23/07N: LOT: 2916, 4516, 5016, 0717, 1618, 4318, 3819, 1520, 5220;  KIR 23/10: LOT: 2016, 2916, 4016, 5016, 0417, 0817, 0917, 1417, 2117A, 2117B, 3917, 4217, 4317, 4517,1618, 4118, 3318, 4818, 4318, 0319, 3319, 4119, 4619, 0520, 1620, 4420, 5220 KIR 23/15: LOT: 1417, 0418, 3319, 2420;  KIR 21/10: LOT: 2916, 4016, 1417, 2117A, 2117B, 0418, 4318, 0719, 2119, 3519, 4619,1020, 1620, 5220;  KIR 21/12: LOT: 2116, 0717, 1618, 2119, 4619, 1020, 3820;  KIR 21/15: LOT: 3416, 0717, 1417, 0418, 3318, 4318, 3819, 1020, 3820;  KIR 21/20: LOT: 3617, 1020;  KIR17/15: LOT: 2417, 5117, 0918;  KIR17/15:45: LOT: 3616, 4216, 2317, 5117, 0918, 3919, 2720;
Recalling firm:
INNOVATIVE TOMOGRAPHY PRODUCT GMBH
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 21, 2021

RAPTAR Laser Range Finders

RAPTAR units are capable of being field modified to enable the use of the higher power visible and IR laser pointers and the IR Illuminator.

ALL 50 STATES
▸Full report

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

Recall #:
88735
Lot/product code:
RAPTAR G02 (Wilcox Part #57200G02)
Recalling firm:
Potomac River Group, Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 23, 2021

Ingenia Ambition S - Model Number: 781359 Diagnostic MR system.

The MR magnet is equipped with 4 lifting blocks, which are positioned on top of the magnet. These blocks are used to allow the magnets to be moved in or out by a lifting crane, e.g. during decommissioning or moving activities. A mechanical issue was detected on these hoisting interface blocks on top of the magnet.

FLGAMIMONHNJNYPASCTXVT
▸Full report

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

Recall #:
87962
Lot/product code:
REF 781359/ UDI-DI 00884838090057 Serial numbers: 48000 48001 48003 48004 48009 48005 48015 48017 48020 48011 48022 48012 48014 48028 48026 48037 48023 48043 48019 48160 48144 48180 48112 48052 ***Updated November 2023*** Added Serial Numbers 48051 48010 48038 48018 48039 48027 48122 48046 48036 48047 48133 48056 48169 48148 48154 48055 48128 48194 48173 48134 48040 48155 48186 48035 48181 48188 48198
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 23, 2021

Ingenia Ambition X - Model Number: 781356, Diagnostic MR system. ***Updated November 2023*** Added Model Number 782109 - Ingenia Ambition X

The MR magnet is equipped with 4 lifting blocks, which are positioned on top of the magnet. These blocks are used to allow the magnets to be moved in or out by a lifting crane, e.g. during decommissioning or moving activities. A mechanical issue was detected on these hoisting interface blocks on top of the magnet.

FLGAMIMONHNJNYPASCTXVT
▸Full report

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

Recall #:
87962
Lot/product code:
REF 781356/UDI-DI 00884838090040 Serial Numbers 47001 47002 47003 47009 47000 47012 47017 47013 47047 47040 47052 47015 47049 47056 47023 47019 47030 47053 47014 47035 47034 (removed from scope as of November 2023) 47020 47048 47080 47032 47057 47041 47072 47075 47091 47219 47184 47058 47258 47215 47197 47004 47026 47006 47007 47018 47027 47011 47037 47039 47029 47038 47043 47022 47044 47070 47062 47071 47054 ***Updated November 2023*** REF 781356/UDI-DI 00884838090040 Serial Numbers 47016 47045 47059 47067 47065 47082 47089 47033 47244 47085 47025 47060 47024 47063 47061 47051 47096 47097 47028 47094 47225 47064 47248 47074 47083 47187 47098 47174 47068 47190 47195 47227 47194 47245 47175 47221 47226 47088 47220 47270 47050 47084 47099 47093 47203 47275 47260 47264 47252 REF 782109/UDI-DI 00884838098350 Serial Numbers 47500, 47519, 47511
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 26, 2021

Leccurate SARS-CoV-2, Antigen Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for the qualitative detection of antigen SARS-CoV-2 in clinical samples (nasal swab).

Antigen Rapid Test Kit is not authorized, cleared, or approved for marketing and/or distribution in the U.S.

ALL 50 STATES
▸Full report

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

Recall #:
87737
Lot/product code:
All Lots distributed within the U.S.
Recalling firm:
LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 26, 2021

IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 - Product Usage: In vitro test for the quantitative determination of iron in human serum and plasma on Roche/Hitachi cobas c and cobas Integra systems.

Roche received several complaints regarding increased control recovery and discrepant elevated results for the Iron Gen.2 (IRON2) assay on the cobas c311, 501, and 502 analyzers and on the COBAS Integra 400 plus analyzer.

ALL 50 STATES
▸Full report

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

Recall #:
87854
Lot/product code:
UDI: 04015630918904
Recalling firm:
Roche Diagnostics Operations, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 26, 2021

Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for qualitative detection of IgM and/or IgG antibodies to SARS-CoV-2 in human serum, plasma and venipuncture whole blood for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) is not authorized, cleared, or approved for marketing and/or distribution in the U.S.

ALL 50 STATES
▸Full report

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

Recall #:
87737
Lot/product code:
All Lots distributed within the U.S.
Recalling firm:
LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 27, 2021

The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14

The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase resistance to flow in the venous line and cause a drop in circuit blood flow.

ALL 50 STATES
▸Full report

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

Recall #:
88000
Lot/product code:
Lot Number: 5290-201001 UDI: (01)00851997007004(10)5290-201001(17)20231021(11)20201021
Recalling firm:
Circulatory Technology Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 29, 2021

Mechanical Filter with Connector Small, Tethered Cap, Item Code 351/5979 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.

The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.

ALL 50 STATES
▸Full report

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

Recall #:
87925
Lot/product code:
GTIN Primary Package: 20884522033234 GTIN Secondary Package: 10884522033237  Lot Number: 20J0699FAX
Recalling firm:
Covidien, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 29, 2021

HME for Tracheostomized Patients, Item Code 353S13046 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.

The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.

ALL 50 STATES
▸Full report

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

Recall #:
87925
Lot/product code:
GTIN Primary Package: 10884521779372 GTIN Secondary Package: 20884521779379  Lot Numbers: 19F0869FAX 19F0870FAX 20G1669FAX 20G1670FAX 20H0377FAX
Recalling firm:
Covidien, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 29, 2021

Adult-Pediatric Electrostatic Filter HME, Item Code 352/5877Z - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.

The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.

ALL 50 STATES
▸Full report

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

Recall #:
87925
Lot/product code:
GTIN Primary Package: 10884521077409 GTIN Secondary Package: 20884521077406  Lot Numbers: 20C1164FAX 20C1165FAX 20C1166FAX 20C1235FAX 20C1236FAX 20D1187FAX 20D1188FAX 20D1189FAX 20D1190FAX 20D1191FAX 20D1429FAX 20D1430FAX 20D1432FAX 20D1433FAX 20D1523FAX 20D1524FAX 20D1525FAX 20D1526FAX 20D1527FAX 20D1528FAX 20E0158FAX 20E0159FAX 20E0160FAX 20E0161FAX 20E0162FAX 20E0163FAX 20E0164FAX 20E0165FAX 20E0390FAX 20E0391FAX 20E0392FAX 20E0393FAX 20E0871FAX 20E0873FAX 20E0874FAX 20E0875FAX 20E0935FAX 20E0936FAX 20E0997FAX 20E0998FAX
Recalling firm:
Covidien, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 29, 2021

Electrostatic Filter Angled, Item Code 350S19006 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.

The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.

ALL 50 STATES
▸Full report

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

Recall #:
87925
Lot/product code:
GTIN Primary Package: 40884522012981 GTIN Secondary Package: 30884522012984  Lot Numbers: 20G1304FAX 20G1305FAX 20L0026FAX 20L0027FAX 20L0410FAX 20L0411FAX 20L0412FAX
Recalling firm:
Covidien, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 30, 2021

ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 1667001

Claim for stability after reconstitution from lyophilized to liquid form does not meet the requirements. New IFU instructions for handling the product provided to end users.

ALL 50 STATES
▸Full report

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

Recall #:
88040
Lot/product code:
Lot Numbers/ Exp. Date: 80516 31/07/2021; 80635 30/09/2021; 90092 31/12/2021; 90599 31/12/2021; 00118 31/12/2021; 00360 31/12/2021; 00610 31/12/2021; 00702 31/12/2021.  UDI: 01)08058056681775( 17)210731( 10)80516(240) 1667001 {01)08058056681775( 17)210930(10)80635{240) 1667001 {01)08058056681775( 17)211231(10)90092(240) 1667001 {01)08058056681775( 17)211231(10)90599{240) 1667001 {01)08058056681775( 17)211231( 10)00118(240) 1667001 {01)08058056681775( 17)211231(10)00360(240) 1667001 {01)08058056681775( 17)211231( 10)00610(240) 1667001 {01)08058056681775( 17)211231(10)00702{240) 1667001
Recalling firm:
Sentinel CH SpA
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 1, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728333 - Spectral CT:

Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.

ALL 50 STATES
▸Full report

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

Recall #:
87974
Lot/product code:
Model/ Serial Number/UDI: N/A 10016 (01)00884838101111(21)10016 10018 (01)00884838101111(21)10018
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 1, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728306 - Brilliance iCT 728311 - Brilliance iCT SP

Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.

ALL 50 STATES
▸Full report

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

Recall #:
87974
Lot/product code:
Model/ Serial Number/UDI: N/A System Code System Serial Number Unique Device Identifier (UDI#) 728306 100788 N/A 728306 100857 (01)00884838059474(21)100857 728306 100739 N/A 728306 100394 N/A 728306 100625 N/A 728306 100664 N/A 728306 100764 (01)00884838059474(21)100764 728306 100280 N/A 728306 100782 (01)00884838059474(21)100782 728306 100830 (01)00884838059474(21)100830 728306 100410 N/A 728306 100413 N/A 728306 100788 N/A 728306 100322 N/A 728306 100374 N/A 728306 100327 N/A 728306 100463 N/A 728306 85033 N/A 728306 85104 N/A 728306 85125 (01)00884838059474(21)85125 728306 85095 (01)00884838059474(21)85095 728306 85018 N/A 728306 85013 N/A 728306 100400 N/A 728306 100402 N/A 728306 100405 N/A 728306 100509 N/A 728306 100331 N/A 728306 100375 N/A 728306 100056 N/A 728306 85019 N/A 728306 100657 N/A 728306 100415 N/A 728306 100507 N/A 728306 100450 N/A 728306 100386 N/A 728306 85113 (01)00884838059474(21)85113 728306 100281 N/A 728306 100441 N/A 728306 100346 N/A 728306 100300 N/A 728306 85039 N/A 728306 100348 N/A 728306 100347 N/A 728306 100345 N/A 728306 100490 N/A 728306 100667 N/A 728306 85054 N/A 728306 100335 N/A 728306 100404 N/A 728306 100604 N/A 728306 100408 N/A 728306 100317 N/A 728306 342002 N/A 728306 85219 (01)00884838059474(21)85219 728306 100682 N/A 728306 100313 N/A 728306 100332 N/A 728306 100092 N/A 728306 100163 N/A 728306 100646 N/A 728306 100714 N/A 728306 85031 N/A 728306 100411 N/A 728306 100720 N/A 728306 100610 N/A 728306 100653 N/A 728306 100517 N/A 728306 85101 (01)00884838059474(21)85101 728306 100632 N/A 728306 100062 N/A 728306 100288 N/A 728306 100365 N/A 728306 100169 N/A 728306 100858 (01)00884838059474(21)100858 728306 100446 N/A 728306 100813 (01)00884838059474(21)100813 728306 100729 N/A 728306 100601 N/A 728306 100205 N/A 728306 100038 N/A 728306 100302 N/A 728306 100723 N/A 728306 N/A 728306 100086 (01)00884838059474(21)100086 728306 100791 (01)00884838059474(21)100791 728306 100193 N/A 728306 85218 (01)00884838059474(21)85218 728306 100638 N/A 728306 100440 N/A 728306 100223 N/A 728306 100645 N/A 728306 100414 N/A 728306 100260 N/A 728306 100314 N/A 728306 100339 N/A 728306 85012 N/A 728306 100299 N/A 728306 100115 N/A 728306 100278 N/A 728306 85097 (01)00884838059474(21)85097 728306 100357 N/A 728306 100412 N/A 728306 100409 N/A 728306 100794 (01)00884838059474(21)100794 728306 100123 N/A 728306 100622 N/A 728306 100631 N/A 728306 100349 N/A 728306 100147 N/A 728306 85029 N/A 728306 100681 N/A 728306 87008 (01)00884838059474(21)87008 728306 85221 (01)00884838059474(21)85221 728306 100144 N/A 728306 85038 N/A 728306 100372 N/A 728306 100044 N/A 728306 100623 N/A 728306 85078 N/A 728306 85202 (01)00884838059474(21)85202 728306 85205 (01)00884838059474(21)85205 728306 100341 N/A 728306 100503 N/A 728306 100325 N/A 728306 100290 N/A 728306 100406 N/A 728306 85127 (01)00884838059474(21)85127 728306 100634 N/A 728306 100064 N/A 728306 100759 (01)00884838059474(21)100759 728306 100040 N/A 728306 100679 N/A 728306 100654 N/A 728306 100416 N/A 728306 100396 N/A 728306 85276 (01)00884838059474(21)85276 728306 100257 N/A 728306 100466 N/A 728306 100453 N/A 728306 100452 N/A 728306 85230 N/A 728306 100351 N/A 728306 85138 (01)00884838059474(21)85138 728306 85285 (01)00884838059474(21)85285 728306 100689 N/A 728306 100626 N/A 728306 100454 N/A 728306 100486 N/A 728306 100633 N/A 728306 87047 (01)00884838059474(21)87047 728306 85283 (01)00884838059474(21)85283 728306 N/A N/A 728306 85145 (01)00884838059474(21)85145 728306 100821 (01)00884838059474(21)100821 728306 100368 N/A 728306 85080 (01)00884838059474(21)85080 728306 100804 (01)00884838059474(21)100804 728306 100802 (01)00884838059474(21)100802 728306 87036 (01)00884838059474(21)87036 728306 100806 (01)00884838059474(21)100806 728306 100501 N/A 728306 100373 N/A 728306 100853 (01)00884838059474(21)100853 728306 100661 N/A 728306 100381 N/A 728306 100852 (01)00884838059474(21)100852 728306 100287 N/A 728306 100045 N/A 728306 85099 (01)00884838059474(21)85099 728306 100462 N/A 728306 85286 (01)00884838059474(21)85286  728311 200119 N/A 728311 83006 (01)00884838059481(21)83006 728311 83009 N/A 728311 200090 N/A 728311 200039 N/A 728311 200137 N/A 728311 200052 N/A 728311 200058 N/A 728311 200078 N/A 728311 83005 (01)00884838059481(21)83005 728311 200011 N/A 728311 200006 N/A 728311 200022 N/A 728311 200018 N/A 728311 200214 N/A 728311 200093 N/A 728311 200101 N/A 728311 200107 N/A 728311 200138 N/A 728311 200121 N/A 728311 200021 (01)00884838059474(21)200021 728311 200213 N/A 728311 200068 N/A 728311 200127 N/A 728311 83002 (01)00884838059481(21)83002 728311 200047 N/A 728311 644 N/A 728311 200089 N/A 728311 200082 N/A 728311 200112 N/A 728311 200217 (01)00884838059481(21)200217 728311 200205 N/A 728311 200203 N/A
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 1, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - CT Vision ACQSIM CT System Number: 728209 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.

Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Monitor Bracket Assembly detaching from the Suspension Arm, and resulting in injury to patient, operator, bystander, or service person located in the path of a falling part

ALL 50 STATES
▸Full report

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

Recall #:
89039
Lot/product code:
Serial Number: 3202
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 1, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 64 System Number: 882471 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.

Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Monitor Bracket Assembly detaching from the Suspension Arm, and resulting in injury to patient, operator, bystander, or service person located in the path of a falling part

ALL 50 STATES
▸Full report

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

Recall #:
89039
Lot/product code:
Serial Number: 7141 7218 7229 7245
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 1, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882476 - Gemini TF Big Bore PET/CT

Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.

ALL 50 STATES
▸Full report

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

Recall #:
87974
Lot/product code:
Model/ Serial Number/UDI: N/A 882476 9006 N/A
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 1, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 16 System Number: 882470 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.

Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Monitor Bracket Assembly detaching from the Suspension Arm, and resulting in injury to patient, operator, bystander, or service person located in the path of a falling part

ALL 50 STATES
▸Full report

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

Recall #:
89039
Lot/product code:
Serial Number: 7084 7145 7584
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 1, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - TruFlight Select PET/CT System Number: 882438 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.

Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Monitor Bracket Assembly detaching from the Suspension Arm, and resulting in injury to patient, operator, bystander, or service person located in the path of a falling part

ALL 50 STATES
▸Full report

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

Recall #:
89039
Lot/product code:
Serial Number: 17006
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 1, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini GXL 16 Slice System Number: 882410 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.

Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Monitor Bracket Assembly detaching from the Suspension Arm, and resulting in injury to patient, operator, bystander, or service person located in the path of a falling part

ALL 50 STATES
▸Full report

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

Recall #:
89039
Lot/product code:
Serial Number: 4165
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 1, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728332 - IQon Spectral CT : IQon Spectral CT

Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.

ALL 50 STATES
▸Full report

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

Recall #:
87974
Lot/product code:
Model/ Serial Number/UDI: N/A 728332 860005 N/A 728332 395001 N/A 728332 860043 (01)00884838059542(21)860043 728332 860131 (01)00884838059542(21)860131 728332 860050 (01)00884838059542(21)860050 728332 860122 (01)00884838059542(21)860122 728332 60038 (01)00884838059542(21)60038 728332 860177 N/A 728332 860185 (01)00884838059542(21)860185 728332 860172 (01)00884838059542(21)860172 728332 60051 (01)00884838059542(21)60051 728332 60009 N/A 728332 860098 (01)00884838059542(21)860098 728332 60054 (01)00884838059542(21)60054 728332 860199 (01)00884838059542(21)860199 728332 860123 (01)00884838059542(21)860123 728332 860059 (01)00884838059542(21)860059 728332 860199 N/A 728332 860015 N/A 728332 860014 N/A 728332 860096 (01)00884838059542(21)860096 728332 860029 N/A 728332 860073 (01)00884838059542(21)860073 728332 860058 (01)00884838059542(21)860058 728332 860082 (01)00884838059542(21)860082 728332 860069 (01)00884838059542(21)860069 728332 860216 (01)00884838059542(21)860216 728332 860193 (01)00884838059542(21)860193 728332 860118 (01)00884838059542(21)860118 728332 860024 N/A 728332 860204 (01)00884838059542(21)860204 728332 60066 N/A 728332 860154 N/A 728332 860175 (01)00884838059542(21)860175 728332 860186 (01)00884838059542(21)860186 728332 860038 N/A 728332 860078 (01)00884838059542(21)860078 728332 60042 (01)00884838059542(21)60042 728332 860110 (01)00884838059542(21)860110 728332 860027 (01)00884838059542(21)860027 728332 860071 (01)00884838059542(21)860071 728332 860139 (01)00884838059542(21)860139 728332 60014 (01)00884838059542(21)60014 728332 N/A 728332 60040 (01)00884838059542(21)60040 728332 860153 (01)00884838059542(21)860153 728332 860103 (01)00884838059542(21)860103 728332 860075 (01)00884838059542(21)860075 728332 860181 (01)00884838059542(21)860181 728332 860012 N/A 728332 860046 (01)00884838059542(21)860046 728332 860152 (01)00884838059542(21)860152 728332 860054 (01)00884838059542(21)860054 728332 860140 (01)00884838059542(21)860140 728332 860020 N/A 728332 860130 (01)00884838059542(21)860130 728332 860147 (01)00884838059542(21)860147 728332 860061 (01)00884838059542(21)860061 728332 860079 (01)00884838059542(21)860079 728332 860218 (01)00884838059542(21)860218 728332 860149 (01)00884838059542(21)860149 728332 860064 (01)00884838059542(21)860064 728332 860121 (01)00884838059542(21)860121 728332 860109 (01)00884838059542(21)860109 728332 60032 (01)00884838059542(21)60032 728332 860200 (01)00884838059542(21)860200 728332 860041 (01)00884838059542(21)860041 728332 860160 N/A 728332 860090 (01)00884838059542(21)860090 728332 860035 (01)00884838059542(21)860035 728332 860057 (01)00884838059542(21)860057 728332 860017 N/A 728332 860203 (01)00884838059542(21)860203 728332 860008 N/A 728332 860128 (01)00884838059542(21)860128 728332 860129 (01)00884838059542(21)860129 728332 860158 N/A 728332 860209 (01)00884838059542(21)860209 728332 860211 (01)00884838059542(21)860211 728332 60029 (01)00884838059542(21)60029 728332 860183 (01)00884838059542(21)860183 728332 860013 N/A 728332 860091 (01)00884838059542(21)860091
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 1, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882442/882456 - Ingenuity TF PET/CT

Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.

ALL 50 STATES
▸Full report

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

Recall #:
87974
Lot/product code:
Model/ Serial Number/UDI: N/A System Code System Serial Number Unique Device Identifier (UDI#) 882442 2155 (01)00884838059443(21)2155 882442 2154 (01)00884838059443(21)2154 882442 2166 (01)00884838059443(21)2166 882442 2171 (01)00884838059443(21)2171 882442 2153 (01)00884838059443(21)2153
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)