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Recalls affecting Vermont

Data last updated: September 9, 2026 at 1:18 PM UTC

16,253 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 August 3, 2020

DJO EMPOWR Tibial Knee Punch Handle Part No. 801-05-040 and 801-05-018 contained in Instrument Tray for EMPOWR Porous Knee - Product Usage: The Tibial Punch Handle is used in conjunction with one of three appropriately sized Tibial Punch Guides to broach the tibial canal in preparation for the tibial baseplate keel.

There is a potential for the retaining pin of the tibial punch handle to become loose and fall out while impacting. If undetected, there is a potential of leaving debris in the joint space.

ALL 50 STATES
Full report

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

Recall #:
86257
Lot/product code:
Model/Catalog no. 801-05-040; :Lot/serial No.s 281905L08, 281905L15, 283808L01, 305197L02, 318871L10 Model/Catalog no. 801-05-018, Lot/serial No.s: 215488L08, 236760L01, 228231L01, 241946L02, 259710L01, 314969L01
Recalling firm:
Encore Medical, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 4, 2020

BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replacement Kits (P/N 49000239, 49000346, 49000438, 49000439) infusion pump.

Pump Module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion or interruption of infusion. Delays in an infusion or interruption can cause serious injury or death in high-risk patient populations.

ALL 50 STATES
Full report

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

Recall #:
85962
Lot/product code:
All serial numbers
Recalling firm:
CareFusion 303, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 4, 2020

BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, noninvasive monitoring of end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2) and respiratory rate (RR). The EtCO2 module and disposables are indicated for use with intubated and nonintubated adult, pediatric and neonatal patients. It is not intended for direct connection to ventilator or breathing systems. Only one EtCO2 module can be connected to the Alaris System.

Infusion pump component defect may result in interruption of patient monitoring

ALL 50 STATES
Full report

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

Recall #:
85997
Lot/product code:
Model: EtCO2 8300; Lot/Serial numbers: 10002682711,  10002720508, 1000287042, 10002882569
Recalling firm:
CareFusion 303, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 4, 2020

PC Unit Front Case with Keypad Replacement Kits: TC10008389 ASSY CASE FRONT W/KEYPAD 8015LS, TC10010217 ASSY FRT CASE W/ KEYPAD 8015 M2, TC10012515 ASSY FR CASE W/ KEYPAD 8015 M2, TC10013702 ASSY, CASE, FRONT W/KEYPAD, 8015LS, TC10013664 ASSY FR CASE W/ KEYPAD 8015 M2

The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion, interruption of infusion, or inability to titrate medication. For high-risk patient populations who are receiving life-sustaining infusions, delays in an infusion or interruption can cause serious injury or death.

Full report

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

Recall #:
85900
Lot/product code:
All kits manufactured from April 07, 2017 to Present.
Recalling firm:
CareFusion 303, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 4, 2020

Alaris System PC Unit Model 8015

The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion, interruption of infusion, or inability to titrate medication. For high-risk patient populations who are receiving life-sustaining infusions, delays in an infusion or interruption can cause serious injury or death.

Full report

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

Recall #:
85900
Lot/product code:
All serial numbers manufactured from April 07, 2017 to Present.
Recalling firm:
CareFusion 303, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 4, 2020

BD Alaris System; Alaris Syringe Module Model 8110; BD Alaris System; Alaris PCA Module Model 8120; BD Alaris System; Syringe/PCA Sizer Sensor Replacement Kit, P/N 122278652

The Alaris PC unit can display incorrect syringe type and/or syringe sizes. This could result in delays in infusion, under-infusion, or over-infusion.

Full report

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

Recall #:
86005
Lot/product code:
Device Model/Serial Number: Syringe/PCA Sizer Sensor Replacement Kit, P/N 122278652: All Kits; PCA Module Model 8120: PCA (8120) 14217746 PCA (8120) 14259835 PCA (8120) 13063333 PCA (8120) 14231894 PCA (8120) 14231522 PCA (8120) 14232093 PCA (8120) 14373709 PCA (8120) 12334465 PCA (8120) 13638955 PCA (8120) 13638959 PCA (8120) 14231764 PCA (8120) 14232010 PCA (8120) 14567433 PCA (8120) 14231895 PCA (8120) 14217150 PCA (8120) 14217736 PCA (8120) 14217764 PCA (8120) 14218525 PCA (8120) 14218830 PCA (8120) 14217763 PCA (8120) 13406723 PCA (8120) 13078712 PCA (8120) 13081384 PCA (8120) 13096518 PCA (8120) 13096520 PCA (8120) 13096532 PCA (8120) 13096538 PCA (8120) 13096800 PCA (8120) 13096812 PCA (8120) 13096814 PCA (8120) 13096944 PCA (8120) 13097130 PCA (8120) 13097157 PCA (8120) 13113383 PCA (8120) 13113468 PCA (8120) 13134042 PCA (8120) 13134073 PCA (8120) 13134172 PCA (8120) 13134186 PCA (8120) 13134230 PCA (8120) 13134323 PCA (8120) 14015426 PCA (8120) 14015566 PCA (8120) 14219103 PCA (8120) 14216794 PCA (8120) 14217593 PCA (8120) 14218526 PCA (8120) 14219469 PCA (8120) 13919809 PCA (8120) 13919202 PCA (8120) 13919567 PCA (8120) 13919591 PCA (8120) 13919328 PCA (8120) 13919810 PCA (8120) 13875008 PCA (8120) 13875021 PCA (8120) 13875207 PCA (8120) 13875293 PCA (8120) 13875611 PCA (8120) 13875635 PCA (8120) 13919066 PCA (8120) 13919219 PCA (8120) 13919239 PCA (8120) 13919278 PCA (8120) 13919281 PCA (8120) 13919365 PCA (8120) 13919431 PCA (8120) 13919444 PCA (8120) 13919462 PCA (8120) 13919467 PCA (8120) 13919556 PCA (8120) 13919574 PCA (8120) 13919589 PCA (8120) 13919613 PCA (8120) 13919614 PCA (8120) 13919615 PCA (8120) 13919626 PCA (8120) 13919641 PCA (8120) 13919721 PCA (8120) 13919723 PCA (8120) 13919769 PCA (8120) 13919776 PCA (8120) 13919777 PCA (8120) 13919778 PCA (8120) 13919811 PCA (8120) 13919833 PCA (8120) 13919834 PCA (8120) 13919927 PCA (8120) 13919928 PCA (8120) 13919780 PCA (8120) 13919448 PCA (8120) 13919378 PCA (8120) 13919445 PCA (8120) 13875499 PCA (8120) 13875181 PCA (8120) 13919463 PCA (8120) 13875484 PCA (8120) 13919283 PCA (8120) 13919768 PCA (8120) 13919742 PCA (8120) 13918879 PCA (8120) 13918765 PCA (8120) 13919419 PCA (8120) 13875454 PCA (8120) 13919363 PCA (8120) 13919069 PCA (8120) 13919779 PCA (8120) 13919726 PCA (8120) 13595964 PCA (8120) 15939612 PCA (8120) 15939491 PCA (8120) 15939540 PCA (8120) 15943034 PCA (8120) 15943030 PCA (8120) 15939588 PCA (8120) 15939561 PCA (8120) 15939562 PCA (8120) 15939521 PCA (8120) 15960206 PCA (8120) 15960188 PCA (8120) 15960093 PCA (8120) 15960051 PCA (8120) 15939610 PCA (8120) 15939523 PCA (8120) 15960253 PCA (8120) 15939522 PCA (8120) 15943690 PCA (8120) 15943693 PCA (8120) 15943503 PCA (8120) 15944032 PCA (8120) 15944036 PCA (8120) 15943694 PCA (8120) 15944039 PCA (8120) 15943559 PCA (8120) 15943691 PCA (8120) 16097240 PCA (8120) 16097238 PCA (8120) 16097249 PCA (8120) 16097449 PCA (8120) 15952783 PCA (8120) 15952707 PCA (8120) 15952694 PCA (8120) 15952730 PCA (8120) 15952697 PCA (8120) 15952807 PCA (8120) 15952699 PCA (8120) 15952705 PCA (8120) 14985338 PCA (8120) 16087046 PCA (8120) 16087051 PCA (8120) 16087058 PCA (8120) 16087077 PCA (8120) 16087107 PCA (8120) 15943699 PCA (8120) 15943707 PCA (8120) 15952689 PCA (8120) 15952704 PCA (8120) 15952706 PCA (8120) 15952708 PCA (8120) 15952757 PCA (8120) 16094953 PCA (8120) 16094959 PCA (8120) 16094961 PCA (8120) 16094976 PCA (8120) 16094978 PCA (8120) 15939514 PCA (8120) 15939515 PCA (8120) 15939539 PCA (8120) 15939609 PCA (8120) 15939611 PCA (8120) 15959499 PCA (8120) 15959516 PCA (8120) 15960126 PCA (8120) 14961137 PCA (8120) 15960078 PCA (8120) 15960139 PCA (8120) 15959572 PCA (8120) 15960137 PCA (8120) 15960062 PCA (8120) 15959729 PCA (8120) 15960103 PCA (8120) 15960118 PCA (8120) 15960119 PCA (8120) 15973938 PCA (8120) 15973865 PCA (8120) 15973940 PCA (8120) 15973910 PCA (8120) 15973866 PCA (8120) 15974058 PCA (8120) 15973453 PCA (8120) 16051471 PCA (8120) 16051408 PCA (8120) 16051466 PCA (8120) 16051404 PCA (8120) 16073302 PCA (8120) 16051372 PCA (8120) 16051474 PCA (8120) 16073289 PCA (8120) 16073290 PCA (8120) 16051452 PCA (8120) 16051478 PCA (8120) 16073292 PCA (8120) 16051379 PCA (8120) 16073286 PCA (8120) 16073288 PCA (8120) 16051443 PCA (8120) 16051468 PCA (8120) 16051469 PCA (8120) 16051403 PCA (8120) 16051465 PCA (8120) 16073305 PCA (8120) 16073287 PCA (8120) 16051401 PCA (8120) 15111989 PCA (8120) 16057070 PCA (8120) 16057106 PCA (8120) 16055273 PCA (8120) 16055274 PCA (8120) 16057075 PCA (8120) 16057083 PCA (8120) 16097243 PCA (8120) 16097446 PCA (8120) 16097447 PCA (8120) 16097448 PCA (8120) 16097450 PCA (8120) 16097451 PCA (8120) 16097452 PCA (8120) 16097466 PCA (8120) 16097480 PCA (8120) 16097487 PCA (8120) 15959561 PCA (8120) 15959649 PCA (8120) 15959663 PCA (8120) 15959671 PCA (8120) 15959739 PCA (8120) 15960070 PCA (8120) 15960125 PCA (8120) 15960148 PCA (8120) 15960175 PCA (8120) 15960210 PCA (8120) 15973432 PCA (8120) 15973450 PCA (8120) 15973854 PCA (8120) 15973… (truncated, 3670361 characters total — see the official FDA record for the full value)
Recalling firm:
CareFusion 303, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2020

Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.

A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation.

ALL 50 STATES
Full report

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

Recall #:
86269
Lot/product code:
Serial Numbers: 200017, 200023, 200024, 200036, 200045, 200047, 230002, 230003, 230004
Recalling firm:
Shanghai United Imaging Healthcare Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2020

Computed Tomography X-Ray System, Model uCT 530, Rx, CE, GTIN: 06971576831012 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular).

A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation.

ALL 50 STATES
Full report

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

Recall #:
86269
Lot/product code:
Serial Numbers: 3000162, 300163, 300174, 300176
Recalling firm:
Shanghai United Imaging Healthcare Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2020

Computed Tomography X-Ray System, Model uCT 760, Rx, CE, GTIN: 06971576831043 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular).

A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation.

ALL 50 STATES
Full report

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

Recall #:
86269
Lot/product code:
Serial Numbers: 600229, 600230, 600232, 600271, 600282
Recalling firm:
Shanghai United Imaging Healthcare Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2020

Computed Tomography X-Ray System, Model uCT 550, Rx, CE, GTIN: 06971576831036 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular).

A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation.

ALL 50 STATES
Full report

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

Recall #:
86269
Lot/product code:
Serial Numbers: 353020, 353021, 353023, 353045, 353049
Recalling firm:
Shanghai United Imaging Healthcare Co., Ltd.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 10, 2020

Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. LLC Bridgewater, NJ, 08807, NDC 0024-5151-75

Failed Stability Specifications: not meeting quality requirements result for enzyme activity levels noted during routine stability testing.

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-1507-2020
Lot/product code:
Lot #: A9306, Exp 2/28/2022
Recalling firm:
Sanofi-Aventis U.S. LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 12, 2020

Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 3.5 mm, Item Code 030455 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.

ALL 50 STATES
Full report

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

Recall #:
86214
Lot/product code:
Lot Numbers:  T0A019X T7K037X T8H021X T8L102X T9E097X T0A105X T7K038X T8H050X T8L103X T9E098X T0A117X T7K039X T8J044X T8M010X T9F025X T0A141X T7K040X T8J045X T9A037X T9F047X T0B132X T7K041X T8J060X T9A128X T9F048X T0C045X T7L040X T8K044X T9B002X T9F098X T0C102X T7L041X T8K045X T9B003X T9H112X T0C128X T8B042X T8K046X T9C065X T9H146X T0D057X T8B043X T8K052X T9C066X T9K003X T0D120X T8C032X T8K075X T9C111X T9L039X T7G002X T8C033X T8K076X T9C145X T9M029X T7H005X T8E059X T8K092X T9D140X T9M049X T7H008X T8E060X T8L033X T9E027X T9M050X T7K036X T8H020X T8L099X
Recalling firm:
Covidien, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 12, 2020

Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item Code 030451 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.

ALL 50 STATES
Full report

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

Recall #:
86214
Lot/product code:
Lot Numbers:  T0A016X T8D009X T8E058X T8H024X T9D052X T0B130X T8D010X T8E069X T8H025X T9D149X T0D070X T8D012X T8H004X T8H061X T9E081X T7H001X T8D013X T8H008X T8M044X T9E082X T7L024X T8D041X T8H009X T9A032X T9F133X T7L025X T8D042X T8H010X T9A033X T9G029X T8B012X T8D043X T8H011X T9A082X T9G037X T8B013X T8D044X T8H012X T9B039X T9G085X T8C026X T8D045X T8H013X T9B040X T9G086X T8C027X T8D046X T8H014X T9D043X T9G093X T8C045X T8E049X T8H022X T9D050X T9K069X T8C046X T8E050X T8H023X T9D051X T9M069X T8C047X T8E057X
Recalling firm:
Covidien, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 12, 2020

Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item Code 030452 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.

ALL 50 STATES
Full report

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

Recall #:
86214
Lot/product code:
Lot Numbers:  T0C085X T8B048X T8K049X T8L087X T9J072X T7H002X T8B049X T8K095X T9G027X T9J099X T7L026X T8E063X T8L084X T9H043X T9L073X T7L027X T8E064X T8L085X T9H115X T9M016X T8B014X T8E075X T8L086X T9H116X T9M111X T8B015X T8F074X
Recalling firm:
Covidien, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 12, 2020

Endo GIA Auto Suture Universal Loading Unit, Item Code 030457 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.

ALL 50 STATES
Full report

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

Recall #:
86214
Lot/product code:
Lot Numbers:  T0A104X T7L042X T8D056X T8L032X T9D044X T0C041X T7L043X T8E053X T8L051X T9D047X T0C042X T7L044X T8E054X T8L104X T9D048X T7F018X T7L045X T8F041X T8L105X T9D049X T7F023X T7L046X T8F042X T8M045X T9D055X T7F024X T7L047X T8F043X T9A007X T9E025X T7J006X T8A005X T8F075X T9A008X T9F051X T7J011X T8A006X T8J011X T9B041X T9H144X T7J012X T8A041X T8K063X T9B042X T9J034X T7K030X T8A042X T8L028X T9C067X T9K078X T7K031X T8C039X T8L029X T9C068X T9K079X T7K032X T8C040X T8L030X T9C146X T9L020X T7K033X T8D055X T8L031X T9C157X T9L034X
Recalling firm:
Covidien, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 12, 2020

Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.

ALL 50 STATES
Full report

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

Recall #:
86214
Lot/product code:
Lot Numbers:  T7F017X T7J023X T7L032X T7L034X T8L100X T7F025X T7J024X T7L033X T7L035X T9F138X T7F026X T7K020X
Recalling firm:
Covidien, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 12, 2020

Endo GIA Auto Suture Universal Articulating Loading Unit 60 mm - 3.5 mm, Item Code 030458 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.

ALL 50 STATES
Full report

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

Recall #:
86214
Lot/product code:
Lot Numbers:  T0A013X  T7L050X  T8E048X  T8K051X  T9F118X T0A051X  T7L051X  T8E055X  T8K093X  T9G028X T0A085X  T7L052X  T8E056X  T8L129X  T9G030X T0B025X  T7M021X  T8E061X  T8L130X  T9G038X T0B032X  T7M022X  T8E062X  T8M009X  T9G088X T0B046X  T8A001X  T8E067X  T8M011X  T9G089X T0B047X  T8A002X  T8E068X  T8M097X  T9G090X T0B056X  T8A003X  T8F001X  T9A009X  T9G094X T0B073X  T8A004X  T8F002X  T9A031X  T9G159X T0B081X  T8A045X  T8F026X  T9A056X  T9G160X T0C043X  T8A046X  T8F045X  T9A099X  T9H042X T0C068X  T8A060X  T8F046X  T9B001X  T9H100X T0C069X  T8A061X  T8F047X  T9B004X  T9H101X T0C070X  T8B003X  T8F077X  T9B005X  T9H113X T0C103X  T8B037X  T8H001X  T9B038X  T9H114X T0D054X  T8B038X  T8H002X  T9C007X  T9J030X T0D059X  T8B039X  T8H003X  T9C008X  T9J035X T0D061X  T8B040X  T8H005X  T9C069X  T9J048X T0D115X  T8B041X  T8H006X  T9C070X  T9J073X T0E050X  T8C012X  T8H019X  T9C071X  T9J096X T7F019X  T8C034X  T8H051X  T9C156X  T9J097X T7F021X  T8C035X  T8H052X  T9E030X  T9J098X T7F022X  T8C041X  T8H072X  T9E069X  T9K002X T7J003X  T8C042X  T8J027X  T9E070X  T9K068X T7J004X  T8C044X  T8J038X  T9E071X  T9K104X T7J005X  T8D011X  T8J041X  T9E072X  T9K105X T7J013X  T8D057X  T8J042X  T9E111X  T9L019X T7J020X  T8D058X  T8J058X  T9E119X  T9L074X T7J032X  T8D059X  T8J067X  T9E120X  T9L075X T7L028X  T8D060X  T8K007X  T9F026X  T9L102X T7L029X  T8D061X  T8K009X  T9F049X  T9L103X T7L030X  T8D062X  T8K043X  T9F050X  T9M109X T7L048X  T8E047X  T8K050X  T9F078X  T9M110X T7L049X
Recalling firm:
Covidien, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 12, 2020

Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code 030450 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.

ALL 50 STATES
Full report

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

Recall #:
86214
Lot/product code:
Lot Numbers:  T0A108X T7H003X T8D008X T8K108X T9G060X T0E051X T7L023X T8H047X  T8M079X T7G003X T8D007X T8K047X T9F132X
Recalling firm:
Covidien, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 12, 2020

Covidien Best Practices Procedure Kits containing Auto Suture Endo GIA Universal Loading Units, Parent Codes 00Z2760 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.

ALL 50 STATES
Full report

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

Recall #:
86214
Lot/product code:
Lot Numbers:  00Z2117
Recalling firm:
Covidien, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 12, 2020

Endo GIA Auto Suture Universal Loading Unit 45 mm - 2.5mm, Item Code 030454 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.

ALL 50 STATES
Full report

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

Recall #:
86214
Lot/product code:
Lot Numbers:  T0A018X T8B045X T8E051X T8L052X T9E050X T0A106X T8B046X T8E052X T8L101X T9F024X T0B131X T8B047X T8E065X T8L131X T9F037X T0D138X T8C025X T8E066X T8L132X T9F040X T0E011X T8C030X T8H015X T8L143X T9F044X T7G001X T8C031X T8H016X T8M080X T9F045X T7H004X T8C043X T8H017X T8M092X T9F046X T7H007X T8D001X T8H018X T8M093X T9F097X T7J025X T8D002X T8H049X T8M094X T9G031X T7K018X T8D003X T8J012X T9A006X T9G124X T7K034X T8D004X T8J026X T9A034X T9G125X T7L022X T8D005X T8J039X T9A035X T9H041X T7L036X T8D006X T8J040X T9A118X T9H102X T7L037X T8D014X T8K006X T9B060X T9H110X T8A058X T8D015X T8K008X T9C023X T9J071X T8A059X T8D047X T8L012X T9C024X T9J114X T8A062X T8D048X T8L013X T9C058X T9K077X T8A063X T8D049X T8L014X T9C059X T9L021X T8A064X T8D050X T8L015X T9D053X T9L037X T8A065X T8D051X T8L016X T9D099X T9M017X T8B001X T8D052X T8L049X T9D124X T9M018X T8B002X T8D053X T8L050X T9D125X T9C060X T8B044X T8D054X
Recalling firm:
Covidien, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 24, 2020

Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180)

The firm has received reports concerning the patient fiducial disk separating from the body and users attempting to re-assemble the device. The use of a re-assembled patient fiducial could lead to inability to navigate or inaccuracies such as improper needle trajectory.

ALL 50 STATES
Full report

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

Recall #:
85258
Lot/product code:
All Serial Numbers
Recalling firm:
Imactis
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 25, 2020

Aquas PowerFlow Tube Set - Product Usage: The device delivers sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris, and smoke from the surgical site

The product design incorporating a motor driven impeller pump powered by one 9V alkaline battery inside the hand-piece did not receive proper premarket clearance from US FDA and lacks a 510(k).

ALL 50 STATES
Full report

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

Recall #:
86173
Lot/product code:
Model # 720-005-000 (BPSI SET WITH NO PROBE); Lot # I9214-C  Model # 720-005-001 (BPSI SET 8 VENT PROBE); Lot Numbers:  I8881-D I8873-D I9057-D I9058-D I9209-D I9213-D I9227-D I9235-D I9236-D I9237-D I9278-D I9280-D I9282-D I9283-D I9299-D I9309-D I9322-D I9324-D I9356-D I9358-D I9360-D I9361-D I9362-D I9363-D I9364-D I9365-D
Recalling firm:
Genicon, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 31, 2020

30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger, REF: 20124-01; Spinning Spiros Closed Male Luer, Red Cap, REF: 20130-01; Spinning Spiros, Closed Male Luer, REF: CH2000S; Spinning Spiros Closed Male Luer, 10 units, REF: CH2000S-10; Spinning Spiros Closed Male Luer, Red Cap, REF: CH2000S-C; Spiros, Closed Male Luer w/Red Cap, 10 Units, RES: CH2000SC-10; Spiros, Closed Male Luer w/Red Cap, 5 Units, REF: CH2000SC-5; Spinning Spiros Closed Male Luer, Purple Cap, REF: CH2000S-PC; Conector macho cerrado Spinning Spiros, tapon purpura, REF: 034-CH2000S-PC; Spiros, Purple Cap, Drop-In Priming Cap, REF: CH2000S-PCP; Spinning Spiros Closed Male Luer w/Red Cap, REF: CH3515; Spinning Spiros Closed Male Luer, REF: Z7072

Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.

ALL 50 STATES
Full report

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

Recall #:
86426
Lot/product code:
Lots:  4749745, 4764622, 4790769, 4806298, 4865663, 4712177, 4749754, 4757981, 4764633, 4793559, 4903194, 4726692, 4756786, 4800185, 4895432, 4726695, 4749730, 4757614, 4761878, 4784740, 4794303, 4895435, 4713514, 4713516, 4749750, 4749755, 4750947, 4750950, 4750952, 4757618, 4763178, 4806832, 4806838, 4849195, 4858381, 4895446, 4711932, 4726709, 4756789, 4761899, 4783763, 4858387, 4962299, 4726711, 4749767, 4774705, 4784757, 4795443, 4857778, 4727446, 4749771, 4711937, 4727450, 4882569, 4741999, 4757713, 4793544, 4908662, 4749745, 4764622, 4790769, 4865663, 4901210, 4749754, 4764633, 4603678, 4726692, 4756786, 4800185, 4895432, 4713516, 4749733, 4749750, 4749755, 4750947, 4750952, 4763174, 4763178, 4774701, 4774702, 4806838, 4849192, 4849195, 4857774, 4858382, 4895442, 4895446, 4896004, 4902104, 4726709, 4761899, 4727446, 4749771, 4774000, 4849201, 4877398, 4877399
Recalling firm:
ICU Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 31, 2020

BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001

Potential for Fluid leaks within the instruments, creating an electrical short inside the power socket, which generates heat, smoke, and eventually burning and melting of the electrical cord connector and socket

ALL 50 STATES
Full report

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

Recall #:
86399
Lot/product code:
All units
Recalling firm:
Roche Diagnostics Operations, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 31, 2020

30" (76 cm) Appx 5.5 mL 20 Drop Admin Set w/Integrated Clave Drip Chamber, 1.2 Micron Filter, Spiros, Bag Hanger, REF: CH3286

Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.

ALL 50 STATES
Full report

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

Recall #:
86426
Lot/product code:
Lots: 4727479, 4784305
Recalling firm:
ICU Medical, Inc.
View official FDA record (opens in a new tab)