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Recalls affecting Pennsylvania

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

17,247 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)
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)
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)
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 October 4, 2019

Prismaflex Control Unit, software versions below 7.21

Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.

ALL 50 STATES
Full report

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

Recall #:
83852
Lot/product code:
Product Code: 6023014700; All Lot numbers; GTIN: 07332414073718.
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled October 4, 2019

Nana's Been a Nut Bread NET WT. 11oz/311.74g cloth bag CONTAINS WHEAT AND SOY. MADE ON EQUIPMENT THAT MAKES PRODUCTS CONTAINING WHEAT, EGGS, MILK, SOY AND TREE NUTS. GULLAH BOURMET Inc. CHARLESTON, SC 29407 UPC 6 50305 01045 9

The product ingredient statement does not list walnuts in the product.

Full report

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

Recall #:
F-0036-2020
Lot/product code:
Item #: 1045. Expiration date 01/30/2020
Recalling firm:
Gullah Gourmet, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 4, 2019

Prismaflex Control Unit, software versions below 7.21

Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.

ALL 50 STATES
Full report

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

Recall #:
83852
Lot/product code:
Product Code: 114870; All Lot numbers; GTIN: 07332414115395. Device not distributed in the US.
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 4, 2019

WECK Hem-O-Lok AutoEndo5, 5mm Automatic Endoscopie Hem-o-lok Applier, REF 543965 Automatic Endoscopic Surgical Ligating Clip Appliers are delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips

Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a discrepancy in the specification a component. Misloading and/or jamming may lead to clips falling out of the applier, clip breakage, or the jaws becoming locked in a partially closed position (jammed).

ALL 50 STATES
Full report

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

Recall #:
84032
Lot/product code:
Codes: 73J1600836 73C1700518 73D1800018 73H1800233 73A1900664 73J1600837 73C1700842 73D1800019 73H1800234 73B1900436 73K1600114 73D1700008 73D1800020 73H1800235 73B1900437 73K1600115 73D1700009 73D1800558 73H1800236 73B1900438 73K1600290 73D1700010 73D1800559 73H1800240  73K1600515 73D1700068 73D1800560 73H1800496  73K1600814 73D1700069 73D1800561 73H1800497  73L1600097 73D1700313 73D1800562 73H1800498  73L1600098 73D1700314 73D1800563 73H1800499  73L1600099 73D1700315 73D1800564 73H1800500  73L1600100 73D1700496 73D1800565 73H1800501  73L1600101 73D1700497 73E1800526 73H1800502  73L1600274 73D1700574 73E1800527 73H1800639  73L1600275 73D1700575 73E1800528 73H1800640  73L1600276 73F1700209 73E1800529 73H1800641  73L1600277 73F1700210 73E1800530 73H1800642  73L1600278 73G1700345 73F1800263 73H1800643  73L1600279 73G1700346 73F1800264 73H1800820  73L1600280 73G1700347 73F1800265 73J1800298  73L1600540 73G1700720 73F1800266 73J1800299  73L1600792 73G1700721 73F1800267 73J1800300  73L1600793 73H1700095 73F1800268 73J1800301  73L1600794 73H1700096 73F1800269 73J1800302  73L1600795 73H1700097 73F1800270 73J1800303  73L1600796 73H1700098 73F1800486 73J1800304  73L1600797 73B1800105 73F1800487 73J1800305  73L1600798 73B1800106 73F1800759 73J1800306  73M1600217 73B1800188 73F1800760 73J1800718  73M1600218 73B1800189 73F1800761 73J1800719  73M1600219 73B1800190 73G1800089 73J1800720  73M1600220 73B1800192 73G1800520 73K1800055  73M1600281 73B1800216 73G1800521 73K1800057  73M1600282 73B1800217 73G1800522 73K1800058  73A1700205 73C1800125 73G1800525 73K1800691  73A1700206 73C1800126 73G1800726 73K1800694  73A1700207 73C1800127 73G1800727 73K1800700  73A1700348 73C1800128 73G1800728 73K1800701  73A1700349 73C1800129 73G1800729 73K1800702  73B1700226 73C1800130 73G1800730 73K1800703  73B1700276 73C1800131 73G1800731 73M1800021  73B1700486 73C1800132 73G1800877 73M1800022  73B1700487 73D1800013 73G1800878 73M1800023  73C1700335 73D1800014 73H1800138 73M1800024  73C1700360 73D1800015 73H1800139 73M1800025  73C1700361 73D1800016 73H1800231 73A1900662  73C1700362 73D1800017 73H1800232 73A1900663
Recalling firm:
Teleflex Medical
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 4, 2019

Prismaflex Control Unit, software versions below 7.21

Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.

ALL 50 STATES
Full report

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

Recall #:
83852
Lot/product code:
Product Code: 115269 (GTIN: 07332414117702), 955542 GTIN: 07332414124236); All Lot numbers
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 4, 2019

Prismaflex Control Unit, software versions below 7.21

Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.

ALL 50 STATES
Full report

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

Recall #:
83852
Lot/product code:
Product Code: 113081; All Lot numbers; GTIN: 07332414105266
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 4, 2019

WECK AutoEndo5, Automatic Hem-O-Lok Clip Applier, REF AE05ML Automatic Endoscopic Surgical Ligating Clip Appliers are delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips

Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a discrepancy in the specification a component. Misloading and/or jamming may lead to clips falling out of the applier, clip breakage, or the jaws becoming locked in a partially closed position (jammed).

ALL 50 STATES
Full report

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

Recall #:
84032
Lot/product code:
Codes: 73J1600836 73C1700518 73D1800018 73H1800233 73A1900664 73J1600837 73C1700842 73D1800019 73H1800234 73B1900436 73K1600114 73D1700008 73D1800020 73H1800235 73B1900437 73K1600115 73D1700009 73D1800558 73H1800236 73B1900438 73K1600290 73D1700010 73D1800559 73H1800240  73K1600515 73D1700068 73D1800560 73H1800496  73K1600814 73D1700069 73D1800561 73H1800497  73L1600097 73D1700313 73D1800562 73H1800498  73L1600098 73D1700314 73D1800563 73H1800499  73L1600099 73D1700315 73D1800564 73H1800500  73L1600100 73D1700496 73D1800565 73H1800501  73L1600101 73D1700497 73E1800526 73H1800502  73L1600274 73D1700574 73E1800527 73H1800639  73L1600275 73D1700575 73E1800528 73H1800640  73L1600276 73F1700209 73E1800529 73H1800641  73L1600277 73F1700210 73E1800530 73H1800642  73L1600278 73G1700345 73F1800263 73H1800643  73L1600279 73G1700346 73F1800264 73H1800820  73L1600280 73G1700347 73F1800265 73J1800298  73L1600540 73G1700720 73F1800266 73J1800299  73L1600792 73G1700721 73F1800267 73J1800300  73L1600793 73H1700095 73F1800268 73J1800301  73L1600794 73H1700096 73F1800269 73J1800302  73L1600795 73H1700097 73F1800270 73J1800303  73L1600796 73H1700098 73F1800486 73J1800304  73L1600797 73B1800105 73F1800487 73J1800305  73L1600798 73B1800106 73F1800759 73J1800306  73M1600217 73B1800188 73F1800760 73J1800718  73M1600218 73B1800189 73F1800761 73J1800719  73M1600219 73B1800190 73G1800089 73J1800720  73M1600220 73B1800192 73G1800520 73K1800055  73M1600281 73B1800216 73G1800521 73K1800057  73M1600282 73B1800217 73G1800522 73K1800058  73A1700205 73C1800125 73G1800525 73K1800691  73A1700206 73C1800126 73G1800726 73K1800694  73A1700207 73C1800127 73G1800727 73K1800700  73A1700348 73C1800128 73G1800728 73K1800701  73A1700349 73C1800129 73G1800729 73K1800702  73B1700226 73C1800130 73G1800730 73K1800703  73B1700276 73C1800131 73G1800731 73M1800021  73B1700486 73C1800132 73G1800877 73M1800022  73B1700487 73D1800013 73G1800878 73M1800023  73C1700335 73D1800014 73H1800138 73M1800024  73C1700360 73D1800015 73H1800139 73M1800025  73C1700361 73D1800016 73H1800231 73A1900662  73C1700362 73D1800017 73H1800232 73A1900663  73F1700597 73M1700020 73C1800265 73E1800326 73F1800733 73F1700598 73M1700074 73C1800266 73E1800327 73F1800734 73F1700599 73M1700112 73C1800267 73E1800328 73G1800171 73G1700468 73M1700113 73C1800268 73E1800329 73G1800172 73G1700469 73M1700114 73C1800515 73E1800330 73G1800264 73G1700472 73M1700115 73C1800516 73E1800331 73G1800265 73G1700473 73M1700116 73C1800517 73E1800332 73G1800266 73G1700554 73M1700286 73C1800578 73E1800333 73G1800267 73G1700555 73M1700287 73C1800627 73E1800334 73G1800289 73G1700556 73M1700288 73C1800628 73E1800764 73G1800290 73G1700557 73M1700289 73C1800629 73E1800765 73G1800291 73G1700558 73M1700290 73C1800630 73E1800766 73G1800292 73H1700821 73M1700291 73C1800631 73E1800767 73G1800293 73H1700835 73A1800244 73C1800632 73E1800768 73G1800294 73H1700836 73A1800589 73C1800633 73E1800769 73G1800295 73K1700553 73A1800596 73D1800209 73E1800770 73G1800296 73K1700567 73A1800597 73D1800210 73E1800771 73G1800868 73K1700568 73A1800598 73D1800211 73E1800772 73G1800872 73K1700570 73A1800605 73D1800212 73F1800091 73G1800873 73K1700571 73A1800742 73D1800213 73F1800092 73G1800874 73L1700001 73A1800823 73D1800372 73F1800093 73G1800875 73L1700002 73A1800824 73D1800373 73F1800094 73G1800876 73L1700004 73A1800825 73D1800374 73F1800095 73H1800071 73L1700007 73A1800827 73D1800375 73F1800096 73H1800140 73L1700023 73A1800828 73D1800376 73F1800097 73H1800141 73L1700107 73B1800286 73D1800377 73F1800098 73H1800142 73L1700108 73B1800287 73D1800668 73F1800099 73H1800143 73L1700189 73B1800288 73E1800023 73F1800407 73H1800144 73L1700190 73B1800289 73E1800024 73F1800408 73H1800145 73L1700277 73B1800291 73E1800025 73F1800409 73H1800228 73L1700278 73B1800292 73E1800026 73F1800410 73H1800229 73L1700280 73B1800468 73E1800027 73F1800411 73H1800638 73L1700281 73B1800469 73E1800028 73F1800412 73H1800829 73L1700282 73B1800525 73E1800033 73F1800586 73H1800830 73L1700351 73B1800526 73E1800034 73F1800587 73J1800030 73L1700462 73B1800527 73E1800165 73F1800588 73J1800031 73L1700463 73B1800528 73E1800166 73F1800589 73J1800032 73L1700464 73B1800529 73E1800167 73F1800590 73J1800033 73L1700465 73B1800676 73E1800198 73F1800591 73J1800034 73L1700466 73B1800677 73E1800199 73F1800675 73J1800035 73L1700467 73B1800678 73E1800200 73F1800727 73J1800036 73L1700587 73B1800679 73E1800201 73F1800728 73J1800385 73L1700588 73B1800680 73E1800202 73F1800729 73J1800386 73L1700589 73B1800681 73E1800203 73F1800730 73J1800387 73L1700590 73C1800263 73E1800204 73F1800731 73J1800388 73L1700591 73C1800264 73E1800325 73F1800732 73J1800480 73J1800481 73L1800353 73A1900048 73B1900227  73J1800482 73L1800354 73A1900049 73B1900228  73J1800483 73L1800355 73A1900233 73B1900229  73J1800484 73L1800356 73A1900234 73B1900230  73J1800485 73L1800357 73A1900235 73B1900231  73J1800486 73L1800358 73A1900236 73B1900429  73J1800487 73L1800359 73A1900237 73B1900430  73J1800488 73L1800541 73A1900238 73B19… (truncated, 6715 characters total — see the official FDA record for the full value)
Recalling firm:
Teleflex Medical
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 4, 2019

Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System s intended use environment includes anatomic pathology (AP) laboratories and histology facilities within hospital, clinic, reference, or private lab settings. The System is to be operated by qualified users in

The firm became aware of a cleaning solution leaking issue from the middle staining module of the Ventana HE 600 instrument, used for histologic section samples in anatomic pathology laboratory settings, which caused fluid to travel down to the electrical wiring connector of the Coverslipper solvent shield circuit board. This can cause an electrical short and result in burned components.

ALL 50 STATES
Full report

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

Recall #:
85526
Lot/product code:
All lots
Recalling firm:
Ventana Medical Systems Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 7, 2019

Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/ PL(Purple)/ RD(Red)

Walkers within the identified serial range have the potential for the front fork to unscrew itself from the leg. A partially unscrewed fork creates unevenness in the wheelbase, which could cause instability, that if not detected by the user, may result in the front fork falling off the walker.

Full report

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

Recall #:
86941
Lot/product code:
Serial # range: HF-4258BKHA0001 to HF4258RDHK0352 (Purchased before April 4th,2019)
Recalling firm:
Nova Ortho-Med Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 8, 2019

Arrow EZ-IO Intraosseous Vascular Access System 25mm Needle+Stabilizer Kit, Product Code 9001P-VC-005 - Product Usage: The Arrow EZ-IO Intraosseous Vascular Access System provides intraosseous access in the proximal humerus, proximal tibia, and distal tibia of adult and pediatric patients, and the distal femur in pediatric patients when vascular access is difficult to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.

The safety cap attached to needles within the needle sets may become dislodged exposing the needle and potentially causing the needle to protrude through the packaging. If this issue is not detected, the immediate risk of exposure to the affected devices is needle stick injury to the clinician or health care professional. In addition, a puncture of the packaging may compromise the sterility of the needle.

ALL 50 STATES
Full report

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

Recall #:
84054
Lot/product code:
All
Recalling firm:
Teleflex Medical
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 8, 2019

Arrow EZ-IO Intraosseous Vascular Access System 15mm Needle+Stabilizer Kit, Product Code 9018P-VC-005 - Product Usage: The Arrow EZ-IO Intraosseous Vascular Access System provides intraosseous access in the proximal humerus, proximal tibia, and distal tibia of adult and pediatric patients, and the distal femur in pediatric patients when vascular access is difficult to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.

The safety cap attached to needles within the needle sets may become dislodged exposing the needle and potentially causing the needle to protrude through the packaging. If this issue is not detected, the immediate risk of exposure to the affected devices is needle stick injury to the clinician or health care professional. In addition, a puncture of the packaging may compromise the sterility of the needle.

ALL 50 STATES
Full report

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

Recall #:
84054
Lot/product code:
All
Recalling firm:
Teleflex Medical
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 8, 2019

Arrow EZ-IO Intraosseous Vascular Access System 45mm Needle+Stabilizer Kit, Product Code 9079P-VC-005 - Product Usage: The Arrow EZ-IO Intraosseous Vascular Access System provides intraosseous access in the proximal humerus, proximal tibia, and distal tibia of adult and pediatric patients, and the distal femur in pediatric patients when vascular access is difficult to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.

The safety cap attached to needles within the needle sets may become dislodged exposing the needle and potentially causing the needle to protrude through the packaging. If this issue is not detected, the immediate risk of exposure to the affected devices is needle stick injury to the clinician or health care professional. In addition, a puncture of the packaging may compromise the sterility of the needle.

ALL 50 STATES
Full report

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

Recall #:
84054
Lot/product code:
All
Recalling firm:
Teleflex Medical
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 9, 2019

Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031, MS18623, MS22862, MS25301

The devices have potential cybersecurity vulnerabilities, which can include Distributed Denial of Service (DDoS), Spoofing, and Tampering.

ALL 50 STATES
Full report

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

Recall #:
84028
Lot/product code:
All systems using Software version VG2.3.1 and lower
Recalling firm:
Draegar Medical Systems, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 10, 2019

Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisting of FCR-S Fusion Capture Reagent - S, Nucleic Acid in a buffered solution and FER-S Fusion Enhancer Reagent-S (Lithium Hydroxide Solution), UDI: 15420045509214

Reagent component included in flu test kit may cause both high background signal in a true negative sample leading to false positive and/or false negative results. This could result in false positive and/or false negative results on patient samples or failed controls leading to invalid runs. This could result in incorrect results being reported and a delay in treatment.

Full report

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

Recall #:
85346
Lot/product code:
Panther Fusion Extraction Reagent-S Lot number: 258402 Panther Fusion Capture Reagent-S Lot number: 257472 Panther Fusion Enhancer Reagent-S Lot number: 257473
Recalling firm:
Hologic, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 11, 2019

Sprotte Needle, REF 32115130C w/ Intro 22 G x 3.5", distributed by Teleflex Medical The SPROTTE lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic lumbar puncture, myelography/discography procedures.

Teleflex received the attached Medical Device Recall Notice from Pajunk Medical. Teleflex Medical is a distributor of Pajunk products. According to the notice, Pajunk internally identified a packaging problem that may affect certain batches of the SPROTTE lumbar puncture cannulas with introducer. Due to this problem Pajunk cannot guarantee the sterility of the affected batches.

ALL 50 STATES
Full report

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

Recall #:
85551
Lot/product code:
Lot/Batch Numbers: 74A1900698, 74C1902955, 74C1900349, 74C1900137, 74E1802338, 74G1802129, 74H1802488, 74K1800901, 74K1801734, 74L1802219
Recalling firm:
TELEFLEX MEDICAL INC
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UnclassifiedRisk not yet known
Medical deviceRecalled October 11, 2019

Sprotte Needle, REF 33115131B w/ Intro 20 G x 3.5", distributed by Teleflex Medical The SPROTTE lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic lumbar puncture, myelography/discography procedures.

Teleflex received the attached Medical Device Recall Notice from Pajunk Medical. Teleflex Medical is a distributor of Pajunk products. According to the notice, Pajunk internally identified a packaging problem that may affect certain batches of the SPROTTE lumbar puncture cannulas with introducer. Due to this problem Pajunk cannot guarantee the sterility of the affected batches.

ALL 50 STATES
Full report

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

Recall #:
85551
Lot/product code:
Lot/Batch Numbers: 74A1900703, 74D1802540, 74E1800978, 74F1801413, 74G1800896, 74H1800162, 74K1801738, 74K1802909, 74L1800502
Recalling firm:
TELEFLEX MEDICAL INC
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UnclassifiedRisk not yet known
Medical deviceRecalled October 18, 2019

Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970

Failed to meet USP minimum average value for knot pull (tensile) strength.

Full report

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

Recall #:
84178
Lot/product code:
Product Code: 494A/494A-IMC; Lot Number: 190123-59; date of manufacture: 03/04/2019
Recalling firm:
CP Medical Inc
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UnclassifiedRisk not yet known
Medical deviceRecalled October 21, 2019

DxM 1040 MicroScan WalkAway Instrument REF B1018-440

WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere

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Full report

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

Recall #:
90087
Lot/product code:
Catalog Number: B1018-440 UDI-DI Code: 15099590690885 Serial Numbers: 44010026 44010027 44010028 44010029 44010030 44010031 44010032 44010033 44010035 44010036 44010037 44010038 44010040 44010041 44010042 44010043 44010044 44010045 44010046 44010047 44010048 44010049 44010050 44010051 44010052 44010053 44010054 44010055 44010056 44010057 44010058 44010059 44010060 44010061 44010063 44010064 44010065 44010066 44010067 44010068
Recalling firm:
Beckman Coulter Inc.
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UnclassifiedRisk not yet known
Medical deviceRecalled October 21, 2019

DxM 1096 MicroScan WalkAway Instrument REF B1018-496

WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere

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Full report

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

Recall #:
90087
Lot/product code:
Catalog Number: B1018-496 UDI-DI Code: 15099590690892 Serial Numbers: 49610039 49610040 49610041 49610042 49610043 49610044 49610045 49610046 49610047 49610048 49610050 49610051 49610052 49610053 49610054 49610055 49610056 49610057 49610058 49610059 49610060 49610062 49610063 49610064 49610065 49610066 49610067 49610068 49610069 49610070 49610071 49610072 49610073 49610074 49610075 49610078 49610079 49610080 49610081 49610082 49610083 49610084 49610085 49610086 49610087 49610088 49610089 49610090 49610091
Recalling firm:
Beckman Coulter Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 21, 2019

MicroScan WalkAway-40 plus Instrument REF B1018-283

WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere

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Full report

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

Recall #:
90087
Lot/product code:
Catalog Number: B1018-283 UDI-DI Code: 1509959065866 Serial Numbers: 34010003 34010004 34010005 34010006 34010007 34010008 34010009 34010010 34010011 34010012 34010013 34010014 34010015 34010016 34010017 34010018 34010019 34010020 34010021 34010022 34010023 34010024
Recalling firm:
Beckman Coulter Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 21, 2019

MicroScan WalkAway-96 plus Reconditioned Instrument REF B1018-396R

WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere

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Full report

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

Recall #:
90087
Lot/product code:
Catalog Number: B1018-396R UDI-DI Code: 15099590684129 Serial Numbers: 39620362 39620406 3967731 3967914
Recalling firm:
Beckman Coulter Inc.
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UnclassifiedRisk not yet known
Medical deviceRecalled October 21, 2019

MicroScan WalkAway-96 plus Instrument REF B1018-284

WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere

ALL 50 STATES
Full report

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

Recall #:
90087
Lot/product code:
Catalog Number: B1018-284 UDI-DI Code: 15099590658687 Serial Numbers: 39610007 39610008 39610009 39610010 39610011 39610012 39610013
Recalling firm:
Beckman Coulter Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 21, 2019

MicroScan WalkAway-40 plus Reconditioned Instrument REF B1018-340R

WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere

ALL 50 STATES
Full report

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

Recall #:
90087
Lot/product code:
Catalog Number: B1018-340R UDI-DI Code: 15099590684112 Serial Numbers: 34020035 34020224 34030054
Recalling firm:
Beckman Coulter Inc.
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UnclassifiedRisk not yet known
Medical deviceRecalled October 22, 2019

EMPOWR Acetabular System, Non-Sterile, Model Numbers 803-15-023 803-15-026 803-15-027 803-15-028 803-15-029 803-15-030 Product Usage: The EMPOWR Acetabular Impactor Balls is intended for use in joint replacement in patients suffering from disability due to noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head; rheumatoid arthritis, correction of functional deformity, femoral fracture, and in the salvage of previously failed surgical attempts.

The firm received complaints that the EMPOWR Acetabular Impactor Balls were fracturing/cracking during impaction which could cause debris to migrate or be left in the joint space.

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Full report

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

Recall #:
85376
Lot/product code:
All lots
Recalling firm:
Encore Medical, LP
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 22, 2019

Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219 NDC's 41167-0300-0, 41167-0300-1, 41167-0300-3, 41167-0300-5, 41167-0300-6, 41167-0300-7, 41167-0300-8

CGMP Deviations: Presence of NDMA impurity detected in product.

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Full report

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

Recall #:
D-0535-2020
Lot/product code:
all lots
Recalling firm:
Sanofi-Aventis U.S. LLC
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