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Recalls affecting Pennsylvania

Data last updated: September 10, 2026 at 1:16 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)
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 September 9, 2020

HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203801

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

ALL 50 STATES
Full report

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

Recall #:
86462
Lot/product code:
Batch Numbers: 2013918 2016156 2017774 2018804 2021456 2023227 2024815 2025049 2027438 2029400 2029401 2033291 2033290 2034431 2034432 2034499 2034500 2034501 2034502 2035698 2037194 2039456 2045894 2048429 2048430 2051045 2051046 2049950 2049951 2053927 2056086 2056434
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2020

GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System

Due to secondary deployment fiber being attached to secondary deployment handle, completion of deployment via the deployment line access hatch was not possible

ALL 50 STATES
Full report

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

Recall #:
86420
Lot/product code:
CATALOG NUMBERS TGM212110X* TGM212115X* TGM212120X* TGM262610X* TGM262615X* TGM262620X* TGM282810X* TGM282815X* TGM282820X* TGM313110X* TGM313115X* TGM313120X* TGM343410X* TGM343415X* TGM343420X* TGM373710X* TGM373715X* TGM373720X* TGM404010X* TGM404015X* TGM404020X* TGM454510X* TGM454515X* TGM454520X* TGM262110X* TGM312610X* TGMR313110X* TGMR313115X* TGMR313120X* TGMR312610X* TGMR373710X* TGMR373715X* TGMR373720X* TGMR404010X* TGMR404015X* TGMR404020X* *X is a placeholder for enumeration code: E=EMEA, Australia, New Zealand; J=Japan  All lot numbers
Recalling firm:
W L Gore & Associates, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2020

HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK- Absorbable Suture anchor Product Number: 72203708

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

ALL 50 STATES
Full report

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

Recall #:
86462
Lot/product code:
Batch Numbers: 2014002 2016196 2017814 2020051 2021388 2023272 2024724 2026266 2024759 2025289 2027469 2030955 2031023 2033400 2035501 2036291 2038328 2039263 2048404 2049924 2051020 2053921 2056432 2057402
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2020

GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System

When the delivery catheter was attempted to be removed, there was an observed connection between the stent graft and the delivery catheter that prevented the delivery catheter from being withdrawn.

ALL 50 STATES
Full report

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

Recall #:
86421
Lot/product code:
CATALOG NUMBERS TGM212110X* TGM212115X* TGM212120X* TGM262610X* TGM262615X* TGM262620X* TGM282810X* TGM282815X* TGM282820X* TGM313110X* TGM313115X* TGM313120X* TGM343410X* TGM343415X* TGM343420X* TGM373710X* TGM373715X* TGM373720X* TGM404010X* TGM404015X* TGM404020X* TGM454510X* TGM454515X* TGM454520X* TGM262110X* TGM312610X* TGMR313110X* TGMR313115X* TGMR313120X* TGMR312610X* TGMR373710X* TGMR373715X* TGMR373720X* TGMR404010X* TGMR404015X* TGMR404020X* *X is a placeholder for enumeration code: E=EMEA, Australia, New Zealand; J=Japan  All Lot Numbers
Recalling firm:
W L Gore & Associates, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2020

EMPOWR Acetabular System *** EMPOWR Acetabular Cup, Cluster Hole, 54G *** Size 54G 54 mm Dia./Cluster Hole Alpha Code G Liner P2 Porous Coated REF 940-02-54G - Product Usage: are intended for treatment of patients who are candidates for total hip arthroplasty per the indications for use.

Due to incomplete machining a small peg remnant on the top of the dome that protrudes above the surrounding porous coating causing the cup not to seat properly.

ALL 50 STATES
Full report

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

Recall #:
86450
Lot/product code:
Model Number: 940-02-54G Lot Number: 801Z1036
Recalling firm:
Encore Medical, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2020

HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL-- Absorbable Suture anchor Product Number: 72203704

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

ALL 50 STATES
Full report

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

Recall #:
86462
Lot/product code:
Batch Numbers: 2014657 2013922 2013943 2013986 2016204 2016148 2016205 2016243 2017825 2017855 2017857 2018810 2018751 2018750 2021052 2020060 2020061 2020062 2021397 2021459 2021463 2023236 2023281 2023282 2023341 2024779 2024736 2024781 2024825 2024827 2025052 2025053 2024829 2025199 2025201 2025430 2027466 2027433 2027499 2029348 2029349 2029397 2029396 2027404 2030950 2030951 2031020 2031021 2031154 2031155 2032822 2032823 2033289 2033288 2034424 2034425 2034497 2035498 2035499 2035535 2035536 2034496 2036303 2036304 2034494 2034495 2036723 2037189 2037149 2037150 2038326 2038327 2038468 2038467 2038802 2039670 2039262 2039450 2039608 2040107 2041200 2041069 2042595 2042596 2042775 2042776 2045868 2048386 2048387 2048388 2048389 2049911 2049912 2049907 2049909 2049910 2049908 2052168 2053908 2053909 2053910 2053911 2056075 2056076 2056077 2056078 2056079 2056425
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2020

TWINFIX ULTRA HA 6.5 W/2 UB (BLUE & BLK)- Absorbable Suture anchor Product Number: 72202631

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

ALL 50 STATES
Full report

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

Recall #:
86462
Lot/product code:
Batch Numbers: 2012720 2024445 2052779 2055899
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2020

TWINFIX AB 5.0 SUTR ANCHR W/2 38 ULTRA-Absorbable Suture anchors Product Number:72200777

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

ALL 50 STATES
Full report

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

Recall #:
86462
Lot/product code:
Batch Numbers: 2012914, 2033371
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2020

TWINFIX ULTRA PLLA HA 6.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202620

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

ALL 50 STATES
Full report

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

Recall #:
86462
Lot/product code:
Batch Numbers: 2025072
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2020

ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Suture anchor Product Number: 72201495

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

ALL 50 STATES
Full report

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

Recall #:
86462
Lot/product code:
Batch Numbers: 2020371 2020372 2020373 2020995 2030838 2035405 2044636 2048178
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2020

TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL--Absorbable Suture anchor Product Number: 72202602

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

ALL 50 STATES
Full report

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

Recall #:
86462
Lot/product code:
Batch Numbers: 2013151 2013152 2013903 2016145 2017808 2018788 2019884 2019885 2025277 2027457 2031003 2031002 2031054 2031055 2033509 2033508 2034401 2038771 2042570 2042752 2048296 2049809 2050955 2053788 2056330 2056872
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2020

MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204984

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

ALL 50 STATES
Full report

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

Recall #:
86462
Lot/product code:
Batch Numbers: 2042787
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2020

ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT-Absorbable Suture anchors Product Number: 72201493

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

ALL 50 STATES
Full report

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

Recall #:
86462
Lot/product code:
Batch Numbers: 2024948, 2024949, 2027356,2029176, 2044635
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2020

TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202626

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

ALL 50 STATES
Full report

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

Recall #:
86462
Lot/product code:
Batch Numbers: 2012719 2024702 2027393 2029380
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2020

TWINFIX ULTRA PLLA HA 5.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202616

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

ALL 50 STATES
Full report

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

Recall #:
86462
Lot/product code:
Batch Numbers: 2025074 2027489 2031006 2042572 2052109 2056058
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2020

HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203697

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

ALL 50 STATES
Full report

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

Recall #:
86462
Lot/product code:
Batch Numbers: 2013959 2016246 2017861 2018756 2019936 2021510 2023286 2024791 2025371 2027465 2027498 2027403 2029347 2031019 2031087 2031153 2033535 2035497 2035534 2037188 2037148 2038325 2039607 2041068 2042774 2044894 2046452 2048384 2048385 2049906 2051015 2051016 2052167 2052166 2056074 2056423 2056424 2057383
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2020

OSTEORAPTOR CRVD 2.3 SA UB COBRD BLACK- Absorbable Suture anchor Product Number: 72203291

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

ALL 50 STATES
Full report

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

Recall #:
86462
Lot/product code:
Batch Numbers: 2012936 2013911 2016129 2018794 2027463 2029395 2033280
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2020

TWINFIX 6.5MM AB PRELOADED ULTRABRAID- Absorbable Suture anchors Product Number: 7210712

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

ALL 50 STATES
Full report

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

Recall #:
86462
Lot/product code:
Batch Numbers: 2025178
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2020

TWINFIX ULTRA HA 4.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202624

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

ALL 50 STATES
Full report

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

Recall #:
86462
Lot/product code:
Batch Numbers: 2013904 2018628 2023177 2025213 2039590 2050959 2052719
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2020

MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204983

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

ALL 50 STATES
Full report

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

Recall #:
86462
Lot/product code:
Batch Numbers: 2034103 2034102 2034104 2042786
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2020

TWINFIX 6.5MM AB PRELOADED SUTURE ANCHOR- Absorbable Suture anchors Product Number: 7210713

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

ALL 50 STATES
Full report

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

Recall #:
86462
Lot/product code:
Batch Numbers: 2027380
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2020

ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number: 72201494

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

ALL 50 STATES
Full report

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

Recall #:
86462
Lot/product code:
Batch Numbers: 2023195 2023243 2024953 2024956 2025090 2025122 2025379 2025380 2026563 2028643 2027357 2027362 2027367 2027371 2029177 2029178 2029179 2029180 2029213 2030836 2030837 2030853 2030854 2030869 2030870 2030871 2030872 2030883 2030884 2032840 2033307 2033418 2033554 2035383 2035384 2035403 2035404 2035413 2035428 2036762 2036763 2037209 2038262 2040397 2040398 2039496 2039175 2039633 2039634 2041088 2041089 2041214 2044784 2042798 2044783 2045734 2045735 2046221 2048174 2048173 2048175 2048176 2048177 2049628 2049629 2049630 2049631 2049632 2050866 2050867 2051658 2050868 2050869 2052035 2053332 2053334 2050865 2053333 2053335 2053336 2053337 2054832 2055528 2054776 2054777 2054778
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2020

TWINFIX ULTRA PLLA/HA 5.5 W/3 UB-Absorbable Suture anchor Product Number: 72202603

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

ALL 50 STATES
Full report

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

Recall #:
86462
Lot/product code:
Batch Numbers: 2012913 2024716 2025341 2031135 2033510 2034402 2036289 2037671
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2020

TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO- Absorbable Suture anchors Product Number: 7210710

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

ALL 50 STATES
Full report

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

Recall #:
86462
Lot/product code:
Batch Numbers: 2025362, 2040057
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 10, 2020

t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology

Insulin pumps may display unexpected fluctuation of the remaining battery life so ensure pump battery life does not fall below 25% remaining power. If the battery life drops to less than 5%, insulin delivery will continue for 30 minutes and then the pump will power off and insulin delivery will stop. If the battery reaches 1%, then insulin delivery will stop, which could lead to hyperglycemia.

ALL 50 STATES
Full report

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

Recall #:
90113
Lot/product code:
Dexcom G5 - All Serial Numbers; Basal-IQ Technology - Software Versions 6.3.01 and Earlier
Recalling firm:
Tandem Diabetes Care Inc
View official FDA record (opens in a new tab)