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Recalls affecting Nevada

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

16,567 recalls found
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Just announced

Straight from FDA press releases — not yet formally classified or risk-graded
UnclassifiedUndeclaredAnnounced September 4, 2026

Business Pill, Branch Manager for Men — dietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

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Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

Grant-Valkaria, Florida - SUPPLX.com is voluntarily recalling Business Pill and Branch Manager for Men, products marketed as dietary supplements for male sexual enhancement, because FDA laboratory analysis confirmed that both products contain yohimbine that is not declared on the product labels.

Company contact: (321) 341-9501 · SupplxRecall@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaAnnounced September 4, 2026

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

Foods Alive Inc of Angola, IN, is recalling its 8-ounce packages of organic moringa leaf powder because they have the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

B. Braun — 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

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Drugs

Recalling firm: B. Braun Medical Inc.

“On September 3, 2026 firm updated their press release to include additional contaminants.” FOR IMMEDIATE RELEASE – September 3, 2026– Bethlehem, PA, B. Braun Medical Inc (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container, to the hospital/healthcare facility/user level due to presence of particulate matter identified as iron…

Company contact: recalls@bbraunusa.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusE. coliAnnounced September 3, 2026

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

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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

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Food & Beverages

Recalling firm: American Regent, Inc.

FOR IMMEDIATE RELEASE – September 3, 2026 – New Albany, OH, American Regent, Inc. is conducting a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vials to the consumer level. Customer complaints were received for leaking and cracked vials, resulting in lack of assurance of sterility.

View FDA’s announcement (opens in a new tab)
UnclassifiedAllergenMilkUndeclaredAnnounced August 31, 2026

Little Temptations — Chocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

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Food & BeveragesAllergens

Recalling firm: Crystal Temptations

Crystal Temptations of North Arlington, NJ is recalling Halloween Chocolatey Eyeballs because they contain undeclared MILK allergens. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

View FDA’s announcement (opens in a new tab)
UnclassifiedUndeclaredAnnounced August 31, 2026

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

▸Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

FOR IMMEDIATE RELEASE - August 27, 2026 - Davie, Florida – Ana Salazar Modela Tu Cuerpo Inc. is recalling Lipofit Extreme Fat Burner 2.0, Lot 25M12F, expiration date 09/2027, to the consumer level.

Company contact: (954) 305-1004 · yandrydy@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced August 31, 2026

Kofinas — Garlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

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Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

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

Everything Sprouts — Robust Radish Mix, 5oz Cups

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

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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

Martina — Mangoes

Potential contamination with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

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

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled August 31, 2020

30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger, REF: CL3011; 31" (79 cm) Appx 3.4 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, Spiros w/Red Cap, Bag Hanger, REF: CL3011T; 40" (102 cm) Appx 4.9 ml, Admin Set w/ChemoLock w/Red Cap, 20 Drop In-Line Drip Chamber, Spiros, Bag Hanger, Drop-In Red Cap, REF: CL3020; 30" (76 cm) Appx 6.1 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, 0.2 Micron Filter, Spiros, Hanger, Drop-In Red Cap, REF: CL3028; 30" (76 cm) Appx 6.1 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, 0.2 Micron Filter, Spiros, Bag Hanger, Drop-In Red Cap, REF: CL3028T; 42" (107 cm) Appx 5.2 ml, Admin Set w/20 Drop In-Line Chamber, ChemoLock w/Red Cap, Spiros, Bag Hanger, Drop-In Red Cap, REF: CL3361; Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock; Spinning Spiros w/Red Cap, REF: CL3538; Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, Spiros; ChemoLock; ChemoLock Universal Vented Vial Spike; Bag Hanger, REF CL3929; 8.5" (22 cm) Appx 1.0 ml, Ext Set w/MicroClave Clear, ChemoLock Port, Spiros w/Red Cap, Clamp, REF: CL3931; 7.5" (19 cm) Appx 1.1 ml, Bifuse Ext Set w/ChemoLock Port, ChemoClave, Spiros, 2 Clamps, REF: CL3932; 30 IN(76cm)APPX 2.1ml, EXT SET w/ChemoLock w/RED CAP, Spiros RED CAP, REF: CL3935; Oncology Kit w/ChemoLock w/ChemoClave; Spinning Spiros w/ Red Cap, REF: CL3941; Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock w/Red Cap, Vented Cap; ChemoLock Port w/Bag Spike; Spiros w/Red Cap, REF: CL3946; Oncology Kit, ChemoLock Bag Spike w/Additive Port, Vented Cap, Spiros, REF: CL3948; Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros, ChemoLock, Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL3960; Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros, ChemoLock, Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL3960T; 60" (152 cm) Appx 7.4 ml, Admin Set w/ChemoLock w/Red Cap, 20 Drop In-Line Chamber, Spiros w/Red Cap, Bag Hanger, REF: CL4100; 30" (76 cm) Appx 3.6 ml, Admin Set w/20 Drop In-Line Drip Chamber, ChemoLock Additive Port, Spiros w/Red Cap, REF: CL4131; 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer, REF: CL4151; 31" (79 cm) Appx 3.4 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, Spiros w/Red Cap, Drop-In ChemoLock Injector, Bag Hanger, REF: CL3978

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:  4720479, 4724743, 4735699, 4775051, 4803047, 4808098, 4868079, 4868080, 4735696, 4763384, 4800367, 4866943, 4908482, 4724700, 4742639, 4758414, 4775030, 4787228, 4808060, 4848204, 4712385, 4724701, 4605106, 4733557, 4757782, 4775514, 4800370, 4724728, 4765922, 4867983, 4724703, 4749489, 4803140, 4878873, 4742641, 4758385, 4794501, 4720364, 4752843, 4799894, 4850394, 4866135, 4790865, 4735669, 4742630, 4758441, 4764898, 4787232, 4848213, 4867995, 4743901, 4765927, 4775070, 4777973, 4794503, 4606697, 4735662, 4803124, 4808069, 4867961, 4897098, 4898098, 4899830, 4573189, 4606684, 4749454, 4756268, 4803136, 4808059, 4848185, 4878880, 4726940, 4742091, 4738028, 4749474, 4560357, 4735675, 4714539, 4763384, 4800367, 4866943, 4908482, 4742641
Recalling firm:
ICU Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 31, 2020

DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material Number: 05987750001

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

76 cm (30") Appx 3.3 ml, Admin Set, 2 Spiros w/Red Cap, 20 Drop In-Line Drip Chamber w/15 Micron Filter, Bag Hanger, REF: 011-CH3261; 44 cm(17 IN) Appx 2.9 ml,PUR YELLOW TRANS SET,ChemoClave,CK VLV,Spiros,PURPLE CAP, REF: 011-CH3568; Oncology Kit, 5 Gang Stopcock w/5 ChemoClave, Spiros w/Red Cap; 10cm Smallbore Bifuse Ext w/2 ChemoClave, Red Ring, BCV; 297cm Ext w/ChemoClave, REF: 011-CH3600; Oncology Kit, 5 Gang Stopcock w/5 ChemoClave, Spiros w/Red Cap; 10cm Smallbore Bifuse Ext, w/2 ChemoClave, Red Ring, BCV; 597 cm Ext w/ChemoClave, REF: 011-CH3601; Kit, 2 5 Gang Stopcocks w/5 MicroClave Clear, Spiros; 2 Smallbore Bifuse Ext Sets, 2 MicroClave Clear, Red Ring, Check Valve, RMLL; 2 Ext Sets, MicroClave Clear Clipped Together, RMLL, REF: 011-CH3610; Admin Set w/Clave, Spiros, REF: 011-CH3772; Admin Set w/Clave, Spiros, REF: 011-CH3773; Admin Set w/Clave, Spiros, REF: 011-CH3967; 76" (193 cm) 50 ml, Diluent Set for Channel 2 w/20 Drop Drip Chamber, Spiros, Drop-In Red Cap, REF: 011-CH4011

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: 4784390, 4784404, 4865931, 4865006, 4590283, 4774210, 4865952, 4711264, 4605516, 4723103, 4882016, 4806569                                                ,
Recalling firm:
ICU Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 31, 2020

42 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros, REF: 20131-01; 31" (79 cm) Admin Set w/20 Drop Integrated Clave Drip Chamber, Spiros, Bag Hanger Drop-in Red Cap, 4 Units, REF: CH3330-C; 60 IN (152 cm) Appx 1.1 ml, Smallbore Set, MicroClave Clear, Spiros, REF: CH3353; 8" (20 cm) Appx 0.43 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Clamps, Spiros, REF: CH3367; 7" (18 cm) Appx 0.40 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, Spiros, 2 Clamps, REF: CH3379; 16" (41 cm) Appx 4.4 ml, Ext Set w/MicroClave, 0.2 Micron Filter, Clave, Spiros, Clamp, REF: CH3381; 31" (79 cm) Appx 3.3 ml, Admin Set w/20 Drop Integrated Clave Drip Chamber, Spiros w/Drop-in Red Cap, 2 Hanger, REF: CH3386; 40" (102 cm) Appx 7.3 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, 0.2 Micron Filter, Spiros, Hanger, REF: CH3401; 60" (152 cm) Appx 0.62 ml, Smallbore Ext Set w/MicroClave, Clamp, Spiros w/Red Cap, REF: CH3405; 75" (191 cm) Appx 9.1 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Clave, Spiros w/Red Cap, REF: CH3453; 73" (185 cm) Appx 2.1 ml, Smallbore Ext Set w/MicroClave Clear, Spiros, Clamp, REF: CH3485; 42" (107 cm) Appx 4.8 ml, 15 Drop Admin Set w/Spiros w/Red Cap, Bag Hanger, Drop-In Priming Cap, REF: CH3517; 8" (20 cm) Appx 0.49 ml, Smallbore Bifuse Ext Set w/MicroClave Clear, 2 Spiros, 3 Clamps, Priming Cap, REF: CH3523; 74" (188 cm) Smallbore Ext Set w/MicroClave, 0.2 Micron Low Protein Binding Filter, Spiros w/Red Cap, Clamp, REF: CH3533; 74 IN (188 cm) Appx 0.92 ml, Smallbore Set, MicroClave, 1.2 Micron Fil, Spiros, Red Cap, REF: CH3538; 18" (46 cm) Appx 5.1 ml, Ext Set w/0.2 Micron Filter, Clave, Spiros, Clamp, REF: CH3556; 60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave Clear, 0.2 Micron Low Protein Binding Filter, Spiros w/Red Cap, Clamp, REF: CH3603; 4-Way Clave Stopcock w/2 Spiros, REF: B4194; Spiros, Closed Male Connector w/Red Cap (10 Units), REF: Z7093; 47" (119 cm) 150 ml Burette Set w/MicroClave, 20 Drop In-Line Drip Chamber w/Ball Shut Off, Spiros, REF: Z7182

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:
Lot:  4764635, 4887770, 4787215, 4877053, 4737148, 4850390, 4749863, 4849350, 4867377, 4741238, 4763286, 4774081, 4809085, 4877072, 4908343, 4719787, 4734320, 4741243, 4749867, 4854763, 4895575, 4849358, 4751063, 4763289, 4775529, 4724813, 4749880, 4854774, 4734335, 4757706, 4849376, 4764061, 4793547, 4749900, 4756873, 4777159, 4799805, 4902253, 4751908, 4793550, 4849389, 4896178, 4733498, 4764065, 4849391, 4719565, 4751101, 4790766, 4774117, 4736129, 4895706, 4858370
Recalling firm:
ICU Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 31, 2020

31" (78 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros, Bag Hanger, REF: 011-CL3011; 40" (102 cm) Appx 4.9 ml, Admin Set w/ChemoLock, 20 Drop In-Line Drip Chamber, Spiros, Bag Hanger, REF: 011-CL3020; ChemoLock Port w/Spiros, Red Cap, REF: CL-35; 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros, Purple Cap, Hanger, REF: CL3951; 40" (102 cm) Appx 7.7 ml, Admin Set w/ChemoLock w/Red Cap, 20 Drop In-Line Drip Chamber, 0.2 Micron Filter, Spiros w/Red Cap, Bag Hanger, REF: CL3962; 31" (79 cm) Appx 3.5 ml, Admin Set w/ChemoLock Bag Spike with Additive Port, 20 Drop In-Line Chamber w/15 Micron Filter, Spiros, Purple Cap, Hanger, REF: CL3999

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: 4867937, 4751234, 4799262, 4894789, 4787230, 4867947, 4897075, 4720480, 4735684, 4758456, 4775068, 4794504, 4860043, 4799897, 4787234, 4808045, 4860044                                       ,
Recalling firm:
ICU Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 4, 2020

B. Braun Introcan IV Safety Catheters, sterile - Product Usage: It is a single-use device to generate intravascular and tissue access to sample blood, monitor blood pressure, or administer fluids and blood intravascular.

Recalled products do not have FDA approval for sale in the United States.

ALL 50 STATES
▸Full report

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

Recall #:
86443
Lot/product code:
All lot numbers under item codes ending in -01: 4251601-01, 4251628-01, 4251652-01, 4251687-01, 4251890-01, 4252500-01, 4252519-01, 4252527-01, 4252535-01, 4252543-01, 4252560-01, 4252586-01, 4252594-01, 4253523-01, 4253540-01, 4254546-01.
Recalling firm:
Braxton Medical Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2020

OSTEORAPTOR 2.9 W. 2 UB WHITE / BLACK -Absorbable Suture anchor Product Number: 72201996

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: 2012912 2017844 2019840 2021496 2024714 2033500 2049663 2052725 2055727
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2020

OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor Product Number: 72201993

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: 2012768 2013311 2012721 2013998 2016127 2018633 2018634 2019989 2020049 2021384 2021453 2023181 2023223 2023335 2025106 2025286 2026922 2025140 2026921 2026923 2025339 2027417 2027452 2029072 2029363 2030909 2030910 2030911 2030985 2030983 2030984 2032785 2033372 2033373 2034382 2034383 2034384 2035515 2035516 2035517 2035518 2036275 2036276 2039986 2038899 2039421 2039422 2040069 2040070 2040071 2044789 2044790 2044791 2050884 2049652 2049653 2050885 2055771 2055772 2056306 2048187 2056871 2056307
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

OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchor Product Number: 72201992

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: 2012908 2016123 2017811 2018793 2018796 2019889 2023270 2024438 2025338 2027482 2029362 2032556 2033493 2034379 2034380 2034381 2036272 2036273 2038763 2050882 2050883 2049650 2049651 2053757 2056870
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2020

OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE -Absorbable Suture anchor Product Number: 72201994

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: 2012769 2013999 2016154 2021495 2023224 2025101 2026924 2027418 2029364 2030912 2030913 2033496 2036691 2049654 2053758 2050886
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 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

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

OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE -Absorbable Suture anchor Product Number: 72201995

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: 2012909 2012911 2012910 2012937 2013912 2013913 2016202 2016230 2016203 2018636 2018637 2018740 2018795 2021326 2022258 2023091 2024440 2024441 2024439 2024448 2024449 2025098 2025094 2025340 2025287 2027419 2027388 2025288 2027453 2029073 2027483 2029325 2029326 2029366 2029365 2030990 2030989 2031123 2031125 2031127 2032788 2033240 2033239 2033375 2033376 2033497 2034385 2034386 2034387 2034458 2034459 2035471 2035472 2035473 2035521 2035522 2035523 2035524 2035526 2035525 2036692 2039227 2039228 2039424 2039584 2039585 2040072 2040706 2040708 2040709 2042563 2042564 2042565 2042745 2042746 2044792 2044794 2044795 2044796 2044797 2044793 2045742 2045743 2045744 2045745 2045746 2046744 2048188 2048189 2048190 2048191 2048192 2049661 2049662 2049655 2049656 2049657 2049658 2049660 2049659 2056309 2056311 2056310 2056312 2056313
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 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 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

BIORAPTOR 2.9MM SUTURE ANCHOR-Absorbable Suture anchor Product Number: 72201702

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: 2029229 2034457 2040701 2050876
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 6.5 W/3 UB- Absorbable Suture anchor Product Number: 72202610

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: 2024447 2039587
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

RAPTORMITE 3.7MM AB W/ NEEDLES AND TWO-Absorbable Suture anchor Product Number: 72201805

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: 2025354 2031116 2040066 2040702 2042557 2049638 2053749 2055239
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-Absorbable Suture anchors Product Number: 7210711

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: 2025421, 2038665,
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 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

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)