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FDA food · drug · device recalls, merged

Before you eat it, take it, or plug it in — check.

Big Nope pulls three separate FDA recall feeds into one list per state, so you’re not searching three government databases to get one answer.

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Just announced

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

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

Products contain undeclared yohimbine

▸Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

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

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

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

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

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

Presence of particulate matter identified as iron oxide

▸Full report
Drugs

Recalling firm: B. Braun Medical Inc.

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

Company contact: recalls@bbraunusa.com

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

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Frutas y Hortalizas del Sur S.A.

September 02, 2026. Frutas y Hortalizas del Sur S.A., San Carlos, Chile expands its July 3, 2026, recall of frozen organic IQF blueberries to include one lot of Great Value frozen Organic Triple Berry Blend 10 OZ because of potential contamination with Escherichia coli O145:H28 (E. coli O145) .

Company contact: Info.foodsafety@comfrut.com

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

American Regent, Inc. — Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial

Presence of particulate matter and lack of sterility assurance

▸Full report
Food & Beverages

Recalling firm: American Regent, Inc.

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

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

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

Undeclared milk

▸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

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

▸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 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)

Recalls nationwide

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

19,422 recalls found
Wording
Class IHigh risk
FoodUndeclaredRecalled April 23, 2026

french broad CHOCOLATE bette's bake sale (a multi-flavor bonbon assortment). 6-piece NET WT. 2.5 OZ (70.75G); 12-piece NET WT. 5 OZ (141.75G); and 24-piece NET WT. 10 OZ (283.5G), French Broad Chocolate Crafted in Asheville, NC 28801, USA

Not listed on the label nut allergen (walnut) due to mislabeling. The product's printed tasting guide incorrectly identifies the Walnut Fudge and Peach Cobbler flavor chocolates (bonbons). Consumers relying on the printed materials could mistakenly consume a nut-containing bonbon.

ALARAZCACOCTDCFLGAIAILINKYLAMAMDMIMNMOMSMTNCNENHNJNMNYOHOKORPASCSDTNTXUTVAVTWAWIWV
▸Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
H-0712-2026
Lot/product code:
6-piece: Batch 260414 Best By Jun. 29 2026 & Batch 260417 Best By Jun. 30 2026 12-piece: Batch 260414 Best By Jun. 22 2026 & Batch 260417 Best By Jun. 30 2026 24-piece: Batch 260414 Best By Jun. 29 2026 & Batch 260417 Best By Jun. 30 2026
Recalling firm:
French Broad Chocolate Factory
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled April 23, 2026

Joy Rose Lassi 16 oz.

Product not adequately pasteurized

NJNYPA
▸Full report

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

Recall #:
H-1082-2026
Lot/product code:
Expiry June 30 through July 30, 2026 UPC:68061710005
Recalling firm:
Joy Gourmet Foods LLC.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 23, 2026

Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 64980-688-10.

Failed Impurities/Degradation Specifications:not meeting quality requirements result occurred in Organic Impurities Test

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-0520-2026
Lot/product code:
Lot #: GEH25023, Expires: 6/30/2027
Recalling firm:
JB Chemicals and Pharmaceuticals Ltd
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled April 23, 2026

Joy Orange Lassi 16 oz.

Product not adequately pasteurized

NJNYPA
▸Full report

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

Recall #:
H-1093-2026
Lot/product code:
Expiry June 30 through July 30, 2026 UPC: 68061710033
Recalling firm:
Joy Gourmet Foods LLC.
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled April 23, 2026

Joy Masala Chaash Lassi 16 oz., 64 oz.

Product not adequately pasteurized

NJNYPA
▸Full report

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

Recall #:
H-1090-2026
Lot/product code:
Expiry June 30 through July 30, 2026 16 oz. UPC Codes: 68061710012 64 oz. UPC code: 68061710014
Recalling firm:
Joy Gourmet Foods LLC.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 23, 2026

Covidien Mon-a-Therm General Purpose Temperature Probe REF: 90044

Temperature probe devices lack FDA clearance.

ALL 50 STATES
▸Full report

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

Recall #:
98859
Lot/product code:
UDI: 30884521828388/ Lot: 25F0945JZX 25H0949JZX, 25I1065JZX, 25I1066JZX
Recalling firm:
Covidien LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 23, 2026

Arvis Hip & Knee 3.0 Instrument Set, REF: IN-28000 containing one of the following components: IN-10500, Impactor V-Block Assembly; IN-10600 , Tracker B; IN-16400, Tracker A; IN-16100, Tracker C; IN-28050, Tracker E

The V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face.

ALL 50 STATES
▸Full report

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

Recall #:
98804
Lot/product code:
All Lots/serial Numbers; UDI: IN-28000: 00810180350020; IN-10500: (01)00810180350686; IN-10600 (01)00810180350693; IN-16400:(01)00810180350525; IN-16100: (01)00810180350563; IN-28050: 00810180350051
Recalling firm:
Kico Knee Innovation Company
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 23, 2026

Arvis Hip & Knee 2.0 Instrument Set, REF: IN-21200 containing one of the following components: IN-10500, Impactor V-Block Assembly; IN-10600 , Tracker B; IN-16400, Tracker A; IN-16100, Tracker C

The Impactor V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face.

ALL 50 STATES
▸Full report

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

Recall #:
98804
Lot/product code:
All Lots/serial Numbers; UDI: IN-28000: 00810180350020; IN-10500: (01)00810180350686; IN-10600 (01)00810180350693; IN-16400:(01)00810180350525; IN-16100: (01)00810180350563;
Recalling firm:
Kico Knee Innovation Company
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 23, 2026

Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that include the Covidien Shiley Disposable Decannulation Plug are: Product Number / UDI-DI code 4DCFN 10884522006576 4DCFS 10884522006583 4DFEN 10884522006606 6DCFN 10884522006613 6DCFS 10884522006620 6DFEN 10884522006644 8DCFN 10884522006651 8DCFS 40884522006690 8DFEN 10884522006675 10DCFN 20884522006535 10DCFS 10884522006545 10DFEN 10884522006569 The Shiley Disposable Decannulation Plug (DDCP) is a universal size and fits any size DCFS, DCFN, DFEN tracheostomy tube. The red DDCP snaplock connector is used to occlude the proximal end of the outer cannula on the Shiley Tracheostomy Tubes. Refer to Table 1 for model types. The DDCP blocks airflow through the tube and directs breathing through the mouth and nose. The Shiley Tracheostomy Tube and the accessory products are intended for use in providing tracheal access for airway management.

Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.

ALL 50 STATES
▸Full report

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

Recall #:
98819
Lot/product code:
Product Number: DDCP UDI-DI code: 10884522004060 The below product numbers and UDI-DI codes that DDCP are: 4DCFN / 10884522006576 4DCFS / 10884522006583 4DFEN / 10884522006606 6DCFN / 10884522006613 6DCFS / 10884522006620 6DFEN / 10884522006644 8DCFN / 10884522006651 8DCFS / 40884522006690 8DFEN / 10884522006675 10DCFN / 20884522006535 10DCFS / 10884522006545 10DFEN / 10884522006569
Recalling firm:
Covidien LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled April 23, 2026

Joy Mint Lassi 16 oz.

Product not adequately pasteurized

NJNYPA
▸Full report

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

Recall #:
H-1091-2026
Lot/product code:
Expiry June 30 through July 30, 2026 UPC Codes:68061710060
Recalling firm:
Joy Gourmet Foods LLC.
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled April 23, 2026

Joy Plain Chaash Lassi 16 oz., 64 oz.

Product not adequately pasteurized

NJNYPA
▸Full report

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

Recall #:
H-1089-2026
Lot/product code:
Expiry June 30 through July 30, 2026 64 oz UPC: 68061710050 16 oz. UPC: 68061710021
Recalling firm:
Joy Gourmet Foods LLC.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 23, 2026

Sharpoint 2.2MM, ANGLED, DOUBLE- BEVEL Model/Catalog Number: 72-2231 Microsurgical Knife

3.0mm surgical knives labeled and packaged as 2.2mm surgical knives.

ALL 50 STATES
▸Full report

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

Recall #:
98911
Lot/product code:
UDI-DI 00848782027514; Lot Number FA22CHQ
Recalling firm:
SSC- Surgical Specialties Corporation
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled April 23, 2026

Joy Mango Lassi 16 oz., 64 oz.

Product not adequately pasteurized

NJNYPA
▸Full report

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

Recall #:
H-1081-2026
Lot/product code:
Expiry June 30 through July 30, 2026 16 oz. UPC: 68061710002 64 oz. UPC: 68061710018
Recalling firm:
Joy Gourmet Foods LLC.
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled April 23, 2026

Joy Saffron Cardamon Lassi 16 oz.

Product not adequately pasteurized

NJNYPA
▸Full report

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

Recall #:
H-1094-2026
Lot/product code:
Expiry June 30 through July 30, 2026 68061710034
Recalling firm:
Joy Gourmet Foods LLC.
View official FDA record (opens in a new tab)
Class IHigh risk
FoodBacteria/virusSalmonellaRecalled April 23, 2026

Pork King Good Onion & Sour Cream Seasoning. Net Wt. 3 oz (85G) bottle. UPC 8 50008-53861 2. Made by Pork King Good, Milwaukee, WI 53110.

Seasoning was made with recalled California Dairies milk powder due to Salmonella contamination.

ALAZCAFLGAILINMDMIMOMSMTNCNDNENHNYOHPARITNTXUTVAWAWI
▸Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
H-0830-2026
Lot/product code:
Lot Number 329-5, Best if Used By 5/30/2027; Lot Number 004-6, Best if Used By 6/30/2027; Lot Number 029-6, Best if Used By 6/30/2027.
Recalling firm:
Pork King Good, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled April 23, 2026

Joy Strawberry Lassi 16 oz.

Product not adequately pasteurized

NJNYPA
▸Full report

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

Recall #:
H-1086-2026
Lot/product code:
Expiry June 30 through July 30, 2026 UPC: 68061710007
Recalling firm:
Joy Gourmet Foods LLC.
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled April 23, 2026

Joy Mango-Pina-Orange Lassi 16 oz., 64 oz.

Product not adequately pasteurized

NJNYPA
▸Full report

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

Recall #:
H-1088-2026
Lot/product code:
Expiry June 30 through July 30, 2026 16 oz. UPC: 68061710008 64 oz. UPC: 68061710008
Recalling firm:
Joy Gourmet Foods LLC.
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled April 23, 2026

Joy Mango-Pina-Strawberry Lassi 16 oz.

Product not adequately pasteurized

NJNYPA
▸Full report

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

Recall #:
H-1087-2026
Lot/product code:
Expiry June 30 through July 30, 2026 UPC: 68061710009
Recalling firm:
Joy Gourmet Foods LLC.
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled April 23, 2026

Joy Sweet Lassi 16 oz.

Product not adequately pasteurized

NJNYPA
▸Full report

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

Recall #:
H-1083-2026
Lot/product code:
Expiry June 30 through July 30, 2026 UPC: 68061710006
Recalling firm:
Joy Gourmet Foods LLC.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 23, 2026

Sharpoint 2.2MM, ANGLED, DOUBLE- BEVEL Model/Catalog Number: 72-2231 Microsurgical Knife

3.0mm surgical knives labeled and packaged as 2.2mm surgical knives.

ALL 50 STATES
▸Full report

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

Recall #:
98911
Lot/product code:
UDI-DI 00848782027514; Lot Number FA22CHQ
Recalling firm:
SSC- Surgical Specialties Corporation
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled April 23, 2026

Joy Peach Lassi 16 oz.

Product not adequately pasteurized

NJNYPA
▸Full report

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

Recall #:
H-1092-2026
Lot/product code:
Expiry June 30 through July 30, 2026 UPC Codes:68061710001
Recalling firm:
Joy Gourmet Foods LLC.
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled April 23, 2026

Joy Pineapple Lassi 16 oz.

Product not adequately pasteurized

NJNYPA
▸Full report

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

Recall #:
H-1085-2026
Lot/product code:
Expiry June 30 through July 30, 2026 UPC: 68061710004
Recalling firm:
Joy Gourmet Foods LLC.
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled April 23, 2026

Joy Salty Lassi 16 oz.

Product not adequately pasteurized

NJNYPA
▸Full report

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

Recall #:
H-1084-2026
Lot/product code:
Expiry June 30 through July 30, 2026 UPC: 68061710010
Recalling firm:
Joy Gourmet Foods LLC.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 23, 2026

Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 59262-700-11

Not guaranteed to be germ-free: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.

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-0501-2026
Lot/product code:
Lot# 5S30B, 5S30C, Exp Date: April 30, 2026; Lot# 5S31B, 6S57B, Exp Date: May 31, 2026.
Recalling firm:
Thea Pharma, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 23, 2026

OneLIF Interbody Cage (REF/Description): 010-107-1007/Small 7 Degree 10mm X 7mm, 010-107-1007-2/Small 7 Degree 10mm X 7mm - Oblique, 010-107-1209/Small 7 Degree 12mm X 9mm, 010-107-1411/Small 7 Degree 14mm X 11mm, 010-107-1613/Small 7 Degree 16mm X 13mm, 010-113-1006/Small, 13 Degree 10mm X 6mm, 010-113-1006-2/Small, 13 Degree, 10mm X 6mm - Oblique, 010-113-1208/Small 13 Degree 12mm X 8mm, 010-113-1410/Small 13 Degree 14mm X 10mm, 010-113-1612/Small 13 Degree 16mm X 12mm, 010-119-1407/19 Degree 14mm X 7mm, 010-119-1609/Small 19 Degree 16mm X 9mm, 010-119-1811/Small 19 Degree 18mm X 11mm, 010-125-1606/Small 25 Degree 16mm X 6mm, 010-125-1808/Small 25 Degree 18mm X 8mm, 010-207-1007/Medium 7 Degree 10mm X 7mm, 010-207-1007-2/Medium 7 Degree 10mm X 7mm - Oblique, 010-207-1209/Medium 7 Degree 12mm X 9mm, 010-207-1411/Medium 7 Degree 14mm X 11mm, 010-207-1613/Medium 7 Degree 16mm X 13mm, 010-213-1206/Medium 13 Degree 12mm X 6mm, 010-213-1408/Medium 13 Degree 14mm X 8mm, 010-213-1610/Medium 13 Degree 16mm X 10mm, 010-213-1812/Medium 13 Degree 18mm X 12mm, 010-219-1406/Medium 19 Degree 14mm X 6mm, 010-219-1608/Medium 19 Degree 16mm X 8mm, 010-219-1810/Medium 19 Degree 18mm X 10mm, 010-225-1807/Medium 25 Degree 18mm X 7mm, 010-225-2009/Medium 25 Degree 20mm X 9mm, 010-307-1006/Large 7 Degree,10mm X 6mm, 010-307-1006-2/Large 7 Degree 10mm X 6mm - Oblique, 010-307-1208/ Large 7 Degree 12mm X 8mm, 010-307-1410/Large 7 Degree 14mm X 10mm, 010-307-1612/Large 7 Degree 16mm X 12mm, 010-313-1205/Large 13 Degree 12mm X 5mm, 010-313-1407/Large 13 Degree 14mm X 7mm, 010-313-1609/Large 13 Degree 16mm X 9mm, 010-313-1811/Large 13 Degree 18mm X 11mm, 010-313-2013/Large 13 Degree 20mm X 13mm, 010-319-1606/Large 19 Degree 16mm X 6mm, 010-319-1808/ Large 19 Degree 18mm X 8mm, 010-319-2010/ Large 19 Degree 20mm X 10mm, 010-325-2007/Large 25 Degree 20mm X 7mm, 010-325-2209/ Large 25 Degree 22mm X 9mm, Implant Kits containing OneLIF Interbody Cages, Name/Kit Family: Kit-OneLIF-10 mm (716)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (717)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (718)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (719)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (722)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (723)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (724)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (733)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (734)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (737)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (738)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (746)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (751)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (761)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (762)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (787)/Kit-OneLIF-10 mm, Kit-OneLIF- IMPOneLIF Implant Kit (701)/Kit-OneLIF-IMP - OneLIF Implant Kit, Kit-OneLIF-IMP - OneLIF Implant Kit (702)/Kit-OneLIF-IMP - OneLIF Implant Kit, Kit-OneLIF-IMP - OneLIF Implant Kit (703) NL/Kit-OneLIF-IMP - OneLIF Implant Kit, Kit-OneLIF-IMP - OneLIF Implant Kit (704)/Kit-OneLIF-IMP - OneLIF Implant Kit, Kit-OneLIF-IMP - OneLIF Implant Kit (705)/Kit-OneLIF-IMP - OneLIF Implant Kit, Kit-OneLIF-IMP - OneLIF Implant Kit (706)/Kit-OneLIF-IMP - OneLIF Implant Kit, Kit-OneLIF-IMP - OneLIF Implant Kit (708)/Kit-OneLIF-IMP - OneLIF Implant Kit, Kit-OneLIF-IMP - OneLIF Implant Kit (709)/Kit-OneLIF-IMP - OneLIF Implant Kit,

Intervertebral body fusion system straight inserter failed to properly attach to affected cages, which may result in an inability to securely engage the implant with the inserter, which could lead to procedural delay and/or the need to select an alternative implant.

ALL 50 STATES
▸Full report

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

Recall #:
98835
Lot/product code:
REF/UDI-DI/ Cage Lots: 010-107-1007/G07001010710070/ 103003, 105701, 118001, 129301; 010-107-1007-2/G070010107100720/ 114301, 117509, 128703; 010-107-1209/G07001010712090/ 102714, 105702, 117501; 010-107-1411/G07001010714110/ 103019, 105703; 010-107-1613/G07001010716130/ 103020, 105704, 127701; 010-113-1006/G07001011310060/ 103021, 105705, 118002, 129801; 010-113-1006-2/G070010113100620/ 117510, 127716, 114302; 010-113-1208/G07001011312080/ 103022, 105706, 117502, 126902; 010-113-1410/G07001011314100/ 102715, 105707, 127702; 010-113-1612/G07001011316120/ 103023, 105708, 127703; 010-119-1407/G07001011914070/ 103024, 105709, 125101, 128701; 010-119-1609/G07001011916090/ 102716, 105710, 127001; 010-119-1811/G07001011918110/ 103025, 105711, 127003; 010-125-1606/G07001012516060/ 102717, 117901, 127002; 010-125-1808/G07001012518080/ 103005, 117902, 127704; 010-207-1007/G07001020710070/ 102702, 106201, 118003, 125102; 010-207-1007-2/G070010207100720/ 117511, 124106, 127717, 114303; 010-207-1209/G07001020712090/ 102701, 105401, 124101, 127705, 101201; 010-207-1411/G07001020714110/ 105001, 105402, 101203; 010-207-1613/G07001020716130/ 103007, 105403, 124102, 127706; 010-213-1206/G07001021312060/ 105002, 105404, 121202, 124103, 127707, 101204; 010-213-1408/G07001021314080/ 102704, 105405, 121203, 124104, 127708; 010-213-1610/G07001021316100/ 103008, 105406, 130101; 010-213-1812/G07001021318120/ 103009, 105407, 127709; 010-219-1406/G07001021914060/ 102705, 105408, 117503, 119301, 121201, 124105; 010-219-1608/G07001021916080/ 103010, 105409, 121204, 127710; 010-219-1810/G07001021918100/ 103011, 105410, 127711; 010-225-1807/G07001022518070/ 102706, 113701, 117001, 121205; 010-225-2009/G07001022520090/ 103001, 117903, 127004, 127712; 010-307-1006/G07001030710060/ 102707, 106202, 118004, 129302; 010-307-1006-2/G070010307100620/ 117512, 127718, 114304; 010-307-1208/G07001030712080/ 102709, 105601, 117504; 010-307-1410/G07001030714100/ 102710, 105602, 127713; 010-307-1612/G07001030716120/ 103012, 105603, 117505; 010-313-1205/G07001031312050/ 103013, 105604, 117506, 129303; 010-313-1407/G07001031314070/ 102711, 105605, 117507, 124107, 128702, 130102; 010-313-1609/G07001031316090/ 103014, 105606; 010-313-1811/G07001031318110/ 103015, 105607, 127714; 010-313-2013/G07001031320130/ 103016, 105608, 127715; 010-319-1606/G07001031916060/ 102712, 105609, 114905, 117508; 010-319-1808/G07001031918080/ 103017, 105610, 125103; 010-319-2010/G07001031920100/ 103018, 105611, 125104; 010-325-2007/G07001032520070/ 102713, 105612, 121206; 010-325-2209/G07001032522090/ 105613, 121207, 101206, 101207, 101208
Recalling firm:
Novapproach Spine, LLC
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