BIGNOPE
Ko-fi

Recalls affecting Alaska

Data last updated: September 10, 2026 at 1:16 PM UTC

16,261 recalls found
NewOld
High RiskLow Risk
AllClear

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)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled January 15, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 42mm Material Number: 66-342 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

ALL 50 STATES
▸Full report

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

Recall #:
87251
Lot/product code:
Batch Number: 333014 333016 338837 341887 343444 346882 351523 355020 361818 364757 367810 369360 370401 372233 379926
Recalling firm:
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 15, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 32mm Material Number: 66-232 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

ALL 50 STATES
▸Full report

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

Recall #:
87251
Lot/product code:
Batch Number: 330973 330975 330976 338830 338831 344099 344100 350516 350517 356798 358456 361803 361804 364749 369336 370393 377188 379018 379542 379543 379544 380874
Recalling firm:
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 15, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 40mm Material Number: 66-240 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

ALL 50 STATES
▸Full report

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

Recall #:
87251
Lot/product code:
Batch Number: 332505 338835 344104 350522 354403 361810 367193 370399 379082
Recalling firm:
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 15, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 100mm Material Number: 66-5100 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

ALL 50 STATES
▸Full report

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

Recall #:
87251
Lot/product code:
Batch Number: 345227 352382 357123 364541 372302 382119
Recalling firm:
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 15, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 68mm Material Number: 66-468 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

ALL 50 STATES
▸Full report

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

Recall #:
87251
Lot/product code:
Batch Number: 342454 348029 351952 357127 364539 370412 380678
Recalling firm:
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 15, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 105mm Material Number: 66-5105 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

ALL 50 STATES
▸Full report

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

Recall #:
87251
Lot/product code:
Batch Number: 345228 352383 357124 364542 370440 382120
Recalling firm:
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 15, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 95mm Material Number: 66-595 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

ALL 50 STATES
▸Full report

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

Recall #:
87251
Lot/product code:
Batch Number: 345226 352381 357122 369366 372235 381293
Recalling firm:
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 15, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 12mm Material Number: 66-112 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

ALL 50 STATES
▸Full report

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

Recall #:
87251
Lot/product code:
Batch Number: 328891 328893 328894 338794 340980 341495 344086 347925 347926 352672 358452 363412 363413 364047 367781 369328 370314 372189 372190 379399 379400 386003
Recalling firm:
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 15, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 30mm Material Number: 66-230 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

ALL 50 STATES
▸Full report

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

Recall #:
87251
Lot/product code:
Batch Number: 330972 330973 338829 344097 344098 350514 350515 352677 358455 361801 361802 364748 367803 369335 370391 370392 377187 379016 379539 379540 379541
Recalling firm:
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 15, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 60mm Material Number: 66-460 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

ALL 50 STATES
▸Full report

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

Recall #:
87251
Lot/product code:
Batch Number: 342452 348027 351950 357125 364537 380155 380156 385417
Recalling firm:
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 15, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 60mm Material Number: 66-360 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

ALL 50 STATES
▸Full report

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

Recall #:
87251
Lot/product code:
Batch Number: 333153 338846 341494 347127 351532 359849 364535 364767 369365 370408 378061 380153
Recalling firm:
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 15, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 14mm Material Number: 66-114 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

ALL 50 STATES
▸Full report

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

Recall #:
87251
Lot/product code:
Batch Number: 328895 328896 328897
Recalling firm:
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 15, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 18mm Material Number: 66-118 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

ALL 50 STATES
▸Full report

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

Recall #:
87251
Lot/product code:
Batch Number: 329481 329482
Recalling firm:
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 15, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 24mm Material Number: 66-224 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

ALL 50 STATES
▸Full report

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

Recall #:
87251
Lot/product code:
Batch Number: 330510 330511 338826 344094 350507 355018 361793 361794 364054 372180 372181 377184 378427
Recalling firm:
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 15, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 76mm Material Number: 66-476 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

ALL 50 STATES
▸Full report

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

Recall #:
87251
Lot/product code:
Batch Number: 342456 348031 351954 357128 364540 370414 381213 381525 383204
Recalling firm:
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 15, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 80mm Material Number: 66-580 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

ALL 50 STATES
▸Full report

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

Recall #:
87251
Lot/product code:
Batch Number: 345223 352338 357119 372239 382116
Recalling firm:
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 15, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 64mm Material Number: 66-464 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

ALL 50 STATES
▸Full report

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

Recall #:
87251
Lot/product code:
Batch Number: 342453 348028 351951 357126 364538 370411 380157
Recalling firm:
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 15, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 80mm Material Number: 66-480 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

ALL 50 STATES
▸Full report

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

Recall #:
87251
Lot/product code:
Batch Number: 342457 348032 351955 357129 364769 381292
Recalling firm:
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 15, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 72mm Material Number: 66-472 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

ALL 50 STATES
▸Full report

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

Recall #:
87251
Lot/product code:
Batch Number: 342455 348030 351953 356880 359851 380679 380680 385418
Recalling firm:
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 15, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 36mm Material Number: 66-236 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

ALL 50 STATES
▸Full report

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

Recall #:
87251
Lot/product code:
Batch Number: 332500 338833 344102 350520 353384 361807 364751 364752 369338 377190 379080 380872
Recalling firm:
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 15, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 90mm Material Number: 66-590 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

ALL 50 STATES
▸Full report

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

Recall #:
87251
Lot/product code:
Batch Number: 345225 352380 357121 359852 370419 382118
Recalling firm:
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 15, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 75mm Material Number: 66-575 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

ALL 50 STATES
▸Full report

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

Recall #:
87251
Lot/product code:
Batch Number: 345222 352337 357118 364543 372238 382115 386005
Recalling firm:
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 15, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 22mm Material Number: 66-122 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

ALL 50 STATES
▸Full report

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

Recall #:
87251
Lot/product code:
Batch Number: 329484 338821 341497 344092 348579 353382 363436 367789 372223 372224 379407
Recalling firm:
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 15, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 54mm Material Number: 66-354 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

ALL 50 STATES
▸Full report

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

Recall #:
87251
Lot/product code:
Batch Number: 333150 338842 341492 347125 351529 351530 358480 359845 364533 367814 369363 370406 377839 380043 380044 381527 381528 382443 382444 382445
Recalling firm:
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 15, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 10mm Material Number: 66-110 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

ALL 50 STATES
▸Full report

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

Recall #:
87251
Lot/product code:
Batch Number: 328891, 328892
Recalling firm:
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
View official FDA record (opens in a new tab)