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Recalls affecting Missouri

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

16,966 recalls found

Just announced

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

Business Pill, Branch Manager for Mendietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

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

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

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

Foods AliveMoringa Leaf Powder

Potential to be contaminated with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

B. Braun0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

Full report
Drugs

Recalling firm: B. Braun Medical Inc.

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

Company contact: recalls@bbraunusa.com

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

Great ValueOrganic Triple Berry Blend

Possible E. Coli Contamination

Full report
Food & BeveragesFoodborne Illness

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

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

Company contact: Info.foodsafety@comfrut.com

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

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

Presence of particulate matter and lack of sterility assurance

Full report
Food & Beverages

Recalling firm: American Regent, Inc.

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

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

Little TemptationsChocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

Full report
Food & BeveragesAllergens

Recalling firm: Crystal Temptations

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

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

LipofitLipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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

KofinasGarlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

Full report
Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

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

Everything SproutsRobust Radish Mix, 5oz Cups

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

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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

MartinaMangoes

Potential contamination with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

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

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled January 14, 2021

PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx The LIFEPAK CR2 defibrillator is designed for indoor and outdoor use in a stationary environment. After the electrode pads are applied, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any responder assistance. The LIFEPAK CR2 defibrillator is indicated for use on patients 1 year of age or older in cardiopulmonary arrest.

Due to complaints received regarding missing lid magnets which may result in premature battery depletion.

ALL 50 STATES
Full report

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

Recall #:
87217
Lot/product code:
Model Number 3321605-xxx,  U.S. Device Part Numbers with Conforming Lids: CR2-2-001281, CR2-2-001279, CR2-2-001285, CR2-2-001278, CR2-2-001283, CR2-2-001280, CR2-2-001451, CR2-2-001452, CR2-2-000396, CR2-2-001457,  Device Serial Numbers: 48603094 48784877 49025132 49091799 48741587 49077058 48764540 48764590 48601446 48603907 48609453 48652129 48652251 48858056 48981644 48722045 48726027 48726129 48726140 48726150 48693695 48694311 48698571 48698584 48952116 48953086 48554965 48817780 48825290 48849399 48899908 48899994 48900065 48900096 48901342 48901357 48901414 48901451 48902351 48977818 48978218 48981319 48981675 48981678 48981736 48981742 48981757 48981799 48982659 48982689 48982706 48982732 48982753 48982964 48983131 48983138 48986526 48999915 49001794 48677566 49000689 48474854 48825196 48744684 49025723 49078040 49084781 49084838 48784171 49076651 49077904 49077974 48999739 49001853 48598011 48597817 48598026 48598034 48598979 48599034 48599040 48599680 48599962 48600312 48600361 48600408 48600544 48600583 48876291 48785897 48720332 48764293 48780563 48781761 48785992 48742916 48784366 48814157 49086935 48523377 48857980 49085692 48734881 48782906 48809106 48809544 48813958 48814187 48814498 48587878 48512628 48779955 48808967 49094200 48719896 48734817 48745596 48772744 48809729 48813731 48813733 48814081 48814519 49094775 49149468 49150775 49150782 49150837 49151602 49151617 49151886 49152891 49152895 48785250 48785409 48785698 48785778 48864860 48865894 48933501 48992026 49027943 49044403 49044413 48699923 48599821 48722047 48821008 48824104 48864884 48876330 48981618 48982708 49025280 49146285 49146389 48704591 48828002 48781767 48782803 48783051 48783294 48783983 48784030 48784180 48784281 48784459 48784468 48784826 48784905 48784983 48784990 48785257 48785313 48785401 48785532 48785590 48876124 48876476 48785259 48887309 48977361 48978607 48828370 48894333 48894340 48782927 49091822 49094089 49094113 49094785 49094873 49095322 49001621 48769222 48885664 48597789 48599786 48584628 48584633 48587221 48606096 48606181 48786686 48588112 48599696 48778810 48779004 48780079 48780121 48490802 48490842 48490862 48828138 48609677 48651847 48677735 48999652 48999652 48901418 48885722 48885777 48943238 48943252 48945704 48945712 48949096 48555102 48410131 48953094 48969902 48970252 48970376 48970413 48970414 48970578 48971044 48972557 48972586 48973712 48974345 48974355 48974359 48974363 48974372 48974375 48974378 48974384 48974396 48974399 48974400 48974418 48974470 48813947 48584539 48584686 48586430 48586633 48587235 48587726 48587843 48587884 48587914 48587957 48587974 48587975 48588426 48784293 48999873 48999950 49000499 49000643 49000648 49001892 49001987 49002003 49004080 49025505 49026012 49027603 49027633 49027638 49028025 49028068 49028076 49028084 49028730 49029341 49043715 49043767 49043775 48400582 48400710 48465771 48489063 48489118 48489171 48489189 48489451 48489457 48489470 48489495 48490783 48490803 48490839 48490846 48490872 48866966 48871871 48872069 48872215 48872230 48872278 48872351 48874912 48875012 48875018 48875069 48875073 48875077 48875081 48875086 48875104 48875156 48875170 48875172 48875173 48875175 48875176 48875179 48875181 48875184 48875187 48875189 48875198 48875205 48875214 48875218 48875227 48875237 48875247 48875262 48875265 48875269 48875277 48875351 48875359 48875366 48875367 48875369 48875370 48875378 48875382 48875387 48875402 48875404 48875409 48875419 48875426 48875431 48875435 48875446 48875452 48875461 48875464 48875467 48875470 48875475 48875478 48875485 48875488 48875502 48875564 48876164 49146490 48539017 48705821 48772775 48813773 48813809 48608364 48609613 48536563 48780035 48780167 48511975 48512088 49048418 48762722 48778493 48982643 48987613 48987869 48988231 48988701 48988720 48900770 48900789 48851632 48851872 48851894 48851992 48852079 48852741 48852927 48853071 48853076 48853080 48853120 48853135 48853144 48853149 48853203 48853223 48853241 48853258 48853268 48853285 48853289 48853300 48853354 48853364 48853376 48853385 48853394 48853398 48853404 48853411 48853419 48853424 48857669 48858061 48858236 48858473 48858480 48858520 48858525 48858528 48858534 48858551 48858593 48858598 48858603 48858622 48858644 48858654 48858658 48858662 48858668 48858671 48858729 48858742 48858743 48858744 48858750 48858760 48858771 48858781 48858783 48858786 48858802 48858823 48858827 48858833 48858836 48858840 48858859 48858880 48858920 48858924 48858931 48858939 48858947 48859669 48859697 48859747 48859754 48859757 48859763 48859765 48859768 48859772 48859778 48859781 48859791 48859796 48859809 48859820 48859832 48859840 48859872 48859877 48859888 48859937 48859943 48859952 48859961 48859971 48859980 48859981 48859983 48859990 48859992 48859998 48860002 48860008 48860037 48860041 48860046 48860052 48860054 48860056 48860059 48860061 48860095 48860099 48860100 48860104 48860108 48860112 48860115 48860116 48860119 48860125 48860131 48860142 48860146 48860161 48860174 4… (truncated, 801728 characters total — see the official FDA record for the full value)
Recalling firm:
Physio-Control, 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, 85mm Material Number: 66-585 - 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: 345224 352339 357120 364544 370418 382117
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, 34mm Material Number: 66-234 - 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: 330976 330977 330978 338832 343961 344101 350518 350519 356799 358457 361805 361806 364750 367806 369337 370395 377189 379019 380051 380052 380053 380054 380055 380056 380687 380688 380689
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)
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, 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, 2Level, 42mm Material Number: 66-242 - 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: 332506 338836 342573 344105 350523 361814 364756 366089 369339 379083
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, 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, 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, 3Level, 63mm Material Number: 66-363 - 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: 333154 338847 341490 347128 351533 359850 364536 367817 370409 378062 380154
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, 3 Level, 45mm Material Number: 66-345 - 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: 333017 333018 338838 346883 346884 351525 354404 358458 359841 364531 369361 370402 377835 377836 379927
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, 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, 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, 28mm Material Number: 66-228 - 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: 330970 330971 338828 340985 344096 350511 350512 352676 355019 361799 364056 367799 369334 370389 372183 372184 378429 378430
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, 3 Level, 48mm Material Number: 66-348 - 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: 333019 333020 338839 341491 346885 351526 354405 359842 359843 363443 364532 369362 370404 377837 379929 385416
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, 24m Material Number: 66-124 - 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: 329485 338822 341498 344093 348580 353383 363437 364053 369331 372220 379408
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, 1 Level, 16mm Material Number: 66-116 - 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: 328898 328899
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, 20mm Material Number: 66-120 - 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: 329483 338820 344091 348578 353381 363435 364051 367788 372225 372226 379406
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, 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)