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Recalls affecting Wisconsin

Data last updated: September 11, 2026 at 1:08 PM UTC

16,962 recalls found
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Just announced

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

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

Products contain undeclared yohimbine

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Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

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

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

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

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

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

Presence of particulate matter identified as iron oxide

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Drugs

Recalling firm: B. Braun Medical Inc.

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

Company contact: recalls@bbraunusa.com

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

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

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Food & BeveragesFoodborne Illness

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

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

Company contact: Info.foodsafety@comfrut.com

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

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

Presence of particulate matter and lack of sterility assurance

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Food & Beverages

Recalling firm: American Regent, Inc.

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

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

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

Undeclared milk

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Food & BeveragesAllergens

Recalling firm: Crystal Temptations

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

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

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

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Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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

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

Contains garlic essential oil not approved for culinary use

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Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

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

Everything Sprouts — Robust Radish Mix, 5oz Cups

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

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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

Martina — Mangoes

Potential contamination with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

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

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled August 16, 2021

MR MAGNETOM Systems with RT Image Suite with syngo MR VA20A, VA30A and VA31A with license SW-Key CT_RT_IMA_SUITE_SYNTHETIC_CT Material Numbers: 11060815

Potential for data loss when using the contouring or patient marking workflow when editing a structure set after saving and reopening a study, resulting in an incomplete structure set sent to the treatment planning system (TPS).

ALL 50 STATES
▸Full report

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

Recall #:
88588
Lot/product code:
Serial Numbers: 176302 175681
Recalling firm:
Siemens Medical Solutions USA, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 18, 2021

Scrip Ultrasound Gel Clear, 5L Intended for use in acoustic coupling of ultrasound transducer to tissue

Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.

ALL 50 STATES
▸Full report

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

Recall #:
88751
Lot/product code:
Item Number: 663 0061, all lots bearing old style logo. Older logo states that product was manufactured by Eco-Med Pharmaceuticals in Canada.
Recalling firm:
Scrip Inc
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled August 18, 2021

X RATED HONEY FOR MEN, packaged in 15g packets, 4 packets per box, UPC 6 13682 41232 2

Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.

ALL 50 STATES
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The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
D-0819-2021
Lot/product code:
All lots, Exp. 12/2025
Recalling firm:
Phe Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 18, 2021

Scrip Creme All Purpose Lotion Intended for use in acoustic coupling of ultrasound transducer to tissue

Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.

ALL 50 STATES
▸Full report

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

Recall #:
88751
Lot/product code:
Item Number: 663 0019, all lots distributed between August 2018 and August 2021
Recalling firm:
Scrip Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 18, 2021

Computed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP5, VA30A_SP2, VA30A_SP2a, VA30A_SP3,VA30A_FP2 in Somatom systems: SOMATOM go.Up - Model 11061620 SOMATOM go.Up - Model 11061628 SOMATOM go.All - Model 11061630 SOMATOM go.Top - Model 11061640 SOMATOM X.cite - Model 11330001 Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

Software versions may result in sporadic problems causing scanning workflow interruptions and unexpected user notifications. Sporadic software errors may also occur during interventional workflows, resulting in delay in diagnosis or scan aborts with the necessity for patient rescan may occur

ALL 50 STATES
▸Full report

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

Recall #:
88581
Lot/product code:
US Serial Numbers: 111307, 111526, 119328, 108158, 123104, 111219, 123054, 117633, 111566, 111427, 123059, 117558, 117533, 119317, 117647, 108088, 123060, 123118, 123055, 111518, 123113, 108108, 123129, 123122, 123069, 111507, 111560, 119142, 108111, 108062, 119376. Update CT016/21/S is a remote update for the following products with software versions syngo CT VA30A SP2 or syngo CT VA30A SP2a or syngo CT VA30A SP3: SOMATOM go.Now (Model #11061610, #11061612, #11061613, #11061618), SOMATOM go.Up (Model #11061620, #11061622, #11061623, #11061628), SOMATOM go.All (Model #11061630, #11061632, #11061638), SOMATOM go.Top (Model #11061640, #11061642, #11061648), SOMATOM go.Sim (Model #11061660, #11061668), SOMATOM go.Open Pro (Model #11061670, #11061678). Update CT018/21/S is a remote update for the following products with software versions syngo.CT VA20A_SP4a or syngo.CT VA20A_SP5: SOMATOM go.Now (Model #11061610, #11061612, #11061613, #11061618), SOMATOM go.Up (Model #11061620, #11061622, #11061623, #11061628), SOMATOM go.All (Model #11061630, #11061632, #11061638), SOMATOM go.Top (Model #11061640, #11061642, #11061648) without dual energy post-processing. Update CT022/21/S is an onsite update for the following product with software versions syngo.CT VA20A_SP4a or syngo.CT VA20A_SP5: SOMATOM go.Top (Model #11061640, #11061642, #11061648) without dual energy post-processing. Update CT025/21/S is an onsite update for the following product with software versions syngo.CT VA30A_SP2, VA30A_SP2a, syngo CT VA30A_SP3, or syngo CT VA30A_FP2 : SOMATOM X.cite (Model #11330001)
Recalling firm:
Siemens Medical Solutions USA, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 19, 2021

P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641

The rear heater plate and cover assembly that contains the electrical wiring for the heaters does not have sufficient bonding to ground.

ALL 50 STATES
▸Full report

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

Recall #:
88628
Lot/product code:
Model number: P2131; NSN: 6530-01-641-4641; Serial Numbers AFS-0001 through AFS-0386. Note: AFS-0297 was not manufactured.
Recalling firm:
Fort Defiance Industries, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 23, 2021

Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.

Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health.

ALL 50 STATES
▸Full report

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

Recall #:
88624
Lot/product code:
All lots with valid expiration dates
Recalling firm:
Aesthetics Systems Usa Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 24, 2021

DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only

Potential for a wire protrusion through the left heart vent catheter tip

ALL 50 STATES
▸Full report

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

Recall #:
88549
Lot/product code:
Model/Reference Number 12116, Lot Number (GTIN Number): 2018080039 (20643169086719), 2018091020 (20643169086719), 2018100911 (20643169086719), 2018111023 (20643169086719), 2018111419 (20643169086719), 2019120925 (20643169086719), 2018080039 (00673978462943), 2018091020 (00673978462943), 2018100911 (00673978462943), 2018111023 (00673978462943), 2018111419 (00673978462943), 2018120581 (20643169086719), 2018120581 (00673978462943), 2018120582 (20643169086719), 2018120582 (00673978462943), 2018121084 (20643169086719), 2018121084 (00673978462943), 2019010456 (20643169086719), 2019010456 (00673978462943), 2019010764 (20643169086719), 2019010764 (00673978462943), 2019020136 (20643169086719), 2019020136 (00673978462943), 2019020368 (20643169086719), 2019020368 (00673978462943), 2019020758 (20643169086719), 2019020758 (00673978462943), 2019030720 (20643169086719), 2019030720 (00673978462943), 2019031167 (20643169086719), 2019031167 (00673978462943), 2019040262 (20643169086719), 2019040262 (00673978462943), 2019040472 (20643169086719), 2019040472 (00673978462943), 2019040473 (20643169086719), 2019040473 (00673978462943), 2019041189 (20643169086719), 2019041189 (00673978462943), 2019050576 (20643169086719), 2019050576 (00673978462943), 2019060984 (20643169086719), 2019060984 (00673978462943), 2019071114 (20643169086719), 2019071114 (00673978462943), 2019090071 (20643169086719), 2019090071 (00673978462943), 2019091024 (20643169086719), 2019091024 (00673978462943), 2019100417 (20643169086719), 2019100417 (00673978462943), 2019101444 (20643169086719), 2019101444 (00673978462943), 2019111049 (20643169086719), 2019111049 (00673978462943), 2019120925 (00673978462943), 2020010368 (20643169086719), 2020010368 (00673978462943), 2020010445 (20643169086719), 2020010445 (00673978462943), 2020011619 (20643169086719), 2020011619 (00673978462943), 2020011620 (20643169086719), 2020011620 (00673978462943), 2020030064 (20643169086719), 2020030064 (00673978462943), 2020030848 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(20643169086719), 2021031307 (20643169086719), 2021040872 (2… (truncated, 5266 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic Perfusion Systems
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 24, 2021

DLP Left Heart Vent Catheters, 18 FR. Sterile, Rx Only

Potential for a wire protrusion through the left heart vent catheter tip

ALL 50 STATES
▸Full report

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

Recall #:
88549
Lot/product code:
Model/Reference Number 12118, Lot Number (GTIN Number): 2018080452 (20643169086702), 2018080452 (00673978462950), 2018090435 (20643169086702), 2018090435 (00673978462950), 2018100525 (20643169086702), 2018100525 (00673978462950), 2018111024 (20643169086702), 2018111024 (00673978462950), 2018111421 (20643169086702), 2018111421 (00673978462950), 2019020369 (20643169086702), 2019020369 (00673978462950), 2019030426 (20643169086702), 2019030426 (00673978462950), 2019031168 (20643169086702), 2019031168 (00673978462950), 2019041190 (20643169086702), 2019041190 (00673978462950), 2019060424 (20643169086702), 2019060424 (00673978462950), 2019070714 (20643169086702), 2019070714 (00673978462950), 2019070715 (20643169086702), 2019070715 (00673978462950), 2019080686 (20643169086702), 2019080686 (00673978462950), 2019081292 (20643169086702), 2019081292 (00673978462950), 2019090394 (20643169086702), 2019090394 (00673978462950), 2019091081 (20643169086702), 2019091081 (00673978462950), 2019100159 (20643169086702), 2019100159 (00673978462950), 2019101446 (20643169086702), 2019101446 (00673978462950), 2019111051 (20643169086702), 2019111051 (00673978462950), 2019120418 (20643169086702), 2019120418 (00673978462950), 2020010051 (20643169086702), 2020010051 (00673978462950), 2020010446 (20643169086702), 2020010446 (00673978462950), 2020020094 (20643169086702), 2020020094 (00673978462950), 2020020764 (20643169086702), 2020020764 (00673978462950), 2020021113 (20643169086702), 2020021113 (00673978462950), 2020040403 (20643169086702), 2020040403 (00673978462950), 2020041125 (20643169086702), 2020041125 (00673978462950), 2020041431 (20643169086702), 2020041431 (00673978462950), 2020050353 (20643169086702), 2020050353 (00673978462950), 2020050919 (20643169086702), 2020050919 (00673978462950), 2020060370 (20643169086702), 2020060370 (00673978462950), 2020060673 (20643169086702), 2020060673 (00673978462950), 2020070374 (20643169086702), 2020070374 (00673978462950), 2020080075 (20643169086702), 2020080075 (00673978462950), 2020120620 (20643169086702), 2020120620 (00673978462950), 2021010035 (20643169086702), 2021010035 (00673978462950), 201906C177 (20643169086702), 201906C177 (00673978462950), 2017090238 (00673978462950), 2018080450 (20643169086702), 2018080451 (20643169086702), 2018090065 (20643169086702), 2018091021 (20643169086702), 2018100523 (20643169086702), 2018100524 (20643169086702), 2018120893 (20643169086702), 2019010457 (20643169086702), 2019010765 (20643169086702), 2019011214 (20643169086702), 2019020007 (20643169086702), 2019030064 (20643169086702), 2019030065 (20643169086702), 2019030721 (20643169086702), 2019031169 (20643169086702), 2019040844 (20643169086702), 2019040845 (20643169086702), 2019040846 (20643169086702), 2019041191 (20643169086702), 2019050167 (20643169086702), 2019050577 (20643169086702), 2019050846 (20643169086702), 2019051127 (20643169086702), 2019060219 (20643169086702), 2019060220 (20643169086702), 2019060687 (20643169086702), 2019060985 (20643169086702), 2019060986 (20643169086702), 2019070613 (20643169086702), 2019071115 (20643169086702), 2019081002 (20643169086702), 2019090072 (20643169086702), 2019090393 (20643169086702), 2019091025 (20643169086702), 2019100418 (20643169086702), 2019101095 (20643169086702), 2019110084 (20643169086702), 2019111050 (20643169086702), 2019120927 (20643169086702), 2020010052 (20643169086702), 2020011621 (20643169086702), 2020020472 (20643169086702), 2020030065 (20643169086702), 2020050354 (20643169086702), 2020050700 (20643169086702), 2020060067 (20643169086702), 2020060068 (20643169086702), 2020060964 (20643169086702), 2020060965 (20643169086702), 2020070055 (20643169086702), 2020070655 (20643169086702), 2020070969 (20643169086702), 2020071273 (20643169086702), 2020081034 (20643169086702), 2020090632 (20643169086702), 2020110762 (20643169086702), 2020120079 (20643169086702), 2020120621 (20643169086702), 2021010553 (20643169086702), 2021011168 (20643169086702), 2021011169 (20643169086702), 2021011170 (20643169086702), 2021031116 (20643169086702), 2021031308 (20643169086702), 2021031309 (20643169086702), 2021040093 (20643169086702), 2021040871 (20643169086702), 2021041149 (20643169086702), 2021050635 (20643169086702), 201901C051 (20643169086702), 201903C128 (20643169086702), 201905C013 (20643169086702), 201906C176 (20643169086702), 202011C198 (20643169086702), 202106C012 (20643169086702), 202106C013 (20643169086702), 202106C014 (20643169086702), 202106C020 (20643169086702), 202106C021 (20643169086702). Expiration date range: 09/30/2020 - 05/19/2024
Recalling firm:
Medtronic Perfusion Systems
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 24, 2021

ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl

Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.

ALL 50 STATES
▸Full report

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

Recall #:
88640
Lot/product code:
All lots for the following distributed product code:  Product Code: ECO 50TS - ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser
Recalling firm:
National Distribution & Contracting Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 24, 2021

ECO 85CB Lotion Ultrasound 8.5 oz 24/cs ECO 40JBC Gel Ultrasound Transmission Clr 8.5 oz BTL 24/cs ECO 40JMC Gel Ultrasound Transmission Clr 5L 4/cs NDC P301008 ProAdvantage Gel Ultrasound Transmission 8.5 oz 12/cs NDC P301105 ProAdvantage Gel Ultrasound Transmission 5 Liter 4/cs NDC P301115 ProAdvantage Ultrasound Lotion 5L W/Empty Btl 4/cs ECO 30GS Ecogel 100 Ultrasound Grn 1in X 5L Cube 1 Dispenser Btl ECO 30GB Ecogel 100 Ultrasound Grn 8.5 oz Btl 24/cs

Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.

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▸Full report

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

Recall #:
88640
Lot/product code:
All lots for the following distributed product codes:  Product Code: ECO 85CB - ECO 85CB Lotion Ultrasound 8.5 oz 24/cs    Product Code: ECO 40JBC - ECO 40JBC Gel Ultrasound Transmission Clr 8.5 oz BTL 24/cs    Product Code: ECO 40JMC - ECO 40JMC Gel Ultrasound Transmission Clr 5L 4/cs    Product Code: NDC P301008 - NDC P301008 ProAdvantage Gel Ultrasound Transmission 8.5 oz 12/cs    Product Code: NDC P301105 - NDC P301105 ProAdvantage Gel Ultrasound Transmission 5 Liter 4/cs   Product Code: NDC P301115 - NDC P301115 ProAdvantage Ultrasound Lotion 5L W/Empty Btl 4/cs    Product Code ECO 30GS - ECO 30GS Ecogel 100 Ultrasound Grn 1in X 5L Cube 1 Dispenser Btl    Product Code: ECO 30GB - ECO 30GB Ecogel 100 Ultrasound Grn 8.5 oz Btl 24/cs
Recalling firm:
National Distribution & Contracting Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 25, 2021

HemosIL Liquid Anti-Xa- automated chromogenic assay for in vitro diagnostic use by laboratory professionals in clinical laboratories. The assay provides quantitative results on 3.2% citrated human plasma Part Number: 0020302602

Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days

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▸Full report

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

Recall #:
88627
Lot/product code:
All currently released lots and future lots
Recalling firm:
Instrumentation Laboratory
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 25, 2021

HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems, (ACL TOP Family, ACL TOP Family 50 Seriest and ACL Elite/Elite Pro/8/9/10000) Part Number: 0020302600

Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days

ALL 50 STATES
▸Full report

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

Recall #:
88627
Lot/product code:
All currently released lots and future lots
Recalling firm:
Instrumentation Laboratory
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 25, 2021

HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems, (ACLTOP Family, ACL TOP Family 50 Seriest and ACL Elite/Elite Pro) Part Number: 0020302601

Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days

ALL 50 STATES
▸Full report

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

Recall #:
88627
Lot/product code:
All currently released lots and future lots
Recalling firm:
Instrumentation Laboratory
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 25, 2021

Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle; Manufactured by Eco-Med. For use in ultrasound procedures.

Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health

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▸Full report

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

Recall #:
88602
Lot/product code:
Distributed from January 1, 2018 thru August 4, 2021
Recalling firm:
Accelerated Care Plus Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 26, 2021

Atrium Pneumostat Chest Drain Valve, Part Number 16100

The firm is revising the Indication for Use, Contraindications, Warnings, and Precautions, after the device was involved in the treatment of a preterm infant who later died.

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▸Full report

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

Recall #:
88446
Lot/product code:
Lots 433297 433298 433974 433692 433693 434040 434962 435699 432585 435659 435660 436107 436106 437111 437530 438520 439396 439891 439905 440201 441182 441183 441392 441184 441185 441553 441554 443330 443362 443849 443968 445021 446022 447065 448203 447066 448138 448139 448618 448995 448996 450275 449702 449703 449992 449993 450659 450467 450923 450924 451439 452012 452013 453085 453472 452575 453404 454260 454344 454345 454803 454589 454850 455370 454851 455360 455359 455898 455900 455901 456447 456448 456904 456905 458298 458300 458299 458301 458642 458643 458644 458645 459216 461545 463439 463441 463469 463442 463443 463586 463587 464069 464103 464809 464104 464105 464669 465368
Recalling firm:
Atrium Medical Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 27, 2021

EcoLotion Transmission Lotion, used in ultrasound procedures. Item/Description: NC70481/Eco Lotion 5 liters, NC70482/Eco Lotion with Aloe 5 liters, NC70482C/Eco Lotion with Aloe 5 liters (4); Myossage Lotion, 1 Gallon, Item: NC31208

Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health

ALL 50 STATES
▸Full report

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

Recall #:
88613
Lot/product code:
All lots within the expiration date.
Recalling firm:
North Coast Medical Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 27, 2021

Norco Ultrasound Gel, Item/Description: NC70479/Norco Ultrasound Gel, 250 mL; NC70479/North Coast Ultrasound Gel, 250 mL; NC70479-5/Norco Ultrasound Gel, 5 liters; NC70479-5/North Coast Ultrasound Gel, 5 liters; NC70479-5C/Norco Ultrasound Gel, 5 liters (4); NC70479-5C/North Coast Ultrasound Gel, 5 liters (4); NC70479C/Norco Ultrasound Gel, 250 mL (24); NC70479C/North Coast Ultrasound Gel, 250 mL (24)

Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health

ALL 50 STATES
▸Full report

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

Recall #:
88613
Lot/product code:
All lots within the expiration date.
Recalling firm:
North Coast Medical Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 30, 2021

OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

ALL 50 STATES
▸Full report

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

Recall #:
88570
Lot/product code:
Item Number (Device Identifier; Serial number(s)): 264-21-09 (10885862068842; 0754387, 0754388, 0754390, 0754391, 0754392, 0754393, 0754394, 0754396, 0754397, 0754398, 0754399, 0754400, 0754401, 0754402, 0754403, 0754404, 0754405, 0754406, 0754407, 0754408, 0754409, 0754410, 0754411, 0754412, 0754413, 0754414, 0754415, 0754416, 0754417, 0754418, 0754419, 0754420, 0754421, 0754422, 0754423, 0754424, 0754425, 0754426, 0754427, 0782395, 0782396, 0782397, 0782398, 0782399, 0782400, 0782401, 0782402, 0782403, 0782404, 0782405, 0782406, 0782407, 0782408, 0782409, 0782410, 0782411, 0782412, 0782413, 0782414, 0782415, 0782416, 0782417, 0782418, 0782419, 0782420, 0782421, 0782422, 0782423, 0782424, 0782425, 0782426, 0782427, 0782428, 0782429, 0782430, 0782431, 0782432, 0782433, 0782434, 0782435, 0782436, 0782437, 0782438, 0782439, 0782440, 0782441, 0782442, 0862418, 0862420, 0862422, 0862424, 0862425, 0862426, 0862427, 0862428, 0862429, 0862430, 0862431, 0862432, 0862434, 0862435, 0862436, 0862437, 0862438, 0862439, 0862440, 0862441, 0862442, 0862443, 0862444, 0862445, 0862447, 0862448, 0862449, 0862450, 0862451, 0862452, 0862453, 0862454, 0862455, 0862456, 0862457, 0862458, 0862459, 0862460, 0862461, 0862462, 0862463, 0862464, 0862466, 0862468, 0862469, 0912159, 0912160, 0912168, 0912169, 0912171, 0912172, 0912175, 0912177, 0912178, 0912179, 0912180, 0912182, 0912187, 0912189, 0912192, 0912195, 0912197, 0912198, 0912201, 0912202, 0912203, 0912204, 0912205, 0912206, 0912207, 0912211, 0912215, 0912216, 0912218, 0912219, 0912220, 0912222, 0912223, 0912225, 0912226, 0912227, 0912228, 0912229, 0912230, 0912231, 0933159, 0933160, 0933161, 0933162, 0933163, 0933164, 0933165, 0933166, 0933167, 0933168, 0933169, 0933170, 0933171, 0933172, 0933173, 0933174, 0933175, 0933176, 0933177, 0933178, 0933180, 0933181, 0933184, 0933185, 1012978, 1012979, 1012980, 1012981, 1012982, 1012983, 1012984, 1012985, 1012986, 1012987, 1012988, 1012989, 1012990, 1012991, 1012992, 1012993, 1012994, 1012995, 1012996, 1012997, 1012998, 1012999, 1013000, 1013001, 1013002, 1013003, 1013004, 1013005, 1013006, 1013007, 1013008, 1013009, 1013010, 1013011, 1013012, 1013013, 1013014, 1013015, 1013016, 1013017, 1013018, 1013019, 1013020, 1013021, 1013022, 1013023, 1013024, 1013025, 1013026, 1013027, 1013028, 1013029, 1013030, 1087277, 1087278, 1087279, 1087280, 1087281, 1087282, 1087283, 1087284, 1087285, 1087286, 1087287, 1087288, 1087289, 1087290, 1087291, 1087292, 1087293, 1087294, 1087295, 1087296, 1087297, 1087298, 1087299, 1087300, 1087301, 1087302, 1087303, 1087304, 1087305, 1087306, 1087307, 1087308, 1087309, 1087310, 1087311, 1087312, 1087313, 1087314, 1087315, 1087316, 1087317, 1087318, 1087319, 1087320, 1087321, 1087322, 1087323, 1087324, 1087325, 1087326, 1087327, 1087328, 1087329, 1087330, 1087331, 1143864, 1143865, 1143866, 1143867, 1143868, 1143869, 1143870, 1143871, 1143872, 1143873, 1143874, 1143875, 1143876, 1143877, 1143878, 1143879, 1143880, 1143881, 1143883, 1143884, 1143885, 1143886, 1143887, 1143888, 1143889, 1143890, 1143891, 1143892, 1143893, 1143894, 1143895, 1143897, 1143898, 1143899, 1143900, 1143901, 1143902, 1143903, 1143904, 1143905, 1143906, 1143907, 1143908, 1143909, 1143910, 1143911, 1143912, 1262413, 1262414, 1262415, 1262416, 1262417, 1262418, 1262419, 1262420, 1262421, 1262422, 1262423, 1262427, 1262428, 1262429, 1262430, 1262431, 1262433, 1262434, 1262435, 1262436, 1262437, 1262439, 1262440, 1262441, 1262442, 1262443, 1262444, 1262445, 1262446, 1262447, 1262448, 1262450, 1262451, 1262452, 1262453, 1262454, 1262455, 1262456, 1262457, 1262458, 1262459, 1262460, 1262461, 1262462, 1262463, 1262464, 1262465, 1262466, 1264736, 1264737, 1264738, 1264739, 1264740, 1264741, 1264742, 1264743, 1264744, 1264745, 1264746, 1264747, 1264748, 1264749, 1264750, 1264751, 1264752, 1264753, 1264754, 1264755, 1264756, 1264757, 1264758, 1264759, 1264760, 1264761, 1264762, 1264763, 1264765, 1264766, 1264767, 1264768, 1264769, 1264770, 1264771, 1264772, 1264773, 1264774, 1264775, 1264776, 1264778, 1264780, 1264781, 1264782, 1264783, 1264784, 1264785, 1264786, 1264787, 1264788, 1391127, 1391128, 1391129, 1391130, 1391131, 1391132, 1391134, 1391135, 1391136, 1391137, 1391138, 1391139, 1391140, 1391141, 1391142, 1391143, 1391144, 1391145, 1415456, 1415457, 1415458, 1415459, 1415460, 1415461, 1415462, 1415464, 1415465, 1415466, 1415467, 1415468, 1415469, 1415470, 1415471, 1415472, 1415473, 1415474, 1415475, 1415476, 1415477, 1415478, 1415479, 1415480, 1415481, 1415482, 1415483, 1415484, 1415485, 1449449, 1449450, 1449451, 1449452, 1449453, 1449455, 1449456, 1449457, 1449458, 1449459, 1449460, 1449461, 1457735, 1457736, 1457737, 1457738, 1457739, 1457740, 1457741, 1462886, 1462887, 1462888, 1462889, 1462890, 1462891, 1462892, 1462893, 1462894, 1462895, 1475263, 1475264, 1475265, 1475266, 1475267, 1475269, 1475270, 1475271, 1494126, 1494127, 1494128, 1494129, 1494130, 1494131, 1494132, 1494133, 1494134, 1494135, 1494136, 1494137, 1494138, 1494139,… (truncated, 298527 characters total — see the official FDA record for the full value)
Recalling firm:
Exactech, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 30, 2021

OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

ALL 50 STATES
▸Full report

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

Recall #:
88570
Lot/product code:
Item Number (Device Identifier; Serial number(s)): 02-012-38-1009 (10885862002358; 2109242, 2109243, 2109244, 2109245, 2109246, 2109247, 2109248, 2109249, 2109250, 2109251, 2109252, 2109253, 2109254, 2109255, 2109256, 2109257, 2109258, 2109261, 2109262, 2109263, 2109265, 2109267, 2109268, 2109269, 2109270, 2109271, 2109272, 2109273, 2109274, 2328032, 2328033, 2328034, 2356324, 2356325, 2356326, 2356327, 2356328, 2356329, 2356330, 2356331, 2356332, 2356334, 2356335, 2356336, 2573198, 2573199, 2573200, 2573201, 2573202, 2573203, 2573204, 2974115, 2974116, 2974117, 2974118, 2974119, 2991806, 2991807, 2991808, 2991809, 2991810, 3628492, 3628493, 3628494, 3628496, 3628499, 3628500, 3628501, 3628502, 3628503, 3628504, 3628506, 3628508, 3628509, 3628510, 3628511, 3826220, 3826221, 3826222, 3870061, 3870062, 3870063, 3870064, 3870065, 3870066, 3870067, 3870068, 3870069, 3870070, 3873437, 3873438, 3873439, 3873440, 3873441, 3873442, 3873444, 3873445, 3873446, 3873447, 3873448, 3873449, 3873451, 3873452, 3873453, 4036097, 4036098, 4036099, 4036100, 4036101, 4036102, 4036103, 4036104, 4036105, 4036108, 4036110, 4036111, 4095990, 4095991, 4095992, 4095993, 4095994, 4095995, 4095997, 4095998, 4095999, 4096000, 4096002, 4096003, 4096004, 4291075, 4291076, 4291077, 4291078, 4291079, 4291081, 4291082, 4291083, 4291085, 4291086, 4291087, 4291088, 4291090, 4291091, 4291092, 4291094, 4291095, 4291096, 4291097, 4291098, 4291099, 4291100, 4291101, 4291102, 4291103, 4706381, 4706382, 4706383, 4706384, 4706385, 4706386, 4706387, 4706389, 4706390, 4766526, 4766527, 4766528, 4766529, 4766530, 4766531, 4766532, 4766533, 4766534, 4901264, 4901265, 4901268, 4901269, 5080411, 5080412, 5080413, 5080415, 5080416, 5080417, 5080418, 5080419, 5080420, 5977948, 5977950, 6112212, 6112218, 6112224, 6112225, 6112226, 6112227, 6112228, 6112229, 6112231, 6561879, 6561886, 6561890, 6561891, 6561892, 6561894, 6561896); 02-012-38-1011 (10885862002365; 2113460, 2113461, 2113462, 2113465, 2113466, 2113467, 2113468, 2113469, 2113470, 2113471, 2113472, 2113473, 2113474, 2113475, 2113476, 2113477, 2113478, 2113479, 2113480, 2113481, 2113483, 2113484, 2113485, 2113487, 2113488, 2256816, 2256817, 2256818, 2256819, 2256820, 2256821, 2378226, 2378227, 2378228, 2378229, 2378230, 2378231, 2378233, 2378234, 2573205, 2573206, 2573207, 2573208, 2573209, 2573210, 2573211, 2573212, 2778423, 2778424, 2778425, 2778426, 2778428, 2939331, 2939332, 2939333, 2939335, 2939337, 2939338, 2939339, 3565084, 3565085, 3565086, 3565087, 3565089, 3565091, 3565092, 3565093, 3565094, 3565095, 3565096, 3565097, 3565098, 3565099, 3565101, 3565102, 3565103, 3870053, 3870054, 3870055, 3870056, 3870058, 3870059, 3870060, 3891149, 3966070, 3966071, 3966073, 3966074, 3966075, 3966076, 3990899, 3990900, 3990901, 3990904, 3990905, 3990907, 4143249, 4143250, 4143251, 4143252, 4143253, 4143255, 4143256, 4143257, 4143258, 4143259, 4143260, 4143262, 4143263, 4143265, 4143266, 4143268, 4143269, 4143270, 4143271, 4143272, 4143273, 4143274, 4143275, 4143276, 4143277, 4476031, 4476032, 4476033, 4476034, 4476035, 4476036, 4476037, 4476038, 4476039, 4476040, 4476041, 4476043, 4476044, 4476045, 4476046, 4476047, 4476048, 4476050, 4476051, 4476052, 4476053, 4476054, 4476057, 4476060, 5236236, 5236238, 5882865, 5882867, 5882869, 5882871, 5882872); 02-012-38-1013 (10885862002372; 2112936, 2112937, 2112939, 2112942, 2112943, 2112945, 2112947, 2112948, 2112949, 2112950, 2112951, 2112952, 2112954, 2112956, 2112957, 2112959, 2112960, 2112962, 2112964, 2112966, 2362197, 2362198, 2362200, 2362205, 2362207, 2573351, 2573353, 2917120, 2917121, 2917124, 2917125, 2917126, 2917127, 2917128, 2917130, 2917131, 3615834, 3615835, 3615841, 3615842, 3826036, 3826037, 3826039, 3826041, 3826043, 3989617, 3989618, 3989619, 3989624, 4152499, 4152504, 4152505, 4152506, 4152510, 4152512, 4152514, 4152521, 5981031, 6411707); 02-012-38-1015 (10885862002389; 2112584, 2112588, 2112594, 2112596, 2112598, 2112600, 2112602, 2573354, 2573355, 2778422, 2901287, 2901289, 2901290, 2901293, 2901294, 3870048, 3870049, 3870051, 3870052, 3991107, 4120497, 4217789, 4217795, 4217813); 02-012-38-1509 (10885862178794; 3616081, 3616082, 3616083, 3616084, 3795243, 3795244, 3795245, 3795247, 3795248, 3836262, 3873433, 4310727, 4310729, 4310730, 4310731, 4310733, 4310734); 02-012-38-1511 (10885862178800; 3607850, 3662935, 3662937, 4259564, 4259566, 4259568, 4259570, 4259572); 02-012-38-1513 (10885862178817; 3873426, 4259573); 02-012-38-2009 (10885862002396; 2113395, 2113396, 2113397, 2113398, 2113399, 2113401, 2113402, 2113403, 2113404, 2113405, 2113406, 2113407, 2113408, 2113409, 2113410, 2113411, 2113412, 2113413, 2113414, 2113415, 2113416, 2113417, 2113418, 2113419, 2113420, 2113421, 2113422, 2113423, 2180482, 2180483, 2180484, 2180485, 2180486, 2180487, 2180488, 2180489, 2180490, 2180491, 2211710, 2211711, 2211712, 2211713, 2211714, 2211715, 2211716, 2211717, 2211718, 2275541, 2275542, 2275543, 2275544, 2275545, 2275546, 2288266, 2288267, 228826… (truncated, 81932 characters total — see the official FDA record for the full value)
Recalling firm:
Exactech, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 30, 2021

OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers: 200-11-XX, 200-12-XX, 200-13-XX, 200-14-XX, 200-15-XX, 200-16-XX; b. OPTETRAK All-polyethylene PS Tibial Components, with Product Line Numbers: 204-11-XX, 204-12-XX, 204-13-XX, 204-14-XX, 204-15-XX, 204-16-XX; c. OPTETRAK HI-FLEX PS Polyethylene Tibial Inserts, with Product Line Numbers: 244-20-XX, 244-21-XX, 244-22-XX, 244-23-XX, 244-24-XX, 244-25-XX; d. OPTETRAK CR Tibial Inserts, with Product Line Numbers: 200-21-XX, 200-22-XX, 200-23-XX, 200-24-XX, 200-25-XX, 200-26-XX, 200-50-XX, 200-51-XX; e. OPTETRAK CR Tibial Slope + Insert, with Product Line Numbers: 200-56-XX, 200-57-XX, 200-61-XX, 200-62-XX, 200-63-XX, 200-64-XX, 200-65-XX; f. OPTETRAK CR Tibial Slope ++ Insert, with Product Line Numbers: 200-57-XX, 200-71-XX, 200-72-XX, 200-73-XX, 200-74-XX, 200-75-XX; g. OPTETRAK PS Tibial Inserts, with Product Line Numbers: 204-21-XX, 204-22-XX 204-23-XX, 204-24-XX, 204-25-XX, 204-26-XX, 204-50-XX, 204-51-XX; h. OPTETRAK "MOMB" Non-Mod Molded Insert, with Product Line Numbers: 204-91-XX, 204-92-XX, 204-93-XX, 204-94-XX, 204-95-XX; i. OPTETRAK CC Tibial Insert, with Product Line Numbers: 208-21-XX, 208-22-XX, 208-23-XX, 208-24-XX, 208-25-XX, 208-51-XX; j. OPTETRAK B-Series PS Tibial Insert, with Product Line Numbers: 224-21-XX, 224-22-XX, 224-23-XX, 224-24-XX. Affected 510(k) numbers include: K932690, K933494, K932776, K011976, K082022, K933610, K030686, K954208, K010434, K033883. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

ALL 50 STATES
▸Full report

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

Recall #:
88570
Lot/product code:
a. Item Number (Device Identifier; Serial number(s)): 200-11-11 (10885862039934; 1010599); 200-12-09 (10885862039965; 0850770, 0850771, 0850773, 0850776, 0850778, 1052587, 1052589, 1070149, 1070150, 1070151, 1070152, 1267585, 1267586, 1267588, 1318739, 1318740, 1318742, 1375833, 1375836, 1375837, 1375839, 1375844); 200-12-11 (10885862039972; 0825651, 0825653, 0825654, 0825657, 0825659, 1052802, 1052803, 1052804, 1309224); 200-12-13 (10885862039989; 0763041, 0763043, 0820424, 0820431, 1053775); 200-13-09 (10885862039996; 0765380, 0765381, 0765382, 0765383, 0789723, 0789724, 0789726, 0789727, 0789728, 0789729, 0789730, 0789731, 0789732, 0897683, 0998654, 0998655, 0998656, 0998657, 0998658, 0998659, 0998660, 0998661, 0998662, 0998663, 0998664, 0998665, 0998666, 1073908, 1073909, 1073910, 1073911, 1084202, 1084203, 1084204, 1084205, 1261436, 1261437, 1261438, 1261439, 1261440, 1316122, 1316123, 1316124, 1316125, 1316126, 1319147, 1319148, 1319149, 1319150, 1319151, 1407772, 1407774, 1407775, 1407776, 1407777, 1407778, 1407779, 1407780, 1407781, 1516714, 1516715, 1516716, 1516717, 1516718, 1976718, 1976719, 1976720, 1976721, 1976722, 2061574, 2097473, 2097474, 2097475, 2097476, 2097477, 2097478, 2097479, 2145890, 2145891, 2145892, 2145894, 2145895, 2145896, 2559776); 200-13-11 (10885862040008; 0769998, 0770002, 0770003, 0770004, 0818558, 0818559, 0818560, 0818562, 0818563, 0818564, 0818565, 1027748, 1027750, 1027752, 1027754, 1084902, 1291129, 1291130, 1291131, 1319746, 1319747, 1319748, 1319752, 1319753, 1319754, 1319756); 200-13-13 (10885862040015; 0767606, 0767607, 0767608, 0767609, 0953412, 1063120, 1307627); 200-14-09 (10885862040039; 0607230, 0607231, 0607232, 0607233, 0607234, 0607235, 0607236, 0607237, 0607238, 1033676, 1033677, 1033678, 1033679, 1040785, 1040786, 1040787, 1040788, 1065019, 1065020, 1065021, 1065022, 1065023, 1065024, 1065025, 1153592, 1153593, 1153594, 1153595, 1153596, 1153597, 1153598, 1153599, 1153600, 1215318, 1215319, 1215320, 1215322, 1281462, 1281463, 1281464, 1281465, 1321078, 1321079, 1321080, 1321081, 1321082, 1389683, 1389684, 1389685, 1400987, 1400988, 1400989, 1400990, 2012144, 2012145, 2048510, 2048511, 2207641, 2207642, 2207643, 2345327, 2345328, 2414649, 2414652, 2454327, 2454328, 2454329, 2565530, 2565533, 2565534); 200-14-11 (10885862040046; 0942385, 0942386, 0942393, 1050502, 1310607); 200-14-13 (10885862040053; 0942535, 1048228, 1048232, 1153792); 200-15-09 (10885862040077; 0822759, 0822761, 0822762, 0822764, 0822765, 0822766, 0822767, 1048609, 1048611, 1048612, 1048614, 1048615, 1048616, 1048617, 1136150, 1136151, 1136152, 1136154, 1214791, 1214792, 1214793, 1214794, 1214795, 1214796, 1283152, 1283153, 1283154, 1283155, 1439852, 1439853, 1439855, 1439856, 2146108, 2146113); 200-15-11 (10885862040084; 1065636, 1065638); 200-15-13 (10885862040091; 0954497, 0954501); 200-16-11 (10885862040121; 1040633, 1040634, 1040635, 1040636, 1073405, 1073407, 1084258); 200-16-13 (10885862040138; 0956887); b. Item Number (Device Identifier; Serial number(s)): 204-11-09 (10885862047823; 0961663, 0961665, 0961666, 0961667, 0961668, 0961669, 0961671, 0961672, 1045876, 1045877, 1045879, 1070620, 1070622, 1070623, 1106799, 1106800, 1106801, 1106802, 1106803, 1106805, 1106807, 1193435, 1193437, 1193438, 1193439, 1232147, 1232151, 1255910, 1255911, 1255912, 1255913, 1255914, 1270806, 1270807, 1270808, 1270809, 1308220, 1308221, 1308222, 1308223, 1308224, 1308225, 1377016, 1377017, 1377018, 1377019, 1377020, 1377021, 1377022, 1377023, 1377024, 1377025, 1545261, 1545262, 1545263, 1545264, 1545265, 1565700, 1565701, 1565702, 1565703, 1565704, 1582779, 1582780, 1582781, 1582782, 1582783, 1582784, 1582785, 1582786, 1582787, 1582788, 1582789, 1582790, 1582791, 1582792, 1582793, 1582794, 1582795, 1582796, 1582797, 1582798, 1659777, 1659778, 1659779, 1659780, 1659781, 1659782, 1659783, 1659784, 1659785, 1659786, 1659787, 1659788, 1659789, 1659790, 1659791, 1659792, 1659793, 1659794, 1659795, 1659796, 1659797, 1659798, 1659799, 1659800, 1659801, 1704209, 1704210, 1704211, 1704212, 1786558, 1786559, 1786560, 1786561, 1786562, 1786563, 1786564, 1786565, 1797016, 1797017, 1797018, 1797019, 1797020, 1797021, 1797022, 1797023, 1797024, 1797025, 1797026, 1797027, 1797028, 1817561, 1817562, 1817563, 1817564, 1817565, 1817566, 1817567, 1817568, 1817569, 1817570, 1817571, 1817572, 1817573, 1842319, 1842320, 1842321, 1842324, 1842325, 1901249, 1901250, 1901251, 1901252, 1901253, 1901255, 1901256, 1901259, 1901260, 1901261, 1901262, 1901263, 1901264, 1901265, 1901266, 1901267, 1901268, 1901269, 1901270, 1901271, 1901272, 1901273, 1901274, 1901275, 1901276, 2266634, 2266635, 2266636, 2266638, 2276586, 2276587, 2276588, 2276589, 2397396, 2397397, 2397398, 2397399, 2397400, 2397401, 2397402, 2397403, 2397404, 2397405, 2425639, 2425640, 2425641, 2425642, 2425643, 2425644, 2425645, 2425646, 2425647, 2425648, 2425650, 2425651, 2425652, 2425653, 2425654, 2425655, 2425656, 2430257, 2430258, 2430259, 2430260, 24… (truncated, 2189610 characters total — see the official FDA record for the full value)
Recalling firm:
Exactech, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 30, 2021

ARTHROFOCUS Polyethylene Tibial Inserts (Product Line: 256-12-XX, 256-13-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

ALL 50 STATES
▸Full report

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

Recall #:
88570
Lot/product code:
Item Number (Device Identifier; Serial number(s)): 256-12-02 (No Device Identifier; 1208624, 1208625, 1208626, 1208627); 256-12-03 (10885862066633; 1208774, 1446326); 256-13-02 (No Device Identifier; 1208710, 1208715); 256-13-03 (No Device Identifier; 1208859, 1208863); 256-13-04 (No Device Identifier; 1209010, 1209013)
Recalling firm:
Exactech, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 30, 2021

OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

ALL 50 STATES
▸Full report

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

Recall #:
88570
Lot/product code:
Item Number (Device Identifier; Serial number(s)): 252-12-01 (10885862065759; 0757895, 0757903, 0757904, 0757912, 0779752, 0779753, 0779755, 0779756, 0779757, 0779761, 0779762, 0779763, 0779764, 0779765, 0779766, 0779768, 0779769, 0779771, 1411813, 1411814, 1411816, 1454118, 1454120, 1454121, 1454122, 1637857, 1637859, 1637862, 1637863, 1705486, 1705487, 1705488, 1705489, 1705491, 1705492, 1705499, 1705500, 1777268, 1777272, 1838362, 1838363, 1838366, 1845014, 1845017, 1845018, 1876225, 1876228, 1876229, 1966561, 1966562, 1966563, 1966565, 2058877, 2058880, 2058883, 2236096, 2236097, 2236100, 2388362, 2388363, 2388364, 2388365, 2782155, 2787073, 2787075, 2787076, 3664728, 3664729, 4149824, 4149840); 252-12-02 (10885862065766; 1064337, 1064339, 1064340, 1064341, 1064342, 1064343, 1064344, 1064345, 1064347, 1064348, 1064349, 1064350, 1064351, 1064352, 1064353, 1064354, 1064355, 1064356, 1064357, 1064358, 1257124, 1257125, 1257126, 1257127, 1257128, 1257130, 1257131, 1257132, 1257135, 1257136, 1257138, 1257141, 1257145, 1257146, 1257147, 1257148, 1257149, 1257150, 1257151, 1257152, 1257153, 1257154, 1257156, 1257157, 1257158, 1257159, 1257160, 1257163, 1257164, 1257165, 1257166, 1257167, 1257168, 1257169, 1257170, 1257171, 1257173, 1257175, 1257176, 1257177, 1257178, 1257179, 1257181, 1856545, 1856546, 1856547, 1856549, 1856550, 1856551, 1856552, 1856554, 1896395, 1896396, 1896397, 1896398, 1896399, 1896400, 1896401, 1896404, 2116639, 2116640, 2116641, 2116642, 2116644, 2288472, 2328963, 2328964, 2328965, 2328966, 2328968, 2509909, 2509911, 2566818, 2649854, 2692694, 2728962, 2728968, 2728971, 2728976, 2728977, 2728979, 2728980, 2728981, 2728988, 2728991, 3808095, 3808101, 3808110, 3808112, 3808116); 252-12-03 (10885862065773; 0764379, 0764380, 0764381, 0764382, 0764384, 0764385, 0764386, 0764387, 0764389, 0764390, 0764391, 0764392, 0764393, 0764394, 0764395, 0764396, 0764398, 0764400, 0764401, 0764402, 0764407, 0766178, 0766179, 0766180, 0766181, 0766182, 0766183, 0766185, 0766188, 0766189, 0766191, 0766193, 0766194, 0766195, 0766196, 0766198, 0766199, 0766200, 1152751, 1152756, 1152758, 1152759, 1152760, 1152763, 1152764, 1152765, 1152767, 1152768, 1152769, 1248425, 1248426, 1248427, 1248429, 1248430, 1248431, 1248432, 1248433, 1248434, 1248435, 1248437, 1248438, 1248439, 1248440, 1248441, 1248442, 1248443, 1248444, 1248445, 1248446, 1248447, 1248448, 1248449, 1248450, 1294270, 1294271, 1294272, 1294273, 1294274, 1294275, 1294276, 1294277, 1294278, 1294279, 1434902, 1434903, 1434904, 1434905, 1434906, 1434907, 1434908, 1434909, 1434910, 1510648, 1510649, 1510650, 1510651, 1526390, 1526391, 1526392, 1526393, 1545560, 1545561, 1548840, 1548841, 1548842, 1617606, 1617607, 1617608, 1617609, 1617610, 1617611, 1618554, 1618555, 1618556, 1618557, 1618558, 1706098, 1706099, 1706100, 1706101, 1706102, 1706104, 1706105, 1706106, 1706107, 1706108, 1706109, 1706110, 1778471, 1778472, 1778473, 1778474, 1778475, 1778476, 1778477, 1778478, 1778479, 1778480, 1778481, 1778482, 1778483, 1778484, 1778485, 1778486, 1778487, 1825147, 1825148, 1825149, 1825150, 1825151, 1825153, 1846127, 1846128, 1846129, 1846130, 1846131, 1846132, 1846133, 1846134, 1846135, 1846136, 1846137, 1933648, 1933649, 1933650, 1933651, 1936093, 1936094, 1936095, 2002988, 2002989, 2002990, 2002991, 2002992, 2002993, 2002994, 2049677, 2049678, 2049679, 2049680, 2049681, 2060180, 2087493, 2087494, 2087495, 2087496, 2087497, 2087498, 2087499, 2087500, 2087502, 2087503, 2087504, 2087506, 2087507, 2205053, 2205054, 2205055, 2205057, 2233544, 2233545, 2233548, 2233549, 2233550, 2233551, 2233553, 2233554, 2233555, 2233556, 2233557, 2233558, 2512172, 2512173, 2567163, 2567164, 2567165, 2567166, 2567168, 2567169, 2567171, 2567172, 2787069, 2787070, 2787071, 2787072, 2829262, 2829263, 2829264, 2906611, 2906612, 2906613, 2991360, 2991362, 2991363, 2991365, 3564018, 3564020, 3564021, 3564022, 3564023, 3564024, 3564025, 3564026, 3691658, 3808084, 3808085, 3808086, 3808089, 3808093, 4279265, 4279268, 4279270, 4279271, 4488796, 4677196, 5839504, 5839509, 5839510, 5839512, 5839513, 5839514, 5839517, 5839518, 5839519, 5839528, 5839531, 5839532, 5839533, 5839534, 5839535, 5839536, 5839537, 5839538, 5839539, 5839540, 5839541, 5839542, 5839543, 5839545, 5839549, 5839550, 5839557, 5839560); 252-12-04 (10885862065780; 1085902, 1085903, 1085904, 1085905, 1085906, 1085907, 1085908, 1085909, 1085911, 1085914, 1085915, 1085916, 1085917, 1085918, 1085919, 1085920, 1085921, 1085922, 1085923, 1085924, 1174118, 1174119, 1174120, 1174121, 1174122, 1174123, 1174124, 1174125, 1174126, 1174127, 1174129, 1174130, 1174131, 1174132, 1174133, 1174134, 1174136, 1174137, 1174139, 1174140, 1174141, 1174142, 1174143, 1174144, 1174145, 1174146, 1174147, 1174148, 1174149, 1174150, 1174151, 1174152, 1174153, 1174154, 1174155, 1174156, 1174157, 1174158, 1174159, 1174160, 1174161, 1174162, 1174163, 1174164, 1174165, 1174166, 1174168, 1174169, 1174170, 1174171, 1544907, 1544908, 1544909, 1544910, 16006… (truncated, 25689 characters total — see the official FDA record for the full value)
Recalling firm:
Exactech, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 30, 2021

OPTETRAK Comprehensive Knee System custom devices labeled as the following: a. CUSTOM OPTETRAK ANGLED PS INSERT (Product Line: 900-06-XX, 900-08-XX); b. CUSTOM OPTETRAK CC TIBIAL INSERT (Product Line: 900-23-XX, 900-30-XX); c. CUSTOM OPTETRAK CC INSERT (Product Line: 900-33-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

ALL 50 STATES
▸Full report

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

Recall #:
88570
Lot/product code:
a. Item Number (Device Identifier; Serial number(s)): 900-06-18 (10885862100375; 1667962, 1667963); 900-06-20 (10885862100382; 1667796, 1667797); 900-06-22(10885862100399; 1667744, 1667745); 900-08-18 (10885862100405; 1667794, 1667795); 900-08-20 (10885862100412; 1667929, 1667930); 900-08-22 (10885862100429; 1667879, 1667880); b. Item Number (Device Identifier; Serial number(s)): 900-23-02 (10885862100863; 0899804, 0899805, 0899806, 0899807); 900-23-03 (10885862100870; 0900400, 0900401, 0900402, 0900403); 900-23-04 (10885862100887; 0900408, 0900409, 0900410, 0900411, 0900412); 900-23-05 (10885862100894; 0900413, 0900414, 0900415, 0900416); 900-23-06 (10885862100900; 0900404, 0900405, 0900406, 0900407); 900-30-11 (10885862101068; 0565754, 0565755); 900-30-13 (10885862101075; 0565756, 0565757); c. Item Number (Device Identifier; Serial number(s)): 900-33-09 (10885862101082; 1822113, 1822114); 900-33-11 (10885862101099; 1822115, 1822116)
Recalling firm:
Exactech, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 30, 2021

OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

ALL 50 STATES
▸Full report

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

Recall #:
88570
Lot/product code:
a. Item Number (Device Identifier; Serial number(s)): 02-012-35-0009 (10885862001641; 1678465, 1678471, 1678474, 1678481, 1957753, 2006036, 2006037, 2013812, 2043308, 2092688, 2554898, 2573058, 4705904); 02-012-35-0011 (10885862001658; 1678302, 1678309, 1678312, 1963089, 2019801, 2104502, 2104504, 2363227, 2666629, 3809531, 3809537, 4760880); 02-012-35-0013 (10885862001665; 1678446, 1678450, 2092581, 2092584, 2523130); 02-012-35-0015 (10885862001672; 1677680); 02-012-35-1009 (10885862001689; 1393427, 1393428, 1393429, 1393430, 1393431, 1393432, 1393433, 1393435, 1393436, 1393437, 1393438, 1393439, 1393440, 1393441, 1398561, 1398562, 1398563, 1398564, 1398568, 1398569, 1398573, 1398575, 1398578, 1398579, 1398580, 1398581, 1398582, 1398583, 1398584, 1398586, 1398587, 1398588, 1398589, 1398590, 1469287, 1469288, 1469289, 1469290, 1469291, 1469292, 1469293, 1469294, 1469296, 1472031, 1472032, 1472033, 1472034, 1472035, 1472038, 1472040, 1472042, 1472043, 1472044, 1472046, 1472047, 1486523, 1486525, 1486526, 1486527, 1486528, 1486529, 1486530, 1486531, 1486533, 1486534, 1486536, 1486537, 1486538, 1486539, 1486541, 1486542, 1486546, 1486548, 1486549, 1486550, 1486551, 1486552, 1491788, 1491789, 1491790, 1634088, 1634089, 1634090, 1634091, 1634092, 1634095, 1634097, 1736119, 1736121, 1736122, 1736123, 1736124, 1736125, 1736126, 1736127, 1736129, 1736130, 1736132, 1736133, 1736134, 1736135, 1736136, 1736137, 1736138, 1736140, 1736142, 1736143, 1736144, 1736145, 1736146, 1764587, 1764588, 1764589, 1764590, 1764592, 1764593, 1764596, 1764598, 1764599, 1764600, 1764601, 1764602, 1764604, 1764605, 1764606, 1767006, 1767007, 1767008, 1767009, 1767010, 1767011, 1767012, 1767013, 1767015, 1767016, 1767017, 1767018, 1767020, 1767022, 1767024, 1767025, 1767026, 1767027, 1767028, 1767029, 1767030, 1767031, 1850578, 1850579, 1850580, 1850581, 1850582, 1850583, 1850584, 1853045, 1853047, 1853048, 1853049, 1853050, 1853051, 1853220, 1853221, 1853222, 1853224, 1853226, 1853227, 1853229, 1853231, 1853232, 1853233, 1876767, 1876768, 1876772, 1876774, 1876775, 1888268, 1888270, 1888271, 1888272, 1888273, 1888274, 1888275, 1888276, 1888277, 1888278, 1888279, 1888282, 1888283, 1888284, 1888285, 1888286, 1888522, 1888523, 1888525, 1888526, 1888527, 1888530, 1888532, 1938613, 1938614, 1938615, 1938616, 1938618, 1938620, 1938622, 1938624, 1938625, 1938626, 1938627, 1938629, 1938630, 1938632, 1938634, 1941660, 1941661, 1941662, 1941664, 1941667, 1941668, 1941669, 1941670, 1941671, 1941674, 1941675, 1941676, 1941677, 1941679, 1941680, 1941681, 1941682, 1941683, 1941684, 1941686, 1941687, 2023267, 2023268, 2023269, 2023270, 2023273, 2023274, 2023276, 2036804, 2036805, 2036807, 2036808, 2036809, 2036810, 2036811, 2036812, 2036813, 2036814, 2036815, 2036816, 2036817, 2036818, 2036819, 2036820, 2036821, 2036822, 2036823, 2036825, 2036826, 2036829, 2036830, 2036832, 2036833, 2077388, 2077389, 2077390, 2077391, 2077392, 2077395, 2077396, 2077397, 2097467, 2097468, 2097469, 2097470, 2097471, 2097472, 2115480, 2115481, 2115483, 2115485, 2115486, 2115487, 2115489, 2115490, 2115493, 2115494, 2115496, 2115497, 2115498, 2143969, 2143970, 2143971, 2143972, 2143975, 2143976, 2143977, 2143978, 2143979, 2143980, 2143981, 2143983, 2143985, 2143988, 2256447, 2256449, 2256450, 2256452, 2256453, 2256454, 2256455, 2286050, 2286051, 2286053, 2286054, 2286055, 2286056, 2286058, 2286059, 2286060, 2286061, 2286064, 2286067, 2286068, 2286070, 2286072, 2286073, 2286075, 2286076, 2286077, 2286078, 2286079, 2286080, 2286081, 2286082, 2286083, 2286084, 2286085, 2286086, 2286088, 2332541, 2332542, 2332543, 2332544, 2332545, 2332546, 2332547, 2332548, 2332549, 2332550, 2332551, 2332554, 2332556, 2332557, 2332558, 2332559, 2332560, 2403623, 2403624, 2403625, 2403627, 2403630, 2403631, 2403636, 2403637, 2403638, 2403641, 2419071, 2419072, 2419073, 2419074, 2419075, 2419076, 2419077, 2419078, 2419079, 2419080, 2419082, 2419083, 2419088, 2419089, 2419091, 2419092, 2419096, 2419097, 2419099, 2419100, 2419101, 2419102, 2419103, 2419104, 2419105, 2419106, 2419108, 2419109, 2473927, 2473928, 2473930, 2473931, 2473932, 2473933, 2473935, 2473936, 2473937, 2473938, 2473939, 2473940, 2473941, 2473942, 2473944, 2491200, 2491201, 2491202, 2491204, 2491206, 2491207, 2491209, 2491210, 2491211, 2491212, 2491213, 2491215, 2491217, 2491218, 2491219, 2515836, 2515837, 2515838, 2515839, 2515840, 2515841, 2515842, 2515843, 2515845, 2515846, 2515848, 2515849, 2515850, 2515851, 2515852, 2515854, 2515855, 2542277, 2542278, 2542279, 2542280, 2542282, 2542283, 2542284, 2542285, 2542287, 2542288, 2542289, 2542290, 2542293, 2542295, 2542296, 2556889, 2556891, 2556892, 2556895, 2556896, 2556899, 2556900, 2556901, 2556902, 2556903, 2556906, 2619366, 2619367, 2619368, 2619369, 2619370, 2619371, 2619372, 2619373, 2619374, 2619375, 2619376, 2619377, 2666888, 2666889, 2666890, 2666891, 2666892, 2666893, 2666894, 2666895, 2694523, 2694524, 2694525, 2694526, 2694527, 2694528, 2694529, 2694530, 2694531, 269… (truncated, 998351 characters total — see the official FDA record for the full value)
Recalling firm:
Exactech, Inc.
View official FDA record (opens in a new tab)