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Recalls affecting Utah

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

16,633 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

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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

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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

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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.

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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.

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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

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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.

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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

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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

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Wording
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

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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 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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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

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▸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, 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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

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, 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

TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. 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)): 02-022-47-1009 (10885862306067; 4904358, 4904362, 4904363, 4904365, 5103012, 5132420, 5132432, 5186119, 5186125, 5186128, 5220427, 5220428); 02-022-47-1010 (10885862306074; 5054265, 5054269, 5054272, 5058395, 5058402, 5063328, 5063330, 5063335, 5063336, 5143808, 5143812); 02-022-47-1011 (10885862306081; 4715514, 4849121, 5101155, 5101164, 5108302, 5108315); 02-022-47-1012 (10885862306098, 5059598, 5059599, 5059601, 5073330, 5073334, 5073349, 5073352, 5073359, 5073378); 02-022-47-1013 (10885862306104; 4758320, 4758326, 4904379, 4904391, 5101413, 5153301, 5153309, 5153317, 5174543, 5174555); 02-022-47-1015 (10885862306128; 4904313, 4904317, 4904331, 5103330, 5124929, 5217018); 02-022-47-1509 (10885862306142; 5036961, 5036979, 5036982, 5058640, 5058655, 5058656, 5058657, 5101225, 5101226, 5101229, 5101231, 5101232, 5101238, 5168416, 5168417, 5168422, S235767); 02-022-47-1510 (10885862306159; 5085658, 5085662, 5085668, 5085681, 5085682, 5085705, 5085707, 5085718, 5085721, 5085722, 5085728, 5148139, 5148140, 5148147, 5230312, 5230322, 5390682); 02-022-47-1511 (10885862306166; 4998108, 4998112, 4998120, 4998128, 4998131, 4998133, 4998138, 5010573, 5010577, 5010578, 5063133, 5152788, 5152794, 5254482); 02-022-47-1512 (10885862306173; 5057888, 5057891, 5057895, 5057897, 5057926, 5128943, 5128946, 5174523, 5174535, 5174541, 5373484, 5373486); 02-022-47-1513 (10885862306180; 5036901, 5036902, 5036906, 5036935, 5091477, 5155207, 5254434); 02-022-47-1515 (10885862306258; 5035052, 5035055, 5035056, 5148160); 02-022-47-1517 (10885862306265; 5174515); 02-022-47-2009 (10885862306272; 4751940, 4751944, 4751946, 4751947, 4751949, 4751950, 4773516, 4773517, 4773518, 4773521, 4773522, 4773523, 4773526, 4773527, 4920753, 4920754, 4920755, 4920756, 4920758, 4920759, 4920762, 5069996, 5069998, 5069999, 5070000, 5070001, 5070002, 5070003, 5070005, 5070006, 5070007, 5070012, 5070017, 5070019, 5119730, 5119733, 5119734, 5119735, 5119737, 5119739, 5119740, 5119743, 5119746, 5119749, 5221997, 5222000, 5222001, 5222004, 5222005, 5222007, 5222009, 5222012, 5222013, 5222016, 5222017, 5222018, 5222022, 5222024, 5222026, 5222029, 5222030, 5222031, 5222033, 5222034, 5222036, 6943269, S044753, S044758, S044761, S044762, S044763, S044764, S044767, S044768, S064697, S064698, S064699, S078054, S078056, S078057, S078062, S078063, S078066, S078067, S078069, S078072, S078073, S078078, S078080, S078081, S078082, S078087, S078097, S078101, S078104, S078107, S246601, S246616, Z056123, Z056124, Z063902, Z063903, Z069601, Z069603); 02-022-47-2010 (10885862311344; 5054239, 5054242, 5054244, 5054245, 5054247, 5056080, 5056082, 5056085, 5056086, 5056087, 5056089, 5056092, 5056093, 5056094, 5056098, 5056101, 5056102, 5056103, 5066380, 5066381, 5066385, 5066396, 5066397, 5066398, 5119885, 5119889, 5119890, 5119894, 5217323, 5217324, 5217325, 5217326, 5217327, 5217329, 5217332, 5217334, S084971, S234331); 02-022-47-2011 (10885862306289; 4684423, 4684424, 4684425, 4684426, 4684428, 4684429, 4718053, 4718056, 4718060, 4718061, 4773399, 4773400, 4773403, 4920741, 4920745, 4920746, 4920750, 4920751, 5101186, 5101192, 5101194, 5101197, 5101199, 5101202, 5130146, 5130147, 5130150, 5130154, 5130162, 5130163, 5130165, 5130168, 5130169, 5130172, 5130176, 5220466, 5220468, 5220470, 5220475, 5220477, 5220479, 5220488, 5220495, S092853, Z053639); 02-022-47-2012 (10885862311429; 5053846, 5053852, 5053853, 5053858, 5053859, 5053861, 5053864, 5053869, 5053871, 5053879, 5053883, 5053884, 5070103, 5070106, 5070107, 5070108, 5070114, 5070123, 5070129, 5070132, 5070134); 02-022-47-2013 (10885862306296; 4684432, 4684435, 4684437, 4684438, 4684441, 4684443, 4753038, 4753048, 4900078, 4900079, 4900083, 4900090, 4900093, 5103469, 5103470, 5103475, 5103476, 5103480, 5103483, 5103485, 5119804, 5119806, 5119808, 5119812, 5119815, 5119819, 5119820, 5119825, 5119832, 5219855, 5219858, 5219859, 5219862, 5219867, 5219869, S221489); 02-022-47-2015 (10885862306302; 4684444, 4684446, 4684447, 4684449, 4684453, 4765784, 4899827, 4899830, 4899833, 4899834, 5064301, 5064304, 5064305, 5064308, 5064314, 5064317, 5129010, 5129019, 5129021, 5129024, 5129028, 5129030, 5220184, 5220189, S203101); 02-022-47-2017 (10885862306319; 5065369, 5065407); 02-022-47-2509 (10885862306326; 4684399, 4684400, 4684401, 4684403, 4684404, 4765817, 4765819, 4765820, 4765822, 4765823, 4765825, 4765826, 4900035, 4900036, 4900037, 4900038, 4900042, 4900043, 4900044, 4900045, 4916904, 4916905, 4916907, 4916908, 4916909, 4916910, 4916911, 4916912, 4916913, 4916914, 4916915, 5042988, 5042991, 5042992, 5042993, 5042995, 5042996, 5042998, 5043000, 5043002, 5043003, 5043007, 5043010, 5043012, 5063223, 5063225, 5063226, 5063229, 5063231, 5063232, 5063233, 5063234, 5209024, 5209026, 5209029, 5209030, 5209036, 5209040, 5209043, 5209045, 5209047, 5209053, 5209054, 5209055, 5209056, 5209058, 5209061, 5209062, 5209063, 5209068, S050046, S050057, S050058, S050059, S077842, S07784… (truncated, 292086 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 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 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)
UnclassifiedRisk not yet known
Medical deviceRecalled August 30, 2021

Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-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)): 350-21-01 (10885862276216; 4833710, 4833714, 4833715, 4833717, 4833723, 5188005, 5188007, 5188008, 5188009, 5188011, 5188013, 5188015, 5188017, 5188021, 5188022, 5188023, 5939820, 5939826, 5939831, 5939832, 5939833, 5939835, 5939836, 5939837, 5939838, 5939839, 5939840, 5939841, 5939842, 5939844, 5939845, 5939846, 6015553, 6015554, 6015556, 6015557, 6015560, 6015563, 6015566, 6015567, 6015569, 6396486, 6396489, 6396493, 6396495, 6396500, 6396504, 6396505, 6489379, 6489381, 6489382, 6489384, 6489386, 6606659, 6606667, 6606678, 6860126, 6860127, 6900582, 6900585, 6900588, Z060698, Z060703, Z060715, Z064072, Z064105, Z064107); 350-21-02 (10885862276223; 4536664, 4536665, 4536666, 4536668, 4536669, 4536670, 4536672, 4842955, 4842956, 4842957, 4842958, 4842959, 5184645, 5184647, 5184648, 5184649, 5184651, 5184652, 5184653, 5184654, 5184656, 5184657, 5184658, 5855814, 5855815, 5855816, 5855819, 5855820, 5855823, 5855824, 5855825, 5855826, 5855827, 5855828, 5855829, 5855830, 6240459, 6240461, 6240463, 6240464, 6240467, 6259881, 6259882, 6259884, 6259885, 6259888, 6356551, 6356552, 6356561, 6356562, 6356564, 6356566, 6356568, 6356569, 6356570, 6395847, 6395848, 6395852, 6395854, 6395855, 6395856, 6395858, 6395860, 6489055, 6489056, 6489059, 6489063, 6489065, 6489066, 6489069, 6489070, 6489071, 6489072, 6489073, 6583838, 6583839, 6583842, 6583843, 6583844, 6583845, 6583846, 6583849, 6583852, 6583853, 6583855, 6583857, 6730685, 6730688, 6730690, 6730696, 6730697, 6899729, 6899744, 6899751, Z068705, Z075029, Z075042); 350-21-03 (10885862276230; 4536738, 4536739, 4536740, 4536741, 4536742, 4536743, 4536745, 4536746, 4841023, 4841024, 4841025, 5184662, 5184663, 5184665, 5184666, 5184668, 5184669, 5184671, 5184672, 5184673, 5184674, 5184675, 5184678, 5184679, 5184680, 5221264, 5221265, 5221266, 5221267, 5221268, 5221269, 5221270, 5221272, 5221273, 5221274, 5221275, 5221276, 5940499, 5940500, 5940502, 5940507, 5940511, 5940516, 5940517, 5940518, 5940519, 5940520, 6039207, 6039208, 6039210, 6039212, 6039213, 6039214, 6039215, 6039218, 6039220, 6039221, 6039222, 6039223, 6039225, 6173447, 6173449, 6173450, 6173451, 6173452, 6173455, 6173456, 6173458, 6173459, 6173460, 6173462, 6173463, 6173464, 6173465, 6372717, 6372718, 6372719, 6372720, 6372721, 6372726, 6372727, 6372729, 6372730, 6372735, 6489128, 6489129, 6489131, 6489133, 6489134, 6489135, 6489136, 6489137, 6489145, 6489146, 6535721, 6535723, 6535724, 6535729, 6535730, 6535731, 6535732, 6535734, 6742242, 6742248, 6742249, 6742250, 6742251, 6742253, 6742255, 6742259, 6811600, 6811611, 6811612, 6900322, Z074962, Z074972, Z074984, Z075184); 350-21-04 (10885862276247; 4537204, 4537205, 4537206, 4537207, 4537212, 4750991, 5184539, 5184541, 5184543, 5184548, 5184550, 5184553, 5184554, 5184557, 5240718, 5240721, 5240727, 5240728, 5909332, 5909335, 5909337, 5909338, 5909344, 5909350, 5954808, 5954810, 5954815, 5954820, 6356463, 6356464, 6356466, 6356471, 6356472, 6356473, 6356477, 6489076, 6489081, 6489083, 6489093, 6758223, 6758226, 6758227, 6856945, 6856949, 6995782, Z068655); 350-21-11 (10885862276254; 4536710, 4536711, 4536714, 4536715, 4536716, 4536717, 4536718, 4704930, 4704938, 4704939, 4704940, 4704944, 4704945, 4704949, 4704951, 4704956, 4704957, 4787630, 4787631, 5184636, 5184639, 5184640, 5184643, 5231854, 5231855, 5231858, 5231860, 5969127, 5969128, 5969129, 5969132, 6356520, 6356523, 6489037, 6489045, 6489052); 350-21-12 (10885862276261; 4704789, 4771382, 4771383, 4771384, 4771387, 4771388, 5184684, 5184689, 5184690, 5184691, 5184697, 5184698, 5237420, 5237421, 5237422, 5237423, 5237424, 5237426, 5237430, 5237431, 5237432, 5939798, 5939801, 5939802, 5939803, 5939807, 5939810, 6356669, 6356670, 6356671, 6356672, 6356677, 6356680, 6356681, 6356683, 6356684, 6489360, 6489363, 6489365, 6489366, 6489369, 6489370, 6489372, 6598979, 6598980, 6598983, 6598985, 6843245, 6843247, 6843261, 6883796, Z058384, Z074986, Z074999); 350-21-13 (10885862276278; 4704790, 4771176, 4977232, 4977233, 4977235, 5181919, 5181921, 5181923, 5181926, 5181927, 5181931, 5181932, 5181934, 5222348, 5222349, 5222352, 5222355, 5222356, 5222357, 5222358, 5908535, 5908536, 5908537, 5908540, 5908541, 5908542, 5908544, 5908548, 5908549, 6061322, 6061327, 6323250, 6323261, 6395423, 6395424, 6395426, 6395428, 6488292, 6488297, 6488301, Z075109, Z075175); 350-21-14 (10885862276285; 4746009, 5184848, 5184851, 5184852, 5184853, 5184858, 5184860, 5184864, 5184865, 6143314, 6143323, 6143326, 6143329, 6143331, 6395394, 6395395, 6719894, Z076042); 350-21-21 (10885862276292; 4676330, 4676331, 4676332, 4676333, 4676334, 4676335, 4676336, 4676338, 4676345, 4676347, 4676351, 4676355, 5185107, 5185108, 5185110, 5185111, 5185113, 5185114, 5185117, 5185118, 5185119, 5245298, 5906409, 5906414, 5938419, 5938422, 5938424, 5938428, 6356532, 6356533, 6356537, 6356542, 6356549, 6486889, 6486890, 6486896, 6804245, 6900926); 350-21-22 (10885862276308; 4750965, 4771177, 51848… (truncated, 22556 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 31, 2021

Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following product numbers: (1) REF 1882916, RAD 60 Sinus Blade, 11 cm x 2.9 mm; (2) REF 1883514, RAD 12 Curved Sinus Blade, 11 cm x 3.5 mm; (3) REF 1884013, Powered Tonsillectomy Blade, 11 cm x 4 mm; (4) REF 1884020, Tricut Laryngeal Blade, 22.5 cm x 4 mm; (5) REF 1884032, Tracheal Blade, 37 cm x 4 mm; (6) REF 1884033, Tracheal Blade, Angle Tip; (7) REF 1882902HRE, Serrated Blade, 11 cm X 2.9 mm, Rotatable; (8) REF 1882905HRE, Silver Bullet Blade, 11 cm x 2.9 mm, Rotatable; (9) REF 1882924HRE, Skimmer Blade, 27 cm x 2.9 mm, Rotatable; (10) REF 1882936E, Angle-Tip Serrated Blade, 18 cm x 2.9 mm; (11) REF 1882937E, Angle-Tip Serrated Blade, 22 cm x 2.9 mm; (12) REF 1882979HRE, Skimmer Blade, 13 cm x 2.9 mm, Rotatable; (13) REF 1883080HRE, Quadcut Blade, 3.0 mm, Rotatable; (14) REF 1883480HRE, Quadcut Blade, 3.4 mm, Rotatable; (15) REF 1883502HRE, Serrated Blade, 11 cm x 3.5 mm, Rotatable; (16) REF 1883506HRE, RAD 40 Blades, 11 cm x 3.5 mm, Rotatable; (17) REF 1883512HRE, RAD 12 Blade, 11 cm x 3.5 mm, Rotatable; (18) REF 1883516HRE, RAD 60 Blade, 11 cm x 3.5 mm, Rotatable; (19) REF 1884005HRE, Silver Bullet Blade, 11 cm x 4 mm, Rotatable; (20) REF 1884030HRE, Tricut Airway Blade, Angled Tip, 22 cm x 4 mm, Rotatable; (21) REF 1884031HRE, Tricut Airway Blade, Angled Tip, 27 cm x 4 mm, Rotatable; (22) REF 1884033HRE, Tricut Airway Blade, Angled Tip, 37 cm x 4 mm, Rotatable; (23) REF 1884380HR, Quadcut Blade, 4.3 mm, Rotatable; (24) REF 1884380HRE, Quadcut Blade, 4.3 mm, Rotatable.

There was an increase in complaints related to tip breaks and wobble/vibration.

ALL 50 STATES
▸Full report

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

Recall #:
88586
Lot/product code:
(1) REF 1882916, GTIN/UPN 20763000041223 - Lot/serial numbers 0217968715, 0218283722, 0218283942, 0218356873, 0218356874, 0218356875, 0218623544, 0219369113, 0219501397, 0219700166, 0220118673, 0220659645, 0220784922, 0220826101, 0220826102, 0221020300, 0221118606, 0221118607, 0221118608, 0221198946, 0221198951, 0221198952, 0221430166, 0221489935, 0221611652, 0221791819, 0221791821; (2) REF 1883514, GTIN/UPN 20763000040967 - Lot/serial numbers 0218283532, 0218791333, 0219215919; (3) REF 1884013, GTIN/UPN 20763000041230 - Lot/serial numbers 0217969616, 0217969617, 0218283944, 0218572177, 0219010745, 0219110914, 0221170726, 0221603993, 0221783424, 0221791809; (4) REF 1884020, GTIN/UPN 20763000040301 - Lot/serial numbers 0219501396, 0220648062, 0220649166, 0220892207, 0221156835, 0221271500; (5) REF 1884032, GTIN/UPN 00763000036140 - Lot/serial numbers 0220057395, 0220057397; (6) REF 1884033, GTIN/UPN 00763000036447 - Lot/serial numbers 0220057389, 0220057390, 0220057392; (7) REF 1882902HRE, GTIN/UPN 00763000036720 - Lot/serial numbers 0217969607, 0218283720, 0218283721, 0219215912, 0219435041, 0221527810, 0221969518; (8) REF 1882905HRE, GTIN/UPN 00763000036782 - Lot/serial numbers 0217968718, 0217968719, 0218283717, 0218283719, 0218356097, 0218790225, 0219215913, 0220177024, 0220659109, 0220659110, 0220878176, 0221091604, 0221091605, 0221118614, 0221258284, 0221527812, 0221611654; (9) REF 1882924HRE, GTIN/UPN 00763000036744 - Lot/serial numbers 0220057236, 0220057237, 0220057238, 0220057239, 0220057241, 0220057242, 0220057243, 0220057244, 0220560777, 0220659671, 0220878169, 0221072336, 0221156836, 0221275006, 0221611653, 0221619324, 0221791822; (10) REF 1882936E, GTIN/UPN 00763000036799 - Lot/serial numbers 0218377217, 0219660525; (11) REF 1882937E, GTIN/UPN 00763000036805 - Lot/serial numbers 0218377221, 0219661147, 0221279640; (12) REF 1882979HRE, GTIN/UPN 00763000033552 - Lot/serial numbers 0217970486, 0217970490, 0218162629, 0218547894; (13) REF 1883080HRE, GTIN/UPN 00763000033989 - Lot/serial numbers 0217261083, 0217261084, 0217261085, 0218354891, 0218421177, 0218790160, 0219036457; (14) REF 1883480HRE, GTIN/UPN 00763000033996 - Lot/serial numbers 0217261083, 0217261084, 0217261085, 0218354891, 0218421177, 0218790160, 0219036457; (15) REF 1883502HRE, GTIN/UPN 00763000036713 - Lot/serial numbers 0217666178, 0217666179, 0218356088, 0218356089, 0218790221, 0219215911, 0219435040, 0220929595, 0221072335, 0221110715, 0221110717, 0221118531, 0221182357, 0221468015; (16) REF 1883506HRE, GTIN/UPN 00763000037376 - Lot/serial numbers 0217666180, 0217666181, 0217667208, 0218356103, 0218790743, 0219728474, 0220070439, 0220118669, 0220158600, 0220484568, 0221119048, 0221258278, 0221468019, 0221611257, 0221611258; (17) REF 1883512HRE, GTIN/UPN 00763000037369 - Lot/serial numbers 0218356098, 0218356099, 0218356100; (18) REF 1883516HRE, GTIN/UPN 00763000037383 - Lot/serial numbers 0217665427, 0217665428, 0217665429, 0217666173, 0217666174, 0217666175, 0217666176, 0217666177, 0218572169, 0219699597, 0219728468, 0219728469, 0219848777, 0219848778, 0219848779, 0219859949, 0220124591, 0220124592, 0220124593, 0220266094, 0220313525, 0220313606, 0220313607, 0220313608, 0220313609, 0220313610, 0220313611, 0220313612, 0220484569, 0220484570, 0220891745, 0220892206, 0221111087, 0221111089, 0221111092, 0221111093, 0221118545, 0221261887, 0221271501, 0221279626, 0221279627, 0221477061, 0221477062, 0221477063, 0221477064, 0221611647, 0221611648, 0221611649, 0221791908, 0221791910, 0221791911; (19) REF 1884005HRE, GTIN/UPN 00763000036737 - Lot/serial numbers 0217968722, 0218161789, 0218161790, 0218356090, 0218790222; (20) REF 1884030HRE, GTIN/UPN 00763000036751 - Lot/serial numbers 0219968104, 0220031839, 0220031841, 0220031842, 0220031843, 0220484572, 0220560783, 0221118618, 0221258283, 0221468017, 0221698794, 0222008093; (21) REF 1884031HRE, GTIN/UPN 00763000036768 - Lot/serial numbers 0219968105, 0220032167, 0220032168, 0220032169, 0220468850, 0220583927, 0220934514, 0221072334, 0221279641, 0221792010, 0222008095; (22) REF 1884033HRE, GTIN/UPN 00763000036775 - Lot/serial numbers 0220057245, 0220057386, 0220057387; (23) REF 1884380HR, GTIN/UPN 20763000038162 - Lot/serial numbers 0217261579, 0217261580, 0217261581, 0217261582, 0217911696, 0217911698, 0217968713, 0218283533, 0218356295, 0218356302, 0218356303, 0218356304, 0218356305, 0218356866, 0218356867, 0218356870, 0218356871, 0218356872, 0218404708, 0218404710, 0218572170, 0218572171, 0218572172, 0218572173, 0218572174, 0218572175, 0218653925, 0218655886, 0218655887, 0218655888, 0218790744, 0218790745, 0218791326, 0218791327, 0218791328, 0218791329, 0218791330, 0218791331, 0218791332, 0219215917, 0219423535, 0219488214, 0219488215, 0219488216, 0219488217, 0219488218, 0219501398, 0219501399, 0219501400, 0219501401, 0219550301, 0219556484, 0219568999, 0219569000, 0219569001, 0219594771, 0219594772, 0219594773, 0219619651, 0219632566, 0219632567, 0219679070,… (truncated, 6050 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic Xomed, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 31, 2021

Medtronic Sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following product numbers: (1) REF 40A2500, Nucleus Removal Angled Blade, 25 cm x 4.0 mm; (2) REF 40R2000, Nucleus Removal Set, 20 cm x 4.0 mm; (3) REF 40R2500, Nucleus Removal Set, 25 cm x 4.0 mm; (4) REF 40S2000, Nucleus Removal Straight Blade, 20 cm x 4.0 mm; (5) REF 40S2500, Nucleus Removal Straight Blade, 25 cm x 4.0 mm; (6) REF 45A2000, Nucleus Removal Angled Blade, 20 cm x 4.5 mm; (7) REF 45A2500, Nucleus Removal Angled Blade, 25 cm x 4.5 mm; (8) REF 45R2000, Nucleus Removal Set, 20 cm x 4.5 mm; (9) REF 45R2500, Nucleus Removal Set, 25 cm x 4.5 mm; (10) REF 45S2000, Nucleus Removal Straight Blade, 20 cm x 4.5 mm; (11) REF 45S2500, Nucleus Removal Straight Blade, 25 cm x 4.5 mm.

There was an increase in complaints related to tip breaks and wobble/vibration.

ALL 50 STATES
▸Full report

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

Recall #:
88586
Lot/product code:
(1) REF 40A2500, GTIN/UPN 00763000033835, Lot/serial number 0220002825; (2) REF 40R2000, GTIN/UPN 00763000033866, Lot/serial number 0218179458; (3) REF 40R2500, GTIN/UPN 00763000033798, Lot/serial number 0218299192; (4) REF 40S2000, GTIN/UPN 00763000033873, Lot/serial number 0218179459; (5) REF 40S2500, GTIN/UPN 00763000043193, Lot/serial number 0220226674; (6) REF 45A2000, GTIN/UPN 00763000033880, Lot/serial number 0220443669; (7) REF 45A2500, GTIN/UPN 00763000043223, Lot/serial number 0218323602; (8) REF 45R2000, GTIN/UPN 00763000033897, Lot/serial numbers 0218284087, 0218292178, 0218973633; (9) REF 45R2500, GTIN/UPN 00763000033811, Lot/serial number 0218297618; (10) REF 45S2000, GTIN/UPN 00763000033903, Lot/serial number 0218299193; (11) REF 45S2500, GTIN/UPN 00763000043216, Lot/serial number 0218297619.
Recalling firm:
Medtronic Xomed, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 31, 2021

Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following product numbers: (1) REF 1883080EM, Rotatable Fusion Blade, Quadcut 3.0 mm x 13 cm; (2) REF 1883480EM, Rotatable Fusion Blade, Quadcut, 3.4 mm x 13 cm; (3) REF 1884006EM, Rotatable Fusion Blade, RAD 40; (4) REF 1884012EM, Rotatable Fusion Blade, RAD 12; (5) REF 1884080EM, Rotatable Fusion Blade, Tricut, 13 cm; (6) REF 1884380EM, Rotatable Fusion Blade, Quadcut, 4.3 mm x 13 cm.

There was an increase in complaints related to tip breaks and wobble/vibration.

ALL 50 STATES
▸Full report

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

Recall #:
88586
Lot/product code:
(1) REF 1883080EM, GTIN/UPN 00763000034009, Lot/serial numbers: 0217668426, 0217668430, 0217668431, 0218547904, 0219386765, 0219387546, 0221279639, 0221597049; (2) REF 1883480EM, GTIN/UPN 00763000034016, Lot/serial numbers: 0218355352, 0218355353, 0218355354, 0218548106, 0218975242, 0218975243, 0219488206, 0219810719, 0221111103, 0221275012, 0221367934, 0221597050, 0221791924; (3) REF 1884006EM, GTIN/UPN 00763000043254, Lot/serial numbers: 0217260953, 0217260954, 0217260955, 0217260956, 0217260957, 0217260958, 0217260959, 0217969622, 0217969623, 0217969624, 0217969625, 0217970026, 0217970027, 0218162408, 0218162409, 0218282135, 0218282136, 0218282139, 0218311142, 0218311143, 0218311144, 0218311145, 0218356286, 0218356287, 0218356288, 0218356289, 0218356290, 0218356291, 0218356292, 0218975837, 0219215914, 0219215915, 0219215916, 0219715476, 0219715477, 0219811260, 0220659888, 0220804521, 0220826103, 0220878167, 0220878168, 0220929588, 0220996074, 0221199850, 0221367938, 0221477065, 0221477146, 0221586895, 0221618118, 0221791912, 0222046728, 0222046729; (4) REF 1884012EM, GTIN/UPN 00763000043247, Lot/serial numbers: 0217667211, 0217667212, 0217667213, 0217667214, 0217667215, 0217667216, 0218159075, 0218159076, 0218159077, 0218159452, 0218159453, 0218159455, 0218159456, 0218159457, 0218159458, 0218423331, 0218975832, 0219036454, 0219036455, 0219122536, 0219122537, 0221791915; (5) REF 1884080EM, GTIN/UPN 00763000033842, Lot/serial numbers: 0217258057, 0217258058, 0217258059, 0217258060, 0217258061, 0217258062, 0217258063, 0217922715, 0217922716, 0217968723, 0217968724, 0217968725, 0217969086, 0217969087, 0217969088, 0217969089, 0217969090, 0217969091, 0217969092, 0217969093, 0217969094, 0217969095, 0217969096, 0217969098, 0217969099, 0217969100, 0218351460, 0218351462, 0218351463, 0218351464, 0218351465, 0218354786, 0218354787, 0218354788, 0218354789, 0218496725, 0218569925, 0218572166, 0218572167, 0218577805, 0218578866, 0218578867, 0218578868, 0218761931, 0218761932, 0218761933, 0218761934, 0218761935, 0218761936, 0218772873, 0218795848, 0218795849, 0218795850, 0218795851, 0218962903, 0218972892, 0218972893, 0218972894, 0218972895, 0218972896, 0219090839, 0219180699, 0219214780, 0219214781, 0219214782, 0219214783, 0219214784, 0219434676, 0219488207, 0219745076, 0220804698, 0220929480, 0220929481, 0220929482, 0220929483, 0221091281, 0221111100, 0221279635, 0221430167, 0221476225, 0221477046, 0221477047, 0221477048, 0221477049, 0221477051, 0221619326, 0221619330, 0221619331, 0221619332, 0221619333, 0221619334, 0221784366, 0221786297, 0221791918, 0221805157, 0221805158, 0221824122, 0221824123; (6) REF 1884380EM, GTIN/UPN 00763000034023, Lot/serial numbers: 0217258064, 0217258065, 0217260946, 0217260947, 0217260948, 0217260949, 0217260950, 0217260951, 0217260952, 0217262726, 0218179453, 0218348413, 0218355677, 0218355678, 0218355679, 0218355680, 0218355681, 0218355682, 0218355683, 0218355684, 0218355685, 0218422557, 0218422558, 0218496125, 0218497688, 0218497689, 0218497690, 0218572168, 0218683395, 0218683396, 0218683397, 0218683398, 0218795858, 0218795859, 0218795860, 0218975828, 0218975829, 0218975830, 0219215906, 0219215907, 0219215908, 0219215910, 0219653288, 0219653289, 0219802564, 0219834731, 0219848776, 0219854757, 0219890572, 0219890573, 0220484577, 0220484578, 0220659891, 0220659896, 0220703724, 0220703986, 0220703987, 0220703988, 0220703989, 0220878170, 0220878171, 0220878172, 0220878173, 0221072337, 0221110719, 0221110720, 0221118536, 0221118537, 0221118538, 0221118539, 0221181704, 0221182518, 0221271504, 0221278671, 0221279628, 0221279629, 0221305678, 0221319087, 0221468021, 0221477059, 0221477060, 0221489745, 0221489926, 0221611261, 0221616348, 0221619315, 0221619316, 0221619317, 0221619318, 0221792011, 0221805165, 0221805386, 0221805388, 0221824447, 0221824448, 0221824449;
Recalling firm:
Medtronic Xomed, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 2, 2021

REF/Catalogue Number GSXE0020, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617630 *Not distributed within the US

Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.

ALARAZCACOCTDCFLGAHIIAIDILINKSKYLAMAMDMEMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPASCSDTNTXUTVAVTWAWIWV
▸Full report

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

Recall #:
88683
Lot/product code:
serial numbers 22689696 through 23569078
Recalling firm:
W L Gore & Associates, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 2, 2021

REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617661 *Not distributed within the US

Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.

ALARAZCACOCTDCFLGAHIIAIDILINKSKYLAMAMDMEMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPASCSDTNTXUTVAVTWAWIWV
▸Full report

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

Recall #:
88683
Lot/product code:
serial numbers 22689696 through 23569078
Recalling firm:
W L Gore & Associates, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 2, 2021

REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631025 *Not distributed within the US

Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.

ALARAZCACOCTDCFLGAHIIAIDILINKSKYLAMAMDMEMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPASCSDTNTXUTVAVTWAWIWV
▸Full report

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

Recall #:
88683
Lot/product code:
serial numbers 22689696 through 23569078
Recalling firm:
W L Gore & Associates, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 2, 2021

REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132648948 *Not distributed within the US

Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.

ALARAZCACOCTDCFLGAHIIAIDILINKSKYLAMAMDMEMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPASCSDTNTXUTVAVTWAWIWV
▸Full report

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

Recall #:
88683
Lot/product code:
serial numbers 22689696 through 23569078
Recalling firm:
W L Gore & Associates, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 2, 2021

REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620128 *Not distributed within the US

Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.

ALARAZCACOCTDCFLGAHIIAIDILINKSKYLAMAMDMEMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPASCSDTNTXUTVAVTWAWIWV
▸Full report

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

Recall #:
88683
Lot/product code:
serial numbers 22689696 through 23569078
Recalling firm:
W L Gore & Associates, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 2, 2021

REF/Catalogue Number GSXE0025B, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620111 *Not distributed within the US

Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.

ALARAZCACOCTDCFLGAHIIAIDILINKSKYLAMAMDMEMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPASCSDTNTXUTVAVTWAWIWV
▸Full report

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

Recall #:
88683
Lot/product code:
serial numbers 22689696 through 23569078
Recalling firm:
W L Gore & Associates, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 2, 2021

REF/Catalogue Number GSX0030A, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631032

Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.

ALARAZCACOCTDCFLGAHIIAIDILINKSKYLAMAMDMEMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPASCSDTNTXUTVAVTWAWIWV
▸Full report

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

Recall #:
88683
Lot/product code:
serial numbers 22689696 through 23569078
Recalling firm:
W L Gore & Associates, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 2, 2021

REF/Catalogue Number GSX0020A, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631018

Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.

ALARAZCACOCTDCFLGAHIIAIDILINKSKYLAMAMDMEMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPASCSDTNTXUTVAVTWAWIWV
▸Full report

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

Recall #:
88683
Lot/product code:
serial numbers 22689696 through 23569078
Recalling firm:
W L Gore & Associates, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled September 2, 2021

Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816, Manufactured by: Aurex laboratories LLC, East Windsor, NJ 08520, NDC 16571-752-01

Labeling: Incorrect Instructions

ALL 50 STATES
▸Full report

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

Recall #:
D-0005-2022
Lot/product code:
Lot # CB21024, Exp 2/2023
Recalling firm:
RISING PHARMACEUTICALS
View official FDA record (opens in a new tab)