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Recalls affecting Kansas

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

16,731 recalls found

Just announced

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

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

Products contain undeclared yohimbine

Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

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

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

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

Foods AliveMoringa Leaf Powder

Potential to be contaminated with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

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

Presence of particulate matter identified as iron oxide

Full report
Drugs

Recalling firm: B. Braun Medical Inc.

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

Company contact: recalls@bbraunusa.com

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

Great ValueOrganic Triple Berry Blend

Possible E. Coli Contamination

Full report
Food & BeveragesFoodborne Illness

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

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

Company contact: Info.foodsafety@comfrut.com

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

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

Presence of particulate matter and lack of sterility assurance

Full report
Food & Beverages

Recalling firm: American Regent, Inc.

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

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

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

Undeclared milk

Full report
Food & BeveragesAllergens

Recalling firm: Crystal Temptations

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

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

LipofitLipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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

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

Contains garlic essential oil not approved for culinary use

Full report
Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

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

Everything SproutsRobust Radish Mix, 5oz Cups

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

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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

MartinaMangoes

Potential contamination with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

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

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled September 30, 2020

COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed of spherical particles (75-125 microns in diameter of calcium hydroxylapatite (CaHA), suspended in aqueous based gel carrier. Gel carrier is composed of sodium carboxymethylcellulose, sterile water for injection, and glycerin. Product is packaged in a 1.0cc syringe and packed in a sterile pouch.

The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study.

Full report

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

Recall #:
86572
Lot/product code:
Model M0068903000, Lots: 100127846, 100127847, 100128709, 100128710, 100129357, 100129614, and 100129615
Recalling firm:
Merz North America, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 8, 2020

Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle, Rx Only, Time-Cap Labs, Inc., Repackaged By: Northwind Pharmaceuticals North Blenheim NY 12131 NDC 70934-334-30

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)

ALL 50 STATES
Full report

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

Recall #:
D-0056-2021
Lot/product code:
N107411901, N107411903, N107411904, N107411905, N107411906, exp 11/30/2020; N107411907, N107412001, exp 4/30/2021; N107412002, N107412004, exp 11/30/2021; N107412003, exp 7/31/2021
Recalling firm:
Denton Pharma, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 8, 2020

Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 30 count (NDC 70934-309-30); b) 60 count (NDC 70934-309-60); c) 90 count (70934-309-90); d) 120 count (NDC 70934-309-98) bottles, Rx Only, Time-Cap Labs Inc. Repackaged by Northwind Pharmaceuticals North Blenheim, NY 12131

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)

ALL 50 STATES
Full report

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

Recall #:
D-0057-2021
Lot/product code:
a) 30 count: N107051905, exp 10/31/2020; N107052002, N107052005, exp 9/30/2021 b) 60 count: N107051907, exp 10/31/2020; N107052001 6/30/2021; N107052010, N107052008, N107052004, exp 9/30/2021; c) 90 count: C107051908, exp 10/31/2020, C107052002, C107051909 exp 6/30/2021, C107052001, exp 12/31/2020, C107052004, N107052006, N107052007, N107052009, N107052011, N107052012 exp 9/30/2021; d) 120 count: C107051907, N107051904, N107051906 exp 10/31/2020 C107051910, exp 6/30/2021; C107052003, C107052005, N107052003 exp 9/30/2021
Recalling firm:
Denton Pharma, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled October 12, 2020

Happy Tot Superfoods Gluten Free Oat Bar Organic Blueberries & Oatmeal. SKU: TB-BLOT-5 and TB-BLOT-5-WM. Ready-to-eat granola bar intended for toddler consumption. Each bar packaged in film (0.88 oz (25g) and packed in a 5 pack box (net wt. 4.4 OZ (125g). UPC code: 819573015072.

Recall due to mold growth observed (Eurotium spp., Aspergillus niger, and Xeromyces bisporus).

Full report

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

Recall #:
F-0067-2021
Lot/product code:
BB 07 APR 2021 20098 BB 08 APR 2021 20099 BB 09 APR 2021 20100 BB 18 MAY 2021 20139 BB 19 MAY 2021 20140 BB 16 JUN 2021 20168 BB 28 AUG 2021 20241
Recalling firm:
Nurture Inc. dba Happy Family
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled October 12, 2020

Happy Kid Gluten Free Fruit & Oat Bar Organic Blueberry & Raspberry. SKU: KB-BLRB-5. Ready-to-eat granola bar intended for toddler consumption. Each bar packaged in film (0.99 oz(28g) and packed in 5 pack box (Net Wt. 4.95 OZ (140g). UPC code: 819573014389.

Recall due to mold growth observed (Eurotium spp., Aspergillus niger, and Xeromyces bisporus).

Full report

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

Recall #:
F-0069-2021
Lot/product code:
BB 14 APR 2021 20105 BB 05 MAY 2021 20126 BB 11 MAY 2021 20132 BB 01 JUN 2021 20153 BB 08 JUL 2021 20190 BB 13 JUL 2021 20195 BB 04 AUG 2021 20217
Recalling firm:
Nurture Inc. dba Happy Family
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled October 12, 2020

Happy Tot Superfoods Gluten Free Oat Bar Organic Bananas, Strawberries, & Sunflower Butter. SKU: TB-BASTSB-5 and TB-BASTSB-5-WM. Ready-to-eat granola bar intended for toddler consumption. Each bar packaged in film (0.88 oz (25g) and packed in a 5 pack box (net wt. 4.4 OZ (125g). UPC code: 819573015089.

Recall due to mold growth observed (Eurotium spp., Aspergillus niger, and Xeromyces bisporus).

Full report

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

Recall #:
F-0068-2021
Lot/product code:
BB 13 APR 2021 20104 BB 08 MAY 2021 20129 BB 20 MAY 2021 20141 BB 21 MAY 2021 20142 BB 08 JUN 2021 20160 BB 09 JUN 2021 20161 BB 15 JUN 2021 20167
Recalling firm:
Nurture Inc. dba Happy Family
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 16, 2020

Puritan Bennett 980 (PB980) Ventilator Series - Product Usage: for use on patient population sizes from Neonatal (NICU) through Adult who require respiratory support or mechanical ventilation SKU: 980X1ENDIUU 980X1ENDIUU 980X3FRAIQC 980X3DEDRAC 980X3ENNISB 980X3NLDRAC 980X3PLDIPC 980X3ESDIEC 980X3ITDIEC 980X3JADIJJ 980X3SVAIQC 980U3ENASAA 980U1ENDICU 980U1FRDICU 980X3ENDRAC 980X1FRDISS 980A3ENNISB 980X1PLDIPC 980X3SKNISC 980U3ESDIUU 980X1DEDISS 980X3DEDISS 980X3HUNISC 980X3ENDIPP 980X1BGDRAC 980X1ENDRAC 980X1NLDRAC 980A1ENNISB 980X3TRDRAC 980X3CSNISC 980U3ESDIUC 980U1ENASAA 980X1JADIJJ 980X1FRAIQC 980X1ENDIPC 980X1ENNISB 980X1ESDIEC 980X1ITDIEC 980X1PTDIPC 980X1DEDRAC 980X1TRDRAC 980X3RODRAC 980S1ENDICU 980X3RUDRAC 980U1ESDIUU 980U3ESDIUA 980X3SRDRAC 980X1ENDIPP 980U1ESDIUC 980X3ENDIUU 980X3ENDIJI 980X1SKNISC 980X3PTDIPC 980U1ESDIUA 980U3PTDIUNA 980X1DAAGAC 980X1FIAGAC 980X1NOAGAC 980X1SVAGAC 980X3ENAIQC 980X1HUNISC 980X2ENDIUU 980X3ENASAA 980X1ENASAA 980S3ESDIUU 980X1RODRAC 980S1PTDIUNA 980X1SLDRAC 980S1ESDIUU 980S1ESDIUC 980S3ESDIUA 980S1ESDIUA 980S3ESDIUC 980S1FRDICU 980S3ENDICU 980X2ENASAA 980X2ITDIEC 980X1ELAIQC 980X2DEDRAC 980X2FRAIQC 980X2ENNISB 980X2ESDIEC 980A2ENNISB 980X2PLDIPC 980X1ENAIQC 980U1PTDIUNA 980X3ENDISS 980X2ENDISS 980X1HRDRAC 980X3RUDIEC 980U3ENDICU 980X1SRDRAC 980X1ENDIJI 980X2RUDRAC 980X3ENDIPB 980P1ZHNISD 980P3ZHNISD 980C1ZHNISD 980C3ZHNISD 980C2ZHNISD 980N1ZHNISD 980N3ZHNISD 980P2ZHNISD 980X1ENNISC 980U3ENDIUU-LA 980U1ENDIUU-LA

In-house lab observations and customer reports of overheating and/or thermal damage to the battery pack, create the risk of exposure to smoke or hazardous materials, which may result in burns and/or bronchospasm,

ALL 50 STATES
Full report

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

Recall #:
86643
Lot/product code:
serial Numbers: 35B1300004 35B1300010 35B1300019 35B1300021 35B1300022 35B1300025 35B1300036 35B1300037 35B1300045 35B1300046 35B1300013 35B1300041 35B1300006 35B1300008 35B1300009 35B1300027 35B1300051 35B1300016 35B1300042 35B1300005 35B1300026 35B1300031 35B1300001 35B1300040 35B1300050 35B1300020 35B1300033 35B1300030 35B1300044 35B1300011 35B1300048 35B1300035 35B1300002 35B1300029 35B1300038 35B1300014 35B1300017 35B1300003 35B1300015 35B1400001 35B1300018 35B1300034 35B1300007 35B1300032 35B1300043 35B1400005 35B1400010 35B1400013 35B1400020 35B1400024 35B1400009 35B1400028 35B1400017 35B1400025 35B1400023 35B1400011 35B1400021 35B1400032 35B1400033 35B1400034 35B1400040 35B1400003 35B1400026 35B1400030 35B1400035 35B1400044 35B1400048 35B1400055 35B1400056 35B1400059 35B1400060 35B1400061 35B1400063 35B1400049 35B1400068 35B1400069 35B1400050 35B1400062 35B1400064 35B1400072 35B1400007 35B1400015 35B1400058 35B1400077 35B1400083 35B1400057 35B1400041 35B1400066 35B1400070 35B1400087 35B1400088 35B1400092 35B1400074 35B1400091 35B1400039 35B1400071 35B1400075 35B1400012 35B1400042 35B1400053 35B1400065 35B1400079 35B1400080 35B1400095 35B1400073 35B1400082 35B1400038 35B1400036 35B1400097 35B1400101 35B1400104 35B1400067 35B1400047 35B1400006 35B1400103 35B1400110 35B1400112 35B1400113 35B1400116 35B1400111 35B1400108 35B1400109 35B1400098 35B1400081 35B1400096 35B1400022 35B1400105 35B1400119 35B1400122 35B1400123 35B1400124 35B1400126 35B1400100 35B1400129 35B1400130 35B1400132 35B1400137 35B1400134 35B1400131 35B1400135 35B1400115 35B1400127 35B1400027 35B1400084 35B1400138 35B1400093 35B1400133 35B1400141 35B1400149 35B1400142 35B1400145 35B1400147 35B1400150 35B1400153 35B1400051 35B1400136 35B1400152 35B1400139 35B1400037 35B1400159 35B1400078 35B1400089 35B1400114 35B1400117 35B1400120 35B1400140 35B1400143 35B1400151 35B1400155 35B1400157 35B1400158 35B1400172 35B1400164 35B1400154 35B1400161 35B1400162 35B1400018 35B1400160 35B1400174 35B1400176 35B1400179 35B1400004 35B1400156 35B1400198 35B1400191 35B1400197 35B1400099 35B1400165 35B1400169 35B1400180 35B1400217 35B1400182 35B1400170 35B1400148 35B1400189 35B1400194 35B1400106 35B1400118 35B1400166 35B1400171 35B1400185 35B1400188 35B1400192 35B1400199 35B1400210 35B1400228 35B1400203 35B1400233 35B1400184 35B1400195 35B1400201 35B1400227 35B1400187 35B1400196 35B1400102 35B1400205 35B1400206 35B1400208 35B1400214 35B1400181 35B1400190 35B1400209 35B1400230 35B1400239 35B1400247 35B1400249 35B1400193 35B1400251 35B1400252 35B1400221 35B1400167 35B1400207 35B1400211 35B1400219 35B1400222 35B1400260 35B1400212 35B1400224 35B1400241 35B1400242 35B1400246 35B1400218 35B1400229 35B1400232 35B1400237 35B1400235 35B1400146 35B1400173 35B1400216 35B1400220 35B1400225 35B1400226 35B1400231 35B1400259 35B1400262 35B1400265 35B1400274 35B1400283 35B1400186 35B1400223 35B1400215 35B1400248 35B1400261 35B1400266 35B1400268 35B1400243 35B1400250 35B1400254 35B1400163 35B1400255 35B1400256 35B1400267 35B1400270 35B1400273 35B1400275 35B1400278 35B1400281 35B1400287 35B1400290 35B1400303 35B1400253 35B1400279 35B1400285 35B1400177 35B1400213 35B1400245 35B1400264 35B1400282 35B1400284 35B1400286 35B1400288 35B1400289 35B1400296 35B1400302 35B1400305 35B1400307 35B1400292 35B1400298 35B1400168 35B1400293 35B1400310 35B1400313 35B1400316 35B1400318 35B1400320 35B1400291 35B1400272 35B1400309 35B1400234 35B1400295 35B1400322 35B1400090 35B1400238 35B1400258 35B1400317 35B1400324 35B1400326 35B1400327 35B1400328 35B1400204 35B1400271 35B1400301 35B1400306 35B1400312 35B1400315 35B1400323 35B1400340 35B1400341 35B1400333 35B1400332 35B1400336 35B1400338 35B1400342 35B1400330 35B1400345 35B1400346 35B1400350 35B1400355 35B1400359 35B1400367 35B1400373 35B1400321 35B1400308 35B1400244 35B1400329 35B1400354 35B1400371 35B1400314 35B1400319 35B1400344 35B1400348 35B1400365 35B1400369 35B1400375 35B1400377 35B1400378 35B1400349 35B1400364 35B1400370 35B1400347 35B1400368 35B1400383 35B1400331 35B1400372 35B1400356 35B1400382 35B1400299 35B1400385 35B1400388 35B1400263 35B1400396 35B1400400 35B1400339 35B1400357 35B1400337 35B1400384 35B1400392 35B1400401 35B1400335 35B1400407 35B1400393 35B1400395 35B1400404 35B1400411 35B1400376 35B1400408 35B1400389 35B1400390 35B1400410 35B1400413 35B1400387 35B1400386 35B1400353 35B1400415 35B1400417 35B1400421 35B1400358 35B1400397 35B1400405 35B1400419 35B1400426 35B1400428 35B1400435 35B1400399 35B1400439 35B1400442 35B1400257 35B1400361 35B1400402 35B1400423 35B1400431 35B1400444 35B1400446 35B1400445 35B1400449 35B1400452 35B1400457 35B1400458 35B1400466 35B1400434 35B1400409 35B1400425 35B1400448 35B1400455 35B1400144 35B1400236 35B1400300 35B1400379 35B1400437 35B1400438 35B1400468 35B1400472 35B1400482 35B1400486 35B1400489 35B1400490 35B1400491 35B1400492 35B1400493 35B1400495 35B1400496 35B1400499 35B1400500 35B1400501 35B1400502 35B1400505 35B1400506 35B1400507 35B1400094 35B1400128 35B1400459 35B1400414 35B1400454 3… (truncated, 274432 characters total — see the official FDA record for the full value)
Recalling firm:
Covidien Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 16, 2020

VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated System - Product Code: 8231474

Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verifier II Lot Q7692 when stored unopened at refrigerated temperatures

ALL 50 STATES
Full report

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

Recall #:
86669
Lot/product code:
Lot Q7692 , EXP: 01-NOV-2021 UDI: 10758750004577
Recalling firm:
Ortho Clinical Diagnostics Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 23, 2020

Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Product Usage: The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO (Mako robot) and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later).

Stryker has discovered a characterization issue associated with the Mako Integrated Cutting System (MICS) Handpiece. The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later). This issue may result in unsuccessful checkpoint verification when the Mako System attempts to verify the location of the saw blade prior to bone preparation. This issue may also cause a discrepancy during bone preparation in a Mako Total Knee or a Mako Partial Knee procedure in which the surgeon uses a straight or angled saw attachment with the MICS Handpiece. The surgeon may make cuts during bone preparation that differ from the surgeon s preoperative plan.

ALL 50 STATES
Full report

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

Recall #:
86700
Lot/product code:
(01) 00848486030193 (21), Serial numbers: 4200052, 4200095, 4200112, 4200117, 4200119, 4200167, 4200190, 4200193, 4200202, 4200203, 4200204, 4200226, 4200233, 4200235, 4200248, 4200250, 4200257, 4200269, 4200270, 4200288, 4200293, 4200305, 4200350, 4200373, 4200384, 4200387, 4200391, 4200397, 4200398, 4200400, 4200409, 4200436, 4200457, 4200459, 4200477, 4200488, 4200512, 4200540, 4200548, 4200550, 4200558, 4200624, 4200645, 4200653, 4200666, 4200717, 4200766, 4200774, 4200785, 4200789, 4200801, 4200806, 4200807, 4200816, 4200843, 4200856, 4200868, 4200904, 4200917, 4201000, 4201040, 4201068, 4201089, 4201102, 4201103, 4201121, 4201167, 4201218, 4201236, 4201238, 4201253, 4201296, 4201302, 4201366, 4201367, 4201376, 4201385, 4201408, 4201412, 4201442, 4201452, 4201454, 4201477, 4201490, 4201630, 4201661, 4201714, 4201752, 4201829, 4201831, 4201851, 4202009, 4202020, 4202038, 4202044, 4202062, 4202063, 4202122, 4202146, 4202162, 4202175, 4202315, 4202333, 4202626, 4202631, 4202659, 4202729, 4202742, 4202882, 4202987, 4203180, 4203198, 4203289, 4203424, 4203441, 4203649, 4203709, 4203728, 4203730, 4203731, 4203736, 4203807, 4203826, 4204015, 4204164, 4204389, 4204448, 4204539, 4204553, 4204577, 4204673, 4204812, 4204934, 4205093, 4205190, 4205380, 4205426, 4206219, 4206271, 4209023, 4209025, 4209044, 4209045, 4209046, 4209065, 4209066, 4209067, 4209068, 4209071, 4209149, 4209151, 4209155, 4209156, 4209157, 4209162, 4209164, 4209166, 4209167, 4209171, 4209185, 4209189, 4209210, 4209211, 4209213, 4209220, 4209244, 4209250, 4209252, 4209255, 4209256, 4209259, 4209261, 4209262, 4209267, 4209268, 4209271, 4209298, 4209299, 4209303, 4209304, 4209306, 4209308, 4209312, 4209317, 4209318, 4209345, 4209346, 4209357, 4209360, 4209363, 4209364, 4209365, 4209387, 4209388, 4209389, 4209398, 4209441, 4209443, 4209460, 4209463, 4209464, 4209466, 4209471, 4209472, 4209473, 4209474, 4209475, 4209476, 4209477, 4209486, 4209487, 4209491, 4209493, 4209494, 4209495, 4209496, 4209500, 4209519, 4209522, 4209526, 4209529, 4209531, 4209532, 4209533, 4209535, 4209541, 4209542, 4209543, 4209546, 4209597, 4209598, 4209599, 4209600, 4209601, 4209602, 4209604, 4209605, 4209606, 4209607, 4209608, 4209609, 4209610, 4209611, 4209612, 4209613, 4209614, 4209615, 4209616, 4209621, 4209628, 4209632, 4209634, 4209635, 4209637, 4209639, 4209640, 4209647, 4209667, 4209671, 4209685, 4209694, 4209698, 4209734, 4209764, 4209771, 4209774, 4209775, 4209776, 4209777, 4209778, 4209779, 4209780, 4209781, 4209782, 4209783, 4209784, 4209785, 4209786, 4209787, 4209788, 4209789, 4209790, 4209791, 4209792, 4209793, 4209794, 4209795, 4209796, 4209797, 4209798, 4209799, 4209800, 4209801, 4209802, 4209803, 4209804, 4209805, 4209806, 4209807, 4209808, 4209809, 4209810, 4209811, 4209812, 4209813, 4209814, 4209815, 4209816, 4209817, 4209818, 4209819, 4209820, 4209821, 4209822, 4209823, 4209834, 4209849, 4209859, 4209860, 4209863, 4209927, 4209928, 4209929, 4209930, 4209931, 4209932, 4209933, 4209934, 4209935, 4209936, 4209937, 4209938, 4209939, 4209940, 4209941, 4209942, 4209943, 4209945, 4209946, 4209947, 4209948, 4209949, 4209950, 4209951, 4209952, 4209954, 4209955, 4209956, 4209957, 4209959, 4209960, 4209961, 4209962, 4209963, 4209964, 4209965, 4209966, 4209967, 4209968, 4209969, 4209985, 4209986, 4209987, 4209988  Updated information submitted: Serial numbers removed from 12/23/20 letter: 4200112, 4200117, 4200202, 4201412, 4201490, 4201661; reason: These devices are still in scope and exhibit the issue. However, it was found that none of these devices were distributed to a customer. Therefore, they were removed from the attachment in the letter and are within Stryker control.  Serial Numbers added to the recall letter: 4209292, 4209646, 4209841, 4202629, 4203963; reason: These devices were originally thought to be in Stryker control, but were shipped to customers.   Serial Numbers added to the recall letter: 4209917, 4209922, 4209924; reason: These devices were shipped to Stryker OUS distributor and were thought to be distributed to customers. (Firm later confirmed that the units are under Stryker control.)
Recalling firm:
Mako Surgical Corporation
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 23, 2020

Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-055-01

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

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-0068-2021
Lot/product code:
MET100201, MET100401 EXP 05/2022
Recalling firm:
Nostrum Laboratories Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 23, 2020

Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-056-01

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

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-0067-2021
Lot/product code:
MET200101, MET200301 EXP 05/2022
Recalling firm:
Nostrum Laboratories Inc
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled October 27, 2020

Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473 mL) NDC 52376-021-02; b) 4 fl oz (118 mL) NDC 52376-021-04, Sunstar Americas, Inc.

Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata.

ALL 50 STATES
Full report

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

Recall #:
D-0103-2021
Lot/product code:
Lot #: a) C170FY, C170FZ, C170GA, C170GB, C170GC, C177GP, C177GQ, C177GR, Exp 6/30/2022; C191KS, C191KT, C191KU, C191KW, C191KX, C191KY, C198LJ, C198LK, C198LL, C198LM, C205BH, C205BJ, C205BK, C205BL, C205BM, C205BN, Exp 7/31/2022; C219DK, C219DL, C219DM, C219DN, C219DP, C219DQ, C219DR, C219DS, Exp 8/31/2022; C240GM, C240GP, C240GQ, C240GR, Exp 9/30/2022; b) C191KR, Exp 7/31/2020
Recalling firm:
Sunstar Americas, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 29, 2020

MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.

Control lots may not meet stability criteria and could result in increased results of patient samples for cortisone.

ALL 50 STATES
Full report

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

Recall #:
86699
Lot/product code:
Order No. 0349, Lot No. 3219 (Expiration 08/01/2021) and Lot No. 1020 (Expiration 03/01/2022)
Recalling firm:
Chromsystems Instruments & Chemicals GmbH
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 29, 2020

MassChrom Cortisol, Cortisone Saliva Control Level II, Order No. 0350 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.

Control lots may not meet stability criteria and could result in increased results of patient samples for cortisone.

ALL 50 STATES
Full report

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

Recall #:
86699
Lot/product code:
Order No. 0350, Lot No. 3219 (Expiration 08/01/2021) and Lot No. 1020 (Expiration 03/01/2022)
Recalling firm:
Chromsystems Instruments & Chemicals GmbH
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 29, 2020

6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.

Calibrator lots may not meet stability criteria and could result in increased results of patient samples for cortisone.

ALL 50 STATES
Full report

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

Recall #:
86699
Lot/product code:
Order No. 73039, Lot 3219 (expiration 08/01/2021) and Lot 1020 (Expiration 03/01/2022)
Recalling firm:
Chromsystems Instruments & Chemicals GmbH
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 30, 2020

Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022

Potential for a false-negative result.

ALL 50 STATES
Full report

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

Recall #:
88137
Lot/product code:
041520022A, 061920022A, and 081120022A
Recalling firm:
Luminex Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 30, 2020

Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018

Potential for a false-negative result.

ALL 50 STATES
Full report

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

Recall #:
88137
Lot/product code:
030620018A, 031420018A, 032020018A, 040120018A, 041020018B, 041720018B, 042420018A, 043020018A, 050220018A, 050720018A, 050920018A, 051320018A, 051420018A, 051520018A, 052020018A,052120018A, 052920018A, 060220018A, 060920018A, 061020018A, 061620018A, 061920018D, 062020018A, 062620018A, 063020018A, 070720018A, 071620018A, 072320018A, 073020018A, 080520018A, 082020018A, 082520018A, 082820018A, and 090120018A
Recalling firm:
Luminex Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 30, 2020

Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023

Potential for a false-negative result.

ALL 50 STATES
Full report

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

Recall #:
88137
Lot/product code:
030420023A, 031720023A, 032520023A, 040820023B, 041520023B, 042220023B, 042820023A, 050120023A, 050620023B, 050820023B, 052720023A, 052820023A, 060420023A, 060620023A, 061120023A, 061820023A, 062520023A, 062720023A, 070220023A, 070920023A, 071420023A, 071720023A, 072820023A, 080420023A, and 090920023A
Recalling firm:
Luminex Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 30, 2020

Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021

Potential for a false-negative result.

ALL 50 STATES
Full report

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

Recall #:
88137
Lot/product code:
030320021B, 031220021A, 032720021B, 040820021A, 041020021A, 041720021A, 042220021A, 042920021A, 050520021A, 051220021A, 051920021A, 053020021A, 060520021A, 061220021A, 061720021A, 070120021A, 072420021A, 081820021B, and 082620021A
Recalling firm:
Luminex Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 30, 2020

Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024

Potential for a false-negative result.

ALL 50 STATES
Full report

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

Recall #:
88137
Lot/product code:
030520024A, 030720024A, 031020024A, 031120024A, 031320024A, 031620024C, 031820024A, 031920024A, 032120024A, 032320024A, 032420024A, 032620024A, 033120024A, 040220024A, 040320024A, 040420024A, 040620024A, 040720024A, 040920024A, 041120024A, 041420024A, 041620024A, 041820024A, 042020024A, 042120024A, 042320024A, 042520024A, 060320024A, 061320024A, 062320024A, 070820024A, 071020024A, 072120024A, 072920024A, 080720024A, 081920024A and 091120024A
Recalling firm:
Luminex Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 30, 2020

Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model Number: 20-006-026

Potential for a false-negative result.

ALL 50 STATES
Full report

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

Recall #:
88137
Lot/product code:
050620026A and 072120026B,
Recalling firm:
Luminex Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 2, 2020

Philips Respironics V60 Ventilator Part Number 1076709 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.

ALL 50 STATES
Full report

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

Recall #:
86697
Lot/product code:
Model: V60 Part Number: 1076709 V60 Ventilator, JAPAN OPT: CFLEX,AVAPS,AT+  Serial Numbers: 100058561 100058562 100058565 100058572 100058573 100058574 100058576 100058835 100058840 100058844 100058845 100058846 100058902 100058903 100058904 100058905 100058906 100058908 100058911 100058914 100058917 100058968 100058970 100058971 100058975 100058977 100058990 100058991 100058994 100058997 100058999 100059002 100059149 100059153 100059163 100059239 100059248 100060123 100060124 100060214 100060215 100060216 100060219 100060220 100060222 100060229 100060232 100060234 100060236 100060239 100060328 100060329 100060330 100060331 100060339 100060340 100060341 100060344 100060345 100060346 100060347 100060388 100060389 100060398 100060400 100060402 100060404 100060406 100060407 100060409 100060410 100060416 100060476 100060483 100060484 100060486 100060487 100060488 100060490 100060491 100060492 100060494 100060496 100064705 100064706 100064707 100064710 100064712 100064830 100064837 100065342 100065346 100065347 100065351 100065353 100065354 100065355 100065356 100065358 100065359 100065360 100065361 100065362 100067432 100067443 100067445 100067447 100067449 100067536 100068184 100068356 100068357 100069968 100070232 100070233 100070234 100070236 100070305 100070307 100070308 100070309 100070396 100070397 100070399 100070400 100070401 100070403 100070404 100070405 100070406 100070407 100070410 100070411 100070412 100070475 100070478 100070479 100070481 100070483 100070485 100070486 100070488 100070489 100070490 100070493 100070495 100070769 100070773 100070775 100070779 100070782 100070856 100070857 100070934 100070970 100070978 100071069 100071076 100071384 100071385 100071387 100071389 100071391 100071392 100071398 100072410 100072411 100072413 100072493 100072593 100072600 100072602 100072603 100072604 100072608 100072675 100072680 100072689 100072694 100074196 100074198 100074204 100074205 100074208 100075092 100075093 100075094 100075097 100075098 100075102 100075103 100075105 100075106 100075165 100075166 100075167 100075168 100075169 100075170 100075171 100075172 100075173 100075174 100075175 100075176 100075177 100075178 100075179 100075180 100075181 100075182 100075183 100075184 100075185 100075186 100075187 100075188 100075294 100075296 100075297 100075298 100075299 100075300 100075301 100075302 100075303 100075304 100075307 100075308 100075309 100075367 100075368 100075372 100075373 100075375 100075377 100075379 100075380 100075382 100078057 100078058 100078059 100078122 100078130 100078131 100078133 100078134 100078135 100078136 100078137 100078138 100078139 100078141 100078142 100078143 100078144 100078146 100078147 100078148 100078149 100078150 100078151 100078152 100078153 100078154 100078155 100078260 100078261 100078262 100078263 100078264 100078265 100078267 100078268 100078270 100078271 100078272 100078273 100078274 100078275 100078276 100078299 100078300 100078301 100078303 100078304 100078305 100078306 100078307 100078308 100078310 100078311 100078312 100078314 100078315 100078316 100078317 100078361 100078363 100078373 100078375 100078376 100078377 100078378 100078380 100078381 100079713 100080234 100080235 100080238 100080270 100080272 100080273 100080274 100080278 100080279 100080280 100080283 100080284 100080287 100080288 100080293 100080296 100080538 100080539 100080646 100080648 100080655 100080703 100080705 100080707 100080710 100080715 100080719 100080720 100080730 100080732 100080735 100080737 100080851 100083533 100083565 100083602 100083812 100083814 100083818 100083826 100083827 100083829 100084956 100084958 100084959 100085081 100085083 100085088 100085091 100085094 100085096 100085097 100085098 100085251 100085335 100085341 100085382 100085384 100085390 100085391 100085392 100085393 100085394 100085396 100085400 100085402 100085403 100085404 100085489 100086237 100086889 100086895 100086899 100086903 100087014 100087015 100087018 100087024 100087026 100087030 100087031 100087048 100087051 100087055 100087056 100087160 100087341 100087355 100087359 100087461 100087467 100087469 100087476 100087480 100087481 100087483 100087486 100087601 100087605 100087610 100087615 100087686 100087690 100087694 100087700 100090529 100090530 100090533 100090534 100090535 100090537 100090538 100090539 100090540 100090541 100090542 100090543 100090544 100090546 100090548 100090549 100090551 100090554 100090555 100090556 100090653 100090655 100090656 100090657 100090659 100090660 100090661 100090662 100090663 100090664 100090666 100090669 100090671 100090673 100090675 100090676 100090678 100090679 100090783 100090785 100090790 100090791 100090795 100090802 100090806 100090807 100090912 100090913 100090915 100090918 100090920 100091021 100091261 100091273 100091377 100091378 100091379 100091394 100091397 100091399 100091403 100091720 100091722 100091723 100091724 100091726 100091728 100091729 100091730 100091732 100091735 100091737 100091738 100091739 100091743 100091745 100091818 100091841 10009184… (truncated, 37611 characters total — see the official FDA record for the full value)
Recalling firm:
Respironics California, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 2, 2020

Philips Respironics V680 Ventilator Part Number 850011 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.

ALL 50 STATES
Full report

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

Recall #:
86697
Lot/product code:
Model: V680 Part Number: 850011 V680 Ventilator, Finished  Serial Numbers: 201009427 201009428 201009429 201009493 201009494 201009495 201009496 201009498 201009499 201009660 201009661 201009662 201009663 201009664 201009665 201009666 201009667 201009668 201009669 201009670 201009671 201009672 201009673 201009675 201009676 201009677 201009678 201009679 201009674 201008743 201008765 201008766 201008770 201008771 201008776 201008785 201008786 201008805 201009497 201008801 201008741 201008744 201008760 201008764 201008767 201008768 201008772 201008775 201008783 201008808 201008762 201008773 201008781 201008809 201008807 100124645 100124646 100125009 100125011 100125012 100125013 100125014 100125148 100125149 100125150 100125152 100125153 100125154 100125155 201008740 201008742 201008774 201008777 201008802 201008804 100125541 100125544 201008780 201008800 201008803 100125504 100125505 100125509 100125512 100125542 100125545 100125550 100125551 100125552 201008784 100125508 100125546 100125549 100125010 100125516 100125517 100125151 100125515 100125547 201008782 100125513 100125510 100129145 201010488 201010551 201010627 100129141 100129142 100129143 201010254 201010535 201010546 201010674 100126254 100129144 100134076 201010428 201010482 201010490 201010536 201010548 201010620 201010622 201010675 100125518 100129147 100134077 201010255 201010360 201010434 201010485 201010538 201010623 201011218 100125553 100129146 100129148 100134073 100134074 100134075 100134078 100134079 100134180 100134181 100134182 100134183 201010251 201010252 201010256 201010257 201010258 201010259 201010426 201010427 201010429 201010430 201010438 201010484 201010491 201010537 201010539 201010540 201010544 201010545 201010547 201010550 201010552 201010553 201010624 201010625 201010626 201011216 201011217 201011220 100134184 201010439 201010483 100134337 100135409 100125543 100134335 100135396 100135398 100135400 100135401 100135402 100135404 100135405 100135406 100135407 100135631 100135633 100135634 100135635 100135636 100135638 100135639 100135630 100135637 100135642 100135644 100135650 201011219 100135640 100135641 100135643 100135647 100135652 100135397 100135645 100135646 100135648 100135649 100135651 100135653 100135654 100135655 100137426 100137427 100137428 100137429 100137430 100137431 100137433 100137434 100137436 100137437 100137438 100137439 100137440 100137444 100137446 100137447 100137448 100137449 100137450 100138009 100138010 100138011 100138012 100138016 100138017 100138018 100138019 100138508 100138510 100135403 100135632 100137435 100137442 100137443 100137445 100138013  100138080 100138082 100138507 100137432 100137441 100138008 100138081 100138083 100138086 100138087 100138503 100138512 100138513 100138514 100138515 100138522 100138084 100138085 100138509 100138511 100138517 100138518 100138519 100138520 100138521 100138705 100138707 100138814 100138816 100138818 100138943 100139067  100138506 100138516    100138819 100138940 100138941 100138942 100139064 100139066 100139068 100139069 100139070 100139071 100139074 100139075 100139077 100139078 100139079 100139080 100139082 100139083 100139084 100139087 100140238 100140239 100140300 100140301 100140302 100140303 100140304 100140305 100140310 100140311 201012739 201013230 201013231 100139076 100139081 100139088 100140308 100140315 100140317 201012733 201012735  201013213 201013220 201013221 201013224 201013225 201013226 201013228 201013229 100138504 100139072 100139085 100140312 100140314 100140316 201012732 201012734 201012736 201013209 201013210 201013211 201013212 201013215 201013223 201013227 201013233 201013234 201013235 100139065 100139073 100140309 201012738 201013214 201013236 100139086 100140306 100140313 100142426 100142428 100142429 100142431 100142432 100142434 100142437 100142460 201013217 201013218 201013219 201013222 100135399 100135408     100142637 100142427 100142436 100142438 201013216 201013232 100142634 100142435 100142638 100142640 100142641 100142635 100142636 100142642 201013271 201013272 201013275 201013273 201013276 201013279 201013720 201013725 201013747 100142639 201013274 201013277 201014176 201014178 201014179 201014182 201014183 201014211 201014213 201013713 201013717 201013749 201013887 201014185 201014214 201013890 201014177 201014181 201014184 201014196 201014198 201014199 201014215 201014216 201014217 201014218 201014219 201013709 201013710 201013711 201013712 201013714 201013715 201013716 201013724 201013744 201013748 201013750 201013753 201013888 201013889 201013891 201013893 201014197 201014340 201014180 201014324 201014342 201014388 201014195 100146372 100146374 201014322 201014323 201014326 201014328 201014386 100146369 100146370 100146371 100146373 100146873 201014321 201014325 201014327 201014341 201014343 201014344 100147209 100146442 100146875 100146375 100146876 100147212 201014544 100147217 201014534 201014536 201014542 201014600 201014538 100147215 100146376 100146377 100146440 100146443 100146872 100147218 100147300 20101… (truncated, 33981 characters total — see the official FDA record for the full value)
Recalling firm:
Respironics California, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 2, 2020

Philips Respironics V60 Ventilator Part Number 1053616 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.

ALL 50 STATES
Full report

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

Recall #:
86697
Lot/product code:
Model: V60 Part Number: 1053616 V60 Ventilator, English Opt: None Serial Numbers: 100087733 100087738 100087932 100087999 100088155 100004031 100004071 100004073 100005244 100005350 100005351 100005599 100006209 100006210 100006217 100006406 100006701 100006702 100006881 100006883 100006886 100006888 100006891 100006929 100006933 100006939 100006940 100006941 100009417 100009501 100009512 100009513 100009549 100009550 100009553 100009554 100009556 100009566 100009679 100009760 100009761 100009762 100009768 100009769 100009770 100009777 100009812 100009816 100009854 100010206 100010242 100010390 100010514 100010515 100010517 100010519 100011308 100011343 100011344 100011468 100011740 100011741 100011744 100011749 100011750 100011751 100011754 100011791 100011794 100011799 100011801 100011820 100011821 100011822 100011823 100011824 100011825 100011826 100011827 100011828 100011829 100011830 100011831 100012694 100012884 100012887 100012890 100012891 100013021 100013023 100013027 100013032 100013034 100013083 100013667 100013669 100013791 100014073 100014088 100014142 100014147 100014153 100014283 100014286 100015076 100015209 100015213 100015281 100015667 100016078 100016597 100016599 100016736 100016746 100016747 100016749 100017103 100017258 100017287 100017293 100017301 100017302 100019586 100020214 100020215 100020217 100020219 100020220 100020227 100020312 100020314 100020316 100020317 100020445 100020885 100021037 100021042 100021874 100021877 100021968 100023238 100024476 100024484 100025989 100026618 100026620 100026805 100026806 100026807 100026816 100027758 100029842 100029849 100030985 100031674 100033326 100033327 100033328 100033329 100033330 100033332 100033333 100033334 100033335 100033336 100033338 100033339 100033340 100033342 100033454 100034684 100034703 100035358 100035365 100035742 100035744 100035755 100037043 100037044 100037049 100037051 100037057 100037059 100037061 100037257 100038935 100038936 100038939 100040185 100042229 100042475 100043439 100043440 100044800 100044801 100047830 100048873 100049578 100049922 100050003 100050633 100050634 100050638 100050891 100052079 100052289 100052290 100052639 100052645 100053142 100053143 100053337 100053356 100053971 100055007 100056058 100056891 100056894 100058686 100058693 100058698 100063885 100064427 100064431 100064439 100064682 100064684 100064784 100064787 100065219 100066227 100071766 100072295 100079339 100079474 100080118 100080120 100080121 100080122 100080123 100080124 100080126 100080127 100081004 100084640 100091078 100095091 100095180 100095333 100095545 100095633 100095634 100096642 100096690 100096788 100096789 100097541 100097922 100097924 100097926 100097927 100104724 201001172 201001189 201001254 201001255 201001256 201001259 201001260 201001682 201001683 201001696 201001699 201001700 201001720 201001729 201001808 201001812 201001814 201001823 201001825 201001826 201001827 201001829 201001830 201001843 201001849 201001873 201001884 201001939 201001944 201002117 201002148 201002184 201002193 201002426 201002427 201002443 201002445 201002448 201002552 201002566 201002574 201002587 201002770 201002778 201002834 201002868 201002873 201002894 201002899 201002900 201003014 201003145 201003149 201003179 201003183 201003185 201003187 201003216 201003219 201003233 201003238 201003263 201003266 201003268 201003269 201003272 201003273 201006557 Amended 07/29/2021: US Products that Faceplates will be replaced Model: V60 Part Number: 1053616 V60 Ventilator, English Opt: None Serial Numbers: 100004031 100004071 100004073 100005244 100005350 100005351 100005599 100006209 100006210 100006217 100006406 100006701 100006702 100006881 100006883 100006886 100006888 100006891 100006929 100006933 100006939 100006940 100006941 100009417 100009501 100009512 100009513 100009549 100009550 100009553 100009554 100009556 100009566 100009679 100009760 100009761 100009762 100009768 100009769 100009770 100009777 100009812 100009816 100009854 100010206 100010242 100010390 100010514 100010515 100010517 100010519 100011308 100011343 100011344 100011468 100011740 100011741 100011744 100011749 100011750 100011751 100011754 100011791 100011794 100011799 100011801 100011820 100011821 100011822 100011823 100011824 100011825 100011826 100011827 100011828 100011829 100011830 100011831 100012694 100012884 100012887 100012890 100012891 100013021 100013023 100013027 100013032 100013034 100013083 100013667 100013669 100013791 100014073 100014088 100014142 100014147 100014153 100014283 100014286 100015076 100015209 100015213 100015281 100015667 100016078 100016597 100016599 100016736 100016746 100016747 100016749 100017103 100017258 100017287 100017293 100017301 100017302 100019586 100020214 100020215 100020217 100020219 100020220 100020227 100020312 100020314 100020316 100020317 100020445 100020885 100021037 100021042 100021874 100021877 100021968 100023238 100024476 100024484 100025989 100026618 100026620 100026805 100026806 100026807 100026816 100027758 100029842… (truncated, 6780 characters total — see the official FDA record for the full value)
Recalling firm:
Respironics California, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 2, 2020

Philips Respironics V60 Ventilator Part Number 1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.

ALL 50 STATES
Full report

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

Recall #:
86697
Lot/product code:
Model: V60 Part Number: 1053617 V60 Ventilator, English Opt: None Serial Numbers: 201000151 100109977 100090432 100091177 100091771 100092004 100092037 100113859 100008140 100009121 100066005 100067771 100068862 100068864 100068866 100229881 100229933 100229936 100244028 100244036 100244037 100342231 201013345 201030470 201030473 201030478 MX0000810 MX0000813 MX0000825 MX0000828 100002909 100002910 100002912 100002915 100002998 100002999 100003000 100003002 100003004 100003006 100003019 100003040 100003041 100003042 100003043 100003044 100003045 100003047 100003048 100003049 100003050 100003051 100003053 100003080 100003082 100003083 100003084 100003085 100003086 100003087 100003088 100003089 100003090 100003091 100003092 100003148 100003149 100003658 100003659 100003661 100003662 100003663 100003664 100003665 100003666 100003667 100003668 100003669 100003670 100003671 100003672 100003673 100003680 100003681 100003682 100003683 100003684 100003686 100003687 100003688 100003690 100003691 100003692 100003725 100003726 100003727 100003729 100003730 100003731 100003732 100003733 100003734 100003735 100003737 100003738 100003739 100003746 100003747 100003748 100003749 100003750 100003751 100003752 100003753 100003754 100003755 100003756 100003758 100003759 100003760 100003860 100003861 100003862 100003863 100003864 100003901 100003902 100003903 100003904 100003905 100003906 100003907 100003908 100003911 100003912 100003914 100003915 100003917 100004016 100004017 100004018 100004019 100004020 100004021 100004022 100004023 100004024 100004025 100004026 100004027 100004028 100004029 100004030 100004034 100004035 100004072 100004074 100004075 100004076 100004078 100004079 100004080 100004082 100004083 100004084 100004085 100004121 100004126 100004129 100004130 100004132 100004133 100004134 100004135 100004136 100004137 100004138 100004139 100004321 100004541 100004544 100004546 100004551 100004552 100004559 100004980 100004981 100004989 100004990 100004991 100004993 100004996 100004997 100004998 100005100 100005101 100005102 100005103 100005104 100005105 100005106 100005107 100005108 100005109 100005111 100005112 100005113 100005114 100005115 100005118 100005119 100005140 100005142 100005143 100005144 100005145 100005146 100005148 100005149 100005151 100005152 100005153 100005154 100005155 100005156 100005157 100005158 100005159 100005235 100005236 100005237 100005238 100005240 100005243 100005245 100005246 100005248 100005249 100005250 100005252 100005253 100005254 100005325 100005326 100005327 100005328 100005329 100005330 100005331 100005332 100005333 100005335 100005336 100005337 100005339 100005340 100005341 100005342 100005344 100005348 100005349 100005353 100005354 100005355 100005356 100005357 100005358 100005359 100005387 100005389 100005390 100005391 100005393 100005394 100005395 100005396 100005397 100005398 100005399 100005400 100005401 100005402 100005403 100005404 100005405 100005484 100005485 100005487 100005488 100005490 100005492 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100006403 100006404 100006405 100006407 100006408 100006409 100006520 100006521 100006522 100006523 100006524 100006525 100006526 100006527 100006528 100006529 100006530 100006531 100006532 100006533 100006534 100006535 100006536 100006537 100006538 100006539 100006587 100006588 100006589 100006590 100006591 100006592 100006593 100006594 100006595 100006596 100006597 100006598 100006599 100006600 100006601 100006602 100006603 100006604 100006605 100006606 100006687 100006688 100006689 100006690 100006691 100006692 100006693 100006694 100006695 100006696 100006697 100006698 100006699 100006700 100006703 100006705 100006706 100006882 100006885 100006889 100006890 100006894 100006895 100006896 100006897 100006898 100006899 100006900 100006928 100006930 100006931 100006935 100006936 100006937 100006938 100006942 100006943 100006944 100006945 100006946 100006947 100007030 100007031 100007032 100007033 100007034 100007035 100007036 100007037 100007038 100007039 100007040 100007041 100007042 1000070… (truncated, 942803 characters total — see the official FDA record for the full value)
Recalling firm:
Respironics California, LLC
View official FDA record (opens in a new tab)