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Recalls affecting Arizona

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

16,934 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 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)
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)
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 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 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
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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

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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
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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

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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
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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.

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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 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.

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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

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.

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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

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.

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

Potential for a false-negative result.

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

Potential for a false-negative result.

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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
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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.

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

Potential for a false-negative result.

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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.

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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.

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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 Plus Ventilator Part Number 1138747 - 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 Plus Part Number: 1138747 V60 Plus Ventilator, US Serial Numbers: 100360666 100363973 100365901 100365983 100365987 100366525 100366542 100367657 100367660 100367732 100370559 100371789 100371876 100371995 100372119 100372901 100372903 100373102 100373106 100373116 100373117 100374141 100374143 100374149 100374168 100374169 100374171 100374236 100374238 100374283 100374285 100374287 100374291 100374406 100374410 100374453 100374456 100374458 100374459 100376350 100376351 100377022 100377275 100377278 100377304 100377307 100377315 100377334 100378833 100378838 100379236 100379341 100379350 100379351 100379352 100379368 100379432 100379438 100379462 100379465 100380046 100380441 100381016 100381020 100381021 100381023 100381024 100381025 100381029 100381049 100382407 100382409 100382413 100382428 100382429 100382432 100382433 100382436 100382439 100382440 100382446 100382448 100382450 100382454 100382460 100382463 100382468 100382469 100382472 100382479 100382481 100382482 100382486 100382491 100382492 100382494 100382496 100382503 100382507 100382509 100382522 100382526 100382529 100382531 100382547 100382548 100384413 100384416 100384680 100384706 100384707 100384710 100384713 100384715 100384717 100384723 100384732 100384735 100384742 100384743 100384747 100384759 100384763 100385374 100385409 100385416 100385421 100385424 100385432 100385437 100385458 100385499 100386092 100386113 100386133 100386142 100386157 100386161 100386162 100386163 100386180 100386181 100386192 100386194 100386196 100386198 100386199 100386205 100386221 100386226 100389961 100389962 100389964 100389978 100389979 100390065 100392648 100392657 100392800 100392808 100392810 100392811 100392815 100392825 100392826 100392828 100392833 100392838 100392840 100392843 100392848 100392850 100392853 100392854 100392855 100392857 100392861 100392862 100392866 100392870 100392871 100392872 100392873 100392874 100392880 100392881 100392883 100392893 100392895 100392901 100392904 100392910 100393193 100393211 100393214 100393215 100393216 100393217 100393218 100393219 100393491 100393492 100393493 100393541 100393542 100393546 100393548 100393549 100393550 100393551 100393552 100393553 100393554 100393555 100393557 100393558 100393570 100393572 100393573 100393574 100393584 100393585 100393729 100393730 100393733 100393739 100393741 100393742 100393743 100393744 100393745 100393747 100393748 100393750 100395458 100395459 100395480 100395481 100395482 100395483 100395484 100395485 100395486 100395488 100395489 100395490 100395491 100395492 100395493 100395494 100395495 100395496 100395497 100395498 100395499 100395500 100395501 100395502 100395503 100395504 100395505 100395506 100395507 100395509 100395511 100395512 100395513 100395514 100395515 100395517 100395518 100395519 100395520 100395521 100395522 100395523 100395524 100395525 100395526 100395527 100395701 100395702 100395703 100395704 100395705 100395706 100395707 100395708 100395709 100395711 100395713 100395714 100395715 100395716 100395717 100395718 100395719 100395800 100395801 100395802 100395803 100395804 100395805 100395806 100395807 100395808 100395809 100395810 100395994 100395995 100395996 100395997 100395998 100395999 100396000 100396001 100396002 100396003 100396004 100396005 100396006 100396007 100396008 100396009 100396010 100396011 100396012 100396013 100396014 100396015 100396016 100396018 100396019 100396020 100396021 100396022 100396023 100396116 100396117 100396118 100396119 100396121 100396122 100396123 100396124 100396125 100396126 100396127 100396128 100396129 100396130 100396132 100396133 100396134 100396136 100396138 100396139 100396140 100396142 100396144 100396145 100396147 100396148 100396150 100396151 100396152 100396154 100396155 100396156 100396157 100396158 100396159 100396162 100396163 100396164 100396165 100396166 100396167 100396168 100396169 100396170 100396171 100396172 100396173 100396174 100396175 100396176 100396177 100396178 100396521 100396522 100396523 100396524 100396525 100396526 100396528 100396529 100396530 100396531 100396534 100396536 100396537 100396538 100396539 100396563 100396564 100396565 100396566 100396568 100396569 100396570 100396571 100396572 100396573 100396574 100396576 100396577 100396578 100396579 100396587 100396588 100396589 100396591 100396594 100396596 100396597 100396599 100396600 100396601 100396742 100396743 100396744 100396756 100396758 100396759 100396760 100396761 100396762 100396763 100367642 100372347 100374144 100374170 100374457 100374460 100377281 100377293 100377305 100377310 100377311 100377314 100377316 100377324 100377327 100377329 100377330 100377331 100377332 100377336 100377337 100381027 100382403 100382408 100382431 100382434 100382435 100382441 100382442 100382443 100382444 100382445 100382447 100382477 100382515 100382524 100382525 100382527 100382535 100382536 100382538 100382539 100382543 100382546 100384517 100384518 100384748 100385393 100385399 100385403 100385411 100385412 100385414 10… (truncated, 50200 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 Plus Ventilator Part Number 1137276 - 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 Plus Part Number: 1137276 V60 Plus Ventilator, International  Serial Numbers: 100341890 100341897 100343602 100343674 100345138 100345145 100345148 100352752 100352754 100354448 100354454 100354464 100354470 100354838 100354875 100357792 100358141 100358158 100358355 100359515 100381237 100381430 100381436 100381765 100381835 100381850 100384222 100384818 100384821 100384875 100384878 100384903 100387138 100387261 100387407 100387412 100387557 100387860 100387941 100387953 100388063 100388068 100388092 100388630 100388634 100388640 100388641 100388649 100388676 201040204 201040216 100345306 100345307 100346866 100346876 100346889 100346894 100346895 100346896 100346898 100346901 100346907 100346908 100346909 100346910 100346911 100346913 100348081 100348085 100348140 100348146 100352062 100355386 100355900 100355923 100356012 100356258 100356302 100356303 100360343 100360364 100360378 100361206 100361563 100361576 100362006 100362051 100364563 100369571 100369619 100369692 100369705 100369912 100375136 100375594 100375911 100375912 100378897 100378926 100378928 100378931 100378932 100378934 100378937 100297858 100298767 100298799 100298928 100298929 100300520 100302008 100302012 100304689 100304697 100304701 100305136 100305821 100306638 100309643 100310997 100311467 100311473 100311480 100314877 100320637 100327540 100327543 100327548 100336899 100337246 100346856 100346858 100348113 100348114 100348445 100350151 100350153 100352753 100352806 100352809 100352829 100354067 100354070 100354076 100354458 100354867 100355162 100355880 100355911 100355917 100355920 100356279 100358146 100359620 100359623 100360200 100361432 100361971 100362036 100362065 100362515 100362567 100362728 100363719 100363755 100363759 100363798 100364540 100365111 100365141 100365653 100367161 100368606 100371204 100371644 100376389 100378064 100378069 100378077 100378215 100378278 100378301 100378302 100378305 100378538 100378665 100378679 100378680 100378681 100378686 100378993 100379006 100380659 100380822 100380929 100380930 100380964 100380995 100381265 100381726 100381768 100381822 100381823 100381826 100381829 100381830 100381832 100381840 100381841 100381843 100381844 100381845 100381848 100381856 100381901 100381906 100381908 100381911 100381912 100381923 100381924 100381928 100381930 100382181 100382190 100384081 100385057 100385165 100385304 100385305 100388680 201040139 201040199 201040202 201040206 201040208 201040210 201040213 201040214 201040311 201040314 201040327 100342965 100343117 100345137 100345591 100345624 100346213 100346218 100346249 100346261 201038743 100381339 100381905 100383913 100384289 100384873 100385163 100390089 100297860 100357138 100298655 100298659 100321724 100321729 100321905 100322861 100322870 100322890 100322896 100322897 100322901 100322902 100353273 100355396 100355670 100355878 100355890 100355895 100355926 100357131 100357731 100357749 100357770 100358145 100358148 100358312 100358341 100348173 100348175 100348176 100348178 100348440 100351489 100351490 100351495 100351497 100351546 100351553 100359604 100359767 100359949 100289710 100290611 100290612 100290642 100290646 100309491 100309492 100309578 100309641 100309646 100309733 100309736 100309738 100309820 100309823 100318609 100318616 100320638 100321702 100321714 100321720 100321796 100322865 100322879 100322884 100322886 100322887 100325103 100325104 100325108 100325117 100325118 100325260 100341866 100341896 100341904 100341908 100341997 100342528 100342896 100342956 100343113 100343120 100343151 100343158 100343162 100343524 100343544 100343568 100343622 100343700 100344208 100344215 100344219 100344370 100344662 100344668 100344670 100344677 100344679 100344680 100344685 100344686 100344689 100344690 100344969 100344970 100344972 100344973 100344975 100345116 100345122 100345140 100345142 100345143 100345144 100345146 100345147 100345151 100345153 100345154 100345303 100345308 100345312 100345339 100345342 100345345 100345518 100345564 100345566 100345570 100345571 100345573 100345581 100345583 100345608 100346257 100346275 100346277 100346297 100346300 100346302 100346304 100346309 100346318 100346321 100346328 100346330 100346331 100346853 100346875 100348128 100348131 100348145 100348147 100348443 100350134 100350663 100350677 100350712 100350715 100350723 100350725 100350935 100351349 100351350 100351356 100351487 100351492 100351496 100351563 100351564 100351570 100351573 100351577 100351581 100351585 100351707 100351709 100351711 100351713 100351715 100351716 100351718 100351719 100351723 100351730 100351732 100351733 100351858 100352040 100352041 100352043 100352046 100352047 100352048 100352049 100352050 100352051 100352052 100352057 100352061 100352066 100352072 100352074 100352075 100352076 100352077 100352078 100352087 100352091 100352092 100352094 100352102 100352105 100352109 100352111 100352116 100352120 100352121 100352747 100352756 100352758 100352803 100352815 100352816 100353242 100353245 100353274 1… (truncated, 38498 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 1076717 - 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: 1076717 V60 Ventilator, CHINA OPT: NONE  Serial Numbers: 100033299 100033300 100033301 100033302 100033303 100033304 100033305 100033306 100033308 100033309 100033310 100033311 100033312 100033313 100033314 100033315 100033316 100033317 100033318 100033319 100033320 100033321 100033322 100033323 100033562 100033563 100033564 100033565 100033566 100033567 100033568 100033569 100033570 100033571 100033572 100033573 100033574 100033575 100033576 100033577 100033578 100033579 100033580 100033581 100033582 100033583 100033584 100033585 100033586 100033587 100033588 100033589 100033590 100033591 100033592 100033593 100033594 100033595 100033645 100033646 100033647 100033648 100033649 100033650 100033651 100033652 100033653 100033654 100033730 100033731 100033732 100033733 100033734 100033735 100033736 100033737 100033738 100033739 100033740 100033741 100033742 100033743 100033744 100033745 100033746 100033747 100033748 100033749 100033750 100033751 100033752 100033753 100033754 100033756 100033757 100033758 100033759 100033762 100033894 100033897 100033898 100033910 100033912 100034502 100034503 100034504 100034505 100034506 100034507 100034508 100034509 100034510 100034511 100034512 100034513 100034514 100034515 100034516 100034517 100034518 100034520 100034521 100034522 100034523 100035774 100035775 100035776 100035777 100035905 100035906 100035908 100035916 100035917 100035920 100035921 100035922 100035923 100035924 100035925 100035927 100035928 100036020 100036021 100036022 100036038 100036039 100036040 100036041 100036042 100036043 100036044 100036045 100036046 100036089 100036090 100036091 100036092 100036093 100036095 100036135 100036136 100036137 100036138 100036139 100036140 100036141 100036142 100036144 100036145 100036146 100036148 100036149 100061636 100061639 201002856 201002857 201002858 201002859 201002920 201002921 201002922 201002923 201002924 201002925 201002926 201002927 201002928 201002929 201002930 201002931 201002932 201002933 201002934 201002935 201002936 201002938 201002939 201002940 201002941 201002942 201002960 201002961 201002962 201002963 201002964 201002965 201002968 201002969 201002970 201002971 201002972 201002973 201002974 201002975 201002983 201004069
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 1053618 - 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: 1053618 V60 Ventilator, Japan Opt: CFLEX,AVAPS  Serial Numbers: 100019618 100019631 100019639 100019822 100019823 100019824 100019827 100019838 100019917 100019920 100019922 100019924 100019965 100019966 100019967 100019971 100019972 100020663 100020664 100020665 100020666 100022148 100023892 100023893 100023894 100023896 100023897 100023899 100023905 100023909 100023940 100023941 100023944 100023956 100023995 100023998 100024000 100024003 100024007 100024008 100024688 100025546 100025549 100026087 100026088 100026089 100026090 100026092 100026095 100026124 100027090 100027095 100027100 100027101 100027108 100027114 100027174 100027176 100027181 100027185 100027191 100027199 100027200 100027543 100027546 100027547 100027548 100027550 100027552 100030134 100030201 100030203 100030205 100030206 100030211 100030355 100031913 100031917 100031921 100031937 100031941 100031942 100032336 100032337 100032338 100032339 100032340 100032341 100032343 100032344 100032345 100032346 100032347 100032348 100032349 100032350 100032351 100032352 100032355 100032356 100032357 100032358 100032359 100032360 100032361 100032362 100032363 100032364 100032365 100032463 100033755 100033760 100033763 100033884 100033886 100033888 100033890 100033891 100033892 100033893 100033896 100033899 100033901 100033902 100033903 100033907 100033908 100033909 100033911 100035915 100036162 100036304 100036305 100038186 100038206 100039145 100039146 100039151 100039154 100039156 100039157 100039158 100039159 100039160 100039162 100039165 100039166 100039169 100039171 100039242 100039243 100039246 100039251 100039253 100039255 100039256 100039257 100039258 100039259 100039260 100039262 100039263 100039264 100039265 100039266 100039267 100039269 100039945 100043931 100043934 100043935 100043937 100043944 100043945 100043949 100043955 100043956 100043958 100044057 100044058 100044063 100044067 100044068 100044069 100044070 100044072 100044085 100044192 100044202 100044204 100044206 100044208 100044334 100044336 100044337 100044338 100044339 100044340 100044343 100044344 100044345 100044346 100044351 100044353 100046137 100046147 100046223 100046225 100046226 100046227 100046228 100046229 100046230 100046231 100046236 100046237 100046238 100046240 100046243 100046244 100046246 100046255 100046256 100046390 100046394 100046395 100046397 100046400 100046409 100046411 100046532 100046534 100046536 100046539 100046540 100046548 100046550 100046552 100046553 100046555 100046557 100046560 100046562 100046563 100046648 100046650 100046651 100046652 100046653 100046654 100046655 100046656 100046718 100046719 100046720 100046722 100046723 100046724 100046725 100046726 100046727 100046729 100046730 100046735 100046736 100046738 100046739 100046743 100046896 100046927 100046928 100047065 100050074 100050077 100050079 100050083 100050084 100050085 100050087 100050088 100050089 100050092 100050093 100050094 100050096 100050098 100050099 100050100 100050101 100050102 100050176 100050199 100050200 100050206 100050208 100050211 100050214 100050216 100050217 100050349 100050353 100050355 100050356 100050357 100050358 100050359 100050360 100050361 100050366 100050371 100050374 100050375 100050376 100050377 100050379 100050380 100050381 100050464 100050466 100050467 100050468 100050510 100050511 100050518 100052745 100052748 100052750 100052753 100053586 100053694 100053697 100053779 100053782 100053783 100053784 100054411 100054412 100054413 100054416 100054417 100054418 100054419 100054420 100054421 100054423 100054525 100054532 100054534 100054620 100054622 100054625 100054627 100054629 100054630 100054631 100054632 100054633 100054634 100054635 100054636 100054735 100054737 100054739 100054740 100054741 100054742 100054743 100054744 100054745 100054746 100054748 100054750 100054751 100054752 100054753 100054755 100054757 100054813 100054814 100054825 100055258 100055259 100055261 100055262 100055263 100055264 100055266 100055267 100055271 100055272 100055352 100055353 100055355 100055358 100055369 100055370 100055552 100055558 100055559 100055560 100055561 100055563 100055564 100055565 100055566 100055567 100055569 100055570 100055572 100055575 100055576 100055577 100055702 100055712 100055713 100055714 100055715 100055716 100055718 100057203 100057216 100057356 201001557 201001558 201001559 201001560 201001561 201001564 201001569 201001579 201001855 201001856 201001859 201001861 201001866 201001867 201001869 201001990 201001992 201001997 201002040 201002043 201002045 201002046 201002047 201002048 201002178 201002179 201002221 201002222 201002226 201002228 201002230 201002293 201002294 201002299 201002300 201002305 201002331 201002333 201002334 201002335 201002336 201002337 201002342 201002345 201002346 201002347 201002348 201002349 201002350 201002352 201002353 201002542 201002543 201002919 201003041 201003063 201003065 201003073 201003075 201003077 201003079 201003087 201003091 201003094 201003096 201003098 201003099 201003100 201003101 20… (truncated, 5427 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)