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Recalls affecting Michigan

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

17,045 recalls found
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Just announced

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

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

Products contain undeclared yohimbine

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Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

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

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

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

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

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

Presence of particulate matter identified as iron oxide

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Drugs

Recalling firm: B. Braun Medical Inc.

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

Company contact: recalls@bbraunusa.com

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

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

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Food & BeveragesFoodborne Illness

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

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

Company contact: Info.foodsafety@comfrut.com

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

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

Presence of particulate matter and lack of sterility assurance

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Food & Beverages

Recalling firm: American Regent, Inc.

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

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

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

Undeclared milk

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Food & BeveragesAllergens

Recalling firm: Crystal Temptations

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

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

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

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Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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

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

Contains garlic essential oil not approved for culinary use

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Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

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

Everything Sprouts — Robust Radish Mix, 5oz Cups

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

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Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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

Martina — Mangoes

Potential contamination with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

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

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled September 8, 2021

Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65

The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference.

ALL 50 STATES
▸Full report

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

Recall #:
88651
Lot/product code:
All lots
Recalling firm:
Datascope Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 8, 2021

Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one battery is installed in the IABP, and the battery is physically removed while the battery is being charged. This occurs during a very specific set of conditions.

ALL 50 STATES
▸Full report

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

Recall #:
88664
Lot/product code:
All lots
Recalling firm:
Datascope Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 8, 2021

Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65

The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one battery is installed in the IABP, and the battery is physically removed while the battery is being charged. This occurs during a very specific set of conditions.

ALL 50 STATES
▸Full report

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

Recall #:
88664
Lot/product code:
All lots
Recalling firm:
Datascope Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 8, 2021

BD Nexiva, 20 GA 1.00 IN (1.1 X 25 mm), 3660 ml/hr. 61ml/min; Closed IV Catheter System- Dual port -61 mL/min (3660 mL/hr)-0.5mL, REF 383536; BD Q-Style Luer Access Split Septum BD Vialon Material; BD Instaflash Needle Technology; Rx Only, Sterile EO. BD Nexiva closed IV catheter systems are over-the-needle, intravascular catheters. These devices have a radiopaque BD Vialon" catheter, needle, needle shield, septum, stabilization platform, integrated extension tubing, clamp, dual port adapter, vent plug and pre-attached BD Q-Syte Luer Access Split Septum. The needle and catheter are protected by a needle cover. A BD Q-Syte device or an end cap with protective cover is provided in the unit package. The closed system is designed to keep blood contained within the device throughout the insertion process. The septum is designed to wipe visible blood from the needle surface as the needle is withdrawn from the catheter, further reducing the risk of blood exposure. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needlestick injury. These devices have BD Instaflash" Needle Technology, allowing for immediate visualization of blood along the catheter. Continuous blood return is seen in the extension tubing. The vent plug prevents blood leakage from the extension tubing during insertion. Both the stabilization platform and dual port adapter are color coded to indicate catheter gauge size (24GA (0.7 mm)=Yellow, 22GA (0.9 mm)=Blue, 20GA (1.1 mm)=Pink, 18GA (1.3 mm)=Green). BD Nexiva closed IV catheter systems are intended to be inserted into a patient s vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when access ports not suitable for use with power injectors are removed.

There is a breach in the product packaging that renders the product non-sterile.

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

Recall #:
88762
Lot/product code:
Catalog number/Model number: 383536; Batch numbers/UDI numbers: Lot: 1193055/(17)240630(10)1193055(30)80/(01)50382903835367, 2024-06-30;  Lot: 1166273: (17)240630(10)1166273(30)80/(01)50382903835367, 2024-06-30 Lot: 1166273: (17)240630(10)1166273(30)80/(01)50382903835367, 2024-06-30 Lot: 1188953: (17)240630(10)1188953(30)80/(01)50382903835367, 2024-06-30
Recalling firm:
Becton Dickinson Infusion Therapy Systems Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 8, 2021

Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference.

ALL 50 STATES
▸Full report

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

Recall #:
88651
Lot/product code:
All lots
Recalling firm:
Datascope Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 8, 2021

Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. This kit is designed for use with CryoTip (Catalog #40709), and Vitrification Thaw Kit (Vit Kit-Thaw) for optimal recovery of specimens. Vitrification Freeze kit (which includes the VS Vitrification Solution) are cryopreservation media intended for use in the vitrification of oocytes (MII) and pronuclear (PN) zygotes, cleavage stage embryos, and blastocyst stage embryos. Catalog numbers: 90133-DCOS Vitrification Freeze kit, contained 9x1 mL. Vitrification solution, VS, Catalog #90132. Product form: Liquid. Equilibration Solution-ES is a HEPES buffered solution of Medium-199 containing gentamicin sulfate, 7.5% (v/v) of each DMSO and ethylene glycol and 20% (v/v) Dextran Serum Supplement (DSS). Vitrification Solution-VS is a HEPES buffered solution of Medium-199 containing gentamicin sulfate, 15% (v/v) of each DMSO and ethylene glycol, 20% (v/v) DSS and 0.5 M sucrose. DSS is a protein supplement consisting of 50 mg/mL therapeutic grade Human Serum Albumin (HSA) and 20 mg/mL Dextran. DSS is used at 20% (v/v) in Vit Kit-Freeze for a final concentration of 10 mg/mL HSA and 4 mg/mL Dextran. These two solutions are to be used in sequence according to the step-wise microdrop vitrification protocol. Vitrification Solution-VS Aseptically filtered. Test results reported on C of A Vit Kit -Freeze (Vitrification Freeze Kit) with Gentamycin and DSS Contains 9 x 1 mL Equilibration Solution- ES; 9 X 1 mL Vitrification Solution-VS ...90133-DCOS...RX Only...Sterile ...20YY-MM-DD

Due to a component in kit being labeled with the incorrect Expiration Date

ALL 50 STATES
▸Full report

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

Recall #:
88720
Lot/product code:
Catalog number: 90133-DSOC Kit- Vitrification Freeze kit: Which contained VS Vitrification solution, Lot/Unit numbers: 90132210403; UDI # 00893727002811; 9 x1 mL Vitrification Solution, VS, Catalog #0132 and 9x1mL. Equilibration Solution, ES Catalog 90131
Recalling firm:
Fujifilm Irvine Scientific, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 8, 2021

Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. This kit is designed for use with CryoTip (Catalog #40709), and Vitrification Thaw Kit (Vit Kit-Thaw) for optimal recovery of specimens. Vitrification Freeze kit (which includes the VS Vitrification Solution) are cryopreservation media intended for use in the vitrification of oocytes (MII) and pronuclear (PN) zygotes, cleavage stage embryos, and blastocyst stage embryos. Catalog numbers: 90133-SO Vitrification Freeze kit, contained 9x1 mL. Vitrification solution, VS, Catalog #90132. Product form: Liquid. Equilibration Solution-ES is a HEPES buffered solution of Medium-199 containing gentamicin sulfate, 7.5% (v/v) of each DMSO and ethylene glycol and 20% (v/v) Dextran Serum Supplement (DSS). Vitrification Solution-VS is a HEPES buffered solution of Medium-199 containing gentamicin sulfate, 15% (v/v) of each DMSO and ethylene glycol, 20% (v/v) DSS and 0.5 M sucrose. DSS is a protein supplement consisting of 50 mg/mL therapeutic grade Human Serum Albumin (HSA) and 20 mg/mL Dextran. DSS is used at 20% (v/v) in Vit Kit-Freeze for a final concentration of 10 mg/mL HSA and 4 mg/mL Dextran. These two solutions are to be used in sequence according to the step-wise microdrop vitrification protocol. Vitrification Solution-VS Aseptically filtered. Test results reported on C of A Vit Kit -Freeze (Vitrification Freeze Kit) with Gentamycin and DSS Contains 2 x 1 mL Equilibration Solution- ES; 2 X 1 mL Vitrification Solution-VS ...90133-DCOS...RX Only...Sterile ...20YY-MM-DD

Due to a component in kit being labeled with the incorrect Expiration Date

ALL 50 STATES
▸Full report

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

Recall #:
88720
Lot/product code:
Catalog number: 90133-SO Vitrification Freeze kit Lot/Unit numbers: 90132210403; UDI # 00893727002811 Product code MLQ
Recalling firm:
Fujifilm Irvine Scientific, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2021

C315-HIS Delivery Catheter

Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter.

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

Recall #:
88688
Lot/product code:
GTIN: 00763000160180; Model: C315HIS02 (Serial Number/Lot Number: 0010567341), C315HIS03 (Serial Number/Lot Number: 10568899), and C315HIS04 (Serial Number/Lot Number: 10568900)
Recalling firm:
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 10, 2021

IUD Insertion Pack

Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.

ALL 50 STATES
▸Full report

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

Recall #:
88656
Lot/product code:
Part Number: 618-034
Recalling firm:
Stradis Medical, LLC dba Stradis Healthcare
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 10, 2021

Foundation Kit

Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.

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

Recall #:
88656
Lot/product code:
Part Number: A10
Recalling firm:
Stradis Medical, LLC dba Stradis Healthcare
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 10, 2021

IUD Insertion Kit

Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.

ALL 50 STATES
▸Full report

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

Recall #:
88656
Lot/product code:
Part Number: 935K
Recalling firm:
Stradis Medical, LLC dba Stradis Healthcare
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 10, 2021

Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight. Catalog Number: 8417400

Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 seconds

ALL 50 STATES
▸Full report

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

Recall #:
88635
Lot/product code:
Software 2.51 and Lower
Recalling firm:
Draeger Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 10, 2021

FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)

The Firmware (FW) of the Automation System Interface Module to ADVIA Centaur XP/XPT may lead to an incorrect association of test results to sample ID. Improper management of the sample may bring an incorrect patient result.

ALL 50 STATES
▸Full report

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

Recall #:
88700
Lot/product code:
Impacted Module: ADVIA Centaur XP/XPT Interface Module, Part No. FLX-021-00; FLX-021-10; APT-021-00  Serial numbers: ***FLEXLAB*** FLX.0109 FLX.0127 FLX.0128 FLX.0129 FLX.0132 FLX.0133 FLX.0139 FLX.0146 FLX.0147 FLX.0149 FLX.0151 FLX.0153 FLX.0154 FLX.0156 FLX.0157 FLX.0159 FLX.0160 FLX.0162 FLX.0165 FLX.0166 FLX.0167 FLX.0169 FLX.0170 FLX.0172 FLX.0173 FLX.0174 FLX.0179 FLX.0180 FLX.0182 FLX.0191 FLX.0192 FLX.0193 FLX.0194 FLX.043 FLX.069 FLX.085 FLX.086 FLX.087 FLX.093 FLX.097  ***ACCELERATOR a3600*** ACP.334   ***APTIO AUTOMATION*** AP2.0002 AP2.0003 AP2.0004 AP2.0005 AP2.0006 AP2.0007 AP2.0008 AP2.009 AP2.0010 AP2.0011 AP2.0012 AP2.0014 AP2.0015 AP2.0016 AP2.0017 AP2.0018 AP2.0019 AP2.0022 AP2.0023 AP2.0024 AP2.0025 AP2.0026 AP2.0027 AP2.0028 AP2.0029 AP2.0031 AP2.0032 AP2.0033 AP2.0035 AP2.0037 AP2.0038 AP2.0039 AP2.0040 AP2.0041 AP2.0043 AP2.0045 AP2.0046 AP2.0047 AP2.0048 AP2.0049 AP2.0050 AP2.0051 AP2.0052 AP2.0053 AP2.0054 AP2.0055 AP2.0057 AP2.0058 AP2.0059 AP2.0061 AP2.0062 AP2.0063 AP2.0064 AP2.0065 AP2.0066 AP2.0067 AP2.0070 AP2.0075 AP2.0076 AP2.0077 AP2.0078 AP2.0079 AP2.0080 AP2.0081 AP2.0082 AP2.0083 AP2.0084 AP2.0085 AP2.0087 AP2.0088 AP2.0089 AP2.0090 AP2.0091 AP2.0092 AP2.0093 AP2.0094 AP2.0095 AP2.0097 AP2.0098 AP2.0100 AP2.0102 AP2.0103 AP2.0104 AP2.0105 AP2.0106 AP2.0107 AP2.0108 AP2.0109 AP2.0110 AP2.0111 AP2.0112 AP2.0115 AP2.0117 AP2.0118 AP2.0119 AP2.0122 AP2.0123 AP2.0124 AP2.0126 AP2.0127 AP2.0128 AP2.0129 AP2.0131 AP2.0132 AP2.0133 AP2.0135 AP2.0136 AP2.0137 AP2.0138 AP2.0141 AP2.0142 AP2.0144 AP2.0145 AP2.0147 AP2.0149 AP2.0150 AP2.0153 AP2.0155 AP2.0156 AP2.0160 AP2.0161 AP2.0162 AP2.0165 AP2.0166 AP2.0168 AP2.0173 AP2.0178 AP2.0179 AP2.0180 AP2.0182 AP2.0186 AP2.0190 AP2.0191 AP2.0192 AP2.0193 AP2.0195 AP2.0198 AP2.0199 AP2.0200 AP2.0204 AP2.0205 AP2.0206 AP2.0207 AP2.0208 AP2.0212 AP2.0216 AP2.0219 AP2.0221 AP2.0222 AP2.0223 AP2.0226 AP2.0233 AP2.0235 AP2.0236 AP2.0237 AP2.0238 AP2.0239 AP2.0243 AP2.0244 AP2.0245 AP2.0247 AP2.0249 AP2.0251 AP2.0252 AP2.0253 AP2.0257 AP2.0267 AP2.0269 AP2.0271 AP2.0272 AP2.0273 AP2.0279 AP2.0280 AP2.0281 AP2.0282 AP2.0284 AP2.0287 AP2.0288 AP2.0301 AP2.0305 AP2.0307 AP2.0309 AP2.0312 AP2.0315 AP2.0327 AP2.0333 AP2.0337 AP2.0341 AP2.0342 AP2.0343 AP2.0345 AP2.0351 AP2.0355 AP2.0357 AP2.0358 AP2.0370 AP2.0371 AP2.0399 AP2.0407 AP2.0409 AP2.0426 AP2.0457 AP2.0474 AP2.0475 AP2.0476 AP2.0486 AP2.0491 AP2.0494 AP2.0498 AP2.0503 AP2.0506 AP2.0509 AP2.0512 AP2.0554 AP2.0563 APT.0009C APT.0058C APT.0065C APT.0093C APT.0125C APT.0091C
Recalling firm:
Inpeco S.A.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 10, 2021

FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units)

During a regular requalification review, affected flexible intubation video endoscopes did not achieve the required sterility assurance level. There is a risk that the patient may be exposed to a higher risk of infection.

ALARAZCACOCTDCFLGAIAILINKSKYLAMAMDMEMIMNMOMSNCNHNJNMNVNYOHORPASCTNTXUTVAVTWAWIWV
▸Full report

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

Recall #:
88694
Lot/product code:
All LOTs with remaining shelf life
Recalling firm:
Karl Storz Endoscopy
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 10, 2021

Endometrial Biopsy Kit

Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.

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▸Full report

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

Recall #:
88656
Lot/product code:
Part Number: 936K
Recalling firm:
Stradis Medical, LLC dba Stradis Healthcare
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 10, 2021

Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients. Catalog Number: 8416400

Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 seconds

ALL 50 STATES
▸Full report

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

Recall #:
88635
Lot/product code:
Software 2.51 and Lower
Recalling firm:
Draeger Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 10, 2021

Tenaculum, Plastic

Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.

ALL 50 STATES
▸Full report

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

Recall #:
88656
Lot/product code:
Part Number: 356T
Recalling firm:
Stradis Medical, LLC dba Stradis Healthcare
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 10, 2021

Standard IUD Insertion Kit

Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.

ALL 50 STATES
▸Full report

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

Recall #:
88656
Lot/product code:
Part Number: M20
Recalling firm:
Stradis Medical, LLC dba Stradis Healthcare
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 13, 2021

Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.

There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.

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▸Full report

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

Recall #:
88685
Lot/product code:
Model 96553 - Serial number 220719040, GTIN 20763000116006; Model 96551 - Serial number 220641720, GTIN 20763000115986.
Recalling firm:
Medtronic Perfusion Systems
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UnclassifiedRisk not yet known
Medical deviceRecalled September 14, 2021

Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy.

Contour changes can be saved on an unintended image set. In addition, these contour edits do not cause the dose to be frozen on the plans associated with that image set.

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

Recall #:
88676
Lot/product code:
Software Builds: 5.40.00, 5.40.01, 5.40.02, 5.51.10; UDI GTIN: (01)00858164002190(10) 5.40.00, (01)00858164002190(10) 5.40.01, (01)00858164002190(10) 5.40.02, (01)00858164002268(10) 5.51.10
Recalling firm:
Elekta Inc
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UnclassifiedRisk not yet known
Medical deviceRecalled September 17, 2021

BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack The BioPlex Syphilis Total & RPR kit is a multiplex flow immunoassay intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of nontreponemal reagin antibodies in human serum or plasma

Due to two issues: 1) Customer complaints associated with greater than expected Rapid Plasma Reagin (RPR) reactivity which does not confirm with treponemal antibody test which may be due to a positive correlation between the mass COVID vaccinations and false reactive RPR results, and 2) During routine stability monitoring, an increase in mean bias above specification was observed which can cause elevated RPR reactivity potentially due to early shelf-life failure.

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

Recall #:
88874
Lot/product code:
Catalog Number: 12000650 UDI Code: 03610520653012 Lot Number: 301210
Recalling firm:
Bio-Rad Laboratories, Inc.
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UnclassifiedRisk not yet known
Medical deviceRecalled September 17, 2021

BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL The BioPlex 2200 Syphilis Total & RPR Calibrator Set is intended for the calibration of the BioPlex 2200 Syphilis Total & RPR Reagent Pack.

Due to two issues: 1) Customer complaints associated with greater than expected Rapid Plasma Reagin (RPR) reactivity which does not confirm with treponemal antibody test which may be due to a positive correlation between the mass COVID vaccinations and false reactive RPR results, and 2) During routine stability monitoring, an increase in mean bias above specification was observed which can cause elevated RPR reactivity potentially due to early shelf-life failure.

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

Recall #:
88874
Lot/product code:
Catalog Number: 12000651 UDI Code: 03610520652770 Lot Number: 52953
Recalling firm:
Bio-Rad Laboratories, Inc.
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UnclassifiedRisk not yet known
Medical deviceRecalled September 20, 2021

Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543

The firm has confirmed the potential for Atellica CH Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely depressed Enzymatic Hemoglobin A1c results may affect consideration of intervention.

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

Recall #:
88784
Lot/product code:
All lots impacted
Recalling firm:
Siemens Healthcare Diagnostics, Inc.
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UnclassifiedRisk not yet known
Medical deviceRecalled September 20, 2021

Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151

The firm has confirmed the potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely depressed Enzymatic Hemoglobin A1c results may affect consideration of intervention.

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

Recall #:
88784
Lot/product code:
All lots impacted
Recalling firm:
Siemens Healthcare Diagnostics, Inc.
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UnclassifiedRisk not yet known
Medical deviceRecalled September 21, 2021

Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) with the below Model Numbers. 1. Cardiosave Hybrid. Model Numbers: 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-35, 0998-00-0800-36, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-0800-33, 0998-UC-0800-52, 0998-UC-0800-53, 0998-UC-0800-55. 2. Cardiosave Rescue. Model Number: 0998-00-0800-83.

A Cardiosave Lithium-Ion Battery Pack used during protocol testing failed to meet the minimum runtime requirement per Getinge internal Product Specification. These nonconforming batteries were inadvertently released to customers.

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

Recall #:
88719
Lot/product code:
Battery Pack Serial Numbers: 192224349IP, 191908720IP, 202369811IP, 202791944IP, 191848115IP, 192099841IP, 192103741IP, 192104141IP, 171218521PE, 181642339PE, 202321308IP, 191912520IP, 191874716IP, 191922620IP, 181642639PE, 192185446IP, 171277935PE, 192190247IP, 202400219IP, 202323808IP, 191910720IP, 181661142PE, 192245250IP, 202599332IP, 181645841PE, 181526530PE, 202403719IP, 181705244PE, 192104541IP, 191787312IP, 181646041PE, 191955422IP, 202389919IP, 191822513IP, 191853415IP, 192004724IP, 192196447IP, 192155645IP, 202330609IP, 171325749PE, 192018828IP, 191778911IP, 192187947IP, 192196247IP, 181609237PE, 192098341IP, 191972823IP, 191860615IP, 202719740IP, 202334109IP, 202651035IP, 191852615IP, 192173146IP, 202386519IP, 202398619IP, 202416720IP, 202599432IP, 191956322IP, 192205847IP, 192220349IP, 192081138IP, 202617233IP, 181659242PE, 202266705IP, 171255732PE, 192179046IP, 192179246IP, 202280605IP, 181673143PE, 192083838IP, 192106442IP, 192216649IP, 191956122IP, 181721730IP, 191943120IP, 191971023IP, 181405120PE, 181474326PE, 181440222PE, 192225649IP, 191969623IP, 192220749IP, 181706344PE, 181694644PE, 191968223IP, 202593632IP, 191863015IP, 171264133PE, 191872616IP, 181487828PE, 171337749PE, 181477426PE, 181748032IP, 191790412IP, 191902319IP, 192195547IP, 192200947IP, 191968723IP, 202552831IP, 191806513IP, 202401419IP, 191904319IP, 181492328PE, 202388319IP, 202482724IP, 192241550IP, 171339849PE, 191831214IP, 192084038IP, 181694244PE, 192210249IP, 202725540IP, 171345550PE, 171348550PE, 191915920IP, 202371511IP, 202723440IP, 202367411IP, 202279305IP, 181513630PE, 181703744PE, 202389819IP, 192175646IP, 192107842IP, 202394719IP, 202401619IP, 192204947IP, 202654636IP, 192196647IP, 192200647IP, 202782744IP. 1. Cardiosave Hybrid. Model Number (UDI Number): 0998-00-0800-31 (10607567109053), 0998-00-0800-32 (10607567111117), 0998-00-0800-33 (10607567109008), 0998-00-0800-35 (10607567109107), 0998-00-0800-36 (10607567114187), 0998-00-0800-45 (10607567108421), 0998-00-0800-52 (10607567108438), 0998-00-0800-53 (10607567108391), 0998-00-0800-55 (10607567108414), 0998-00-0800-65 (10607567113432), 0998-UC-0800-31 (10607567109053), 0998-UC-0800-33 (10607567109008), 0998-UC-0800-52 (10607567108438), 0998-UC-0800-53 (10607567108391), 0998-UC-0800-55 (10607567108414). 2. Cardiosave Rescue. Model Number: 0998-00-0800-83 (10607567108407).
Recalling firm:
Datascope Corp.
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