BIGNOPE
Ko-fi

Recalls affecting South Carolina

Data last updated: September 10, 2026 at 1:16 PM UTC

16,870 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 December 30, 2020

Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 106289 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.

Complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.

ALL 50 STATES
Full report

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

Recall #:
87150
Lot/product code:
UDI 07332414007812, All lots within expiry
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 4, 2021

Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 tablets per bottle, 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-0227-2021
Lot/product code:
MET200501 07/2022
Recalling firm:
Nostrum Laboratories Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 6, 2021

PHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(1058272), LOT M94663-P1 - Product Usage: The ventilator is intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

Due to unqualified "design verification" batteries being shipped to customers.

ALL 50 STATES
Full report

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

Recall #:
87314
Lot/product code:
Battery Model/Part Number: 1076374 Lot Code: M94663-P1
Recalling firm:
Respironics California, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceForeign materialRecalled January 7, 2021

Gown Isolation W/Ties Xl Ylw, SKU 1101PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are expected.

There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.

ALL 50 STATES
Full report

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

Recall #:
87134
Lot/product code:
All lot numbers from 18KXBXXXXX to 20KXBXXXXX
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceForeign materialRecalled January 7, 2021

Gown Isolation W/Ties Univ Blu, SKU 1200PG, 2200PG, 552200PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are expected.

There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.

ALL 50 STATES
Full report

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

Recall #:
87134
Lot/product code:
All lot numbers from 18KXBXXXXX to 20KXBXXXXX
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceForeign materialRecalled January 7, 2021

Gown Kendall Blue RG, SKU CT5000 Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are expected.

There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.

ALL 50 STATES
Full report

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

Recall #:
87134
Lot/product code:
All lot numbers from 1901XXK to 2010XXK
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceForeign materialRecalled January 7, 2021

Lab Coats SMS Large White, SKU 2302LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are expected.

There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.

ALL 50 STATES
Full report

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

Recall #:
87134
Lot/product code:
All lot numbers from 18KXBXXXXX to 20KXBXXXXX
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceForeign materialRecalled January 7, 2021

Gown Isolation W/Ties Univ Ylw, SKU 1100PG, V1100PG, 2100PG, V2100PG, 2150PG, V2100PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are expected.

There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.

ALL 50 STATES
Full report

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

Recall #:
87134
Lot/product code:
All lot numbers from 18KXBXXXXX to 20KXBXXXXX
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceForeign materialRecalled January 7, 2021

Lab Coats SMS 2X-Large Blue, SKU 2204LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are expected.

There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.

ALL 50 STATES
Full report

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

Recall #:
87134
Lot/product code:
All lot numbers from 18KXBXXXXX to 20KXBXXXXX
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceForeign materialRecalled January 7, 2021

Lab Coats SMS Medium White, SKU 2301LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are expected.

There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.

ALL 50 STATES
Full report

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

Recall #:
87134
Lot/product code:
All lot numbers from 18KXBXXXXX to 20KXBXXXXX
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceForeign materialRecalled January 7, 2021

Gown Isolation W/Ties Xl Blue, SKU 2201PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are expected.

There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.

ALL 50 STATES
Full report

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

Recall #:
87134
Lot/product code:
All lot numbers from 18KXBXXXXX to 20KXBXXXXX
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceForeign materialRecalled January 7, 2021

Gown Kendall Blue XXL, SKU CT5102 Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are expected.

There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.

ALL 50 STATES
Full report

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

Recall #:
87134
Lot/product code:
All lot numbers from 1901XXK to 2010XXK
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceForeign materialRecalled January 7, 2021

Gown Kendall Blue L, SKU CT5100, CT5101 Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are expected.

There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.

ALL 50 STATES
Full report

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

Recall #:
87134
Lot/product code:
All lot numbers from 1901XXK to 2010XXK
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceForeign materialRecalled January 7, 2021

Lab Coats SMS Large Blue, SKU 2202LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are expected.

There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.

ALL 50 STATES
Full report

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

Recall #:
87134
Lot/product code:
All lot numbers from 18KXBXXXXX to 20KXBXXXXX
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceForeign materialRecalled January 7, 2021

Lab Coats SMS 2X-Large White, SKU 2304LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are expected.

There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.

ALL 50 STATES
Full report

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

Recall #:
87134
Lot/product code:
All lot numbers from 18KXBXXXXX to 20KXBXXXXX
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceForeign materialRecalled January 7, 2021

Lab Coats SMS X-Large Blue, SKU 2203LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are expected.

There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.

ALL 50 STATES
Full report

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

Recall #:
87134
Lot/product code:
All lot numbers from 18KXBXXXXX to 20KXBXXXXX
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 8, 2021

WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/ 00841983102561 ORG 9700A/No UDI

Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter.

Full report

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

Recall #:
87264
Lot/product code:
ORG 9100A serial numbers: 00001 to 01413 ORG 9110A serial numbers: 00001 to 02706  ORG 9700A serial numbers: 00001 to 00894
Recalling firm:
Nihon Kohden America Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 11, 2021

Medtronic PS Medical Cerebro Spinal Fluid (CSF)-Flow Control Valves for the following CFNs: 22011 L- SHUNT 22011 L INTL ONLY ULTRA SM LOW 22011 LL - SHUNT 22011 LL INTL ONLY ULTRA SM L-L 22011 M - SHUNT 22011 M INTL ONLY ULTRA SM MED 22017 B-L - SHUNT 22017 B-L ASSY US PER 90CM SM LOW 22017 B-M - SHUNT 22017 B-M ASSY US PER 90CM SM MED 22017B-LL - SHUNT 22017B-LL ASSY US PER 90CM SM LL 23093 - VALVE 23093 CONT. REG. LOW-LOW 27102 - VALVE 27102 CONTOURED SML LOW LOW 27553 M - VALVE 27553 M CSF-FLOW CNTRL SM EXTR MP 27643M - SHUNT 27643M ASSY SM PCATH130CM MED 27683M - SHUNT 27683M RG SNP PCATH90 PLI STD OE 42312 - VALVE 42312 SM CONTOURED LOW PRES IMP 42314- VALVE 42314 SM CONTOURED MED PRESS IMP 42316 - VALVE 42316 SM CONTOURED HIGH PRESS 42322 - VALVE 42322 CONTOURED REG LOW PRESS IMP 42324 - VALVE 42324 CONTOURED REG MED PRESS IMP 42326 - VALVE 42326 CONT HIGH PRESS IMP 42410 - VALVE 42410 ULTRA SMALL LOW-LOW 42414 - VALVE 42414 ULTRA SMALL MEDIUM PRESS IMP 42532 - VALVE 42532 BURR HOLE 12MM LOW PRESS IMP 42534 - VALVE 42534 BURR HOLE 12MM MED PRESS IMP 42536 - VALVE 42536 BURR HOLE 12MM HI PRESS IMP 42542 - VALVE 42542 BURR HOLE 16 MM LOW IMP 42544 - VALVE 42544 BURR HOLE 16MM MED PRESS IMP 42546 - VALVE 42546 BURR HOLE 16MM HI PRESS IMP 46564 - SHUNT 46564 CSF SNAP ASSY US MEDIUM 46622 - SHUNT 46622 CSF ASSY SMALL LOW CONT C/P 46624 - SHUNT 46624 CSF ASSY SMALL MED CONT C/P 46626 - SHUNT 46626 CSF ASSY SMALL HIGH CONT C/P 46642 - SHUNT 46642 ASSY REG LOW C/P-90CM 46644 - SHUNT 46644 ASSY REG MED C/P-90CM 46646 - SHUNT 46646 ASSY REG HIGH C/P-90CM 9003 A - KIT 9003 A INTL ONLY SHUNT CONT SM LO 9003 B - KIT 9003 B INTL ONLY SHUNT CONT SM ME 9003 C - KIT 9003 C INTL ONLY SHUNT CONT SM HI 9003 D - KIT 9003 D SHUNT INTL ONLY CONT REG L 9003 E - KIT 9003 E SHUNT INTL ONLY CONT REG M 9003 F - KIT 9003 F SHUNT INTL ONLY CONT REG H 9040 A - KIT 9040 A SHUNT INTL ONLY BH 12MM LOW 9040 B - KIT 9040 B SHUNT INTL ONLY BH 12MM MED 9040 C - KIT 9040 C SHUNT INTL ONLY BH 12MM HIGH 9040 D - KIT 9040 DSHUNT INTL ONLY BH 16MM LOW 9040 E - KIT 9040 E SHUNT INTL ONLY BH 16MM MED 9040 F - KIT 9040 A SHUNT INTL ONLY BH 12MM LOW 92322 - VALVE 92322 CSF CONT REG LOW BIO 92324 - VALVE 92324 CSF CONT REG MED BIO

Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus

ALL 50 STATES
Full report

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

Recall #:
87157
Lot/product code:
Lot numbers for the affected CFNs: 0219278853, 0219278854, 0220099072, 0219278855, 0219278856, 0219768090, 0219768091, 0219798970, 0219798971, 0219798972, 0220010048, 0220112693, 0220141392, 0219802495, 0219802494, 0219583129, 0220286100, 0218796592, 0219952709, 0218806424, 0219316930, 0220280248, 0220286709, 0219480202, 0219802492, 0218045303, 0218045304, 0218045527, 0218408997, 0218408998, 0218408999, 0218590082, 0218721471, 0218721472, 0219234579, 0219497114, 0219648109, 0219978722, 0220100564, 0220444728, 0217286212, 0217286213, 0217286214, 0217706616, 0217706621, 0217706622, 0217706623, 0217962420, 0217962421, 0217971628, 0217971633, 0218409003, 0218409004, 0218409005, 0218590077, 0218590078, 0218590079, 0218590080, 0218590081, 0218720196, 0218720202, 0218972089, 0218972090, 0219234580, 0219312365, 0219375930, 0219761087, 0220122285, 0220124886, 0220124887, 0220124888, 0220272309, 0220444084, 0220444085, 0220444726, 0217286211, 0217706612, 0217962419, 0217971634, 0217971635, 0218424703, 0218424704, 0218590071, 0217286216, 0217962409, 0217962418, 0217971637, 0217971638, 0218424701, 0218424702, 0217962422, 0217962423, 0217962424, 0217962425, 0218402220, 0218408987, 0218408988, 0218408989, 0218408990, 0218408991, 0218408992, 0218408993, 0218408994, 0218408996, 0218590073, 0218590074, 0218590075, 0218590076, 0218720244, 0218720287, 0218720289, 0219234581, 0219234582, 0219320159, 0219320160, 0219320162, 0219320163, 0219574223, 0219761097, 0219910255, 0219910256, 0220324658, 0220530229, 0218590084, 0218590085, 0219312364, 0219978742, 0220444083, 0219277363, 0219278519, 0219278520, 0219278516, 0219278517, 0219374313, 0219374314, 0219733266, 0219733267, 0218605545, 0218605686, 0218605539, 0218605540, 0218605541, 0218605542, 0218605543, 0218605544, 0219375125, 0219375926, 0219375927, 0219375928, 0219375929, 0219438310, 0219761086, 0219910252, 0219910253, 0220444735, 0218605538, 0218605536, 0218605537, 0220280189, 0218605688, 0218605689, 0218605690, 0218605691, 0218978999, 0218979001, 0218979002, 0218979003, 0218979005, 0218979086, 0218979087, 0219123064, 0219123586, 0219123588, 0219123589, 0219422860, 0219422861, 0219465702, 0219465703, 0219761093, 0219761094, 0219761095, 0219761096, 0220272311, 0218605687, 0219579789, 0219894795, 0219279151, 0220288369, 0219278874, 0219894797, 0220201981, 0220602456, 0220285339, 0219279160, 0219278877, 0219278878, 0219278879, 0219278880, 0219694364, 0220075413, 0220075414, 0219354851, 0219354852, 0219354853, 0219354854, 0220114768, 0220398628, 0219278737, 0219278738, 0219278739, 0219278740, 0219708098, 0219708099, 0219851768, 0219851769, 0219851770, 0219981926, 0220053812, 0220053813, 0220081704, 0220085756, 0220085757, 0220099077, 0220099078, 0220134024, 0220134025, 0220156462, 0220156463, 0220173989, 0220285673, 0220352833, 0220398644, 0219278736, 0220393229, 0219278734, 0219278735, 0220011262, 0219278731, 0219278733, 0219769315, 0219769316, 0219851771, 0219851772, 0219851773, 0220305451, 0220622330, 0220680023, 0219354855, 0219927060, 0220546836, 0219278730, 0220011259, 0220397733, 0219127889, 0219128109, 0219128111, 0219128112, 0219128113, 0219128115, 0219128117, 0219128118, 0219128119, 0219128120, 0219128121, 0219917405, 0220009922, 0220009923, 0220040136, 0220059298, 0220059299, 0220099075, 0220099076, 0220102737, 0220118172, 0220156744, 0220156745, 0220201972, 0220201979, 0220217393, 0220249127, 0220397688, 0220397689, 0220397691, 0220397699, 0220397703, 0220400359, 0220702309, 0219969972, 0219272921, 0219950183, 0219127462, 0219127463, 0219127464, 0219127465, 0219127886, 0219127887, 0219127890, 0219127891, 0219127892, 0219127893, 0219127894, 0219127895, 0219127896, 0219127897, 0219127898. 0219698790, 0219698792, 0219721377, 0219721378, 0219721379, 0219721380, 0219721381, 0219917404, 0219988521, 0220075419, 0220141390, 0220141391, 0220141405, 0220141706, 0220156743, 0220173988, 0220249134, 0220255058, 0220262090, 0220285669, 0220285670, 0220285672, 0220301203, 0220324602, 0220330904, 0220360618, 0220637047, 0219278729, 0219698786, 0220522999, 0219067893, 0219067894, 0220400350,
Recalling firm:
Medtronic Neurosurgery
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 11, 2021

Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts. STRATA II Valves and Shunts for the following CFNs: 27739 - SHUNT 27739 STRATA NSC SNAP SML 120CM, 27740 - SHUNT 27740 STRATA NSC SNAP REG 120CM, 27812 - VALVE 27812 STRATA II SM EXTRACTED, 27814 - SHUNT 27814 STRATA II ASSY SML, 27815 - SHUNT 27815 STRATA II ASSY REG, 27816 - SHUNT 27816 SNAP STRATA II SMALL, 27817 - SHUNT 27817 SNAP STRATA II REG, 27818 - SHUNT 27818 STRATA II SML BIO, 27819 - SHUNT 27819 STRATA II REG BIO, 27823 - SHUNT 27823 STRATA II ASSY SNP REG BIO, 27827 - VALVE 27827 STRATA II REG EXTRACTED, 27888 - SHNT 27888 STRATA II SNAP ASSY REG PCATH, 42335 - VALVE 42335 STRATA NSC BURR HOLE, 42355 - VALVE 42355 FP STRATA NSC SMALL, 42365 - VALVE 42365 FP STRATA NSC REGULAR, 42836 - VALVE 42836 STRATA II BURR HOLE, 42856 - VALVE 42856 FP-STRATA 2 SMALL, 42866 - ASSY 46866 FP-STRATA 2 SHUNT REG, 44420 - SHUNT 44420 STRATA KIT NSC LP, 44421 - KIT 44421 STRATA NSC LP OPEN LUMBAR, 44430 - SHUNT 44430 STRATA KIT NSC LP ASSY, 44465 - VALVE 44465 STRATA NSC LP, 46636 - SHUNT 46636 STRATA NSC BURR, 46655 - ASSY 46655 FP SHUNT STRATA NSC SMALL, 46665 - ASSY 46665 FP SHUNT STRATA NSC REG, 46837 - SHUNT 46837 STRATA II BURR HOLE, 46856 - ASSY 46856 FP-STRATA 2 SHUNT SML, 46866 - ASSY 46866 FP-STRATA 2 SHUNT REG, 92355 - VALVE 92355 STRATA NSC SML BIOGLIDE, 92856 - VALVE 92856 FP STRATA 2 SML BG, 92866 - VALVE 92866 FP STRATA 2 REG BG,

Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus

ALL 50 STATES
Full report

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

Recall #:
87157
Lot/product code:
Lot numbers for the affected CFNs:  0219498492, 0219471229, 0218700308, 0219498495, 0220423969, 0219378043, 0219802947, 0219395919, 0219395920, 0219395921, 0219471351, 0219470063, 0219470064, 0219471352, 0219127878, 0219127879, 0219127880, 0219550965, 0219551126, 0219551128, 0219551134, 0219127871, 0219127872, 0219127873, 0219127874, 0219127875, 0219127876, 0219480196, 0219480197, 0219480199, 0219480200, 0219499010, 0219551136, 0219551138, 0219551139, 0219551140, 0219471237, 0219931727, 0218700307, 0219267902, 0219471227, 0219931726, 0219467660, 0219467661, 0219467663, 0217207127, 0217207128, 0218226186, 0218247716, 0218287189, 0218605901, 0218605902, 0218609097, 0218609100, 0218609101, 0219171583, 0219171709, 0219352151, 0219352152, 0219480334, 0219480335, 0219497185, 0219497646, 0219497661, 0217205762, 0217205763, 0217207129, 0218226204, 0218226205, 0218287187, 0218287188, 0218287201, 0218396013, 0218415313, 0218415314, 0218415315, 0218609102, 0218609103, 0218609104, 0218609105, 0218609586, 0218609587, 0219081907, 0219115460, 0219115461, 0219307371, 0219307372, 0219352155,, 0219352157, 0219396250, 0219396252, 0219396254, 0219396255, 0219479762, 0219479763, 0219497751, 0219497755, 0218807819, 0219309515, 0219815331, 0220314446, 0220314447, 0220393226, 0220393227, 0216868584, 0217254777, 0217254778, 0217255248, 0217778039,, 0217778040, 0217778041, 0217817029, 0217817030, 0217817031, 0217817032, 0217817033, 0217971140, 0217971141, 0218033642, 0218033643, 0218033644, 0218033645, 0218034266, 0218034267, 0218286596, 0218286597, 0218286598, 0218286599, 0218416085, 0218605889, 0218605890, 0218605891, 0218605892, 0218605893, 0218605894, 0218609602, 0218609603, 0218609604, 0218639469, 0218639470, 0218639471, 0218639472, 0218787024, 0218787025, 0218787926, 0218787927, 0218787928, 0218787934, 0218873198, 0218873200, 0218873201, 0218873202, 0218964967, 0219053149, 0219071024, 0219103301, 0219497757, 0219497758, 0219497759, 0219497760, 0219497761, 0216105046, 0216105047, 0216105052, 0216105053, 0216259301, 0216259302, 0216362463, 0216362464, 0216362467, 0216363865, 0216418659, 0216418660, 0216513862, 0216513864, 0216579072, 0216579074, 0216666644, 0216729340, 0216732201, 0216732202, 0216732203, 0216732204, 0216732205, 0216733948, 0216821015, 0216821121, 0216821122, 0216821123, 0216821138, 0216821139, 0216868349, 0216868350, 0216868351, 0216868352, 0216868355, 0216868356, 0216868357, 0216868358, 0216868359, 0216868360, 0216868581, 0216868582, 0216868583, 0217254779, 0217254780, 0217254781, 0217254782, 0217254783, 0217254784, 0217254785, 0217255246, 0217255247, 0217260220, 0217260221, 0217260969, 0217260970, 0217778042, 0217778043, 0217817034, 0217817035, 0217817036, 0217817037, 0217817038, 0217817039, 0217817040, 0217923546, 0217923549, 0217923550, 0217923551, 0217923552, 0217923555, 0217971129, 0217971131, 0217971134, 0217971135, 0217971136, 0217971137, 0217971138, 0217971139, 0218033424, 0218033629, 0218033630, 0218033631, 0218033632, 0218033633, 0218033634, 0218033635, 0218033636, 0218033637, 0218033638, 0218033639, 0218033640, 0218033641, 0218034268, 0218286600, 0218286601, 0218286602, 0218286603, 0218286604, 0218286605, 0218287186, 0218287199, 0218287200, 0218417806, 0218417807, 0218417808, 0218417809, 0218417810, 0218417811, 0218417812, 0218605895, 0218605896, 0218605897, 0218605899, 0218605900, 0218609594, 0218609595, 0218609596, 0218609599, 0218609600, 0218610066, 0218639473, 0218639474, 0218639475, 0218639476, 0218639477, 0218639478, 0218964983, 0219000135, 0219000143, 0219081908, 0219103305, 0219115462, 0219115463, 0219118937,, 0219123053, 0219128329, 0219307369, 0219307370, 0219395719, 0219395720, 0219395721, 0219395723, 0219395724, 0219395725, 0219480328, 0219480329, 0219480330, 0219480331, 0219480332, 0219480333, 0219497762, 0219497763, 0219497764, 0220440998, 0220440999, 0219467664, 0219467665, 0219468526, 0220040131, 0220048557, 0220075411, 0220141393, 0220262093, 0220355866, 0220355867, 0219332742, 0219332743, 0220075412, 0220121098, 0220141394, 0220166866, 0220328424, 0219498721, 0217268265, 0218808947, 0220285340, 0219498725, 0220059296, 0220400355, 0219354861, 0219929565, 0220217121, 0220278246, 0219132084, 0219132085, 0219132126, 0220288366, 0219123889, 0219330677, 0219123853, 0219123854,
Recalling firm:
Medtronic Neurosurgery
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 11, 2021

Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control Valves for the following CFNs/REF numbers: 24048 - VALVE 24048 DELTA RGL PL 0.5, 24053 - CHAMBER 24053 DELTA, 24147 - VALVE 24147 DELTA SML PL0.5, 25121-1 - ASSY 25121-1 DELTA SML SNAP PERIT 120, 25121-5 - ASSY 25121-5 DELTA SML SNAP P-CATH 120, 25131-1 - DELTA 25131-1 INTL ONLY SHUNT SM 1.0, 25131-2 - SHUNT 25131-2 INTL ONLY DELTA SM 2.0, 25131-5 - SHUNT 25131-5 INTL ONLY DELTA SM 1.5, 25132-2 - SHUNT 25132-2 INTL ONLY DELTA REG.2.0, 25132-5 - SHUNT 25132-5 INTL ONLY DELTA REG 1.5, 27219-1 - VALVE 27219-1 NEONATE DELTA, 27219-2 - VALVE 27219-2 NEONATE DELTA, 27219-5 - VALVE 27219-5 DELTA NEONATE 1.5 IMP, 27554-1 - VALVE 27554-1 DELTA SM EXTRACTED PL 1.0, 27554-2 - VALVE 27554-2 DELTA SM EXTRACTED PL 2.0, 27554-5 - VALVE 27554-5 DELTA SM EXTRACTED PL 1.5, 42812 - VALVE 42812 DELTA SMALL LEVEL I, 42813 - VALVE 42813 DELTA SMALL LEVEL 1.5, 42814 - VALVE 42814 DELTA SMALL LEVEL II, 42822 - VALVE 42822 DELTA REG PRESS LEVEL I IMP, 42823 - VALVE 92823 BIOGLIDE DELTA REG. 1.5, 42824 - VALVE 42824 DELTA REG PRESS LEVEL II IMP, 46812 - ASSY 46812 DELTA SHUNT SMALL PL 1, 46813 - ASSY 46813 DELTA SHUNT SM LEV 1.5, 46822 - ASSY 46822 DELTA SHUNT REG P/L 1, 46823 - ASSY 46823 DELTA SHUNT REG LEV 1.5, 46824 - ASSY 46824 DELTA SHUNT REG P/L 2, 46832 - SHUNT 46832 NEONATAL DELTA SNAP L 1, 46833 - SHUNT 46833 NEONATAL DELTA SNAP 1.5, 46834 - SHUNT 46834 NEONATAL DELTA SNAP L 2, 92822 - VALVE 92822 BIOGLIDE DELTA REG. 1.0, 92823 - VALVE 92823 BIOGLIDE DELTA REG. 1.5,

Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus

ALL 50 STATES
Full report

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

Recall #:
87157
Lot/product code:
Lot numbers for the affected CFNs: 0218796596, 0220173993, 0220631950, 0218806959, 0219354642, 0220201977, 0219404900, 0219404902, 0219501288, 0219501289, 0219869817, 0219278742, 0219278743, 0219278744, 0219698794, 0219809171, 0219948890, 0220112694, 0220180486, 0220217387, 0220262088, 0220397742, 0220397744, 0219272923, 0220279501, 0219278741, 0219927059, 0220149614, 0220393237, 0219281777, 0219948893, 0220166870, 0220236215, 0220720015, 0220285334, 0220285335, 0220285336, 0217135294, 0218720240, 0218720241, 0218992842, 0219621242, 0220251046, 0217135293, 0218720605, 0218721466, 0218721467, 0218721468, 0218992826, 0218992827, 0219154178, 0219289039, 0219289040, 0219312362, 0219761091, 0217135298, 0218720604, 0219284249, 0219284250, 0219761089, 0217150648, 0217244574, 0217244584, 0218721469, 0218721470, 0218986445, 0217135290, 0217286224, 0217344860, 0217344861, 0218720187, 0218753744, 0218753745, 0219312363, 0219800605, 0219802486, 0217135295, 0217135302, 0219423220, 0219761099, 0219279163, 0219278857, 0219278858, 0220352837, 0220398089, 0219279162, 0220400352, 0220602457, 0219279147, 0220352830, 0220088041, 0220602458, 0220285342, 0219894798, 0220398845, 0220285343, 0219067896, 0219067897
Recalling firm:
Medtronic Neurosurgery
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 12, 2021

Grasper/Retriever, Alligator Jaw, Rat Tooth 2.4 mm x 8 mm x 230 cm Catalog Number: 7226 Intended use: single use accessory devices used through the working channel of a GI endoscope

Mislabeled: Devices labeled as catalog #7208 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 230 cm) may actually be catalog #7226 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 8 mm x 230 cm) and Devices labeled as catalog #7226, (Grasper/Retriever, Alligator Jaw, Rat Tooth, 2.4 mm x 8 mm x 230 cm) may actually be catalog #7208, Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 230 cm).

ALL 50 STATES
Full report

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

Recall #:
88136
Lot/product code:
Lot Code: D20177226-19
Recalling firm:
Shent USA, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 12, 2021

Grasper/Retriever, Alligator Jaw 2.4 mm x 5 mm x 230 cm Catalog Number: 7208 Intended use: single use accessory devices used through the working channel of a GI endoscope

Mislabeled: Devices labeled as catalog #7208 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 230 cm) may actually be catalog #7226 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 8 mm x 230 cm) and Devices labeled as catalog #7226, (Grasper/Retriever, Alligator Jaw, Rat Tooth, 2.4 mm x 8 mm x 230 cm) may actually be catalog #7208, Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 230 cm).

ALL 50 STATES
Full report

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

Recall #:
88136
Lot/product code:
Lot Code: 020377208
Recalling firm:
Shent USA, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 13, 2021

Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to provide repeated access to the vascular system.

The 5F Dignity CT Port kits were packaged with the incorrect size port. The kits include a 6.6F port instead of the correct 5F port. The inability to connect the catheter lumen to the port stem because of the incorrect size may not be noted until well into the procedure, after the catheter lumen is placed in the vessel. An alternate port will need to be obtained prolonging the procedure. A prolonged insertion procedure increases any risk associated with a surgical procedure.

ALL 50 STATES
Full report

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

Recall #:
87265
Lot/product code:
Catalog Number: MRDP50AXS, Lot Number: MPDX180, UDI Number: 884908149753 (updated 3/11/2021 added lot number: MPCY660)
Recalling firm:
Medical Components, Inc dba MedComp
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 14, 2021

PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx The LIFEPAK CR2 defibrillator is designed for indoor and outdoor use in a stationary environment. After the electrode pads are applied, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any responder assistance. The LIFEPAK CR2 defibrillator is indicated for use on patients 1 year of age or older in cardiopulmonary arrest.

Due to complaints received regarding missing lid magnets which may result in premature battery depletion.

ALL 50 STATES
Full report

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

Recall #:
87217
Lot/product code:
Model Number 3321605-xxx,  U.S. Device Part Numbers with Conforming Lids: CR2-2-001281, CR2-2-001279, CR2-2-001285, CR2-2-001278, CR2-2-001283, CR2-2-001280, CR2-2-001451, CR2-2-001452, CR2-2-000396, CR2-2-001457,  Device Serial Numbers: 48603094 48784877 49025132 49091799 48741587 49077058 48764540 48764590 48601446 48603907 48609453 48652129 48652251 48858056 48981644 48722045 48726027 48726129 48726140 48726150 48693695 48694311 48698571 48698584 48952116 48953086 48554965 48817780 48825290 48849399 48899908 48899994 48900065 48900096 48901342 48901357 48901414 48901451 48902351 48977818 48978218 48981319 48981675 48981678 48981736 48981742 48981757 48981799 48982659 48982689 48982706 48982732 48982753 48982964 48983131 48983138 48986526 48999915 49001794 48677566 49000689 48474854 48825196 48744684 49025723 49078040 49084781 49084838 48784171 49076651 49077904 49077974 48999739 49001853 48598011 48597817 48598026 48598034 48598979 48599034 48599040 48599680 48599962 48600312 48600361 48600408 48600544 48600583 48876291 48785897 48720332 48764293 48780563 48781761 48785992 48742916 48784366 48814157 49086935 48523377 48857980 49085692 48734881 48782906 48809106 48809544 48813958 48814187 48814498 48587878 48512628 48779955 48808967 49094200 48719896 48734817 48745596 48772744 48809729 48813731 48813733 48814081 48814519 49094775 49149468 49150775 49150782 49150837 49151602 49151617 49151886 49152891 49152895 48785250 48785409 48785698 48785778 48864860 48865894 48933501 48992026 49027943 49044403 49044413 48699923 48599821 48722047 48821008 48824104 48864884 48876330 48981618 48982708 49025280 49146285 49146389 48704591 48828002 48781767 48782803 48783051 48783294 48783983 48784030 48784180 48784281 48784459 48784468 48784826 48784905 48784983 48784990 48785257 48785313 48785401 48785532 48785590 48876124 48876476 48785259 48887309 48977361 48978607 48828370 48894333 48894340 48782927 49091822 49094089 49094113 49094785 49094873 49095322 49001621 48769222 48885664 48597789 48599786 48584628 48584633 48587221 48606096 48606181 48786686 48588112 48599696 48778810 48779004 48780079 48780121 48490802 48490842 48490862 48828138 48609677 48651847 48677735 48999652 48999652 48901418 48885722 48885777 48943238 48943252 48945704 48945712 48949096 48555102 48410131 48953094 48969902 48970252 48970376 48970413 48970414 48970578 48971044 48972557 48972586 48973712 48974345 48974355 48974359 48974363 48974372 48974375 48974378 48974384 48974396 48974399 48974400 48974418 48974470 48813947 48584539 48584686 48586430 48586633 48587235 48587726 48587843 48587884 48587914 48587957 48587974 48587975 48588426 48784293 48999873 48999950 49000499 49000643 49000648 49001892 49001987 49002003 49004080 49025505 49026012 49027603 49027633 49027638 49028025 49028068 49028076 49028084 49028730 49029341 49043715 49043767 49043775 48400582 48400710 48465771 48489063 48489118 48489171 48489189 48489451 48489457 48489470 48489495 48490783 48490803 48490839 48490846 48490872 48866966 48871871 48872069 48872215 48872230 48872278 48872351 48874912 48875012 48875018 48875069 48875073 48875077 48875081 48875086 48875104 48875156 48875170 48875172 48875173 48875175 48875176 48875179 48875181 48875184 48875187 48875189 48875198 48875205 48875214 48875218 48875227 48875237 48875247 48875262 48875265 48875269 48875277 48875351 48875359 48875366 48875367 48875369 48875370 48875378 48875382 48875387 48875402 48875404 48875409 48875419 48875426 48875431 48875435 48875446 48875452 48875461 48875464 48875467 48875470 48875475 48875478 48875485 48875488 48875502 48875564 48876164 49146490 48539017 48705821 48772775 48813773 48813809 48608364 48609613 48536563 48780035 48780167 48511975 48512088 49048418 48762722 48778493 48982643 48987613 48987869 48988231 48988701 48988720 48900770 48900789 48851632 48851872 48851894 48851992 48852079 48852741 48852927 48853071 48853076 48853080 48853120 48853135 48853144 48853149 48853203 48853223 48853241 48853258 48853268 48853285 48853289 48853300 48853354 48853364 48853376 48853385 48853394 48853398 48853404 48853411 48853419 48853424 48857669 48858061 48858236 48858473 48858480 48858520 48858525 48858528 48858534 48858551 48858593 48858598 48858603 48858622 48858644 48858654 48858658 48858662 48858668 48858671 48858729 48858742 48858743 48858744 48858750 48858760 48858771 48858781 48858783 48858786 48858802 48858823 48858827 48858833 48858836 48858840 48858859 48858880 48858920 48858924 48858931 48858939 48858947 48859669 48859697 48859747 48859754 48859757 48859763 48859765 48859768 48859772 48859778 48859781 48859791 48859796 48859809 48859820 48859832 48859840 48859872 48859877 48859888 48859937 48859943 48859952 48859961 48859971 48859980 48859981 48859983 48859990 48859992 48859998 48860002 48860008 48860037 48860041 48860046 48860052 48860054 48860056 48860059 48860061 48860095 48860099 48860100 48860104 48860108 48860112 48860115 48860116 48860119 48860125 48860131 48860142 48860146 48860161 48860174 4… (truncated, 801728 characters total — see the official FDA record for the full value)
Recalling firm:
Physio-Control, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 15, 2021

CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 90mm Material Number: 66-590 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

ALL 50 STATES
Full report

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

Recall #:
87251
Lot/product code:
Batch Number: 345225 352380 357121 359852 370419 382118
Recalling firm:
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
View official FDA record (opens in a new tab)