Another major class one recall has been issued by the FDA. This one involves a “computer aided surgery platform that surgeons can use to perform Hip, Knee, Spine, Neuro and ENT surgical procedures.”

Designed by Stryker Corporation, the company announced today that it is initiating… “a worldwide, Class 1 recall of 23 Operating Room System II Surgical Navigation Systems because there is a potential for the navigation PC SPC-1 component to stop working which could result in the screen freezing, the system updating at a slow rate, or not responding at all.”

The items being recalled are…

* Navigation System II-Cart with Stryker Catalog Number 7700-100-000 and Serial #s 100715-100735

* PC SPC-1 Assembly with Stryker Catalog Number 7700-101-201 and Lot # K7P00F6000

Normally, if a computer locks up on you, you’ve usually lost whatever you were working on. But when a computer is an integral part of a surgical procedure, you really don’t want to lose the last thing you were working on. According to the press release, “the potential harms associated with this failure are: delay in surgery, reschedule of the procedure resulting in an additional surgery, risk of infection, increased morbidity, potential neurological deficits, or injury due to the surgeon operating in an area where they did not intend to operate. Depending on the type of surgery, these failures could potentially lead to serious adverse health consequences, including death.”

So a five minute reboot during something like a posterior lumbar interbody fusion would be really, really bad.

But this is a release that is mostly for those customers Stryker that has not been able to reach. According to the press release,  Stryker already told everyone who had one of these items that a repair is on the way and… “as of October 30, 2009 all domestic units have been repaired.”

But if you do have a Stryker unit, you should check to be sure that it doesn’t fall into the recall category and/or has already been repaired. If not, you can call Stryker Instruments at 1-800-253-3210.

Here’s the link to the FDA recall.

If you have a child that sleeps in a crib, you need to check and see who made that crib as soon as possible.

After four child deaths and 15 entrapments, the U.S. Consumer Product Safety Commission (CPSC) “…announced the voluntary recall of more than 2.1 million Stork Craft drop-side cribs, including about 147,000 Stork Craft drop-side cribs with the Fisher-Price logo. The recall involves approximately 1,213,000 units distributed in the United States and 968,000 units distributed in Canada.”

Pretty much every Stork Craft crib with a manufacturing date between January 1993 and October 2009 and Stork Craft cribs with the Fisher-Price logo with manufacturing dates between October 1997 and December 2004 are subject to this recall. This recall only involves Stork Craft cribs with a “plastic trigger and one-hand-system drop-side hardware” and not those with “metal rod drop-side hardware”. Any Stork Craft crib that does NOT have a drop down side are not affected by this recall.

You can find the “manufacture date, model number, crib name, country of origin, and the firm’s name, address, and contact information… on the assembly instruction sheet attached to the mattress support board. The firm’s insignia “storkcraft baby” or “storkling” is inscribed on the drop-side teething rail of some cribs. In Stork Craft cribs that contain the “Fisher-Price” logo, this logo can be found on the crib’s teething rail, in the manufacturer’s instructions, on the assembly instruction sheet attached to the mattress support board, and on the end panels of the Twinkle-Twinkle and Crystal crib models.”

If you have one of these cribs, the CPSC urges you to immediately stop using the crib, wait for a free repair kit (that you need to go online and ask for), and do not attempt to use or fix the crib before you get the kit.

Here’s a link to the official US CONSUMER PRODUCT SAFETY COMMISSION recall. And another link to the STORKCRAFT.COM website.

UPDATE : Photos from the CPSC website illustrate the problem…

Crib Recall

Crib Recall 2

Crib Recall 3

Now this is a much more specific and targeted recall. Today Unilever announced that they are recalling “certain Shedd’s Country Crock chilled side-dish products because they may contain undeclared sulfites.”

The specific recall list is limited to…

“Shedd’s Country Crock® Side Dishes DELUXE Cheddar Broccoli Rice, with Best-By dates of NOV 29 09 through to JAN 16 10. The UPC code is 027400218316. The product comes in a 21-ounce (1 LB 5 OZ / 595 g) plastic tub inside a paperboard sleeve.”

…and also…

“Shedd’s Country Crock® Side Dishes DELUXE Four Cheese Pasta, withBest By dates of DEC 05 09 through to JAN 16 10.  The UPC code is 027400230875. The product comes in a 20-ounce (1 LB 4 OZ / 567 g) plastic tub inside a paperboard sleeve. The UPC code is located on the bottom of the sleeve and the Best-By date is located on the same side of the sleeve and the side of the tub.”

Here’s the link to the official FDA recall notice.

This is a tough recall to sift through, mainly because there are no identifying stickers or marks on some of the affected items.

Five Crowns Marketing announced today that they are… “voluntarily recalling cantaloupes packed under the Majesty label because of a potential health risk due to possible contamination of Salmonella.”

“Cantaloupes were packed in various sizes with and without individual label stickers. All cartons carry the label “Majesty” and are further identified with lot numbers 198 2 or 198 3, packed dates Nov 4, Nov 6, and Nov 10. Also those cantaloupes that contain stickered labels are identified with the label “Majesty”.”

So pretty much you have to remember if you saw “majesty” on the box you picked them from at the grocery store because not all the cantaloupes are properly identified.

I’ve always wondered why RIFD tags aren’t on each stem of everything in the produce isle. RIFD tags cost a fraction of a penny to make, and this would help out immensely in cases like this. I would tag everything as it comes into the US as it enters the nation’s food supply and keep all this information in a master database at the FDA. When a bad batch comes up, you know where everything went. The RIFD tag would be wiped at the checkout scan, and can be tossed along with the stem or skin of the produce. This tagging would help keep a safer food supply chain and definitely create jobs as part of the labeling and cataloging process.

Here’s the link to the FDA recall notice.

This one specifically applies to the New York area, New Jersey, Connecticut, Baltimore, Los Angeles, and Portland.

Service Smoked Fish Corp is recalling some of their “Brooklyn’s BEST brand SMOKED NOVA SALMON” because they may be contaminated with Listeria. The press release explains that “Listeria monocytogenes… can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.  Although healthy individuals may possibly suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.”

I love the placement of “only” in that last part. Hey, it’s “only” a 103 degree fever! Whatsamatter with you?

Anyhow, the specific recall is limited to… “3 oz., 4 oz., 8 oz., 12 oz., 16 oz. and random weight sides with the brand name “Brooklyn’s BEST” appearing on a circular label inside the vacuum bag. A “Use-By” date appears on the bottom of the gold board. Units with “Use-By” dates of 12/03/09 through 12/19/09 are being recalled.  The product was also air-packed in bulk boxes. Air-packed units with lot numbers 060 through 043 are being recalled.  No other use-by dates or lots numbers are involved in this recall.”

Here’s the link to the official FDA recall notice.

Some lots of Vicks Sinex are being recalled due to a finding of bacteria in some lots that were shipped to the US, the UK and Germany.

The press release says “The company said it is taking this precautionary step after finding the bacteria B. cepacia in a small amount of product made at its plant in Gross Gerau, Germany.  There have been no reports of illness.  However, the bacteria could cause serious infections for individuals with a compromised immune system, or those with chronic lung conditions, such as cystic fibrosis.  B. cepacia poses little medical risk to healthy individuals.”

The problem lot numbers, listed on the outside carton and bottle, are

Here’s the link to the official recall notice.

This is pretty serious. The FDA just announced that there is a big problem If you take the anti-clotting drug Plavix in addition to the stomach acid reducer Prilosec. It turns out that Prilosec cuts the effectiveness of Plavix by half. For people with blood clotting problems, that’s really bad.

The official announcement says… “patients at risk for heart attacks or strokes who use Plavix to prevent platelet aggregation will not get the full effect of this medicine if they are also taking Prilosec.”

The science behind it is pretty straightforward. “Plavix does not have anti-clotting effects until it is converted or metabolized into its active form with the help of the liver enzyme, CYP2C19. Prilosec blocks this enzyme, thereby reducing the effectiveness of Plavix.”

But it’s not just Prilosec that causes problems with Plavix. Others on the hit list are… “Nexium (esomeprazole), Tagamet and Tagamet HB (cimetidine), Diflucan (fluconazole), Nizoral (ketoconazole), VFEND (voriconazole), Intelence (etravirine), Felbatol (felbamate), Prozac, Serafem, Symbyax (fluoxetine), Luvox (fluvoxamine) and Ticlid (ticlopidine).”

The good news is that … “Zantac (ranitidine), Pepcid (famotidine), Axid (nizatidine), and antacids [that] do not inhibit the CYP2C19 enzyme aren’t expected to interfere with the anti-clotting activity of Plavix.”

Here’s the link to the official FDA warning here.

To me, a “Dietary Supplement” is a glass of OJ with my eggs. Some bacon in my Whataburger. Things you actually consume with a meal as part of a meal to enhance said meal.

Having said that, I still fail to see how something called “RockHard Weekend” from RockHard Laboratories has anything to do whatsoever with “Dietary Supplement”. It’s either that or I’ve been doing something horribly wrong for breakfast, lunch and dinner this whole time.

The FDA announced that “RockHard Laboratories is conducting a voluntary recall after being informed by the Food and Drug Administration (FDA) that voluntary lab analysis found… sulfoaildenfil, an analogue of Sildenfil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED) making RockHard Weekend an unapproved drug.”

In other words, just like the “stiff nights” recall, “RockHard Weekend” has some prescription-based ingredients that they tried to slip under the radar.

The FDA’s justification for the recall is the same one they used on the “stiff nights” recall. It might kill you! Maybe.

“The undeclared ingredient may pose a threat to consumers because the analogue may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.”

Here’s the link to the official FDA recall notice.

This is a strange one. Mostly because of the veeeery carefully selected wording in the recall release.

Cardiac Science Corporation announced today that is “is initiating a voluntary field correction after it was determined certain automated external defibrillators (AEDs) may experience a rare product issue in which the AED may not be able to deliver therapy during a resuscitation attempt.”

Lots of adjectives back yonder. The release continues…

“Device failure may affect resuscitation of the patient, which could lead to serious adverse events or death. These AEDs have electronic components which may fail and the failure may not be detected by the device’s periodic self-tests. The affected models include the Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E, and CardioVive 92531, 92532, and 92533 devices.”

Most of the remainder of the recall is pretty straightforward. That is until you get to the last paragraph. Put your waders on for this next part. It’s deep.

“This press release contains forward-looking statements. The word “believe,” “expect,” “intend,” “anticipate,” variations of such words, and similar expressions identify forward-looking statements, but their absence does not mean that the statement is not forward-looking. Forward looking statements in this press release include, but are not limited to, predictions of AED component failure rates, the availability of software updates to improve detection of the component issue, and the effectiveness of the planned software update. These are forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results and performance may vary significantly from those expressed or implied in such statements. Factors that could cause or contribute to such varying results and other risks are more fully described in the Annual Report on Form 10-K filed by Cardiac Science Corporation for the year ended December 31, 2008, as updated by subsequent quarterly reports on Form 10-Q. Cardiac Science Corporation undertakes no duty or obligation to update the information provided herein.”

Looks like the legal team got to slime this one before it got out the door. Sad.

Anyhow, here’s the link to the official recall NOT FORWARD LOOKING but MAYBE IT IS FORWARD LOOKING notice.

Steroids? In dietary supplements? And muscle building products? No! Say it isn’t so!

The FDA release says “IDS Sports announced today that it is conducting a voluntary nationwide recall of… Bromodrol, Dual Action Grow Tabs, Grow Tabs, Mass Tabs, and Ripped Tabs TR. The Food And Drug Administration (FDA) has notified IDS Sports that the recalled products contain the following undeclared substances, which FDA considers to be steroids: “Madol,” “Turinabol,” “Superdrol,” and/or “Androstenedione.””

The items specifically recalled are…

You know, with steroids causing “shrinkage of the testes and male infertility, masculinization of women, breast enlargement in males, short stature in children, a higher predilection to misuse other drugs and alcohol, adverse effects on blood lipid levels, and increased risk of heart attack, stroke, and death” as side effects, is all that really a good trade for 19 inch guns?

Lemme get back with you on that…

Here’s the link to the official FDA recall notice.